Amgen annuncia dati positivi per bemarituzumab nel trattamento del tumore gastrico e della giunzione gastro-esofagea (GC/GEJC)

Amgen announced positive interim analysis from P3 FORTITUDE-101 (NCT05052801) of bemarituzumab (Bema, anti-FGFR2b mAb) + chemo in 1L HER2-negative FGFR2b-positive GC/GEJC.

The press release states that bema + chemo demonstrated a statistically significant and clinically meaningful improvement in OS as compared to placebo + chemo with ocular toxicities being observed with greater frequency and severity than those seen in the P2 FIGHT study. 

• The FORTITUDE-101 regimen presents a direct competitive threat to STAR-221 as it may further segment the 1L HER2 GC/GEJC market and impact the addressable population for STAR-221
  • Per available literature and previous Amgen commentary, FGFR2b protein overexpression is seen in ~38% of patients with advanced G/GEJ cancer and Amgen will seek to position bema as the therapy of choice for this patient population
• Detailed results from this study are expected to be presented at ESMO 2025 and will clarify the magnitude of OS benefit over chemo and the safety and tolerability profile
  • Grade 3 corneal AEs were reported in 28% patients in the bema arm while none in the placebo arm from the P2 FIGHT (NCT03694522) trial
  • In addition to educating HCPs about the FGFR2b biomarker, implementing FGFR2b testing, Amgen will need to highlight management of ocular toxicities to ensure strong adoption of bema
• Data from P1b/3 FORTITUDE-102 ((bema + nivolumab (Opdivo, anti-PD-1) + chemo in 1L HER2-negative FGFR2b-positive GC/GEJC is expected in H2 2025
  • Combined global filing for FORTITUDE-101 and FORTITUDE-102 is expected for these two studies, with earliest potential US approval in Q3 2026 and EU approval in Q4 2026