OncoSec announces results from Phase 2 KEYNOTE-695 clinical trial

OncoSec Medical (ONCS) announced primary endpoint data from the Phase 2 KEYNOTE-695 clinical trial. This global, open-label single-arm trial is evaluating TAVO-EP, OncoSec’s proprietary interleukin 12 encoding plasmid delivered by intratumoral electroporation, in combination with KEYTRUDA, Merck’s (MRK) anti-PD-1 therapy, in patients with unresectable or metastatic melanoma who had confirmed disease progression after at least 12 weeks exposure to immediate prior anti-PD-1 antibody therapy. The last patient started treatment in December 2020; clinical database lock occurred in October 2022. The primary endpoint of overall response rate per RECIST v1.1 assessed by blinded independent central review (BICR) was not met. Among 98 efficacy evaluable patients with at least one post-baseline tumor assessment, the confirmed ORR per RECIST v1.1 by BICR assessment is 10.2%, which did not achieve the pre-specified clinically meaningful ORR of greater than or equal to17%. The BICR results for 98 efficacy evaluable patients are lower than the ORR per RECIST v1.1 by investigator assessment of 18.8% for the 101 patients previously reported as the key secondary endpoint of the KEYNOTE-695 trial. BICR assessment, i.e., review of the available images of treated and non-treated lesions by radiologists and oncologists, blinded to investigator assessments, showed that 4 patients had a complete response, 6 patients had a partial response, and 25 patients had stable disease as a best response, for a disease control rate of 35.7%. The durable response rate of greater than or equal to24 weeks is 8.2% and the median duration of response is 25.5 months.