TAVO + Keytruda demonstrated 41% overall response rate and 36% complete response in a late-stage metastatic melanoma study featured in ‘Clinical Cancer Research’.- Oncosec Medical.

Oncosec Medical announced published data in Clinical Cancer Research that demonstrated its lead product candidate, TAVO (interleukin-12 or “IL-12” plasmid), in combination with the anti-PD-1 checkpoint inhibitor Keytruda (pembrolizumab), produced a 41% overall response rate (ORR), with 36% complete response in a Phase II, 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 results published in Clinical Cancer Research were also highlighted in a recent press release issued by the American Association for Cancer Research.

“This study provided evidence of how TAVO may convert immunologically ‘cold’ melanomas to ‘hot’ and enable checkpoint monotherapies, like Keytruda, to be more effective with minimal side effects,” said Daniel J. O’Connor, President and CEO of OncoSec. “These findings provided the clinical rational for our ongoing pivotal KEYNOTE-695 study of Tavo and Keytruda combination therapy in patients with anti-PD-1 checkpoint resistant metastatic melanoma. Because KEYNOTE-695 is treating patients with late-stage metastatic melanoma who have no FDA approved treatment options, nearly all study sites remain open and are actively recruiting patients during the current COVID-19 pandemic”.

Following completion of the KEYNOTE-695 study OncoSec intends to file for accelerated U.S. approval.

See- “Phase II Trial of IL-12 Plasmid Transfection and PD-1 Blockade in Immunologically Quiescent Melanoma”-Alain P. Algazi et al.Clinical Cancer Research published 6 May 2020 DOI: 10.1158/1078-0432.CCR-19-2217