Roche to present divarasib, giredestrant and Tam-Peli data at ESMO 2026
Roche will bring a substantial cluster of late-stage oncology data to the European Society for Medical Oncology Annual Meeting in Madrid, running from 23 to 27 October 2026. The Basel-headquartered pharmaceutical group will present results across lung, breast and other solid tumours, with two presentations accepted as late-breaking abstracts at Presidential and Proffered Paper sessions.
The headline readout is the Phase III Krascendo 1 trial of divarasib, a next-generation KRAS G12C inhibitor. According to Roche, the study demonstrated superior efficacy over first-generation approved KRAS G12C inhibitors sotorasib and adagrasib in patients with previously treated, locally advanced or metastatic NSCLC harbouring the G12C mutation. Roche describes Krascendo 1 as the only global head-to-head trial to pit a next-generation KRAS G12C inhibitor against approved first-generation agents, positioning divarasib as a potential best-in-class candidate in the space.
Breast cancer and next-generation ADC data
In breast cancer, Roche will present patient-reported outcomes from the Phase III lidERA study of giredestrant, an investigational oral selective oestrogen receptor degrader, in early-stage ER-positive, HER2-negative disease. The company says these data indicate that giredestrant's efficacy advantage over standard endocrine therapy does not come at the cost of tolerability or health-related quality of life, a finding that could prove important for physicians choosing between oral SERD candidates. The oral SERD class has attracted intense commercial and clinical attention in recent years, with AstraZeneca's camizestrant and Merus and other groups also running late-stage programmes.
Additional breast cancer presentations will include biomarker analyses from the evERA trial of giredestrant plus everolimus in the post-CDK4/6 inhibitor setting, and updated interim results from the MORPHEUS basket study examining giredestrant in combination with the PI3K inhibitor inavolisib.
The third major data set covers Tam-Peli, known generically as tambotatug pelitecan, an investigational antibody-drug conjugate targeting B7-H3. Phase III interim results from the TAISHAN-301 study in recurrent or metastatic nasopharyngeal carcinoma will be presented as a late-breaking abstract. Roche notes these findings build on TAISHAN-302 data in second-line small cell lung cancer, presented at the World Conference on Lung Cancer in September, where the study met all three pre-specified endpoints of overall survival, progression-free survival and objective response rate at first interim analysis. Roche holds development and commercialisation rights for Tam-Peli outside mainland China, Hong Kong and Macau.
Market and competitive context
The KRAS G12C space has been one of the most actively contested targets in thoracic oncology since sotorasib gained FDA approval in 2021. Head-to-head superiority data of the kind Roche claims with divarasib would, if confirmed and accepted by regulators, represent a meaningful differentiation in a market where physicians have so far been guided largely by cross-trial comparisons. The full hazard ratios and safety profile from Krascendo 1 will be scrutinised closely; Roche has not yet disclosed those figures ahead of the ESMO presentation.
In the ADC segment, B7-H3 is an increasingly crowded target, with several programmes from Asian biotechs and larger Western groups in development across solid tumour types. Roche's territorial licensing arrangement for Tam-Peli from its Chinese partner positions it to run global registration trials, which it says it plans to initiate rapidly across multiple tumour types. Whether that pace and breadth can be matched against well-capitalised rivals will be a key investor question heading into 2027.
Levi Garraway, Roche's Chief Medical Officer, said the ESMO presentations reflect the company's aim to deliver medicines that "not only extend life, but also seek to improve treatment experience, tolerability and quality of life for people living with cancer."