RE:RE:RE:Stuff is happening Sanofi was responsible for sponsoring and operating Mirati Therapeutics' Phase 1/2 study in a collaboration that began in October 2021 with an Accelerated Approval being granted in December 2022.on the Phase 2 data.
Mirati Therapeutics reported topline Phase 1/2 results on 11 patients at ESMO in September 2021.
Results showed that the investigator assessed ORR was 58%. Two of the 11 responses occurred in patients after being on treatment for more than 10 months. The median follow-up was 17.3 months. The median duration of treatment and median duration of response were 9.5 months and 12.6 months, respectively. In addition, 64% of responders were still on treatment, and continuing to respond. The median progression free survival was 8.3 months and median overall survival was not reached. Grade 3/4 treatment related adverse events were observed in 26% of patients, with one Grade 5 event.
https://ir.mirati.com/press-releases/press-release-details/2023/Mirati-Presents-Two-Year-Follow-Up-Data-from-KRYSTAL-1-Study-Demonstrating-Durable-Response-and-Long-Term-Overall-Survival-at-2023-World-Conference-on-Lung-Cancer/default.aspx
https://ir.mirati.com/press-releases/press-release-details/2021/Mirati-Therapeutics-Announces-Positive-Phase-2-Topline-Results-for-Investigational-Adagrasib-in-Patients-with-KRAS-G12C-Mutated-Advanced-Non-Small-Cell-Lung-Cancer/default.aspx#:~:text=Results%20showed%20that%20the%20investigator,months%20and%2012.6%20months%2C%20respectively.
https://ir.mirati.com/press-releases/press-release-details/2021/Mirati-Therapeutics-to-Collaborate-with-Sanofi-on-Phase-12-Study-Evaluating-Combination-of-adagrasib-with-a-SHP2-Inhibitor-in-KRAS-G12C-mutated-Lung-Cancer/default.aspx