Statistically Significant Survival Benefit Demonstrated in Pancreatic Cancer Patients Treated with Novel Immunotherapy
January 12, 2015 04:00 PM Eastern Standard Time
BERKELEY, Calif. -- Aduro Biotech, Inc. today announced that results from a Phase 2 clinical trial of patients with metastatic pancreatic cancer were published in the most recent issue of the Journal of Clinical Oncology (JCO). The multi-center trial, which enrolled 93 pancreatic cancer patients, demonstrated a statistically significant survival benefit in patients receiving the combination immuno-oncology regimen of CRS-207 and GVAX Pancreas.
In the clinical trial, the median overall survival of Arm A patients receiving the combination regimen of CRS-207 and GVAX Pancreas was 6.1 months compared to 3.9 months for Arm B patients receiving GVAX monotherapy (HR=0.5930, one-sided p=0.0172). One-year survival probability for patients in Arm A was 24 percent compared with 12 percent for patients in Arm B. The most frequent drug-related Grade 3 or 4 adverse event (AE) was lymphopenia, with three patients experiencing Grade 3 lymphopenia and two patients experiencing Grade 4 lymphopenia. There were no other Grade 4 AEs, and there were no other Grade 3 AEs with frequencies higher than five percent in either arm. The most common Grade 3 AEs were transient lymphopenia, fevers, elevated liver enzymes and fatigue. The trial enrolled advanced-stage metastatic pancreatic cancer patients who previously received or refused prior chemotherapy, with most patients having received two or more prior therapies in the metastatic setting. Patients were randomized in a 2:1 ratio to receive two doses of GVAX Pancreas vaccine followed by four doses of CRS-207 (Arm A) or to receive six doses of GVAX Pancreas vaccine alone (Arm B).
The results were more pronounced in a pre-defined subset of patients who received at least three doses in either treatment group (GVAX Pancreas dose followed by at least one CRS-207 dose in Arm A or at least three doses of GVAX Pancreas in Arm B). The median overall survival was 9.7 months in Arm A compared to 4.6 months in Arm B (HR=0.5290, one-sided p=0.0167).
“We are encouraged by these Phase 2 results in this difficult-to-treat patient population with limited effective treatment options,” said Stephen Isaacs, chairman, president and chief executive officer of Aduro. “We are particularly pleased to see the results published in JCO and must acknowledge the patients who enrolled in the study, their families and the hard work and dedication of our partners at all of the clinical sites, led by lead investigator Dung Le, M.D., Assistant Professor of Oncology at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, who have been instrumental in development of this novel immuno-oncology regimen. Ultimately, our goal with this program is to make a difference in the lives of pancreatic cancer patients by offering a more effective, less toxic therapeutic option.”
Based on the Phase 2 results, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Aduro’s combination of CRS-207 and GVAX Pancreas. According to the FDA, a Breakthrough Therapy designation is for product candidates that are intended, alone or in combination with other products, to treat a serious or life-threatening condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint over available therapies.
Aduro is currently conducting a 240 patient Phase 2b clinical trial, ECLIPSE, in patients with metastatic pancreatic cancer who have received prior chemotherapy in a metastatic setting. The randomized, controlled three-arm trial will involve over 20 clinical trial sites in the United States and Canada and will evaluate the safety, immune response and efficacy of Aduro’s immuno-oncology regimen of CRS-207 and GVAX Pancreas, compared to both single-agent chemotherapy and CRS-207 monotherapy. The primary endpoint of the trial is overall survival. More information about ECLIPSE can be found at www.clinicaltrials.gov identifier NCT02004262.
LADD is Aduro’s proprietary platform of live, attenuated, double-deleted Listeria monocytogenes strains that have been engineered to initiate a powerful innate immune response and drive a targeted, durable adaptive immune response.
CRS-207 is Aduro’s lead LADD product candidate, engineered to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers including mesothelioma and pancreatic, lung, ovarian and gastric cancers.
About GVAX Pancreas
GVAX Pancreas is one of a family of GVAX vaccines derived from human cancer cell lines and is designed to activate specific T cell immunity to cancer antigens including mesothelin, enabling a broad-based immune response.
About Aduro Biotech
Aduro Biotech, Inc. is a private, clinical-stage immuno-oncology company focused on the development of its live, attenuated, double-deleted (LADD) Listeria monocytogenes and cyclic dinucleotide (CDN) technology platforms to initiate powerful innate immune responses and drive targeted, durable adaptive immune responses against cancer. Aduro has received Breakthrough Therapy designation from the FDA for its lead immuno-oncology regimen, CRS-207 and GVAX Pancreas, in pancreatic cancer. The company is evaluating CRS-207 and GVAX Pancreas in the ongoing Phase 2b ECLIPSE clinical trial and has additional ongoing clinical trials with its LADD product candidates in mesothelioma and glioblastoma. The company is also developing clinical candidates using synthetic small molecule CDNs that are designed to activate the intracellular STING receptor. For more information, please visit www.aduro.com.
Aduro Biotech, Inc.
Greg W. Schafer, 510-809-4801
Chief Operating Officer
Angela Bitting, 925-202-6211