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.|