Merck's Keytruda Gains New China Approval for Perioperative Treatment of Resectable NSCLC

On December 3, MSD's official WeChat account showed that a new indication for MSD's PD-1 inhibitor Pembrolizumab (K drug) has been approved for marketing in China. The indication isNeoadjuvant therapy combined with platinum-based chemotherapy followed by pembrolizumab monotherapy as adjuvant treatment after surgery for operable stage II, IIIA, and IIIB non-small cell lung cancer patients.（NSCLC）。

Screenshot source: Official WeChat account of the company

This approval was based on the positive results of the global Phase III clinical trial KEYNOTE-671. At the 2023 ESMO Congress, MSD announced the overall survival rate for perioperative pembrolizumab in the treatment of early-stage NSCLC. As of the median follow-up of 36.6 months,The median OS was not reached in subjects receiving pembrolizumab, and the median OS in the placebo group was 52.4 months.；The 36-month OS rates were 71.3% and 64.0%, respectively. The median EFS for subjects receiving pembrolizumab was 47.2 months.(vs 18.3 months).

In terms of safety, the incidence of grade ≥ 3 related adverse events in patients receiving pembrolizumab was 45.2%, compared to 37.8% in the placebo group. The incidence of any adverse events leading to discontinuation was 20.2% in the pembrolizumab group and 9.3% in the placebo group, while the incidence of adverse events leading to death was 1.0% and 0.8%, respectively.

Screenshot source: Insight database

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