Merck marks Merck in Merkel

Merkel cell carcinoma is an aggressive but rare cancer, and served as the way into the market for Merck KGaA/Pfizer’s Bavencio back in March 2017. Now the negligible sales that the drug generates here will come under threat, given that Merck & Co’s rival Keytruda just became the second checkpoint blocker to secure US approval in this cancer type. Keytruda was already a threat because of its considerable presence in much larger uses like lung cancer, and yesterday’s UD FDA green light came in Merkel cell patients naive to systemic therapy, effectively representing a first-line label. Bavencio’s approved use is based on a study that tested it in patients who had progressed after chemotherapy (AACR – Keytruda threatens avelumab, but feels more heat from Opdivo, April 20, 2016). Of the other PD-(L)1 players only Bristol-Myers Squibb looks to be involved in an active study of metastatic Merkel cell carcinoma; with just 2,000 new patients a year estimated in the US this is probably too small an opportunity for competitors to worry about.

Selected immunotherapy studies in metastatic Merkel cell carcinoma
Drug Company Study Line of therapy; data Trial ID
Bavencio* Merck KGaA/Pfizer Javelin Merkel-200 2L; 33% ORR, 10/88 CRs NCT02155647
Keytruda** Merck & Co Keynote-017 1L; 56% ORR, 12/50 CRs NCT02267603
Opdivo + Yervoy Bristol-Myers Squibb MCC-18786 2L; ORR primary, OS & PFS secondary endpoints; ends Jul 2023 NCT03071406
Accelerated US approval on *23 Mar 2017 and **19 Dec 2018. 

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