OncoSec Medical (NASDAQ:ONCS) slumps 56% premarket on robust volume following its announcement of preliminary results from an open-label Phase 2b clinical trial, KEYNOTE-695, evaluating the combination of TAVO (tavokinogene telseplasmid/IL-12) with Merck's (NYSE:MRK) Keytruda (pembrolizumab) in patients with unresectable advanced melanoma who progressed after anti-PD-1 therapy alone.
At data cutoff, nine patients completed 12 weeks of treatment and reached the first tumor evaluation point. All previously received anti-PD-1 therapy while 56% (n=5/9) received more than one prior line of treatment.
The response rate was 22% (n=2/9), all partials, while one had stable cancer, implying a disease control rate of 33% (n=3/9).
Despite a statement from the lead investigator that a 10% response is meaningful in this treatment-resistant population, investors are clearly disappointed with the data.
The study should wind up in 2019. OncoSec says it plans to a U.S. marketing application seeking accelerated approval in Q4 2019/Q1 2020.
The company says TAVO uses electroporation (ImmunoPulse) to deliver IL-12 into the tumor microenvironment which stimulates an immune response to the cancer.
Now read: A Migrating Biotech Bear »
Subscribe for full text news in your inbox