Your Health, We Care
Release date: 2026-04-22 11:44:00 Recommended: 6
The pivotal study supporting the approval of Adagrasib is a multicenter, single-arm Phase II trial that enrolled 116 adult patients with KRASG12C-mutant advanced non-small cell lung cancer. These patients had all received at least one prior systemic therapy (including platinum-based chemotherapy and immunotherapy) and experienced disease progression after treatment. In the study, all patients received oral Adagrasib twice daily, with no placebo control or active comparator. The primary efficacy endpoint was objective response rate assessed by an independent review committee, and secondary endpoints included duration of response, progression-free survival, and overall survival.
The study results showed that among the 116 evaluable patients, 48 achieved partial or complete remission, with an objective response rate of 41.4%. This means that over 40% of patients experienced clinically meaningful tumor shrinkage after treatment with Adagrasib. Among those who achieved a response, the median duration of response was 8.5 months, i.e., the time from first documented response to disease progression or death was 8.5 months. These data indicate that Adagrasib provides rapid and durable tumor control for patients with KRASG12C-mutant lung cancer who have failed multiple lines of prior therapy.
Although the above study did not directly compare Adagrasib with standard chemotherapy or docetaxel, the 41.4% objective response rate is relatively high in previously treated advanced lung cancer patients, and the responses were durable. Given the longstanding lack of effective targeted therapies for patients with KRASG12C mutations and the clear unmet medical need, the European Medicines Agency granted conditional approval to Adagrasib. As a condition of approval, the sponsor must complete an ongoing randomized controlled Phase III study directly comparing the efficacy and safety of Adagrasib versus docetaxel in patients with KRASG12C-mutant lung cancer who have received at least one prior line of therapy, and submit final results to convert to full approval.
