Checkpoint's low-cost oncology project inches towards the market

Fortress Biotech's subsidiary Checkpoint Therapeutics has promised to lower prices in the highly competitive anti-PD-(L)1 space, but how much of a threat it presents to incumbents remains unclear. The company took one step towards the market today: it needed an objective response rate of at least 36% to support a filing of its anti-PD-L1 MAb, cosibelimab, in metastatic cutaneous squamous cell carcinoma, and a 47.4% ORR crosses that threshold comfortably. How effectively cosibelimab will compete with existing agents – Sanofi/Regeneron’s Libtayo and Merck & Co’s Keytruda – remains uncertain, however, with executives declining to detail complete responses, or many other aspects of the data. At Esmo 2020 CRs reached 13.5% among 37 patients but all Checkpoint said on a call today was that the data were “competitive with what’s out there”; Libtayo and Keytruda have CRs of 17% and 11% on their labels respectively. On a topline, cross-trial comparison, with all the normal caveats, the agents do look similar. Another potential issue is that Checkpoint’s data were generated in a phase 1 open-label basket study conducted outside the US. To compete on price cosibelimab must get to market first, a prospect that still feels some way off.