Merck and Co Inc (MRK)

[DewDiligence]

Keytruda hits EFS co-primary_endpoint_in_neoadjuvant/adjuvant TNBC:

https://finance.yahoo.com/news/merck-announces-phase-3-keynote-104500585.html

Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), neoadjuvant KEYTRUDA plus chemotherapy followed by adjuvant KEYTRUDA as monotherapy showed a statistically significant and clinically meaningful improvement in EFS compared with neoadjuvant chemotherapy alone. As previously communicated, KEYNOTE-522 met its other dual primary endpoint of pathological complete response (pCR).

The pCR data from this trial (KEYNOTE-522) were announced in 2019 (#msg-151418671), but MRK received a CRL in Mar 2021 when it sought FDA accelerated approval based on only the pCR data (#msg-162862301). Now, a quick resubmission of the sBLA and (full) FDA approval looks like a fait accompli.