NewLink Genetics writes off pancreatic cancer immunotherapy after phase 3 failure
- NewLink genetics has ended clinical development of its pancreatic cancer immunotherapy, algenpantucel-L, which was aimed at patients with pancreatic cancer who have already undergone surgery.In a phase 3 trial of the vaccine, survival rates in treated patients were three months shorter than the control group (27.3 months versus 30.4 months).
- There was no statistically significant difference in long-term survival rates, which were 42.1% vs. 41.4% (treated vs. controls) for three years, and 32.7% vs. 32.6%, respectively.
- The stock plummeted on the news. Overall, NewLink lost more than one-third of its value Monday, trading under the $11 mark for a time.
The failure of NewLink's pancreatic cancer vaccine, which was designed to stimulate patients' immune systems to kill pancreatic cancer cells, is a major disappointment for the company. Given the dismal survival rates associated with pancreatic cancer— the one-year survival rate for patients with pancreatic cancer is 28%, while the five-year survival rate is 7% — the need for more therapies is acute.
"We are deeply disappointed for patients that the impress Phase 3 study was not successful. We want to extend our sincere appreciation to all the patients, caregivers, investigators, research nurses, employees and others who contributed to the study," said Nicholas Vahanian, chief medical officer of Newlink in a statement.
Until the approval Merrimack's Onivyde last October for treatment of metastatic pancreatic cancer, there had been no new treatments for decades. In a phase 3 study of 417 patients with metastatic pancreatic cancer, those treated with Onivyde combined with chemotherapy lived an average of 6.1 months, compared with 4.2 months for patients only treated with chemotherapy. Likewise, in each treatment group, patients experienced no tumor growth for 3.1 and 1.5 months, respectively.
As for NewLink Genetics, algenpantucel-L was the star candidate, though the company said that it is looking towards its pipeline to continue to develop cancer therapies. NewLink also manufactures the Ebola Vaccine, rVSV-EBOV.
Before the news, NewLink's 52-week low as $15.15, but it broke through that Monday, hitting an all-time low and trading roughly 70% off of its 52-week high of $56.15. NewLink has received some criticism for not allowing independent data monitors to conduct a futility analysis — something that could have led to the trial ending earlier, saving time, money and the efforts of patients.
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