[Ad hoc announcement pursuant ... Note

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s divarasib shows superiority in head-to-head phase III trial against approved KRAS G12C inhibitors in non-small cell lung cancer

Roche has announced positive results from the phase III Krascendo 1 study evaluating divarasib, an investigational next-generation KRAS G12C inhibitor, in patients with previously treated KRAS G12C non-small cell lung cancer. The study met its primary and key secondary endpoint, with divarasib achieving clinically meaningful and statistically significant improvements in both progression-free survival and overall survival. The safety profile for divarasib remained consistent with previous data, with no new findings detected and the most common treatment-related events being manageable and reversible. The results of the study demonstrate the potential of divarasib to improve clinical outcomes for people with KRAS G12C non-small cell lung cancer. The data from the Krascendo 1 study will be presented at an upcoming medical meeting and submitted to health authorities with the aim of bringing this potential treatment option to people with KRAS G12C NSCLC as soon as possible. The KRAS G12C mutation is one of the most common KRAS oncogene mutations, found in approximately 14% of NSCLC cases and associated with poor prognosis for patients. Roche is committed to advancing the field of lung cancer treatments, leveraging more than 20 years of deep scientific expertise to improve patient outcomes and their overall experience. The company has a comprehensive phase III clinical development programme in NSCLC, investigating divarasib as both a monotherapy and as a chemotherapy-free combination, across different disease settings and lines of therapy. The US Food and Drug Administration granted Breakthrough Therapy Designation to divarasib in 2022, and in 2026, Orphan Drug Designation for KRAS G12C non-small cell lung cancer. Overall, the results of the Krascendo 1 study are a significant step forward in the treatment of KRAS G12C non-small cell lung cancer, and Roche is committed to bringing this potential treatment option to patients as soon as possible.