On Wednesday, Amgen Inc. (NASDAQ:AMGN) and its partner Zai Lab (NASDAQ:ZLAB) said the final analysis of the Phase 3 FORTITUDE-101 trial evaluating bemarituzumab in combination with chemotherapy (mFOLFOX6) in first-line gastric cancer has been completed.
At the pre-specified interim analysis, which was the primary analysis, the bemarituzumab plus chemotherapy regimen demonstrated a clinical and statistically significant improvement in overall survival (OS) compared to chemotherapy alone.
However, at the final analysis, the magnitude of the previously observed survival benefit has attenuated.
Also Read: Amgen Stock Sinks As Market Eyes MariTide’s Next Move
Amgen has indicated that the results from both the interim analysis and final analysis will be presented at an upcoming major medical meeting.
Based on the updated results of the FORTITUDE-101 trial, Zai Lab intends to await the results of FORTITUDE-102, evaluating bemarituzumab in combination with nivolumab and chemotherapy in the same patient population, prior to regulatory filing.
Bristol-Myers Squibb & Co (NYSE:BMY) markets nivolumab as Opdivo.
Data readout from FORTITUDE-102 is anticipated by the end of 2025 or the first half of 2026.
William Blair analyst Matt Phipps on Wednesday wrote that they have been cautious on the opportunity for bemarituzumab following the FORTITUDE-101 announcement, given the known safety issues with ocular toxicity and the importance of FORTITUDE-102, given Opdivo plus chemotherapy has become standard of care in the indication.
“It is disappointing to see the survival benefit deteriorate with additional follow-up, which now appears to place full reliance on positive FORTITUDE-102 results to support a regulatory filing,” Phipps wrote.
The analyst had assumed the commercial launch of bemarituzumab in 2026 with sales reaching roughly $480 million by 2030, but will likely need to adjust our approval timelines to account for the timing of the FORTITUDE-102 results.
“Regardless, we believe bemarituzumab has a limited market opportunity and therefore is not a major value driver for Amgen,” Phipps said.
William Blair maintains an Outperform rating for Amgen.
AMGN Price Action: Amgen shares were down 1.48% at $279.66 at the time of publication on Thursday. The stock is trading within its 52-week range of $253.30 to $339.17, according to Benzinga Pro data.
Read Next:
Photo: motorolka/Shutterstock
