Boston Biomedical, an industry leader in the development of novel compounds designed to target cancer stemness pathways, today announced dosing of the first patient in CanStem303C, a new global Phase III study investigating napabucasin in combination with standard of care (FOLFIRI) in patients with previously treated metastatic colorectal carcinoma (mCRC).
Approximately 1.4 million patients are diagnosed with colorectal cancer each year, making the disease the fourth leading cause of cancer-related deaths annually with nearly 700,000 deaths reported worldwide. An estimated 50 percent of all colorectal cancer patients will experience disease recurrence.
“Early clinical data for napabucasin in combination with FOLFIRI in advanced colorectal cancer has demonstrated encouraging anti-tumor activity even in FOLFIRI-pretreated patients, so we are eager to understand more deeply its potential therapeutic benefits in this difficult-to-treat cancer,” said Chiang J. Li, M.D. FACP, President, CEO and Chief Medical Officer of Boston Biomedical, and the Head of Global Oncology for Sumitomo Dainippon Pharma Group. “This milestone study is evidence of our commitment to uncover the full potential of cancer stemness pathway inhibition, and develop innovative second-line options for the colorectal cancer patient population.”
Patients in this global Phase III study will be randomized in a 1:1 ratio to receive either two daily doses of 240 mg napabucasin – an orally administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3 – plus biweekly FOLFIRI or biweekly FOLFIRI alone. The study also allows for the addition of bevacizumab per direction by the study investigator.
A total of 1,250 patients will be enrolled in the study. The primary endpoint of the study is overall survival. Secondary endpoints include progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), safety and quality of life. Overall survival, PFS, ORR and DCR analyses will be conducted in the general study population as well as in biomarker-positive patients.
“Cancer stem cells are known to be resistant to traditional therapies such as chemotherapy and radiation, and represent a more therapeutically challenging subgroup of cancer cells,” said Axel Grothey, M.D., Professor of Oncology, Mayo Clinic in Rochester, MN. “Therefore, the opportunity to investigate the addition of a cancer stemness inhibitor to established chemotherapeutic regimens in colorectal cancer research is attractive to clinicians seeking to improve long-term outcomes for metastatic colorectal cancer patients.”
Filed Under: Drug Discovery