On May 18, 2026 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported first quarter 2026 financial results and provided a corporate update.

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"The first quarter of 2026 has been a truly defining period for Alpha Tau, reflecting the convergence of two powerful dynamics that have been years in the making: the maturation of clinical data from our most advanced programs, and the global initiation of novel trials addressing some of the most pressing unmet needs in oncology," said Alpha Tau CEO Uzi Sofer. "The groundbreaking interim results from our U.S. REGAIN trial in recurrent glioblastoma, with 100% local disease control and a 67% complete response rate as of May 3, represent powerful potential clinical benefit in patients facing a devastating disease with virtually no curative options. Our pancreatic cancer program has also continued to build compelling data, first with positive new results from our Montreal study presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, then with the oral presentation of pooled pancreatic data at Digestive Disease Week 2026, and most recently with the expansion of our IMPACT pancreatic trial to include patients receiving gemcitabine with Abraxane (nab-paclitaxel)."

"At the same time, we have continued to make significant strides toward commercialization on both sides of the Pacific, following our receipt of PMDA marketing approval in Japan for Alpha DaRT in unresectable locally advanced or locally recurrent head and neck cancer," continued Mr. Sofer. "In Japan, we are working closely with our selected leading clinical centers to advance the post-market surveillance study that supports our marketing approval. In the United States, we are advancing steadily along our path to potential FDA approval, with the recent completion of patient enrollment with 88 patients in our pivotal ReSTART trial, our very first U.S. pivotal study to reach this milestone."

"Taken together, this quarter is a true culmination of years of disciplined execution across each of our strategic priorities. With a strong balance sheet with $80.2 million of liquidity to support our continued momentum, we aim to translate this remarkable progress into meaningful impact for patients."

Recent Corporate Highlights:

In May 2026, Alpha Tau announced groundbreaking interim results as of May 3 from the U.S. REGAIN trial of Alpha DaRT in recurrent glioblastoma (GBM), conducted at The Ohio State University Comprehensive Cancer Center. In the first three patients treated, 100% local disease control, a 67% complete response rate (two complete responses and one stable disease with a 30% tumor reduction), and a favorable safety profile were observed, with only one associated grade 3 serious adverse event that resolved with administration of steroids. The REGAIN study is expected to enroll up to ten U.S. patients with recurrent GBM not amenable to surgical resection. For more information, please see here: View Source
In May 2026, Alpha Tau announced the completion of patient enrollment in its U.S. multicenter pivotal ReSTART trial of Alpha DaRT for the treatment of recurrent cutaneous squamous cell carcinoma (cSCC), with 88 patients enrolled, making ReSTART the Company’s first U.S. pivotal study to complete enrollment – a critical milestone on the path toward potential FDA pre-market approval (PMA). Alpha DaRT has received Breakthrough Device Designation from the FDA for this indication, and the Company submitted the first module of its modular PMA application in January 2026. For more information, please see here: View Source
In May 2026, Alpha Tau presented updated pooled results from two first-in-human pancreatic cancer trials at Digestive Disease Week (DDW) 2026, with 100% local disease control observed in evaluable patients and a favorable safety profile. The oral presentation, delivered in the Pancreatic Cancer I: Diagnosis and Treatment session, marked the first time clinical results of Alpha DaRT in pancreatic cancer have been featured at a major international gastroenterology conference.
In May 2026, Alpha Tau treated the first patient in Italy with Alpha DaRT for locally advanced pancreatic cancer, in a feasibility and safety study conducted at the world-renowned Pancreas Institute of the University of Verona. The protocol is the first Alpha DaRT pancreatic cancer protocol worldwide to permit both endoscopic ultrasound (EUS)-guided and percutaneous delivery of Alpha DaRT sources, broadening physician access across multiple interventional specialties.
In May 2026, Alpha Tau announced that an abstract entitled "Management of Locally Advanced and Metastatic Head and Neck Squamous Cell Carcinoma in Elderly Patients Using Diffusing Alpha-Emitter Radiation Therapy in Combination with Pembrolizumab" was accepted for podium presentation at the AHNS 12th International Conference on Head and Neck Cancer, taking place July 18-22, 2026 in Boston. The presentation reports complete top-line data from a clinical study conducted at Hadassah Medical Center, marking a key milestone in the Company’s combination therapy strategy.
In April 2026, Alpha Tau announced that an abstract entitled "Combined Safety and Efficacy Results from Three Clinical Studies Evaluating Alpha Radiotherapy for Advanced Pancreatic Cancer," presenting a pooled analysis of 58 patients across three prospective clinical studies conducted in Canada and Israel, was accepted for presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting taking place May 29 – June 2, 2026. The abstract is expected to be published on the ASCO (Free ASCO Whitepaper) conference website on May 21, 2026.
In April 2026, Alpha Tau announced FDA approval of an Investigational Device Exemption (IDE) supplement to expand its U.S. multicenter IMPACT pancreatic cancer pilot trial to include patients receiving gemcitabine with Abraxane (nab-paclitaxel). The supplement also adds ten newly diagnosed patients – five with unresectable locally advanced and five with metastatic pancreatic adenocarcinoma – bringing total planned enrollment to 40 patients. Patient recruitment is now expected to complete in Q3 2026 to allow for site approvals and additional enrollment. For more information, please see here: View Source." target="_blank" title="View Source." rel="nofollow">View Source
In April 2026, Alpha Tau successfully treated the first European pancreatic cancer patient with Alpha DaRT at CHU Grenoble Alpes, under the ACAPELLA multicenter trial in France evaluating Alpha DaRT in combination with capecitabine for patients with inoperable locally advanced pancreatic ductal adenocarcinoma who have completed first-line mFOLFIRINOX chemotherapy, a population for whom no standard consolidation therapy exists.
Expected Upcoming Milestone Targets:

Completion of patient recruitment in IMPACT pancreatic cancer pilot study in the U.S. in Q3 2026, with initial data targeted for late 2026 or early 2027. For more information, please see here: View Source
Completion of patient recruitment in REGAIN recurrent GBM trial in the U.S. in the second half of 2026, with additional data expected to be released by around the end of 2026. For more information, please see here: View Source
Top-line data in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma around the end of 2026. For more information, please see here: View Source
Financial Results for the Three Months Ended March 31, 2026

Research and Development expenses for the three months ended March 31, 2026 were $11.0 million, compared to $7.2 million for the same period in 2025, primarily due to increased clinical trial activity, increased employee compensation and benefits, including share-based compensation, increased raw material purchases, and milestone payments associated with our receipt of PMDA marketing authorization in Japan.

Marketing expenses for the three months ended March 31, 2026 were $0.2 million, compared to $0.5 million for the same period in 2025, primarily due to decreased employee compensation and benefits and marketing conference activities.

General and Administrative expenses for the three months ended March 31, 2026 were $2.1 million, compared to $1.7 million for the same period in 2025, primarily due to increased employee compensation and benefits, including share-based compensation, and higher professional fees.

Financial expenses, net, for the three months ended March 31, 2026 were $9.6 million, compared to financial income, net, of $0.7 million for the same period in 2025, primarily due to the remeasurement of warrants liability.

For the three months ended March 31, 2026, the Company had a net loss of $22.9 million, or $0.26 per share, compared to a net loss of $8.7 million, or $0.12 per share, for the three months ended March 31, 2025.

Balance Sheet Highlights

As of March 31, 2026, the Company had cash and cash equivalents, short-term deposits and restricted deposits of $80.2 million, compared to $76.9 million at December 31, 2025.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

(Press release, Alpha Tau Medical, MAY 18, 2026, View Source [SID1234665847])

On May 18, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported a strategic research collaboration with Parabilis Medicines to discover and develop multiple therapeutic candidates based on Parabilis’ Helicon peptide platform, with a particular focus on Antibody-Helicon Conjugates (AHCs), a novel class of therapeutics designed to target challenging and historically "undruggable" targets.

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Helicons are stabilized, cell-penetrant alpha-helical peptides designed to engage intracellular protein targets, including flat surfaces not well suited to traditional small molecule binding. The collaboration is designed to explore the use of Helicons both as stand-alone therapies and as part of AHCs.

"This collaboration reflects Regeneron’s approach of advancing cutting-edge and diversified science to produce a robust portfolio of innovative medicines for patients in need," said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer of Regeneron. "In addition to the potential of Helicons to address previously undruggable targets, the collaboration’s intent to couple Helicons to our VelocImmune derived-antibodies so as to precisely deliver them to cells of interest represents an exciting new approach with the potential to create an entirely new therapeutic class that can span multiple therapeutic areas."

Antibody–drug conjugates traditionally use antibodies to selectively deliver drug payloads into target cells to drive cell death from within. The AHCs envisioned by this collaboration are underpinned by the same delivery principle: pairing antibody-targeted cell access with Helicon payloads designed to selectively modulate specific intracellular proteins, including some long considered undruggable.

Under the terms of the agreement, Parabilis is to receive $125 million from Regeneron in the form of a $50 million upfront payment and a commitment to invest $75 million in Parabilis’ next equity financing, subject to certain conditions. Parabilis is also eligible to receive milestone payments for development, regulatory and commercial milestones, as well as tiered royalties up to the low double-digits on future net sales of any approved medicines resulting from the collaboration. With five initial targets, the agreement provides the potential for up to approximately $2.2 billion in total milestone payments to Parabilis. Under the terms of the agreement, additional targets may be pursued upon additional option payments from Regeneron.

The agreement provides for the parties to collaborate to discover new Helicons and AHCs, which Regeneron will then be responsible for advancing through development, manufacturing and worldwide commercialization.

(Press release, Regeneron, MAY 18, 2026, View Source [SID1234665829])

On May 18, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported an update on recent business developments following the release of its financial results for the first quarter ended March 31, 2026, which were reported on May 15, 2026.

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Recent Milestones & Business Highlights

Israeli Ministry of Health Approval to Initiate Phase 2/3 Clinical Trial of SIL204: On March 24, 2026, Silexion announced that it had received formal approval from the Israeli Ministry of Health to initiate its Phase 2/3 clinical trial evaluating the Company’s lead product candidate SIL204 for the treatment of locally advanced pancreatic cancer. The approval represented a defining regulatory milestone for the Company, marking the transition of SIL204 into clinical-stage development of a next-generation siRNA therapy designed to silence mutated KRAS – a driver present in approximately 90% of pancreatic cancers – and positioning Silexion as a clinical-stage biotechnology company focused on KRAS-driven cancers. The approval followed strong positive anti-tumor activity demonstrated across multiple preclinical models, successful completion of two-species toxicology studies, and constructive regulatory engagement supporting the Phase 2/3 trial design.
Phase 2/3 Clinical Trial Application Submitted to Germany: On April 28, 2026, subsequent to quarter end, the Company announced the successful submission of a Clinical Trial Application (CTA) to Germany for the planned Phase 2/3 clinical trial of SIL204 in patients with locally advanced pancreatic cancer. The CTA was submitted through the EU Clinical Trials Information System (CTIS), with Germany serving as the Reporting Member State leading the scientific assessment of the trial across the European Union. The submission was informed by the positive written Scientific Advice received from Germany’s Federal Institute for Drugs and Medical Devices (BfArM) in December 2025, and was supported by the Company’s comprehensive regulatory and preclinical package, including completed two-species toxicology studies.
Phase 2/3 Trial Initiation Planned for the Second Quarter of 2026: The planned Phase 2/3 clinical study is expected to begin in the second quarter of 2026 and will include an initial safety run-in cohort of approximately 18 patients, followed by expansion into a randomized cohort of approximately 166 patients. The study is designed to evaluate SIL204 in combination with standard chemotherapy in patients with locally advanced pancreatic cancer using Silexion’s dual-route administration approach – combining intratumoral delivery to target primary tumors with systemic administration to address metastatic disease. The Company plans to conduct the trial at leading oncology centers in Germany and across additional EU member states, in parallel with previously announced Israeli sites led by Sheba Medical Center.
Ilan Hadar, Chairman and Chief Executive Officer of Silexion, commented: "The first quarter and the period since represented a defining moment in Silexion’s evolution. With the Israeli Ministry of Health approval to initiate our Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer, and our subsequent submission of a Clinical Trial Application to Germany under the EU Clinical Trials Regulation, we have advanced SIL204 from a preclinical asset into clinical-stage development across two major regulatory jurisdictions. We remain on track to initiate the Phase 2/3 clinical trial in the second quarter of 2026, with the goal of bringing an RNAi-based approach to patients with KRAS-driven cancers who have limited treatment options today."

Mirit Horenshtein Hadar, Chief Financial Officer of Silexion, added: "During the first quarter and subsequent to quarter end, we executed a series of capital-raising and corporate actions designed to support our clinical development plan and our continued Nasdaq listing. These included our May 2026 warrant exercise inducement transaction, additional capital raised under our at-the-market facility, and obtaining shareholder approval for a prospective reverse share split. We continue to evaluate financing alternatives as we work to support the advancement of SIL204 into the clinic in the second quarter of 2026."

Financial Results for the Three Months Ended March 31, 2026

Research and development ("R&D") expenses for the three months ended March 31, 2026, were approximately $1.4 million, compared to approximately $0.6 million for the same period in 2025, an increase of 133.3%. The increase was primarily driven by approximately $0.7 million in higher subcontractor and consultant expenses related to toxicology studies and product development required to support initiation of the planned human clinical trial expected in the second quarter of 2026, including GMP manufacturing of our drug product, as well as approximately $0.1 million in non-cash share-based compensation expenses related to executive officer grants awarded in February 2026.
General and administrative ("G&A") expenses for the three months ended March 31, 2026, were approximately $1.4 million, compared to approximately $1.1 million for the same period in 2025, an increase of 27.3%. The increase was primarily driven by approximately $0.26 million in higher professional services costs, including legal, investor relations, director compensation, and other expenses associated with operating as a public company, as well as approximately $0.2 million in non-cash share-based compensation expenses related to executive officer and director grants awarded in February 2026.
Net loss for the three months ended March 31, 2026, was approximately $2.7 million, compared to approximately $1.7 million for the same period in 2025, an increase of 58.8%. The increase was primarily attributable to higher research and development expenses, primarily related to preparations for the human clinical trial, and higher general and administrative expenses.
Balance Sheet Highlights

Cash and cash equivalents were $2.4 million as of March 31, 2026, compared to $6.0 million as of December 31, 2025. The decrease primarily reflects ongoing operating expenses supporting preclinical and clinical readiness activities for the planned initiation of the Phase 2/3 clinical trial of SIL204.
Subsequent to quarter end, the Company strengthened its balance sheet through a May 2026 warrant exercise inducement transaction generating approximately $1.0 million in gross proceeds and through utilization of its at-the-market facility. The Company has reported that the May 2026 warrant exercise transaction, together with additional equity-increasing transactions effected on or about May 15, 2026, have raised its shareholders’ equity above the $2.5 million minimum under the Nasdaq Capital Market continued listing requirements, which the Company believes constitutes restored compliance with those requirements.

(Press release, Silexion Therapeutics, MAY 18, 2026, View Source [SID1234665848])

On May 18, 2026 Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), reported it will present new data from nine approved and investigational medicines across more than 15 indications at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held May 29 to June 2 in Chicago.

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"Genentech’s ASCO (Free ASCO Whitepaper) data reflect our commitment to addressing those cancers that impose the highest burden on patients and society," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "In particular, our ASCO (Free ASCO Whitepaper) data highlight significant advances in breast cancer, including the latest results for giredestrant and our evolving approach to HER2-positive metastatic disease."

Redefining the standard of care in breast cancer
Genentech’s ASCO (Free ASCO Whitepaper) 2026 focus is on giredestrant, an investigational, oral, selective estrogen receptor degrader (SERD) being studied in early and advanced estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

This subtype accounts for approximately 70% of breast cancer cases, and the majority are diagnosed in the early stage. Data from three Phase III trials demonstrate giredestrant’s potential as a future standard of care endocrine therapy across multiple disease stages:

lidERA Breast Cancer: Building on the transformational results shared in December 2025, which demonstrated a 30% reduction in the risk of invasive disease recurrence or death, new data will indicate whether the efficacy and safety of giredestrant remain consistent across pre- and post-menopausal patients with early breast cancer. The lidERA data have been submitted to the U.S. Food and Drug Administration (FDA).
persevERA Breast Cancer: Primary results investigating giredestrant in combination with palbociclib as a first-line therapy in locally advanced or metastatic cancer will be presented. These data will provide context following the announcement that while the study did not meet its primary endpoint, the giredestrant combination showed a numerical improvement in this distinct patient population, suggesting that giredestrant is active in the first-line setting.
evERA Breast Cancer: New post-progression treatment analyses will be shared exploring the sustained clinical benefit for people treated with giredestrant plus everolimus in the post-cyclin-dependent kinase 4/6 inhibitor setting. The U.S. FDA recently accepted the New Drug Application for giredestrant based on the positive evERA data.
Our ASCO (Free ASCO Whitepaper) data also highlight progress in HER2-positive breast cancer, an area Genentech has led for over 30 years:

RG6596/ZN-A-1041 in HER2-positive breast cancer: Preliminary results from a Phase Ic expansion trial will provide early information on the safety and efficacy of ZN-A-1041, a highly blood-brain barrier-permeable, HER2-selective tyrosine kinase inhibitor, in combination with other HER2-targeted therapies, for patients with pre-treated HER2-positive metastatic breast cancer. Designed for enhanced brain penetration, ZN-A-1041 may improve the ability to prevent and treat brain metastases, a major challenge in metastatic breast cancers.
Advancing precision medicine and novel combinations
Genentech is also presenting data from its diverse pipeline targeting specific genetic drivers and difficult-to-treat cancers, including:

Divarasib in non-small cell lung cancer (NSCLC): Genentech will present results from the Krascendo 170 Phase Ib/II study evaluating the next-generation oral KRAS G12C inhibitor divarasib combined with pembrolizumab in treatment-naive patients with KRAS G12C+ advanced NSCLC. These data informed the Phase III Krascendo 2 study, which investigates this combination as a first-line therapy regardless of PD-L1 status. Divarasib is currently being evaluated in three pivotal Phase III studies as a monotherapy or in chemotherapy-free combinations.
Lunsumio (mosunetuzumab) plus Polivy (polatuzumab vedotin) in diffuse large B-cell lymphoma (DLBCL): Genentech will present updated data from the Phase III SUNMO trial to further establish the efficacy and safety of Lunsumio plus Polivy compared to chemotherapy (R-GemOx) particularly in second-line patients with relapsed/refractory DLBCL who are not eligible for transplant. This first combination of a bispecific antibody and antibody-drug conjugate could potentially provide patients who often face poor prognoses and significant treatment burdens with an effective, fixed-duration, chemotherapy-free regimen.

Overview of key presentations featuring Genentech medicines and molecules:

Medicine or molecule

Abstract title

Abstract number/ presentation details

Breast cancer

Giredestrant

Giredestrant (GIRE) + palbociclib (PALBO) vs letrozole (LET) + PALBO as first-line (1L) therapy in patients (pts) with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer (ER+, HER2– LA/mBC): Primary analysis of the Phase III persevERA Breast Cancer (BC) trial

#LBA1006 oral

Breast Cancer — Metastatic

Tuesday June 2, 2026

11:45 – 11:57 AM CDT

Giredestrant

Efficacy and safety of giredestrant (GIRE) in patients (pts) with estrogen receptor-positive, HER2-negative early breast cancer (ER+, HER2– eBC) in the Phase III lidERA BC clinical trial: Results by menopausal status

#502 oral

Breast Cancer —Local/Regional/Adjuvant

Saturday May 30, 2026

1:39 – 1:51 PM CDT

Giredestrant

Post-progression treatment (tx) analyses of evERA Breast Cancer (BC): A Phase III trial of giredestrant (GIRE) + everolimus (E) in patients (pts) with estrogen receptor-positive, HER2-negative advanced BC (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i)

#1016 rapid oral

Breast Cancer — Metastatic

Sunday May 31, 2026

12:00 – 12:06 PM CDT

RG6596/ ZN-A-1041

Safety and efficacy of ZN-A-1041, a highly blood–brain barrier (BBB)-permeable HER2 tyrosine kinase inhibitor (TKI), + trastuzumab deruxtecan (T-DXd) or pertuzumab-trastuzumab (PH) in HER2-positive metastatic breast cancer (HER2+ mBC): Phase Ic expansion results from the ZN-A-1041-101-US trial

#1055 poster

Breast Cancer — Metastatic

Monday June 1, 2026

1:30 – 4:30 PM CDT

Itovebi (inavolisib)

Outcomes by lobular (lob) histology status at initial diagnosis in patients (pts) in the INAVO120 Phase III trial with PIK3CA-mutated (mut), hormone receptor-positive (HR+), HER2-negative (HER2–), endocrine-resistant advanced breast cancer (aBC) treated with inavolisib (INAVO)/placebo (PBO) + palbociclib (PALBO) + fulvestrant (FULV)

#1079 poster

Breast Cancer — Metastatic

Monday June 1, 2026

1:30 – 4:30 PM CDT

Kadcyla (trastuzumab emtansine)

Adjuvant antibody–drug conjugate (ADC) eligibility and corresponding prognosis in HER2+ early breast cancer (eBC): A US-based real-world comparison of KATHERINE and DESTINY-Breast05 populations

#535 poster

Breast Cancer —Local/Regional/Adjuvant

Monday June 1, 2026

1:30 – 4:30 PM CDT

Blood cancer

Lunsumio (mosunetuzumab) and Polivy (polatuzumab vedotin)

Mosunetuzumab plus polatuzumab vedotin (Mosun-Pola) versus rituximab, gemcitabine and oxaliplatin (R-GemOx) in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL): Updated efficacy and safety from the Phase III SUNMO study including in second-line (2L) versus third-line plus (3L+) patient subgroups

#7007 oral

Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia

Saturday May 30, 2026

5:12 – 5:24 PM CDT

Columvi (glofitamab)

Fixed-duration glofitamab monotherapy in relapsed/refractory (R/R) mantle cell lymphoma (MCL) with/without prior Bruton’s tyrosine kinase inhibitor (BTKi) exposure: updated data after a 3.5-year follow-up

#7006 oral

Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia

Saturday May 30, 2026

5:00 – 5:12 PM CDT

Polivy

Outcomes by LymphoMAP archetypes in untreated diffuse large B-cell lymphoma from the POLARIX trial

#7017 rapid oral

Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia

Friday May 29, 2026

2:12 – 2:18 PM CDT

Columvi, Lunsumio and Polivy

Multivariable analyses (MVAs) of overall survival (OS) in the Phase III SUNMO, STARGLO and POLARGO trials in relapsed/refractory large B-cell lymphoma (LBCL)

#7093 poster

Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia

Monday June 1, 2026

9:00 – 12:00 PM CDT

Lung cancer

Divarasib

First-line (1L) divarasib plus pembrolizumab (pembro) in advanced or metastatic KRAS G12C+ non-small cell lung cancer (NSCLC): results from the Krascendo-170 study

#8510 clinical science symposium

Lung Cancer — Non-Small Cell Metastatic

Saturday May 30, 2026

8:36 – 8:48 AM CDT

Tecentriq (atezolizumab)

Transcriptomic analyses of molecular subsets and correlations with clinical outcomes from the Phase III IMforte study of lurbinectedin (lurbi) + atezolizumab (atezo) maintenance treatment (Tx) in extensive-stage small-cell lung cancer (ES-SCLC)

#8014 rapid oral

Lung Cancer — Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Sunday May 31, 2026

5:12 – 5:18 PM CDT

Tecentriq

IMforte: Quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis of first-line maintenance (1Lm) treatment (Tx) with lurbinectedin (lurbi) + atezolizumab (atezo) vs atezo in extensive-stage small cell lung cancer (ES-SCLC)

#8086 poster

Lung Cancer — Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Sunday May 31, 2026

9:00 – 12:00 PM CDT

Gastrointestinal cancer

Tecentriq

IMbrave251: Final analysis of atezolizumab (atezo) plus lenvatinib (lenva) or sorafenib (sora) vs lenva or sora alone in locally advanced or metastatic hepatocellular carcinoma (LA/mHCC) previously treated with atezo and bevacizumab (bev)

#4002 oral

Gastrointestinal Cancer —Gastroesophageal, Pancreatic, and Hepatobiliary

Monday June 1, 2026

10:09 – 10:21 AM CDT

Tecentriq

Health-related quality of life (HRQOL) in the Phase III trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III deficient DNA mismatch repair (dMMR) colon cancer (Alliance A021502, ATOMIC)*

#3626 poster

Gastrointestinal Cancer —Colorectal and Anal

Saturday May 30, 2026

9:00 – 12:00 PM CDT

Bladder cancer

Tecentriq

Patient-reported outcomes from IMvigor011: A Phase III study of circulating tumor (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer (MIBC)

#4627 poster

Genitourinary Cancer — Kidney and Bladder

Sunday May 31, 2026

9:00 – 12:00 PM CDT

*Study led by the Alliance for Clinical Trials in Oncology and supported by Genentech

[1] Lunsumio and Lunsumio VELO U.S. Indication

Lunsumio (mosunetuzumab-axgb) or Lunsumio VELO is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments.

It is not known if Lunsumio or Lunsumio VELO is safe and effective in children.

The conditional approval for this use is based on response rate. There are ongoing studies to establish how well the drug works.

Important Safety Information

What is the most important information I should know about Lunsumio or Lunsumio VELO?

Lunsumio or Lunsumio VELO can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Lunsumio or Lunsumio VELO, and can also be severe or life-threatening.

Get medical help right away if you develop any signs or symptoms of CRS at any time, including:

fever of 100.4°F (38°C) or higher
chills
low blood pressure
fast or irregular heartbeat
tiredness or weakness
difficulty breathing
headache
confusion
feeling anxious
dizziness or light-headedness
nausea
vomiting
Due to the risk of CRS, you will receive Lunsumio or Lunsumio VELO on a "step-up dosing schedule."

The step-up dosing schedule is when you receive smaller "step-up" doses before receiving higher doses of Lunsumio or Lunsumio VELO during your first cycle of treatment
If your dose of Lunsumio or Lunsumio VELO is delayed for any reason, you may need to repeat the "step-up dosing schedule"
You may receive medicines to help reduce your risk of CRS before your dose
Your healthcare provider will check you for CRS during treatment with Lunsumio or Lunsumio VELO and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Lunsumio or Lunsumio VELO, if you have severe side effects.

What are the possible side effects of Lunsumio or Lunsumio VELO?

Lunsumio or Lunsumio VELO can cause serious side effects, including:

Neurologic problems. Lunsumio or Lunsumio VELO can cause serious and life-threatening neurologic problems. Your healthcare provider will check you for neurologic problems during treatment with Lunsumio or Lunsumio VELO. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with Lunsumio or Lunsumio VELO, including:
headache
numbness and tingling of the arms, legs, hands, or feet
dizziness
confusion and disorientation
difficulty paying attention or understanding things
forgetting things or forgetting who or where you are
trouble speaking, reading or writing
sleepiness or trouble sleeping
tremors
loss of consciousness
seizures
muscle problems or muscle weakness
loss of balance or trouble walking
tiredness
Serious infections. Lunsumio or Lunsumio VELO can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with Lunsumio or Lunsumio VELO, including:
fever of 100.4°F (38°C) or higher
cough
chest pain
tiredness
shortness of breath
painful rash
sore throat
pain during urination
feeling weak or generally unwell
Hemophagocytic lymphohistiocytosis (HLH). Lunsumio or Lunsumio VELO can cause overactivity of the immune system, a condition called hemophagocytic lymphohistiocytosis. HLH can be life-threatening and has led to death in people treated with Lunsumio or Lunsumio VELO. Your healthcare provider will check you for HLH especially if your CRS lasts longer than expected. Signs and symptoms of HLH include:
fever
enlarged spleen
easy bruising
low blood cell counts
liver problems
Low blood cell counts. Low blood cell counts are common during treatment with Lunsumio or Lunsumio VELO and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with Lunsumio or Lunsumio VELO. Lunsumio or Lunsumio VELO can cause the following low blood cell counts:
low white blood cell counts (lymphopenia [for Lunsumio VELO only] and neutropenia). Low white blood cells can increase your risk for infection
low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath
low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems
Growth in your tumor or worsening of tumor-related problems (tumor flare). Lunsumio or Lunsumio VELO can cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with Lunsumio or Lunsumio VELO:
chest pain
cough
trouble breathing
tender or swollen lymph nodes
pain or swelling at the site of the tumor
Your healthcare provider may temporarily stop or permanently stop treatment with Lunsumio or Lunsumio VELO if you develop severe side effects.

The most common side effects of Lunsumio include: CRS, tiredness, rash, headache, fever, muscle pain, cough, itching, and numbness, tingling, or pain in the hands or feet (nerve damage).

The most common side effects of Lunsumio VELO include: injection site reactions, tiredness, rash, CRS, COVID-19, muscle and joint pain, and diarrhea.

The most common severe abnormal blood test results with Lunsumio include: decreased phosphate, increased glucose, and increased uric acid levels.

The most common severe abnormal blood test results with Lunsumio VELO include: decreased white blood cell counts and increased uric acid levels.

Before receiving Lunsumio or Lunsumio VELO, tell your healthcare provider about all of your medical conditions, including if you:

have ever had an infusion reaction after receiving Lunsumio
have an infection or have had an infection in the past which lasted a long time or keeps coming back
have or have had Epstein-Barr Virus
are pregnant or plan to become pregnant. Lunsumio or Lunsumio VELO may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Lunsumio or Lunsumio VELO
Females who are able to become pregnant:

your healthcare provider should do a pregnancy test before you start treatment with Lunsumio or Lunsumio VELO
use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of Lunsumio or Lunsumio VELO
are breastfeeding or plan to breastfeed. It is not known if Lunsumio or Lunsumio VELO passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of Lunsumio or Lunsumio VELO
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while receiving Lunsumio or Lunsumio VELO?

Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.

These are not all of the possible side effects of Lunsumio or Lunsumio VELO. Talk to your healthcare provider for more information about the benefits and risks of Lunsumio or Lunsumio VELO.

You may report side effects to the FDA at (800) FDA-1088 or View Source You may also report side effects to Genentech at (888) 835-2555.

Please see Important Safety Information, including Serious Side Effects, as well as the Lunsumio full Prescribing Information and Medication Guide and Lunsumio VELO full Prescribing Information and Medication Guide and on View Source

Polivy U.S. Indication

Polivy is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL).

Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat DLBCL in adults who have progressed after at least 2 prior therapies.

Important Safety Information

Possible serious side effects

Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects.

Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern
Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion
Low blood cell counts: Treatment with Polivy can cause severe low blood cell counts. Your doctor will monitor your blood counts throughout treatment with Polivy
Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you Polivy, which may prevent some infections
Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication

Side effects seen most often

The most common side effects during treatment were

Nerve problems in arms and legs
Nausea
Tiredness or lack of energy
Diarrhea
Constipation
Hair loss
Redness and sores of the lining of the mouth, lips, throat, and digestive tract

Polivy may lower your red or white blood cell counts and increase uric acid levels.

Polivy may not be for everyone. Talk to your doctor if you are

Pregnant or think you are pregnant: Data have shown that Polivy may harm your unborn baby
Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for 5 months after their last Polivy treatment
Breastfeeding: Women should not breastfeed while taking Polivy and for 2 months after the last dose

These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of Polivy treatment.

You may report side effects to the FDA at (800) FDA-1088 or View Source." target="_blank" title="View Source." rel="nofollow">View Source You may also report side effects to Genentech at (888) 835-2555.

Please see the full Prescribing Information and visit View Source for additional Important Safety Information.

What is Itovebi?

Itovebi (inavolisib) is a prescription medicine used in combination with the medicines palbociclib and fulvestrant to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic), and has come back after hormone (endocrine) therapy.

Your healthcare provider will test your cancer for abnormal PIK3CA genes to make sure that Itovebi is right for you.

It is not known if Itovebi is safe and effective in children.

Important Safety Information

What are the possible side effects of Itovebi?

Itovebi may cause serious side effects, including:

High blood sugar levels (hyperglycemia). High blood sugar is common with Itovebi and may be severe or fatal. Untreated severe hyperglycemia can lead to a condition called diabetic ketoacidosis that can happen in people treated with Itovebi. Diabetic ketoacidosis is a serious condition that requires treatment in a hospital and that can lead to death. Your healthcare provider will monitor your blood sugar levels before you start and during treatment with Itovebi. Your blood sugar levels may be monitored more often if you have a history of Type 2 diabetes. Your healthcare provider may also ask you to self-monitor and report your blood sugar levels at home. This will be required more frequently in the first 4 weeks of treatment. If you are not sure how to test your blood sugar levels, talk to your healthcare provider. You should stay well-hydrated during treatment with Itovebi. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including:
difficulty breathing
nausea and vomiting (lasting more than 2 hours)
stomach pain
excessive thirst
dry mouth
more frequent urination than usual or a higher amount of urine than normal
blurred vision
unusually increased appetite
weight loss
fruity-smelling breath
flushed face and dry skin
feeling unusually sleepy or tired
confusion
Mouth sores (stomatitis). Mouth sores are common with Itovebi and may be severe. Tell your healthcare provider if you develop any of the following in your mouth:
pain
redness
swelling
ulcers
Diarrhea. Diarrhea is common with Itovebi and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your healthcare provider right away if you develop diarrhea, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with Itovebi. Your healthcare provider may tell you to drink more fluids or take medicines to treat your diarrhea

Your healthcare provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with Itovebi if you develop certain serious side effects.

The most common side effects and abnormal blood test results of Itovebi when used in combination with palbociclib and fulvestrant include:

decreased white blood cell counts, red blood cell counts, and platelet counts
decreased blood levels of calcium, potassium, sodium, and magnesium
increased creatinine blood levels
tiredness
increased blood levels of the liver enzyme alanine transaminase (ALT)
nausea
rash
loss of appetite
COVID-19 infection
headache

Itovebi may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of Itovebi. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or View Source." target="_blank" title="View Source." rel="nofollow">View Source You may also report side effects to Genentech at (877) 436-3683.

Before you take Itovebi, tell your healthcare provider about all of your medical conditions, including if you:

have a history of diabetes or high blood sugar
have kidney problems
are pregnant or plan to become pregnant. Itovebi can harm your unborn baby.
Females who are able to become pregnant:

Your healthcare provider will check to see if you are pregnant before you start treatment with Itovebi.
You should use effective non-hormonal birth control (contraception) during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about what birth control method is right for you during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Itovebi.
Males with female partners who are able to become pregnant:

You should use effective birth control (contraception) during treatment with Itovebi and for 1 week after your last dose.
are breastfeeding or plan to breastfeed. It is not known if Itovebi passes into your breastmilk. Do not breastfeed during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with Itovebi.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see additional Important Safety Information in the full Itovebi Prescribing Information or visit View Source

Kadcyla U.S. Indication Statement

Kadcyla is approved as an adjuvant (after surgery) treatment for HER2-positive early breast cancer when the patient has taken neoadjuvant (before surgery) treatment including a taxane and trastuzumab (Herceptin) and there is cancer remaining in the tissue removed during surgery. Patients are selected for therapy based on an FDA-approved test for Kadcyla.

Kadcyla is approved to treat HER2-positive breast cancer that has spread to other parts of the body (metastatic breast cancer) after prior treatment with trastuzumab (Herceptin) and a taxane. Prior treatment could have been for the initial treatment of breast cancer or for the treatment of cancer that had spread to other parts of the body. Patients are selected for therapy based on an FDA-approved test for Kadcyla.

Important Safety Information

Most important safety information about Kadcyla

Liver problems

Kadcyla may cause severe liver problems that can be life-threatening. Symptoms of liver problems may include vomiting, nausea, eating disorder (anorexia), yellowing of the skin (jaundice), stomach pain, dark urine, or itching.
Heart problems

Kadcyla may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). Symptoms may include swelling of the ankles or legs, shortness of breath, cough, rapid weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness, or irregular heartbeat.
Pregnancy

Receiving Kadcyla during pregnancy can result in the death of an unborn baby and birth defects. Birth control should be used while receiving Kadcyla and for seven months after a patient’s last dose of Kadcyla.
If a patient thinks she may be pregnant, she should contact her healthcare provider immediately.
If a patient is exposed to Kadcyla during pregnancy or becomes pregnant within seven months following her last dose of Kadcyla, she is encouraged to report Kadcyla exposure to Genentech by calling (888) 835-2555.
If a male patient has a female partner that could become pregnant, birth control should be used during treatment and for four months following his last dose of Kadcyla.
A patient should not breastfeed during treatment and for seven months after the last dose of Kadcyla.
A patient should contact their doctor right away if they experience symptoms associated with these side effects.

Additional possible serious side effects of Kadcyla

Lung problems

Kadcyla may cause lung problems, including inflammation of the lung tissue, which can be life-threatening. Signs of lung problems may include trouble breathing, cough, tiredness, and fluid in the lungs.
Infusion-related reactions

Symptoms of an infusion-related reaction may include one or more of the following: the skin getting hot or red (flushing), chills, fever, trouble breathing, low blood pressure, wheezing, tightening of the muscles in the chest around the airways, or a fast heartbeat. A patient’s doctor will monitor the patient for infusion-related reactions.
Serious bleeding

Kadcyla can cause life-threatening bleeding. Taking Kadcyla with other medications used to thin the blood (antiplatelet) or prevent blood clots (anticoagulation) can increase the risk of bleeding. A patient’s doctor should provide additional monitoring if the patient is taking one of these other drugs while on Kadcyla. Even when blood thinners are not also being taken, life-threatening bleeding may occur with Kadcyla.
Low platelet count

Low platelet count may happen during treatment with Kadcyla. Platelets help the blood to clot. Signs of low platelets may include easy bruising, bleeding, and prolonged bleeding from cuts. In mild cases there may not be any symptoms.
Nerve damage

Symptoms of nerve damage may include numbness and tingling, burning or sharp pain, sensitivity to touch, lack of coordination, muscle weakness, or loss of muscle function.
Skin reactions around the infusion site

Kadcyla may leak from the vein or needle and cause reactions such as redness, tenderness, skin irritation, or pain or swelling at the infusion site. If this happens, it is more likely to happen within 24 hours of the infusion.

Most common side effects of Kadcyla

The most common side effects seen in people taking Kadcyla for early breast cancer are:

Tiredness
Nausea
Liver problems
Pain that affects the bones, muscles, ligaments, and tendons
Bleeding
Low platelet count
Headache
Weakness, numbness, and pain in the hands and feet
Joint pain

The most common side effects seen in people taking Kadcyla for metastatic breast cancer are:

Tiredness
Nausea
Pain that affects the bones, muscles, ligaments, and tendons
Bleeding
Low platelet count
Headache
Liver problems
Constipation
Nosebleeds

Patients are encouraged to report side effects to Genentech and the FDA. Patients may contact Genentech by calling (888) 835-2555. Patients may contact the FDA by visiting View Source or calling (800) FDA-1088.

Please click here for Kadcyla full Prescribing Information, including Most Important Safety Information, for additional Important Safety Information.

Columvi U.S. Indication

Columvi (glofitamab-gxbm) is a prescription medicine to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more prior treatments for their cancer.

It is not known if Columvi is safe and effective in children.

The conditional approval of Columvi is based on response rate and durability of response. There are ongoing studies to establish how well the drug works.

What is the most important information I should know about Columvi?

Columvi can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Columvi, and can also be serious and lead to death.

Call your healthcare provider or get emergency medical help right away if you develop any signs or symptoms of CRS, including:

fever of 100.4°F (38°C) or higher
chills or shaking
fast or irregular heartbeat
dizziness or light-headedness
trouble breathing
shortness of breath

Due to the risk of CRS, you will receive Columvi on a "step-up dosing schedule".

A single dose of a medicine called obinutuzumab will be given to you on the first day of your first treatment cycle (Day 1 of Cycle 1).
You will start the Columvi step-up dosing schedule a week after the obinutuzumab dose. The step-up dosing schedule is when you receive smaller "step-up" doses of Columvi on Day 8 and Day 15 of Cycle 1. This is to help reduce your risk of CRS. You should be hospitalized during your infusion and for 24 hours after receiving the first step-up dose on Day 8. You should be hospitalized during your infusion and for 24 hours after receiving the second step-up dose on Day 15 if you experienced CRS during the first step-up dose.
You will receive your first full dose of Columvi a week after the second step-up dose (this will be Day 1 of Cycle 2).
If your dose of Columvi is delayed for any reason, you may need to repeat the "step-up dosing schedule".
If you had more than mild CRS with your previous dose of Columvi, you should be hospitalized during and for 24 hours after receiving your next dose of Columvi.
Before each dose of Columvi, you will receive medicines to help reduce your risk of CRS and infusion-related reactions.

Your healthcare provider will monitor you for CRS during treatment with Columvi and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Columvi if you have severe side effects.

Carry the Columvi Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Columvi Patient Wallet Card lists the signs and symptoms of CRS you should get emergency medical help for right away.

What are the possible side effects of Columvi?

Columvi may cause serious side effects, including:

Cytokine Release Syndrome.
Neurologic problems. Columvi can cause serious neurologic problems that may lead to death. Your healthcare provider will monitor you for neurologic problems during treatment with Columvi. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems, including:
headache
confusion and disorientation
difficulty paying attention or understanding things
trouble speaking
sleepiness
memory problems
numbness, tingling, or weakness of the hands or feet
dizziness
shaking (tremors)
Serious Infections. Columvi can cause serious infections that may lead to death. Your healthcare provider will monitor you for signs and symptoms of infection and treat you as needed. Tell your healthcare provider right away if you develop any signs of an infection, including: fever, chills, weakness, cough, shortness of breath, or sore throat.
Growth in your tumor or worsening of tumor related problems (tumor flare).
Tell your healthcare provider if you get any of these signs or symptoms of tumor flare:

tender or swollen lymph nodes
pain or swelling at the site of the tumor
chest pain
cough
trouble breathing
The most common side effects of Columvi include: CRS, muscle and bone pain, rash, and tiredness.

The most common severe abnormal lab test results with Columvi include: decreased white blood cells, decreased phosphate (an electrolyte), increased uric acid levels, and decreased fibrinogen (a protein that helps with blood clotting).

Your healthcare provider may temporarily stop or completely stop treatment with Columvi if you develop certain side effects.

Before receiving Columvi, tell your healthcare provider about all of your medical conditions, including if you:

have an infection
have kidney problems
are pregnant or plan to become pregnant. Columvi may harm your unborn baby
Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with Columvi.
You should use effective birth control (contraception) during treatment and for 1 month after your last dose of Columvi. Talk to your healthcare provider about what birth control method is right for you during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Columvi.
are breastfeeding or plan to breastfeed. Columvi may pass into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of Columvi.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while receiving Columvi?

Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, shaking (tremors), sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems.

These are not all the possible side effects of Columvi. Talk to your health care provider for more information about the benefits and risks of Columvi.

You may report side effects to the FDA at (800) FDA-1088 or View Source." target="_blank" title="View Source." rel="nofollow">View Source You may also report side effects to Genentech at (888) 835-2555.

Please see Important Safety Information, including Serious Side Effects, as well as the Columvi full Prescribing Information and Medication Guide or visit View Source

What are Tecentriq and Tecentriq Hybreza?

Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) are prescription medicines used to treat:

Adults with a type of lung cancer called "extensive stage small cell lung cancer (SCLC)", which is SCLC that has spread or grown

Tecentriq or Tecentriq Hybreza may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment
Tecentriq or Tecentriq Hybreza may be used with the medicine lurbinectedin as maintenance treatment when your lung cancer:
has not progressed after first treatment with Tecentriq or Tecentriq Hybreza and the chemotherapy medicines carboplatin and etoposide.

Adults with a type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq or Tecentriq Hybreza may be used with the medicine bevacizumab when your liver cancer:

has spread or cannot be removed by surgery, and
you have not received other medicines by mouth or injection through your vein (IV) to treat your cancer.

Adults with a type of bladder cancer called muscle invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body. Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your bladder cancer:

to help prevent your bladder cancer from coming back after your bladder has been removed by surgery, and
small pieces of DNA from the tumor (called circulating tumor DNA [ctDNA]) were found in your blood, showing that cancer cells remain in the body (molecular residual disease). Your healthcare provider will perform a test to make sure that Tecentriq or Tecentriq Hybreza is right for you.

It is not known if Tecentriq Hybreza is safe and effective when used:

in children for the treatment of SCLC, HCC, or MIBC.

It is not known if Tecentriq is safe and effective when used:

in children for the treatment of SCLC, HCC, or MIBC.

Important Safety Information

Who should not receive Tecentriq Hybreza?

Do not receive Tecentriq Hybreza if you are allergic to hyaluronidase or any of the ingredients in Tecentriq Hybreza

What is the most important information about Tecentriq and Tecentriq Hybreza?

Tecentriq and Tecentriq Hybreza can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

Lung problems

cough
shortness of breath
chest pain
Intestinal problems

diarrhea (loose stools) or more frequent bowel movements than usual
stools that are black, tarry, sticky, or have blood or mucus
severe stomach-area (abdomen) pain or tenderness
Liver problems

yellowing of your skin or the whites of your eyes
severe nausea or vomiting
pain on the right side of your stomach area (abdomen)
dark urine (tea colored)
bleeding or bruising more easily than normal
Hormone gland problems

headaches that will not go away or unusual headaches
eye sensitivity to light
eye problems
rapid heartbeat
increased sweating
extreme tiredness
weight gain or weight loss
feeling more hungry or thirsty than usual
urinating more often than usual
hair loss
feeling cold
constipation
your voice gets deeper
dizziness or fainting
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems

decrease in your amount of urine
blood in your urine
swelling of your ankles
loss of appetite
Skin problems

rash
itching
skin blistering or peeling
painful sores or ulcers in your mouth or your nose, throat, or genital area
fever or flu-like symptoms
swollen lymph nodes

Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq or Tecentriq Hybreza. Call or see your healthcare provider right away for any new or worsening signs or symptoms, including:

Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
Persistent or severe muscle pain or weakness, muscle cramps
Low red blood cells, bruising

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

chills or shaking
itching or rash
flushing
shortness of breath or wheezing
dizziness
feeling like passing out
fever
back or neck pain

Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Tecentriq or Tecentriq Hybreza. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq or Tecentriq Hybreza. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq or Tecentriq Hybreza if you have severe side effects.

Before you receive Tecentriq or Tecentriq Hybreza, tell your healthcare provider about all of your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ or tissue transplant, including corneal transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have received radiation treatment to your chest area
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. Tecentriq and Tecentriq Hybreza can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Tecentriq or Tecentriq Hybreza. Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with Tecentriq or Tecentriq Hybreza.
You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of Tecentriq or Tecentriq Hybreza.
are breastfeeding or plan to breastfeed. It is not known if Tecentriq or Tecentriq Hybreza passes into your breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq or Tecentriq Hybreza.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used alone include:

feeling tired or weak
decreased appetite
nausea
cough
shortness of breath
The most common side effects of Tecentriq Hybreza when used alone include:

feeling tired or weak
muscle or bone pain
Cough
shortness of breath
decreased appetite

The most common side effects of Tecentriq and Tecentriq Hybreza when used in lung cancer with other anti-cancer medicines include:

feeling tired or weak
nausea
hair loss
constipation
diarrhea
decreased appetite

The most common side effects of Tecentriq and Tecentriq Hybreza when used in hepatocellular carcinoma (HCC) with bevacizumab include:

high blood pressure
feeling tired or weak
too much protein in the urine

The most common side effect of Tecentriq and Tecentriq Hybreza when used alone in MIBC is:

urinary tract infection

Tecentriq and Tecentriq Hybreza may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of Tecentriq and Tecentriq Hybreza. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq and Tecentriq Hybreza.

You may report side effects to the FDA at 1-800-FDA-1088 or View Source." target="_blank" title="View Source." rel="nofollow">View Source You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information for Tecentriq and Tecentriq Hybreza and the Medication Guides for Tecentriq and Tecentriq Hybreza for additional Important Safety Information.

(Press release, Genentech, MAY 18, 2026, View Source [SID1234665831])

On May 18, 2026 Provectus Biopharmaceuticals, Inc. ("Provectus" or the "Company") (OTCQB: PVCT) reported data from a preclinical safety and efficacy evaluation of PV-10 — a formulation of the Company’s proprietary, pharmaceutical-grade rose bengal sodium (RBS) active pharmaceutical ingredient — administered by oral and intravesical routes as a single agent and in combination with anti-human PD-1 against an orthotopic bladder carcinoma tumor xenograft model in immunologically humanized mice. Translational Drug Development, LLC (TD2 Oncology) of Scottsdale, Arizona, an oncology contract research organization, conducted the study. TD2 Oncology was created from the Translational Genomics Research Institute (TGEN) in 2003. TGEN, a precision medicine research organization, is a part of City of Hope, one of the largest cancer research and treatment organizations in the U.S.

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Across the seven-arm study, oral PV-10 monotherapy was the top-ranked treatment arm under a scoring framework that assessed anti-tumor response, survival benefit, safety and tolerability, data quality, and translational potential. Notably, two animals treated with oral PV-10 — one from the monotherapy group and one from the group of PV-10 in combination with anti-PD-1 — survived to study end and showed an absence of gross bladder tumor at necropsy, a finding not observed in any untreated, vehicle-control, or anti-PD-1 monotherapy animal.

Study Design and Context

This preclinical study utilized the UMUC3-Luc luciferase-expressing bladder carcinoma cell line implanted orthotopically into the bladder of human peripheral blood mononuclear cell (PBMC)-engrafted NOD.Cg-Prkdcscid Il2rgtm1Sug/JicTac (NOG) mice, an immunologically humanized model that allows evaluation of treatment effects in the presence of a functional human immune compartment. Tumor progression was monitored longitudinally by bioluminescence imaging (BLI). The study used 54 female mice across seven groups and ran for 45 days. As is inherent to human PBMC-engrafted NOG models, graft-versus-host disease (GvHD) independently contributed to morbidity across all engrafted groups; the scoring framework weighted survival accordingly and all arm-level comparisons are interpreted in this context.

The seven study arms were:

Group 1: No treatment (negative control, n=8),
Group 2: Human PBMC engraftment + vehicle instillation (active vehicle control, n=7),
Group 3: Human PBMC + PV-10 3 mg/dose intravesical (OB-IVS), once weekly ×4 weeks (n=7),
Group 4: Human PBMC + PV-10 2 mg/dose oral (PO), 5 days on/2 days off to study end (n=8),
Group 5: Human PBMC + anti-human PD-1 10 mg/kg intraperitoneal, twice weekly ×4 weeks (n=8),
Group 6: Human PBMC + PV-10 3 mg/dose OB-IVS + anti-PD-1 10 mg/kg (n=8), and
Group 7: Human PBMC + PV-10 2 mg/dose PO + anti-PD-1 10 mg/kg (n=8).

To evaluate the study’s treatment arm (Groups 3-7) results, Provectus applied a scoring framework of five weighted domains: anti-tumor response (30%), survival benefit (25%), safety and tolerability (25%), data quality and interpretability (12%), and translational and development potential (8%). Each domain was scored on a zero-to-ten scale using a pre-specified rubric grounded exclusively in observed study data, including Day 23 BLI tumor burden, time-to-morbidity, body weight trajectory, evaluable animal counts at key timepoints, and long-term survivor necropsy findings. The scoring framework was then validated through a sensitivity analysis across five weighting scenarios: base case, safety-first, efficacy-heavy, survival-dominant, and equal weight configurations. Notably, the rank order of all five active treatment arms was invariant across every scenario tested.

Key Study Findings

Oral PV-10 monotherapy (Group 4): The top-ranked arm:

Day 23 BLI tumor burden approximately 40% lower than the vehicle control on a geometric mean basis (log₁₀ mean 10.39 vs. 10.61),
Body weight nadir of −1.9% across all eight animals, the best tolerability profile among all PBMC-engrafted groups,
One long-term survivor (Day 45) whose gross necropsy did not record bladder tumor, compared to the near-universal "tumor throughout bladder" finding in untreated, vehicle-control, and anti-PD-1 monotherapy animals,
Top scores in survival, safety, and data quality domains of the scoring framework, each at 10.0 out of 10.0, and
Weighted total score of 9.24 out of 10.

Oral PV-10 + anti-PD-1 combination (Group 7): The second-ranked arm:

Highest translational potential score, reflecting the established clinical rationale for combining checkpoint blockade with novel immunomodulatory agents in bladder cancer,
Body weight nadir of −14.4%; anti-PD-1-associated GvHD burden limited safety score relative to Group 4,
One long-term survivor (Day 45) whose gross necropsy similarly did not record bladder tumor, and
Weighted score of 7.84 out of 10.
Intravesical PV-10 (Groups 3 and 6): The intravesical arms at 3 mg/dose (30–60 mg/mL concentration) were not tolerated at the instillation parameters tested:

Six of seven Group 3 mice and three of eight Group 6 mice were lost by Day 12, following the first intravesical dosing event, consistent with acute mucosal toxicity at the concentrations employed.

These findings represent a maximum tolerated concentration failure at the doses tested, not a negative efficacy signal. The intravesical route remains scientifically open at lower concentrations; clinical intravesical agents such as BCG and mitomycin-C are administered at substantially lower concentrations than those employed in this study.

Drug Development Evaluation Framework

Domain scores and sensitivity analysis results are presented in Tables 1 and 2 below.

Table 1. Domain Scores by Arm

Group Treatment Response (30%) Survival (25%) Safety (25%) Data Quality (12%) Translation (8%) Weighted Total
1 No Treatment 4.5 10.0 10.0 10.0 5.0 7.95/10
2 PBMC + Vehicle 6.0 10.0 9.0 9.0 5.0 8.03/10
3 PV-10 OB-IVS 0.0 0.0 5.0 1.0 1.0 1.45/10
4 PV-10 PO 8.0 10.0 10.0 10.0 8.0 9.24/10
5 anti-PD-1 5.0 10.0 6.0 10.0 7.0 7.26/10
6 PV-10 OB-IVS + anti-PD-1 5.0 0.0 1.0 3.0 2.0 2.27/10
7 PV-10 PO + anti-PD-1 7.4 8.8 6.0 10.0 9.0 7.84/10

Groups 1 and 2 are control arms of the study and are included in the above table for scoring framework calibration. They are not ranked against the treatment arms of Groups 3 to 7.

Table 2. Sensitivity Analysis

Weighting scenario Group 3
PV-10 OB-IVS Group 4
PV-10 PO Group 5
anti-PD-1 Group 6
PV-10 OB-IVS + anti-PD-1 Group 7
PV-10 PO + anti-PD-1 G4 lead over G7
Base case (30/25/25/12/8) 1.45 (#5) 9.24 (#1) 7.26 (#3) 2.27 (#4) 7.84 (#2) +1.40
Safety-first (20/20/40/12/8) 2.20 (#4) 9.44 (#1) 7.16 (#3) 1.92 (#5) 7.56 (#2) +1.88
Efficacy-heavy (40/30/15/10/5) 0.90 (#5) 9.10 (#1) 7.25 (#3) 2.55 (#4) 7.95 (#2) +1.15
Survival-dominant (20/40/25/10/5) 1.40 (#5) 9.50 (#1) 7.85 (#3) 1.65 (#4) 7.95 (#2) +1.55
Equal weight (20/20/20/20/20) 1.40 (#5) 9.20 (#1) 7.60 (#3) 2.20 (#4) 8.24 (#2) +0.96

In Table 2, the narrowest Group 4–Group 7 margin occurs under equal weight (+0.96), driven by Group 7’s high translation domain score (9.0 vs Group 4’s 8.0). Group 4’s lead widens under safety-first weighting (+1.88), reflecting Group 4’s perfect safety score versus Group 7’s GvHD-penalized score of 6.0.

Dominic Rodrigues, Provectus’s President and Vice Chairman of the Board of Directors, said "This preclinical study marks three firsts for Provectus: the first evaluation of PV-10 in bladder cancer, the first evaluation of any PV-10 route in an orthotopic tumor model, and the first evaluation of oral PV-10 against a solid tumor cancer. Historical Company and research collaborator preclinical work employed solid tumor cancer flank mouse models to evaluate PV-10 administered by intratumoral injection."

He added, "These oral PV-10 findings are encouraging. The long-term survivor necropsy findings — two animals treated with oral PV-10 that showed an absence of gross bladder tumor at Day 45 — are an important signal. PV-10’s mechanism’s capacity to perturb the tumor microenvironment and drive antitumor immune activity is not bladder cancer-specific. That is precisely what makes this result scientifically interesting and developmentally promising beyond the indication in which it was observed."

Ed Pershing, Provectus’s Chairman and Chief Executive Officer, said, "The path from this preclinical signal to the clinic requires FDA acceptance of an expanded Investigational New Drug application, which we currently have for intratumoral administration of PV-10, to permit oral PV-10 human testing. That is our next goal and regulatory milestone. As we consider which indication to pursue first in a Phase 1 study, we are drawn to cancers where the gap between what standard of care offers and what patients need remains widest. Bladder cancer is one such disease. Pancreatic cancer and glioblastoma are others we are watching closely. Oral PV-10’s tolerability profile — demonstrated here in a tumor model with no dose-limiting events and a body weight nadir below two percent — is directly relevant to patients in those settings. This preclinical study tells us oral PV-10 belongs in that conversation."

(Press release, Provectus Biopharmaceuticals, MAY 18, 2026, View Source [SID1234665849])