OncoSec's TAVO-KEYTRUDA Shows 41% ORR In Late-Stage Metastatic Melanoma Study

(RTTNews) - Oncosec Medical Inc. (ONCS) said Wednesday that its lead product candidate, TAVO, in combination with the anti-PD-1 checkpoint inhibitor KEYTRUDA or pembrolizumab, produced a 41% overall response rate or ORR, with 36% complete response in a Phase 2, single arm study evaluating patients with metastatic melanoma selected to be anti-PD-1 checkpoint resistant.

In the trial, responses were observed in nine of 22 evaluable patients, for an objective response rate of 41 percent. Thirty-six percent of patients experienced a complete response.

Median progression-free survival was 5.6 months, with median overall survival not yet reached after a median follow-up of 19.6 months. Grade 3 or higher adverse events were limited and included pain, chills, sweat and cellulitis, as well as certain toxicities usually observed with immune checkpoint inhibitors such as pembrolizumab.

The KEYNOTE-695 study is a pivotal, global, open-label trial of TAVO in combination with KEYTRUDA in patients with anti-PD-1 checkpoint resistant metastatic melanoma.

TAVO has been designated fast track and orphan drug status by the U.S. FDA and following completion of the KEYNOTE-695 study OncoSec intends to file for accelerated U.S. approval.