Genentech, a member of the Roche Group, announced plans to present new data from the Phase III Krascendo 1 trial evaluating divarasib in previously treated advanced G12C-mutated non-small cell lung cancer. In addition, the company will share patient-reported outcomes from the Phase III lidERA study evaluating giredestrant in early-stage breast cancer at the upcoming European Society for Medical Oncology Annual Meeting. The scientific presentations are scheduled to take place during the event held from 23 to 27 October in Madrid, and will include two late-breaking abstracts covering lung, breast, and other cancer indications.
The Krascendo 1 trial is a global head-to-head study assessing divarasib, an investigational KRAS G12C inhibitor, against approved first-generation inhibitors. According to the company, results from this Phase III trial demonstrated the superiority of divarasib over the current standard of care involving first-generation KRAS G12C inhibitors in patients with previously treated advanced G12C-mutated non-small cell lung cancer.
Giredestrant is categorized as an investigational, oral, selective estrogen receptor degrader and full antagonist designed for estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer. This particular subtype accounts for more than 90% of cases diagnosed at an early stage, specifically stages I through III. Data from the Phase III lidERA study indicated that giredestrant improved efficacy over standard endocrine therapy while maintaining tolerability and health-related quality of life for early-stage breast cancer patients.
Additional data presentations will feature exploratory biomarker findings derived from the evERA Breast Cancer trial, which tests giredestrant in combination with everolimus for estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer within the post-cyclin-dependent kinase 4/6 inhibitor setting. Furthermore, the presentation includes updated interim results for giredestrant combined with inavolisib sourced from the MORPHEUS Breast Cancer trial, evaluating treatment combinations in locally advanced or metastatic settings.
Results for Tam-Peli, a B7-H3 targeted antibody-drug conjugate, will also be featured. Phase 3 results evaluated in Chinese patients with metastatic nasopharyngeal carcinoma demonstrated both efficacy and a favorable safety profile. The data package for Tam-Peli encompasses late-breaking interim Phase 3 results in heavily pretreated recurrent or metastatic nasopharyngeal carcinoma, evaluations of interstitial lung disease among patients with advanced solid tumours from Phase I and II studies, and Phase I efficacy and safety figures for patients with locally advanced or metastatic non-small cell lung cancer. These findings build upon positive Phase 3 TAISHAN-302 results, which previously satisfied key endpoints including overall survival, progression-free survival, and objective response rate in second-line small cell lung cancer.
Roche maintains responsibility for developing and commercialising Tam-Peli outside of mainland China, Hong Kong, and Macau, and has stated intentions to launch global clinical trials across multiple tumour types.
Regarding market performance, shares of the Roche Group traded between $301.27 and $514.08 over the course of the preceding year. The equity security closed the trading session on Friday at $458.47.
