OncoSec Medical Incorporated (NASDAQ: ONCS) jumped 21.86% after entering a Clinical Trial Collaboration and Supply Agreement with Merck (NYSE: MRK) to study the combination of its DNA plasmid interleukin-12 TAVO with Merck’s KEYTRUDA (pembrolizumab) in a randomized third phase clinical study, KEYNOTE-C87.
Merck and OncoSec to conduct KEYNOTE-C87 study
The clinical trial will assess overall patient survival for patients treated with OncoSec’s TAVO in combination with Merck’s KEYTRUDA compared to standard of care in late-stage metastatic melanoma patients that are nonresponsive to immune checkpoint therapy.
The US FDA granted TAVO Fast Track designation as a novel intratumoral anti-cancer gene therapy expressing IL-12 for metastatic melanoma treatment after progression to OPDVIO or KEYTRUDA. In addition, the KEYNOTE-C87 study will support accelerated FDA approval. According to the terms of the collaboration agreement, Merck will supply KEYTRUDA, and OncoSec will provide TAVO with each party responsible for its internal costs.
OncoSec CEO Brian Leuthner said, “We are thrilled to enter into this collaboration and supply agreement with Merck – one of the world’s leading immuno-oncology companies – to help bring TAVO™ to patients with metastatic melanoma whose disease did not respond to initial checkpoint inhibitor therapy or who have developed progressive disease and therefore do not have additional treatment options available.”
Merck receives approval for KEYTRUDA in cSCC
Merck has also received approval from the FDA for expanded KEYTRUDA indication as a monotherapy for locally advanced subcutaneous squamous cell carcinoma (cSCC) patient treatment. The approval is of cSCC that is not treatable through radiation or surgery.
The FDA based the approval on the second interim data analysis from the second phase of the KEYNOTE-629 study. Results demonstrated that KEYTRUDA had a 50% ORR with a17% complete response rate and a partial response rate of 33% in patients with locally advanced cSCC.