On May 19, 2026 Roche (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 29 May to 2 June in Chicago.

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"Roche’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, MD, PhD, Roche’s 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
Roche’s ASCO (Free ASCO Whitepaper) 2026 focus is on giredestrant, an investigational, oral, selective oestrogen receptor degrader (SERD) being studied in early and advanced oestrogen 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.1,2 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,3 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 Roche 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
Roche 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): Roche 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): Roche 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 Roche 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 02 June 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 30 May 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 31 May 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 01 June 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 3 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 01 June 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 01 June 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 3 SUNMO study including in second-line (2L) versus third-line plus (3L+) patient subgroups #7007 oral

Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia

Saturday 30 May 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 30 May 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 29 May 2026
2:12 – 2:18 PM CDT
Columvi, Lunsumio and Polivy Multivariable analyses (MVAs) of overall survival (OS) in the phase 3 SUNMO, STARGLO and POLARGO trials in relapsed/refractory large B-cell lymphoma (LBCL) #7093 poster

Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia

Monday 01 June 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 30 May 2026
8:36 – 8:48 AM CDT
Tecentriq (atezolizumab) Transcriptomic analyses of molecular subsets and correlations with clinical outcomes from the phase 3 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 31 May 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 31 May 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 01 June 2026
10:09 – 10:21 AM CDT
Tecentriq Health-related quality of life (HRQOL) in the phase 3 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 30 May 2026
9:00 – 12:00 PM CDT
Bladder cancer
Tecentriq Patient-reported outcomes from IMvigor011: A phase 3 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 31 May 2026
9:00 – 12:00 PM CDT
*Study led by the Alliance for Clinical Trials in Oncology and supported by Roche

(Press release, Hoffmann-La Roche, MAY 19, 2026, View Source [SID1234665845])

On May 19, 2026 Mestag Therapeutics, a clinical-stage biotech company harnessing fibroblast immunology for the benefit of patients with inflammatory disease and cancer, reported the dosing of the first patient in a Phase 1 clinical trial evaluating MST-0312 in patients with selected advanced solid tumors. The first in human trial, named the STARLYS trial, is an adaptive, modular multi-part, multi-arm open-label study designed to evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics and anti-tumor activity of MST-0312 alone and in combination with pembrolizumab.

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MST-0312 is a bispecific antibody designed to activate lymphotoxin-beta receptor (LTBR) in the tumor microenvironment to induce the formation of tertiary lymphoid structures (TLS) and associated high endothelial venules (HEV) in tumor tissue. TLS are a hallmark of effective anti-tumor immunity consisting of aggregates of T, B and dendritic cells, associated with the recruitment, education, and activation of immune cells to drive anti-tumor immune responsesi,ii. Patients with TLS and HEV in their tumors show significantly improved response to treatment and extended survival outcomes compared to patients whose tumors lack these structuresiii,iv,v,vi. The STARLYS trial will initially evaluate MST-0312 in tumors formed in barrier organs (lung, gut, bladder, breast and skin), which are believed to be particularly sensitive to TLS formation.

"Dosing the first patient with MST-0312 is a significant milestone in developing this potential new therapeutic class," said Dr. Lindsey Rolfe, MBChB, Chief Medical Officer of Mestag. "Our carefully designed study evaluates monotherapy and combination therapy in immunologically ‘cold’ and ‘warm’ tumors, generating multiple mechanistic and clinical insights to inform future development. This important step reflects the scientific rigor and dedication of the Mestag team, as we advance novel therapies for patients."

Dr. Emiliano Calvo MD PhD, a Principal Investigator of the study and Director of Clinical Research at START Madrid-CIOCC (Centro Integral Oncológico Clara Campal) Hospital in Madrid, Spain where the first patient was dosed, said "MST-0312 is an exciting new investigative approach for the treatment of solid tumors and we are thrilled to have dosed the first patient in the STARLYS trial."

Dr. Elena Garralda MD PhD, Co-Director of the Clinical Research Program and Head of Early Drug Development at Vall d’Hebron Institute of Oncology in Barcelona, Spain, and coordinating Principal Investigator of the STARLYS trial, added, "Published data show that the presence of TLS is associated with significantly improved outcomes for patients. Despite recent therapeutic advances, many patients with solid tumors derive limited benefit from current therapies. MST-0312 is designed to address this unmet need by inducing TLS and reshaping anti-tumor immunity. I look forward to working with the STARLYS investigators to evaluate MST-0312 in the clinic."

(Press release, Mestag Therapeutics, MAY 19, 2026, View Source [SID1234665844])

On May 19, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that it is initiating a Phase 2b study of narmafotinib in pancreatic cancer exploring a new dosing regimen. Designed in alignment with FDA feedback, the study will form the basis – and first stage – of a registrational study in this indication given the high existing unmet need for innovative treatments. Narmafotinib is a best-in-class FAK inhibitor that has received orphan drug designation and fast track designation from the U.S. FDA as a potential treatment in pancreatic cancer.

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To-date narmafotinib has shown no significant tolerability burden over chemotherapy alone, and we have observed a range of compelling efficacy signals across responses and survival. This has been achieved with only an intermittent dosing schedule, giving us confidence that moving into daily dosing may further enhance the therapeutic potential of narmafotinib", said Dr Chris Burns, CEO and Managing Director of Amplia. "We have been able to accelerate this phase of the narmafotinib program with redeployed resources, including drug product, following the wind-down of recruitment in the AMPLICITY trial. We believe our registrational study submission to the FDA will be stronger for the inclusion of this portion of the Phase 2b study and we look forward to further engagement with regulators."

The study will investigate, for the first time, a daily dosing schedule for narmafotinib, at two dosing levels, with the chemotherapies gemcitabine and Abraxane in newly diagnosed advanced pancreatic cancer patients. In this first stage, each dosing cohort will have 6 patients (12 patients in total), which will be combined with gemcitabine and Abraxane given on their conventional schedule. In addition to safety and tolerability, pharmacokinetics (PK) and efficacy will be assessed. Exploratory endpoints will include effects on disease biomarkers as well as effects on fibrosis, a key indicator of FAK activity. The study will enrol patients across 3-4 sites in Australia. The Company anticipates patient enrolment will begin by the fourth quarter of this year with the safety, tolerability and PK assessment for the 12 patients completed in the second quarter of 2027.

(Press release, Amplia Therapeutics, MAY 19, 2026, View Source [SID1234665832])

On May 18, 2026 Parabilis Medicines reported a strategic research collaboration with Regeneron Pharmaceuticals, Inc. to discover and develop multiple therapeutic candidates based on Parabilis’s 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.

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.

"Through our own pipeline, we have demonstrated the potential of Helicon peptides to directly inhibit or degrade several disease-driving proteins in oncology that have long been considered out of reach," said Mathai Mammen, M.D., Ph.D., Chairman, CEO and President of Parabilis Medicines. "We are thrilled to enter into a collaboration with Regeneron that builds on this foundation, combining the intracellular access and binding capabilities of our Helicons against challenging targets with antibodies from Regeneron."

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’s 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, Parabilis Medicines, MAY 18, 2026, View Source [SID1234666534])

On May 18, 2026 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in a fireside chat at A.G.P.’s Annual Virtual Healthcare Conference, taking place on Wednesday, May 20, 2026. The fireside chat is scheduled to begin at 12:20pm ET.

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To register for the conference, visit the A.G.P. Registration Link.

(Press release, Fortress Biotech, MAY 18, 2026, View Source [SID1234665854])