Breakthrough Designation For Aduro Biotech For Pancreatic Cancer
Pancreatic Cancer is certainly on the move! Lots of interesting research happening in this cancer type which is still considered one of the toughest cancers to treat. The latest bit of good news comes from Aduro Biotech based in San Francisco, which received the Breakthrough Designation from the FDA.
For a company to receive Breakthrough therapy designation, it needs to have clinical results that could be considered truly a breakthrough. Aduro had earlier at ASCO 2014 announced the outcome of the Phase 2 randomized, open-label study testing the efficacy and immune response to GVAX pancreas vaccine alone vs GVAX followed by CRS-207 (modified listeria monocytogenes) in pancretic cancer patients who had either progressed on chemotherapy or refused chemotherapy.
The outcome of the study was indeed quite impressive showing a median overall survival 6.1 months in the Listeria monocytogenes arm compared to 3.9 months for those receiving GVAX monotherapy (HR=0.59, one-sided p=0.0172).
Earlier this year, another company, Merrimack, demonstrated that its drug, a novel nanoliposomal form of irinotecan MM-398, improved overall survival in second line Pancreatic Cancer from 4.2 months to 6.1 months when combined with 5-FU and leucovorin.
These ~two months increase in median overall survival may not seem like much but progress in science is based on these incremental improvements. One day we hope that Pancreatic cancer will become like breast cancer where patients are diagnosed early, and treated quickly such that their lifespan is extended by 10, 15, or 20 or more years.
Congratulations to Aduro for a big milestone. Long road still ahead, and each small victory is worth celebration. Undoubtedly the Breakthrough designation will give this tiny biotech some much needed boost in interest in their technology.
For a company to receive Breakthrough therapy designation, it needs to have clinical results that could be considered truly a breakthrough. Aduro had earlier at ASCO 2014 announced the outcome of the Phase 2 randomized, open-label study testing the efficacy and immune response to GVAX pancreas vaccine alone vs GVAX followed by CRS-207 (modified listeria monocytogenes) in pancretic cancer patients who had either progressed on chemotherapy or refused chemotherapy.
The outcome of the study was indeed quite impressive showing a median overall survival 6.1 months in the Listeria monocytogenes arm compared to 3.9 months for those receiving GVAX monotherapy (HR=0.59, one-sided p=0.0172).
Earlier this year, another company, Merrimack, demonstrated that its drug, a novel nanoliposomal form of irinotecan MM-398, improved overall survival in second line Pancreatic Cancer from 4.2 months to 6.1 months when combined with 5-FU and leucovorin.
These ~two months increase in median overall survival may not seem like much but progress in science is based on these incremental improvements. One day we hope that Pancreatic cancer will become like breast cancer where patients are diagnosed early, and treated quickly such that their lifespan is extended by 10, 15, or 20 or more years.
Congratulations to Aduro for a big milestone. Long road still ahead, and each small victory is worth celebration. Undoubtedly the Breakthrough designation will give this tiny biotech some much needed boost in interest in their technology.
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