Roche highlights divarasib, giredestrant and Tam-Peli data ahead of ESMO 2026

Roche will present new late-stage oncology data across lung, breast and other solid tumours at the 2026 European Society for Medical Oncology Annual Meeting in Madrid.

The company’s programme includes new Phase III findings for divarasib in KRAS G12C-mutated non-small cell lung cancer, additional giredestrant data across early and advanced breast cancer, and new results for the B7-H3-targeted antibody drug conjugate Tam-Peli.

A major presentation will focus on the Phase III Krascendo 1 study of divarasib.

The global head-to-head trial compared the next-generation KRAS G12C inhibitor with approved first-generation KRAS G12C inhibitors in previously treated advanced non-small cell lung cancer.

Roche said the study demonstrated superior efficacy with divarasib over the current standard-of-care treatments.

Detailed findings are scheduled to be presented as a late-breaking abstract during a Presidential Symposium.

The company will also present further data for giredestrant, an investigational oral selective oestrogen receptor degrader being developed for ER-positive, HER2-negative breast cancer.

New patient-reported outcomes from the Phase III lidERA Breast Cancer study will assess whether the previously observed efficacy advantage of giredestrant over standard endocrine therapy was achieved without negatively affecting tolerability or health-related quality of life.

Roche is also presenting exploratory biomarker findings from the Phase III evERA study evaluating giredestrant with everolimus in advanced ER-positive, HER2-negative breast cancer following CDK4/6 inhibitor treatment.

Additional interim data from the MORPHEUS Breast Cancer programme will evaluate giredestrant in combination with inavolisib in locally advanced or metastatic disease.

Another major area of Roche’s ESMO programme is Tam-Peli, also known as tambotatug pelitecan.

Tam-Peli is an investigational next-generation B7-H3-targeted antibody drug conjugate designed to deliver a high-potency anti-tumour payload while limiting off-target toxicity.

Late-breaking interim Phase III data will be presented in heavily pretreated recurrent or metastatic nasopharyngeal carcinoma.

Roche will also share analyses of interstitial lung disease from Phase I and II studies in advanced solid tumours and Phase I efficacy and safety findings in locally advanced or metastatic non-small cell lung cancer.

The new results build on previously reported TAISHAN-302 data in second-line small cell lung cancer, where the study met its specified endpoints for overall survival, progression-free survival and objective response rate at the first interim analysis.

Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development at Roche, said the ESMO presentations reflect the company’s focus on advancing targeted therapies across tumour types with high unmet need.

He said the programme includes head-to-head targeted therapy, oral endocrine treatment and next-generation antibody drug conjugates intended to improve both clinical outcomes and treatment experience.

Roche is developing and commercialising Tam-Peli outside mainland China, Hong Kong and Macau and plans to initiate further global studies across multiple tumour types.

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Related Topics and Keywords

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