BMS, Bavarian Nordic kick off combo trial testing Prostvac/Yervoy in prostate cancer

Bristol-Myers Squibb and Bavarian Nordic are getting underway with their $1 billion Prostvac clinical partnership, kicking off a Phase II trial testing Yervoy and Prostvac in early prostate cancer.

It’s the first trial in a collaboration potentially worth up to $975 million pairing BMS immunotherapies with BN’s Prostvac. The companies will test a combo of Prostvac and Yervoy in 75 patients, divided into three groups.

Patients in each group will receive either Prostvac, Yervoy or the combo, testing primarily for CD3+ T cell immune responses. For secondary milestones, investigators will measure immunologic infiltration, circulating effector T cells and regulatory T cells.

After some large-scale cancer vaccine flops in 2014 damaged the industry’s prospects, biopharma companies started exploring combination approaches that pair vaccines with checkpoint inhibitors. Since then, pharma players such as BMS, Johnson & Johnson and AstraZeneca have inked sizable collaborations with cancer vaccine biotechs to test those combos.

BMS and Bavarian Nordic teamed up in March 2015 in a deal worth $60 million up front and $915 million in potential milestone payments. Bavarian Nordic CEO Paul Chaplin in a statement Monday said the vaccine and CTLA-4 checkpoint inhibitor have “complementary mechanisms of action.”

In a previous Phase I trial, the combo posted a survival advantage in patients with metastatic castration-resistant prostate cancer. Bristol-Myers and BN will next test a combo of Prostvac, Yervoy and Opdivo, BMS' PD-1 checkpoint inhibitor, the release said.

The two drugmakers are also working outside of the Prostvac pact; in August, they announced a trial pairing Opdivo with another of the Danish biotech’s cancer vaccines, CV301, in previously treated non-small cell lung cancer. After Opdivo fell short in a key first-line lung cancer trial, BMS said it is counting on follow-up combinations to continue fueling the drug's impressive launch.

In early-stage prostate cancer, BN is running a Phase II trial testing Prostvac as a solo treatment. In metastatic, castration-resistant prostate cancer, the candidate is expected to post Phase III data next year.

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