OncoSec Medical Inc. and Merck have entered into a supply and clinical trial agreement for pembrolizumab (Keytruda) and tavokinogene telseplasmid (Tavo) for the potential treatment of late-stage metastatic melanoma.
OncoSec Medical Inc. announced it has agreed to collaborate on a phase 3 randomized clinical trial and supply arrangement with Merck.1 The goal of the clinical trial (KEYNOTE-C87) is to evaluate the overall survival of patients with late-stage metastatic melanoma being treated with tavokinogene telseplasmid (Tavo, OncoSec), DNA-plasmid interleukin (IL)-12, in combination with anti-PD-1 therapy pembrolizumab (Keytruda) vs standard of care.
Tavokinogene telseplasmid received Fast Track designation from the FDA in February 2017 as a potentially first-in-class, intratumoral anti-cancer gene therapy that expresses IL-12 for the treatment of metastatic melanoma, following progression on pembrolizumab or nivolumab (Opdivo; Bristol-Myers Squibb), according to the press release.
The clinical trial is intended to help accelerate approval by the FDA and serve as a pivotal study to support a full licensure.
In the agreement, Merck will provide pembrolizumab and OncoSec will provide tavokinogene telseplasmid. Also, each company will be responsible for its own internal costs, and OncoSec will cover any third-party costs.
For the clinical trial, eligible patients must have Stage 3 or 4 unresectable, metastatic melanoma, and must be refractory to prior checkpoint therapy. KEYNOTE-C87 plans on enrolling roughly 400 patients from the U.S., Canada, EU, and Australia.
"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," said Brian Leuthner, interim CEO of OncoSec.
He added, "This phase 3 collaboration represents a crucial milestone for OncoSec as we advance Tavo through the clinic and toward potential approval globally and expands upon our initial 2017 clinical collaboration and supply agreement with Merck. We look forward to our continued work and progress with Merck and its experienced team of immuno-oncology leaders as we continue to explore Tavo in combination with Keytuda with the goal of helping more patients with cancer."
1. OncoSec enters into a collaboration agreement with merck for a pivotal global phase 3 study, keynote-c87, of tavo combined with keytruda for late-st…. Accessed July 7, 2021. https://www.firstwordpharma.com/node/1843855