Keytruda filed in Japan in NSCLC neoadjuvant/adjuvant setting
Merck Inc., announced that it has filed its PD-1 inhibitor Keytruda (pembrolizumab) in Japan for its use as a neoadjuvant therapy together with chemotherapy and continuing as a single-agent adjuvant therapy for certain non-small cell lung cancers (NSCLCs)
The label expansion is being sought based on data from the PIII global KEYNOTE-671 trial, which covered patients with resectable stage II, IIIA or IIIB (T3-4N2) NSCLC. The trial was designed to gauge neoadjuvant Keytruda plus chemo, followed by adjuvant Keytruda as a monotherapy, versus placebo plus neoadjuvant chemotherapy followed by adjuvant placebo.
In the study, the Keytruda arm yielded a statistically significant and clinically meaningful improvement versus placebo in event-free survival (EFS), the primary endpoint.
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