On May 18, 2026 AstraZeneca and Roche Diagnostics Asia Pacific reported a three-year Memorandum of Understanding to help advance digital pathology capabilities and elevate cancer care across nine Asia markets, a first in the region. This landmark collaboration aims to accelerate the adoption of AI-powered digital and computational pathology through educational and training initiatives and improve biomarker testing in breast and lung cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Globally, nearly half of all breast cancer cases[1] and over 60% of new lung cancer diagnoses[2] occur in Asia. In breast cancer, almost half of Asian women present lower levels of HER2,[3] while TROP2 is present in 82–90% of non-small cell lung cancer.[4] Precise biomarker testing is hence key to guiding treatment decisions, and AI-enabled TROP2 assessment helps identify patients who are more likely to respond to antibody drug conjugate therapies.

This collaboration addresses the critical knowledge and adoption gap in AI-assisted pathology across Asia. Only 17% of clinicians consider themselves very aware of advanced pathology technologies, and usage of computational pathology-based tests in clinical settings is low.[5] For example, in the Philippines, 60% of medical oncologists report that unavailability of biomarker testing has hindered their practice.[6]

"Building resilient health systems is fundamental to our mission of transforming cancer care," said Arun Krishna, Area Vice President, Asia, AstraZeneca. "This collaboration aims to address existing diagnostic gaps across the region. By combining efforts with Roche Diagnostics to advance education and adoption of AI-powered pathology, we can support the integration of precision diagnostics into the patient journey, helping to match more patients to the right treatment at the right time."

AI-assisted pathology helps standardise diagnostic processes, reducing subjectivity, and improving accuracy. Studies show that AI-assisted workflows can[7]:

Improve diagnostic accuracy by up to 5%, reducing reading time per case by 36%.
Increase interpretation concordance by up to 15% by mitigating human fatigue and subjective bias.
Expand access to targeted therapies by reclassifying 24% of cases previously labelled as HER2-negative to HER2-low category.
Enable more precise patient identification through the first AI-powered companion diagnostic for TROP2.[8]
When patients are matched to the right therapies, clinical benefits could include improved response rates, extended progression-free survival,[9] and optimised healthcare resources.

"At Roche Diagnostics, we believe that timely and accurate diagnosis is the foundation of effective cancer care. Across Asia Pacific, gaps in access to advanced diagnostics continue to impact patient outcomes," said Lance Little, Head of Region, Roche Diagnostics Asia Pacific. "Through this collaboration, we are focused on strengthening diagnostic capabilities and accelerating the adoption of digital pathology across healthcare systems. This is key to enabling more consistent and reliable diagnosis, raising the standard of care for patients with lung and breast cancer."

Across Singapore, Taiwan, Korea, Thailand, Malaysia, India, Indonesia, Vietnam, and the Philippines, the collaboration will activate educational and training initiatives that address local healthcare system needs and accelerate the integration of AI-assisted computational pathology into diagnostic workflows.

(Press release, AstraZeneca, MAY 18, 2026, View Source [SID1234665839])

On May 18, 2026 Biotheryx, Inc., a biopharmaceutical company focused on the discovery and development of first-in-class protein degraders for cancer and inflammatory diseases, reported the data from its first-in-human Phase 1 Dose Escalation study evaluating BTX-9341, a novel CDK4/6 bifunctional degrader, as monotherapy and in combination with fulvestrant in participants with advanced/metastatic HR+/HER2- breast cancer who received prior CDK4/6 inhibitor therapy. The Phase 1 Dose Expansion portion of the study is currently ongoing.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"BTX-9341 has a highly favorable safety profile, with no clear evidence of key class related toxicities of other CDK4/6 inhibitors including gastrointestinal toxicities (diarrhea, nausea, vomiting), hepatotoxicity and prolongation of the QTc interval," said Dr. Rachel M Layman, MD (Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center). "The drug shows encouraging clinical activity in a heavily pretreated patient population in the post-CDK4/6 inhibitor setting and shows compelling evidence of the importance of targeting CDK2/4/6 to address multiple resistance pathways."

Data from the Phase 1 Dose Escalation study demonstrate evidence of clinical activity, including prolonged partial response and stable disease in a heavily pretreated patient population. Pharmacokinetic analyses showed BTX-9341 exposures consistent with target engagement concentrations. Importantly, BTX-9341 was well tolerated, with participants on treatment for over 12 cycles (48 weeks), including on monotherapy and in combination with fulvestrant. Adverse events were mild to moderate and easily manageable.

Key Highlights from Dose Escalation Portion of the Phase 1 Study

Favorable safety and tolerability profile with no serious adverse events or treatment discontinuations due to adverse events in all participants (N=28). Hematologic adverse events were transient and reversible. There were no ≥ Grade 3 non-hematologic events.
Approximate dose-proportional pharmacokinetics supporting once-daily dosing.
Clinical activity was observed in a heavily pretreated patient population post-CDK4/6 inhibitors with up to 6 prior lines of therapy in the metastatic setting; approximately 40% and 36% of participants had received chemotherapy and PI3K/AKT/mTOR or other targeted therapies, respectively. Clinical Benefit Rates1 (CBRs) of 41.7% and 80% were observed in treatment-evaluable participants2 (n=24), and participants representative of the dose expansion criteria (n=10), respectively.
Target engagement consistent with CDK4/6 degradation mechanism based on a significant reduction in serum Thymidine Kinase activity, and reductions in the levels of CDK4, CDK6, and CDK2 in peripheral blood mononuclear cells (PBMCs). This is consistent with BTX-9341’s unique ability to address multiple convergent resistance mechanisms to CDK4/6 inhibitor therapies by degrading CDK4/6 and inhibiting downstream transcription of CDK2.
The study is still ongoing with multiple participants remaining on treatment for 12 to >18 cycles. The data are as of May 6, 2026.
"These encouraging clinical results mark an important milestone for our Phase 1 study evaluating BTX-9341, a first-in-class CDK4/6 bifunctional degrader," said Dr. Leah Fung, CEO of Biotheryx. "BTX-9341 has demonstrated a promising safety and tolerability profile, along with early signs of clinical activity in participants whose disease progressed following prior CDK4/6 inhibitor therapy. Given that CDK6 upregulation and Cyclin E amplification are established mechanisms of resistance to CDK4/6 inhibitors, these findings highlight the importance of degrading CDK4/6 and inhibiting downstream transcription of CDK2 to address convergent resistance mechanisms and may redefine the post-CDK4/6 inhibitor setting in advanced/metastatic HR+/HER2- breast cancer."

Advancing to Dose Expansion

Based on these findings, the company is continuing with its Phase 1 Dose Expansion portion of the trial. The expansion cohorts have begun enrolling participants and will further evaluate the efficacy and safety of BTX-9341 in combination with fulvestrant and will build on the safety, tolerability, pharmacokinetics and pharmacodynamic activity of BTX-9341 established in the Dose Escalation phase. The trial is being conducted at multiple sites in the United States and is expected to enroll up to 78 participants across two treatment arms based on the recommended dose identified in the earlier Dose Escalation phase. The primary endpoint of this study is the Overall Response Rate (ORR), with key secondary endpoints including the measurement of investigator-assessed Clinical Benefit Rate (CBR) and Progression Free Survival (PFS).

About BTX-9341

BTX-9341 is a first-in-class, oral degrader of CDK4/6, important targets for a range of cancers and clinically validated in HR+/HER2- breast cancer. In preclinical breast cancer models, BTX-9341 demonstrated enhanced activity compared with CDK4-only and CDK4/6 inhibitors through potent and highly selective catalytic degradation of CDK4 and CDK6, robust inhibition of CDK2 transcription, cell cycle arrest, and ultimately superior in vivo efficacy in breast cancer xenografts. Beyond this increased efficacy potential, BTX-9341 is differentiated from CDK4-only and CDK4/6 inhibitor approaches through the ability to overcome key resistance mechanisms that can limit the impact of inhibitors in second line HR+/HER2- metastatic breast cancer.

(Press release, BioTheryX, MAY 18, 2026, View Source;breast-cancer-302774140.html [SID1234665838])

On May 18, 2026 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported it will present new data across its oncology portfolio at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 29 – June 2 in Chicago, reinforcing Astellas’ sustained commitment to improving outcomes for people living with cancer. The data will provide further insight into the durable efficacy of established treatment approaches, their use in clinical practice, and ongoing areas of research and development.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Urothelial carcinoma
In urothelial cancer, a key highlight will be a 3.5-year follow-up oral presentation from the Phase 3 EV-302 study (also known as KEYNOTE-A39), evaluating enfortumab vedotin in combination with pembrolizumab in previously untreated locally advanced or metastatic disease. These data provide additional insight into the durability of outcomes with this treatment approach in advanced disease, an important consideration in clinical management.

Additional data from multiple studies exploring the use of this combination in earlier settings will be presented during the congress. Together, these findings contribute to a broader understanding of how this treatment approach may be applied across advanced disease settings, as well as across patient subgroups.

Prostate cancer
In advanced prostate cancer, additional analyses from established clinical programs in non-metastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC) with high-risk biochemical recurrence (BCR) and hormone- (or castration-) sensitive prostate cancer (mHSPC or mCSPC), including EMBARK and ARCHES, will provide further insight into treatment outcomes in patients with varying clinical characteristics, supporting clinical decision-making in practice.

Women’s health
For the first time at ASCO (Free ASCO Whitepaper), Astellas will present an update on HIGHLIGHT 1, a trial-in-progress investigating the safety and efficacy of fezolinetant for the treatment of moderate to severe vasomotor symptoms in women with stage 0 to 3 hormone receptor-positive breast cancer who are receiving adjuvant endocrine therapy. The safety and efficacy of fezolinetant have not been established in this patient population. Fezolinetant is currently approved by the U.S. Food and Drug Administration for the treatment of moderate to severe vasomotor symptoms due to menopause.

Astellas Presentations at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting

Enfortumab vedotin

Presentation Title

Lead Author

Presentation Details

Enfortumab vedotin plus pembrolizumab vs chemotherapy for previously untreated locally advanced or
metastatic urothelial carcinoma: 3.5-year follow-up and response analyses from the phase 3 EV-302 study

T. Powles

Type: Oral Presentation

Abstract Number: 4507

Date: May 29, 2026, 2:45 PM-5:45 PM CDT

Health-related quality of life with neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab in
participants with muscle-invasive bladder cancer who are cisplatin ineligible: Phase 3 KEYNOTE-905 study

P. O’Donnell

Type: Oral Presentation

Abstract Number: 4510

Date: May 30, 2026, 8:00 AM-9:30 AM CDT

Neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab in participants with cisplatin-ineligible
muscle-invasive bladder cancer: An analysis of clinically relevant subgroups in KEYNOTE-905

N. Adra

Type: Poster Presentation

Abstract Number: 4613

Date: May 31, 2026, 9:00 AM-12:00 PM CDT

Exploratory subgroup outcomes in the phase 3 KEYNOTE-B15 study of neoadjuvant-adjuvant enfortumab
vedotin plus pembrolizumab for participants with muscle-invasive bladder cancer eligible for cisplatin

C. Hoimes

Type: Poster Presentation

Abstract Number: 4614

Date: May 31, 2026, 9:00 AM-12:00 PM CDT

Enzalutamide

Presentation Title

Lead Author

Presentation Details

Predictors of treatment duration in patients with metastatic hormone-sensitive prostate cancer treated with
enzalutamide: a post hoc analysis of ARCHES

A. Armstrong

Type: Poster Presentation

Abstract Number: 5093

Date: May 31, 2026, 9:00 AM-12:00 PM CDT

Efficacy and safety of enzalutamide in patients with metastatic hormone-sensitive prostate cancer and
cardiometabolic comorbidities and/or related concomitant medications: ARCHES post hoc

A. Stenzl

Type: Poster Presentation

Abstract Number: 5092

Date: May 31, 2026, 9:00 AM-12:00 PM CDT

EMBARK: Testosterone recovery to >250 ng/dL following treatment suspension

S. Freedland

Type: Poster Presentation

Abstract Number: 5088

Date: May 31, 2026, 9:00 AM-12:00 PM CDT

Outcomes with androgen-deprivation therapy (ADT) plus androgen receptor pathway inhibitors (ARPIs) in
veterans with de novo metastatic castration-sensitive prostate cancer (mCSPC) who were elderly, frail,
or had high comorbidity: a subgroup analysis of enzalutamide and high-volume disease

M. Schoen

Type: Poster Presentation

Abstract Number: 5094

Date: May 31, 2026, 9:00 AM-12:00 PM CDT

Fezolinetant

Presentation Title

Lead Author

Presentation Details

HIGHLIGHT 1: A randomized, placebo-controlled, double-blind, phase 3 clinical study to investigate the
efficacy and safety of fezolinetant for treatment of moderate to severe vasomotor symptoms (hot flashes)
in women with stage 0 to 3 hormone receptor–positive breast cancer who are receiving adjuvant
endocrine therapy

C. Bouchard

Type: Poster Presentation

Abstract Number: TPS642

Date: June 1, 2026, 1:30 PM-4:30 PM CDT

Pipeline

Presentation Title

Lead Author

Presentation Details

Trial in progress: ASP2998, a trophoblast cell-surface antigen 2 (TROP2)–targeted immunostimulatory
antibody-drug conjugate with dual payloads, in patients with locally advanced unresectable or metastatic
solid tumors: A phase 1b/2 study.

G. Sonpavde

Type: Poster Presentation

Abstract Number: TPS2665

Date: May 30, 2026, 1:30 PM-4:30 PM CDT

(Press release, Astellas, MAY 18, 2026, View Source [SID1234665837])

On May 18, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that its proprietary PD-L1/4-1BB bispecific antibody, Opamtistomig (LBL-024), has received approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to initiate a pivotal Phase III clinical trial for the first-line treatment of advanced extrapulmonary neuroendocrine carcinoma (EP-NEC). This approval marks the successful advancement of Opamtistomig’s clinical development in EP-NEC from late-line monotherapy to first-line combination therapy — Opamtistomig had previously received CDE approval for a pivotal single-arm registration trial in 3L+ EP-NEC patients; this Phase III approval further expands Opamtistomig’s addressable patient population in EP-NEC, potentially reshaping the treatment landscape for this malignancy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This randomized, double-blind, multicenter Phase III study is led by Professor Lin Shen of Peking University Cancer Hospital. The approval was based on the promising efficacy and favorable safety profile demonstrated by Opamtistomig in a successfully completed Phase Ib/II proof-of-concept study. Detailed results are planned to be presented at the 2026 ESMO (Free ESMO Whitepaper) Congress.

As an integral part of the overall EP-NEC development strategy, Leads Biolabs plans to submit a Biologics License Application (BLA) in the third quarter of 2026 for Opamtistomig as a single agent for the treatment of advanced EP-NEC in the third-line or later setting. In parallel, Leads Biolabs is advancing multiple proof-of-concept studies and preparing to initiate at least two additional Phase III clinical trials for Opamtistomig, exploring its application across 13 solid tumor indications, including first-line NSCLC, first-line BTC, small cell lung cancer, and ovarian cancer, thereby building a comprehensive, multi-tumor, multi-stage development layout. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across four indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC) and extrapulmonary neuroendocrine carcinoma (EP-NEC).

Executive Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "The Phase Ib/II data for Opamtistomig in first-line treatment of EP-NEC are encouraging. In our communications with the CDE, we have seen the regulatory agency’s strong focus on unmet clinical needs and its recognition of Opamtistomig’s clinical value. Based on the clear regulatory feedback, we are rapidly implementing the pivotal Phase III study protocol, and we look forward to validating its potential to extend patient survival through a high-quality trial, bringing this innovative therapy to EP-NEC patients as soon as possible."

About EP-NEC

EP-NEC is a highly aggressive, immunologically "cold" tumor. To date, no drug has received regulatory approval for this indication worldwide. The current first-line standard treatment for advanced EP-NEC remains platinum-based chemotherapy, with an objective response rate (ORR) of 30%-50% and a median overall survival (mOS) of approximately 1 year, underscoring a pressing unmet need for new therapeutic options.

About Opamtistomig

Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig is designed to simultaneously block PD-1/L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across four indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

As the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, Opamtistomig has been evaluated in 13 solid tumor indications in China, including 1 pivotal registration trial and 8 proof-of-concept studies. These cover EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), malignant melanoma, and other areas with high unmet medical needs.

Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors. Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine carcinoma in November 2024. Additionally, in January 2026, Opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission for the treatment of EP-NEC, further underscoring its potential to address unmet medical needs in this patient population.

(Press release, Nanjing Leads Biolabs, MAY 18, 2026, View Source [SID1234665835])

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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])