In another step forward for cancer vaccine combos, Aduro Biotech announced Thursday that an investigator-led Phase II trial of its GVAX and CRS-207 for pancreatic cancer with Opdivo, Bristol-Myers Squibb's ($BMY) PD-1 drug, would begin.
The first patient has been enrolled in the Phase II trial, which will involve about 88 adults with metastatic pancreatic cancer and which will take place at up to 5 U.S. sites. The patients will also have had one prior chemotherapy regimen for metastatic disease. One arm of the trial will test the combo with Opdivo, while the other arm will test CRS-207 and GVAX alone.
"For some time, we have recognized and embraced the power of combination strategies for immuno-oncology and this trial will evaluate expanding our lead combination to include Opdivo, the first-in-class anti-PD-1," Stephen Isaacs, Aduro's chairman, president and CEO, said in a statement.
In 2014, the FDA granted CRS-207 and GVAX its Breakthrough Therapy designation. Aduro is currently conducting a separate Phase IIb trial for CRS-207 and GVAX, comparing overall survival between three groups: one getting the combo, one receiving only CRS-207 and one undergoing standard chemotherapy alone.
Like other cancer vaccine prospects around the industry--including bagged projects from GlaxoSmithKline ($GSK) and Merck KGaA--GVAX flopped on its first try. It was developed by San Francisco's Cell Genesys, which halted its 2008 trial because more people died among those on GVAX than among those undergoing another treatment.
Other companies also taking the combo route include Amgen ($AMGN) and Advaxis ($ADXS), which are both testing their cancer vaccines with Merck's ($MRK) Keytruda.
- here's the release
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