OncoSec tanks as TAVO-EP in combo with Keytruda trial fails

OncoSec Medical (Nasdaq: ONCS) closed down almost 50% on Monday and fell a further 6% to $1.22 pre-market today, after the company announced primary endpoint data from the Phase II KEYNOTE-695 clinical trial that missed its goals.

This global, open-label single-arm trial is evaluating TAVO-EP, OncoSec's proprietary interleukin 12 (IL–12) encoding plasmid delivered by intratumoral electroporation, in combination with Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab), in patients with unresectable or metastatic (Stage III/IV) melanoma who had confirmed disease progression after at least 12 weeks exposure to immediate prior anti-PD-1 antibody therapy (pembrolizumab or nivolumab).

The last patient started treatment in December 2020; clinical database lock occurred in October 2022. The primary endpoint of overall response rate (ORR) per RECIST v1.1 assessed by blinded independent central review (BICR) was not met.