- Aduro Biotech's pancreatic cancer immunotherapy failed to significantly improve patient outcomes in a Phase 2b trial, the company said Monday. The news sent its stock tumbling by as much as 32% yesterday, although it recovered somewhat by the end of the day.
- The company has been testing its listeria-derived immuno-oncology drug, CRS-207, in combination with the pancreatic vaccine GVAX Pancreas. But patients treated with the combination had lower median overall survival times than the two control arms.
- Aduro's CEO Stephen Isaacs called the results "disappointing" but pointed optimistically toward upcoming interim results from the company's ongoing trial evaluating CRS-207 and GVAX with Bristol-Myers Squibb's Opdivo
This is not the first failure in the pancreatic cancer space. Challenges in drug development have stymied efforts to improve the bleak statistics associated with pancreatic cancer. One-year survival rates stand at around 28%, while the five-year survival rate sinks as low as 7%-8%
Cambridge, MA-based Merrimack broke through last October, winning FDA approval for Onivyde in combination with chemotherapy—the first approval for a pancreatic cancer drug in decade. But the survival benefit, while significant, was still small at a little under two months longer than chemo.
In Aduro's trial, patients treated with the CRS-207/vaccine combo had median overall survival of 3.8 months, compared with 5.4 months for patients treated with CRS-207 alone and 4.6 months in patients treated with standard chemotherapy.
Although CRS-207 appeared to show more efficacy as a monotherapy, Aduro said the overall survival curve for the drug as a single agent was comparable to that seen with chemotherapy.
The company still has an ongoing trial evaluating CRS-207 and GVAX with and without the anti-PD1 immunotherapy Opdivo. "We believe the scientific rationale for combining CRS-207 with a checkpoint inhibitor is compelling," said Isaacs.
While this recent trial failure is a significant setback, Aduro has around $400 million in cash and short-term securities—something Isaacs made sure to point out in a statement on the results.