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

Bavarian Nordic
Bavarian Nordic's headquarters in Kvistgaard, Denmark.

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.

Related Articles:
Bristol-Myers bets $1B on Bavarian Nordic cancer vaccine
Bavarian Nordic starts PhII of Prostvac in early-stage cancer
Bristol-Myers, Bavarian Nordic to advance Opdivo combo in NSCLC after recent trial failure
Combo of Bavarian Nordic's Prostvac and BMS' Yervoy yields promising PhI results
Immunotherapy combos could provide a new path forward for troubled cancer vaccine field
Cancer vaccine partners J&J, Aduro add $817M pact
Cancer vaccines field to see sizable growth, report says

Suggested Articles

Pfizer isn't giving up in biosims. This week, it unveiled launches to three Roche blockbusters, with two already on the market.

Novo Nordisk is betting big on GLP-1 Saxenda in its global obesity push, but England's cost watchdog is unimpressed with the drug's long-term outlook.

Tecentriq didn’t show benefit against simple observation at delaying cancer recurrence or death in patients with muscle-invasive urothelial cancer.