Merck and Co Inc (MRK)

[DewDiligence]

MRK—Keytryda/chemo shows statig-better pCR than chemo alone in neoadjuvant TNBC—trial continues to evaluate event-free survival (co-primary endpoint):

https://www.businesswire.com/news/home/20190729005182/en

Merck…today announced that the Phase 3 KEYNOTE-522 trial investigating KEYTRUDA…in combination with chemotherapy met one of the dual-primary endpoints of pathological complete response (pCR) following the neoadjuvant part of the neoadjuvant/adjuvant study regimen in patients with triple-negative breast cancer (TNBC). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), KEYTRUDA in combination with chemotherapy demonstrated a statistically significant improvement in pCR rates compared with chemotherapy alone, regardless of PD-L1 status. A pathological complete response or pCR is defined as a lack of all signs of cancer in tissue samples analyzed following completion of neoadjuvant therapy and definitive surgery.

Based on the recommendation of the DMC, the trial will continue without changes to evaluate the other dual-primary endpoint of event-free survival (EFS), per the trial design.

Full results will be reported after the trial is completed.