Benzinga | Jun 4, 2021 09:01AM EDT

Amgen Offers Updated Results For Bemarituzumab In Comb With Chemo: Median Overall Survival 5.7 Months Longer

Median Overall Survival was 5.7 Months Longer in Patients Treated with Bemarituzumab Compared to Chemotherapy Alone

Full Results Presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting

THOUSAND OAKS, Calif., June 4, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced updated results for investigational bemarituzumab in combination with chemotherapy from the Phase 2 FIGHT trial. The trial evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus chemotherapy alone in patients with FGFR2b-positive, HER2-negative frontline advanced gastric or gastroesophageal junction cancers (GEJ). New data includes median overall survival (OS), a secondary endpoint that was reached with longer follow-up, as well as additional analyses of patient subgroups.

With a median follow-up of 12.5 months, the addition of bemarituzumab to chemotherapy resulted in a median OS of 19.2 months versus 13.5 months for chemotherapy alone in all randomized patients (n=155, HR: 0.6; 95% CI: 0.38, 0.94). In an exploratory pre-specified subgroup analysis, in patients with >10% of tumor cells overexpressing FGFR2b by immunohistochemistry (IHC), the median OS for bemarituzumab was 25.4 months versus 11.1 months (n=96, HR: 0.41; 95% CI: 0.23, 0.74).

The incidence of all grade adverse events was similar in the bemarituzumab plus chemotherapy and chemotherapy only arm of the study (100% versus 98.7%, respectively). The incidence of corneal adverse events was higher in the bemarituzumab plus chemotherapy arm versus the chemotherapy arm (all grade AEs 67.1% versus 10.4%), with dry eye reported as the most common corneal event (26.3%). The majority of the corneal adverse events were reversible.

The results were presented today in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting taking place virtually from June 4-8, 2021.

"Gastric cancer is the fourth leading cause of cancer death globally and 30% of frontline HER2-negative gastric cancer patients have tumors that overexpress FGFR2b," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "These updated results underscore the benefits that bemarituzumab plus chemotherapy may bring to patients who have been fighting this aggressive disease with chemotherapy alone. We now look forward to advancing bemarituzumab into Phase 3 development."

More than one million new gastric cancer cases are diagnosed annually, and gastric cancer is particularly prevalent in Asia.1,2 Approximately 80 to 85% of advanced gastric and GEJ cancers are HER2-negative, and approximately 30% of these tumors overexpress FGFR2b.3,4

"These updated results further validate our work on the role of FGFR2b overexpression in gastroesophageal cancer and demonstrate that treatment with bemarituzumab in combination with chemotherapy can deliver a clinically significant reduction in the risk of disease progression for patients whose tumors overexpress FGFR2b," said Daniel V.T. Catenacci, MD, PhD, medical oncologist and principal investigator at the University of Chicago.

In April 2021, bemarituzumab was granted Breakthrough Therapy Designation by the U.S. FDA based upon a subset of patients from the FIGHT trial who showed at least 10% of tumor cells overexpressing FGFR2b. Amgen continues to investigate the role of FGFR2b and will continue to work with regulatory agencies on next steps, including Phase 3 development, to bring this potential first-in-class therapy to patients.