Checkpoint Therapeutics Inc. (NASDAQ:CKPT) has announced interim results of its on-going open-label, multicohort, global Phase 1 clinical study of cosibelimab, its PD-L1 antibody in the treatment of Advanced cancers that include enrolment of patients with metastatic cutaneous squamous cell carcinoma.
Results show 51.4% ORR with cosibelimab treatment
The preliminary results showed a 51.4% objective response rate for cosibelimab with a 13.5% complete response rate, which almost doubles the complete response rate shown in a previous analysis. If the study successfully meets the pre-defined endpoints, it will support the submission of marketing approval applications for cosibelimab globally. The company presented the preliminary results in a 2-poster during the 2020 European Society for Medical Oncology Virtual Congress.
James F. Oliviero, the CEO and President of Checkpoint, stated that the preliminary results were encouraging, and they demonstrated the potential of cosibelimab having a best-in-class safety and efficacy profile. Olivero said that the most important thing is that the ORR and complete response rate observed in almost half of the expected pivotal patient cohort continued trending higher than response rates that supported regulatory approval for the existing anti-PD-1s in mCSCC. This is attributed to the two-fold mechanism of action of cosibelimab of engaging natural killer cells and TR-cells in augmenting its efficacy. The results also showed the continued potential of cosibelimab having a favorable safety profile compared to the currently available anti-PD-1 therapies with fewer observed adverse events.
Cosibelimab to lower costs of treatment
According to Oliviero, US patients usually pay around 20% of the drug costs as coinsurance, with most insured patients paying out of pocket costs of around $2,000 for each anti-PD-1 therapy infusion. Oliviero said that once cosibelimab is approved, their market-disruptive pricing approach will significantly lower access to the costs patients have to pay for anti-PD-1 therapy. Therefore, this will enable more patients to access this potential life-saving cancer treatment therapy that some may not currently afford.
The study’s co-principal investigator, Professor Phillip Clingan, said that the preliminary data presented was highly promising and confirms previously observed efficacy and safety results in mCSCC patients that received cosibelimab treatment.