SU2C commends FDA’s approval of new cancer therapy

Stand Up To Cancer (SU2C) welcomed the recent Food and Drug Administration (FDA) approval this month of encorafenib in combination with cetuximab for patients with advanced BRAF-mutated colorectal cancer.

Research by the SU2C-Dutch Cancer Society (KWF) Translational Research Team: Prospective Use of DNA-Guided Personalized Cancer Treatment contributed to the development of this treatment.

This is the seventh FDA approval for a new cancer therapy supported by SU2C research. The work of this team demonstrates how SU2C's research accelerates development of new effective treatments showing promise in patients."

Phillip A. Sharp, PhD, Nobel Laureate and Chair of the SU2C Scientific Advisory Committee

Sharp is also the Institute professor, David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology.

BRAF-mutant colorectal cancer is a hard to treat type of colorectal cancer that affects 10 to 15 percent of colorectal patients. Across the US and Canada, approximately, this new treatment could potentially help between 17,500-26,000 patients each year.

"Colorectal cancer is the second leading cause of cancer death in men and women combined," stated SU2C CEO Sung Poblete, PhD, RN. "Stand Up To Cancer is proud to have contributed to the development of this new targeted treatment option for people with the historically difficult to treat colorectal cancer whose cancer has progressed, despite receiving prior therapy."

The SU2C-KWF Research Team participated in a Phase 1b/ Phase 2 multi-institutional dose escalation clinical trial (NCT01719380) which studied the effects of encorafenib, alpelisib and cetuximab in BRAF-mutated colorectal cancers.

The study compared a two-drug combination of encorafenib and cetuximab; and a triple-drug combination of encorafenib, alpelisib, and cetuximab. Both combinations showed promise for treating metastatic colorectal cancer characterized by BFAF mutations and were well tolerated by the patients.

The team made an important observation that patients carrying key mutations in genes associated with the MAP kinase signaling pathway were more responsive to the combination.

Supported by the team's findings, the FDA granted Breakthrough Therapy Designations for both the combination of encorafenib, binimetinib, and cetuximab and the combination of encorafenib and cetuximab for patients with BRAF V600E-mutant metastatic colorectal cancer, which sped regulatory review.

"We now have clinical proof that science can guide smart treatment combinations which will further stimulate intelligent use of combinations of targeted anti-cancer drugs," said Emile Voest, MD, PhD, professor of Medical Oncology, medical director of the Netherlands Cancer Institute, and leader of the SU2C-KWF Translational Research Team: Prospective Use of DNA-Guided Personalized Cancer Treatment.

"These results highlight how novel insights gained from basic research can lead to novel therapeutic options for cancer patients," said Rene Bernards, PhD, Netherlands Cancer Institute, and co-leader of the Research Team.

This Research Team engaged just over a dozen scientists from the Netherlands Cancer Institute, Erasmus Medical Center, University Medical Center Utrecht in the Netherlands, and University of California San Diego and UC San Francisco.