In a new phase 2 trial, Bavarian Nordic and Bristol-Myers Squibb plan to test the power of the Big Pharma's immunotherapies when paired up with the vaccine maker's prostate-cancer fighter Prostvac.
The new trial will enroll up to 55 patients with localized prostate cancer who will receive Prostvac in combination with either BMS's Yervoy or Opdivo, or a combination of all three, prior to surgery. Investigators plan to study changes in T cell infiltration in the tumor.
The test will begin with a lead-in stage assessing the safety of the three-med combo in 10 patients with castration-resistant prostate cancer.
The new BMS combo trial brings Prostvac's ongoing study count to 11 in various stages of prostate cancer, BN chief Paul Chaplin said in a statement. Top-line data from the vaccine’s first phase 3 study—which is testing the candidate, with or without an adjuvant known as GM-CSF, in early-stage prostate cancer—is expected later this year.
The trials are part of a $1 billion pact formed in 2015 between Bristol-Myers and Bavarian Nordic. The U.S.-based pharma forked over $60 million up front for an option on Prostvac, and it could owe up to $915 million in milestones if it moves forward to license and ultimately commercialize the treatment.
Last October, BMS and BN kicked off a phase 2 trial testing Prostvac and Yervoy as a combo therapy in prostate cancer patients. Bavarian Nordic sees "huge potential" in such cancer vaccine tie-ups, Chaplin said in a previous interview with FiercePharma.
Now, the addition of Opdivo to the phase 2 mix could be seen as part of Bristol-Myers’ determination to breathe new life into its PD-1 checkpoint inhibitor, which last year suffered a major setback in first-line non-small lung cancer as a monotherapy.
Bavarian Nordic is testing another cancer vaccine, CV301, with checkpoint inhibitors as well. It's studying that candidate with Opdivo in non-small cell lung cancer and with Roche’s third-to-market Tecentriq in advanced bladder cancer.
As for Keytruda, Merck has picked Agenus’ Prophage to be its cancer vaccine partner in a phase 2 trial in glioblastoma.