Dive Brief:
- 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
Dive Insight:
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%
Gilead's simtuzumab failed in a phase 2 trial in September 2014 and NewLink Genetics called it quits with its pancreatic cancer immunotherapy algenpantucel-L earlier this month.
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.