The P-III (KEYNOTE-412) trial evaluating Keytruda (200mg, q3w) + CRT (cisplatin + radiation) vs PBO + cisplatin & CRT as maintenance therapy in 780 adults with unresected LA HNSCC
The trial failed to meet its 1EPs of EFS. In the final analysis, the therapy sword an improvement in EFS in patients with Keytruda but did not meet statistical significance per the pre-specified statistical plan & the safety profile was consistent with prior reported studies in HNSCC
Keytruda is currently approved as monothx. & in combination regimens in the US, EU, China, Japan & other countries globally for the same indication The company has an extensive clinical program in lung cancer & the therapy is being evaluated in multiple registration-enabling studies
Ref: Bussinesswire | Image: Merck
