About three years ago Aduro BioTech licensed in the failed cancer vaccine GVAX from BioSante with a plan to study it in combination with its own CRS-207 to see if the one-two punch could extend the lives of patients with advanced pancreatic cancer. And investigators say they got a positive early read out in Phase II, with one group patients living several months longer after receiving the combination treatment.
The overall survival benefit for the combo was only a couple of months longer than the control arm. But particularly encouraging, the investigators add, were the results for one group of patients getting at least two doses of GVAX followed by at least one dose of CRS-207. The group's median survival rate was 9.7 months compared to an average of 4.6 months for patients receiving only GVAX.
The trial--which recruited 93 patients--was stopped early after meeting the primary efficacy endpoint at a pre-planned interim analysis. And Aduro CEO Stephen Isaacs says that the trial provides some evidence to support the effectiveness of cancer vaccines--which have experienced a string of setbacks in late-stage studies. Checkpoint immunotherapies like the PD-1 programs at Merck ($MRK) and Bristol-Myers Squibb ($BMY), meanwhile, have largely been hogging the spotlight in oncology.
Quite a few people had largely given up on GVAX after it failed a key study in 2008. Now Isaacs intends to open a new chapter with a novel combination of cancer vaccines. But it faces a huge hurdle in Phase III.
"The significant improvement in survival in patients treated with our combination therapy expands on building evidence that immunotherapy can be a promising approach in oncology, even in a difficult-to-treat disease such as pancreatic cancer," said Isaacs in a statement. "We are thrilled to be at the forefront of innovation in the field and look forward to advancing our vaccines into additional clinical trials in pancreatic cancer and other indications."
- here's the release