OncoSec reports updated tumor responses in study of melanoma combinaton
OncoSec (ONCS) announced an update regarding tumor responses in its Keynote-695 global, multicenter Phase 2b, open-label trial of intratumoral delivery of Tavo with intravenous Keytruda in patients with unresectable, advanced melanoma. The company previously reported that, of the first nine patients to reach initial tumor evaluation, two patients had a partial response. Both responses have been confirmed by blinded independent review. Further, in both cases, response duration has now reached six months. One of these previously assessed partial responses has now become a complete response per investigator assessment at the six-month tumor evaluation timepoint. Enrollment is ongoing and the company expects to complete the study next year. Tavo was well-tolerated, with primarily Grade 1 adverse advents associated with injection site or procedural pain. One Tavo related Grade 3 SAE of cellulitis was reported and resolved. Keynote-695 is expected to be completed in 2019. Based on the outcome of the study, the company plans to file for accelerated approval by end of 2019 or early 2020. Tavo has received both Orphan Drug and Fast-Track Designation by the FDA.