NewLink's Pancreatic Cancer Vaccine Fails to Improve Survival in Phase 3

Algenpantucel-L, an allogenic whole-cell immunotherapeutic vaccine being developed to destroy a patient’s pancreatic cancer cells, has failed to improve overall survival (OS).

In a press release prior to a conference call, NewLink Genetics, the company developing the vaccine, announced phase 3 results of the IMmunotherapy for Pancreatic RESectable cancer Study (IMPRESS) trial that evaluated the vaccine in combination with the standard-of-care, gemcitabine. The comparator arm of this randomized, controlled 2-arm study was gemcitabine alone. Trial participants were 722 surgically resected patients of pancreatic cancer who were enrolled between May 2010 and September 2013.

Phase 2 studies of the trial evaluated algenpantucel-L in 70 patients who were treated with gemcitabine and 5-fluorouracil—based chemoradiotherapy, as well as. After a median follow-up of 21 months, the 12-month disease-free survival was 62%, and the 12-month OS was 86%. However, in the phase 3 studies, OS was not statistically different between the arms: median survival was 30.4 months in the control group and 27.3 months in the vaccine-treated group. Long-term survival was not very different either: 3-year survival was 41.4% and 42.1%, while 4-year survival was 32.6% and 32.7% in the control and study groups, respectively.

“We are deeply disappointed for patients that the IMPRESS Phase 3 study was not successful,” said Nicholas N. Vahanian, MD, president and CMO of NewLink Genetics in the press release. “We want to extend our sincere appreciation to all the patients, caregivers, investigators, research nurses, employees and others who contributed to the study.”

One of the investigators on the study, George Fisher, MD, PhD, professor of Medicine at Stanford University, was optimistic despite the results. “The median overall survival of 29.3 months in this study represents a significant increase compared with prior trials and may be due to multiple factors, including the emergence of more effective treatment regimens for recurrent or metastatic disease. Although a negative study, these results represent an important and meaningful contribution to the understanding of the modern treatment of resected pancreatic cancer,” Fisher said.

According to TheStreet, if an interim analysis by an independent data monitoring committee had been conducted last May, it could have hinted to failure of the vaccine and could have allowed for early trial termination. But NewLink’s statistical plan prevented that.

Company CEO Charles Link has hinted at the vaccine being shelved following these disappointing results.