On February 9, 2021 Sumitomo Dainippon Pharma Oncology, Inc., a developer of novel cancer therapeutics, reported that the CanStem303C study evaluating the efficacy and safety of investigational agent napabucasin when given in combination with FOLFIRI with or without bevacizumab in patients with previously treated metastatic colorectal cancer failed to reach the primary endpoints of overall survival (OS) (Press release, Sumitomo Dainippon Pharma, FEB 9, 2021, View Source [SID1234574821]). Napabucasin in combination with FOLFIRI failed to show significant OS improvement in the general study population and in patients whose tumor was positive for the phosphorylated signal transducer and activator of transcription 3 (pSTAT3) biomarker.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Patients with metastatic colorectal cancer have a high unmet medical need, and our hope was to develop a new treatment option for this population. We are disappointed with the results of this Phase 3 trial and would like to express gratitude to the trial participants, investigators and staff for their efforts and contributions to the study," said Patricia S. Andrews, CEO and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "SDP Oncology is committed to continuing our pursuit of advancing our pipeline to bring forward innovative treatments for patients with cancer."

The multicenter, open-label, randomized Phase 3 CanStem303C study evaluated the efficacy and safety of napabucasin in approximately 1,250 patients with previously treated metastatic colorectal cancer. Patients were randomized 1:1 in the study. The study had two primary endpoints – overall survival in all randomized patients and overall survival in a subpopulation of patients whose tumor was positive for the pSTAT3 biomarker. Napabucasin at a dose of 240 mg was administered orally, twice daily in combination with FOLFIRI with or without bevacizumab versus FOLFIRI with or without bevacizumab.

The most common adverse events, occurring in patients in the napabucasin combination arm, were consistent with previously published data and included diarrhea, nausea, vomiting and abdominal pain.

Final data and analyses of this study will be published for the oncology community.

About Napabucasin

Napabucasin is an investigational, orally administered reactive oxygen species (ROS) generator that is bioactivated by the intracellular antioxidant NAD(P)H:quinone oxidoreductase 1 (NQO1).1 Napabucasin exerts its antitumor activity by increasing levels of ROS beyond a cytotoxic threshold, causing cancer cell death.1,2

About Colorectal Cancer

Colorectal cancer is the third leading cause of cancer-related deaths in men and in women in the U.S. It is estimated that there will be 149,500 new cases of colorectal cancer and 52,980 deaths from colorectal cancer in the U.S. this year.3 Metastatic colorectal cancer occurs when cancer cells break way from a tumor in the colon or the rectum to other parts of the body through the bloodstream or lymphatic system.4 Approximately 22% of colorectal cancer cases are metastatic at initial diagnosis, and about 70% of patients will eventually develop metastatic relapse. Patients with metastatic colorectal cancer face poor prognosis in general, with a relative 5-year survival rate of 14%, compared to 71% and 90% in those with regional and localized colorectal cancer in the U.S.5