Roche to present pivotal data at ESMO 2026, showcasing advances across its lung and breast cancer late-stage portfolio

The presentations span head-to-head lung cancer efficacy, breast cancer patient-reported outcomes and Tam-Peli development.

Rhea-AI Summary

Roche (RHHBY) will present phase III cancer results at ESMO 2026, including divarasib’s superiority over first-generation KRAS G12C inhibitors. The meeting runs from 23 to 27 October in Madrid. Krascendo 1 compared divarasib with sotorasib or adagrasib in previously treated advanced KRAS G12C-mutated non-small cell lung cancer.

Patient-reported outcomes from lidERA suggest giredestrant’s improved efficacy versus standard endocrine therapy in early-stage breast cancer did not compromise tolerability or health-related quality of life. Roche also highlighted potential efficacy and a favourable safety profile for Tam-Peli in phase III results in Chinese patients with metastatic nasopharyngeal carcinoma. It plans to initiate global Tam-Peli trials across multiple tumour types.

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Positive

• Major pointTAISHAN-302 met overall survival, progression-free survival and objective response rate endpoints at its first interim analysis.
• Moderate pointDivarasib demonstrated superior efficacy versus first-generation KRAS G12C inhibitors in previously treated advanced KRAS G12C-mutated lung cancer.
• Moderate pointTam-Peli phase III results in Chinese metastatic nasopharyngeal carcinoma patients suggest efficacy and favourable safety, Roche said.
• Minor pointLidERA patient-reported outcomes suggest giredestrant’s improved efficacy came without compromising tolerability or health-related quality of life.
• Minor point. Forward-looking: it has not happened yet and may not happen.Global Tam-Peli trials across multiple tumour types are planned by Roche.

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• None.

News Explained

Roche also reports that its phase III TAISHAN-302 study of Tam-Peli in second-line small-cell lung cancer met all three specified endpoints at its first interim analysis, with results presented at the September World Conference on Lung Cancer.

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• Phase III Krascendo 1 results demonstrated divarasib’s superiority over current standard of care, first-generation KRAS G12C inhibitors in previously treated advanced G12C-mutated non-small cell lung cancer
• Patient-reported outcomes from phase III lidERA study showed improved efficacy of giredestrant over standard endocrine therapy is achieved without compromising tolerability and health-related quality of life in early-stage breast cancer
• Phase III results in Chinese patients with metastatic nasopharyngeal carcinoma demonstrate the potential of Tam-Peli, a next-generation B7-H3-targeted ADC, to deliver robust efficacy with a favourable safety profile in high-unmet-need solid tumours

Basel, 19 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) will present new data, including two late-breaking abstracts, across lung, breast and other cancers at the 2026 European Society for Medical Oncology (ESMO) Annual Meeting, held from 23 to 27 October in Madrid.

“Our presentations at ESMO 2026 highlight the depth and impact of Roche’s oncology pipeline, driven by emerging science capable of bringing new treatment benefits across diverse and high-unmet-need cancers,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “From establishing head-to-head superiority with divarasib in KRAS G12C-mutated lung cancer to advancing patient-centered oral SERD therapies like giredestrant and next-generation ADCs such as Tam-Peli, we are committed to delivering medicines that not only extend life, but also seek to improve treatment experience, tolerability and quality of life for people living with cancer.

Divarasib demonstrated superior efficacy and best-in-class potential in KRAS G12C NSCLC
Roche will share phase III Krascendo 1 results, which demonstrated divarasib’s best-in-class efficacy, advancing the standard of care in previously treated KRAS G12C-mutated lung cancer.

• Krascendo 1 is the only global head-to-head trial to evaluate a next-generation KRAS G12C inhibitor versus approved first-generation inhibitors.¹
• Results for this potential best-in-class, next-generation KRAS G12C-targeted therapy will be presented as a late-breaking abstract during a Presidential Symposium.

Giredestrant data support its potential to become the new standard of care in early-stage and advanced breast cancer
Roche will present new data highlighting the potential role of giredestrant, an investigational, oral, potent next-generation selective oestrogen receptor degrader (SERD) and full antagonist,² in oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, a subtype in which more than 90% of cases are diagnosed at an early-stage (I-III).^3-6 Key presentations from early-stage to advanced disease include:

• Patient-reported outcomes from the phase III lidERA Breast Cancer trial suggesting that the improved efficacy of giredestrant compared to endocrine therapy is achieved without compromising tolerability or Health-Related Quality of Life.
• Exploratory biomarker findings from the evERA Breast Cancer trial of giredestrant in combination with everolimus in ER-positive, HER2-negative advanced breast cancer in the post-cyclin-dependent kinase 4/6 inhibitor setting.
• Updated interim results for giredestrant plus inavolisib from the MORPHEUS Breast Cancer trial evaluating giredestrant treatment combinations in ER-positive, HER2-negative locally advanced or metastatic breast cancer.

Data demonstrate the potential of a next generation B7-H3 targeted antibody-drug conjugate (ADC) Tam-Peli (tambotatug pelitecan)
New data will also be presented for Tam-Peli, an investigational next generation B7-H3-targeted ADC designed to deliver high-potency anti-tumour activity while limiting off-target toxicity.⁷ Tam-Peli is currently being investigated across multiple solid tumour indications:

• ESMO data include late-breaking interim phase III results in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma, analyses of interstitial lung disease in patients with advanced solid tumours from phase I/II studies, and phase I efficacy and safety data for Tam-Peli in patients with locally advanced or metastatic NSCLC.
• These findings build on the TAISHAN-302 phase III data in second-line small cell lung cancer presented at the World Conference on Lung Cancer in September, where the study met all three specified endpoints of overall survival, progression free survival and objective response rate at its first interim analysis.
• Roche is developing and commercialising Tam-Peli outside mainland China, Hong Kong, and Macau, and plans to rapidly initiate global trials across multiple tumour types.

Overview of key presentations featuring Roche medicines and molecules:

Medicine or molecule	Abstract title	Abstract number/ presentation details
Lung cancer
Divarasib	Krascendo 1: Efficacy and safety of divarasib (diva) vs sotorasib (soto) or adagrasib (ada) in previously treated locally advanced or metastatic KRAS G12C-mutated NSCLC.	#LBA5 Proffered Paper Session Presidential Symposium II Sunday 25.10.2026 16:30 - 16:42 CET
Divarasib	Krascendo 3: A randomised, phase III trial in progress of divarasib vs immunotherapy or observation in patients with resected, stage II-IIIB, KRAS G12C+ non-small cell lung cancer.	#2551 TiP Poster NSCLC, Early-Stage Monday 26.10.2026 12:00 – 12:45 CET
Tam-Peli	Tambotatug pelitecan (YL201): Efficacy and safety in locally advanced/ metastatic NSCLC from a phase I study.	#2577 Poster NSCLC, Locally Advanced Monday 26.10.2026 12:00 – 12:45 CET
Non-specific	Immunogenomic signature associated with ICI-related pneumonitis in non-small-cell lung cancer (NSCLC) patients.	#4247 Rapid Oral Basic Science and Translational Research Sunday 25.10.2026 09:14 - 09:19 CET
Breast cancer
Giredestrant	Patient (pt)-reported outcomes (PROs) from the phase III lidERA Breast Cancer (BC) trial of giredestrant (GIRE) in pts with oestrogen receptor-positive, HER2-negative early BC (ER+, HER2− eBC).	#538 Rapid Oral Breast Cancer, Early-Stage Friday 23.10.2026 16:20 – 16:25 CEST
Giredestrant	Retrospective exploratory biomarker (BM) analyses from evERA Breast Cancer (BC): A phase III trial of giredestrant (GIRE) + everolimus (E) in patients with oestrogen receptor-positive, HER2-negative advanced BC (ER+, HER2− aBC) in the post-CDK4/6 inhibitor (I) setting.	#2 Rapid Oral Breast Cancer, Advanced Stage Saturday 24.10.2026 10:20 – 10:25 CEST
Giredestrant	Updated interim analysis of giredestrant (GIRE) + inavolisib (INAVO) in MORPHEUS Breast Cancer (BC): A phase Ib/II study of GIRE treatment (tx) combinations in patients (pts) with oestrogen receptor-positive, HER2-negative locally advanced/metastatic BC (ER+, HER2− LA/mBC).	#23 Poster Advanced Breast Cancer, Other Saturday 24.10.2026 12:00 – 12:45 CEST
Pertuzumab	Real-world eligibility for DESTINY-Breast11 (DB-11) neoadjuvant escalation criteria and outcomes of DB-11-eligible vs DB-11-ineligible patients with HER2-positive early breast cancer (HER2+ eBC).	#594 Poster Breast Cancer, Early-Stage Saturday 24.10.2026 12:00 – 12:45 CEST
ZN-1041	BREnnA: Phase II/III randomised study of ZN-A-1041 or tucatinib (TUC), in combination with trastuzumab + capecitabine (HX), in patients with HER2-positive locally advanced or metastatic breast cancer (HER2+LA/mBC) with or without central nervous system (CNS) metastases.	#1796 TiP Poster HER2+ Breast Cancer Saturday 24.10.2026 12:00 – 12:45 CEST
Solid tumours
Tam-Peli	Tambotatug pelitecan (YL201): Analyses of interstitial lung disease in patients with advanced solid tumours from phase I/II studies.	#1057 Poster Developmental Therapeutics Friday 23.10.2026 15:15 – 16:00 CEST
YL211 (cMET ADC)	Phase I First-in-Human (FIH) Results of YL211, a c-Met targeting Antibody-Drug Conjugate (ADC), in patients (pts) with advanced solid tumors.	#1017 Poster Developmental Therapeutics Friday 23.10.2026 15:15 – 16:00 CEST
Tam-Peli	Tam-Peli versus chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): a multicenter, randomised, open-label, phase III study (TAISHAN-301).	#LBA43 Proffered Paper Session Head and Neck Cancer Sunday 25.10.2026 08:40 - 08:50 CET
Tecentriq (atezolizumab) + Avastin (bevacizumab)	Outcomes by baseline tumor burden using 6-and-12 scores and the up-to-7 criteria in TALENTACE: phase III study of on-demand transarterial chemoembolization (TACE) combined with atezolizumab + bevacizumab (Atezo/Bev) or on demand TACE alone in patients  with systemically untreated, unresectable hepatocellular carcinoma (uHCC).	#1700 ePoster Hepatocellular Carcinoma
Tecentriq (atezolizumab)	ATOMIC (A021502/AIO-KRK-0317): Presentation and outcomes in patients (pts) with stage III d-MMR early-onset colon cancer (EOCC) and average-onset colon cancer (AOCC).	#858 Poster Colon Cancer Sunday 25.10.2026 12:00 - 12:45 CET
Tecentriq (atezolizumab)	Adjuvant atezolizumab in patients with MSI-high/MMR-deficient stage III colorectal cancer ineligible for oxaliplatin-based chemotherapy: the phase II ANTONIO-study (AIO-KRK-0220).	#802 Poster Colon Cancer Sunday 25.10.2026 12:00 - 12:45 CET

About Roche in Oncology
For over 60 years, Roche has delivered transformative medicines and diagnostics, redefining the treatment of some of the most challenging cancers. Driven by a vision of a future where cancer can be cured, we focus our efforts on cancers with the highest societal impact and where we bring deep expertise, including breast, lung, and blood cancers, while pursuing breakthrough innovation in other areas of unmet need. Our pipeline features a diverse array of modalities, from small molecules and antibodies to next-generation ADCs and allogeneic CAR T-cell therapies. By advancing best-in-class precision medicine, pioneering novel combinations, and leveraging key technologies and partnerships, Roche tackles oncology's toughest challenges with the goal of delivering life-changing outcomes for people with cancer.

About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.

Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.

Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Gadgeel S, et al. P3.12D.07 Divarasib Versus Adagrasib or Sotorasib in Pretreated KRAS G12C+ Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC). J of Thorac Oncol. 2024; 19 (10, Supplement): S349.
[2] Martin M, et al. Giredestrant (GDC-9545) vs physician choice of endocrine monotherapy (PCET) in patients (pts) with ER+, HER2– locally advanced/metastatic breast cancer (LA/mBC): Primary analysis of the phase 2, randomised, open-label acelERA BC study. Presented at: ESMO Annual Meeting; 2022 September 9-13; Paris, France. Abstract #211MO.
[3] F. Hoffmann‑La Roche Ltd. (2026) SEER Explorer All BCa by Stage. Data on file.
[4] F. Hoffmann‑La Roche Ltd. (2026) Stage Distribution. Data on file.
[5] F. Hoffmann‑La Roche Ltd. (2026) KREBS and TRM. Data on file.
[6] F. Hoffmann‑La Roche Ltd. (2026). UK_CRUK_EDHub_IncidenceByStageRCRD_DataTable2026-01-08. Data on file.
[7] Xu J, et al. Cancer Res. 2023;83:6304.

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Attachment

• Media&Investor Release Roche ESMO 2026 English

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Roche’s Krascendo 1 trial show for divarasib?

Divarasib demonstrated superior efficacy versus sotorasib or adagrasib in previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer. The phase III Krascendo 1 results will be presented as a late-breaking abstract at ESMO 2026.

What did Roche’s lidERA patient-reported outcomes show for giredestrant?

Patient-reported outcomes suggest that giredestrant’s improved efficacy compared with standard endocrine therapy did not compromise tolerability or health-related quality of life. The phase III lidERA trial concerns oestrogen receptor-positive, HER2-negative early-stage breast cancer.

Where does Roche develop and commercialise Tam-Peli?

Roche develops and commercialises Tam-Peli outside mainland China, Hong Kong and Macau. The company plans to rapidly initiate global trials across multiple tumour types.