Merck and Co Inc (MRK)

[DewDiligence]

FDA approves Keytruda in HNSCC with/without chemo— based on KEYNOTE-048 study:

https://finance.yahoo.com/news/fda-approves-two-indications-merck-104500594.html

Merck…today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) or in combination with platinum and fluorouracil (FU)…for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) [i.e. the chemo-combination indication is without regard to PD-L1 status].

The approval is based on results from the pivotal Phase 3 KEYNOTE-048 trial, where KEYTRUDA demonstrated a significant improvement in overall survival (OS) compared with the EXTREME regimen (cetuximab with carboplatin or cisplatin plus FU), a standard treatment, as monotherapy in patients whose tumors expressed PD-L1 (CPS ≥1) (HR=0.78 [95% CI, 0.64-0.96]; p=0.0171) and in combination with chemotherapy in the total study population (HR=0.77 [95% CI, 0.63-0.93]; p=0.0067). With these new indications, KEYTRUDA is the first anti-PD-1 therapy approved in the first-line setting as monotherapy in patients whose tumors express PD-L1 (CPS ≥1) or in combination with chemotherapy regardless of PD-L1 expression for patients with metastatic or with unresectable, recurrent HNSCC and the first anti-PD-1 therapy to demonstrate a statistically significant improvement in OS in these patients.

Yesterday was the PDUFA date.