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Update on Amgen’s bemarituzumab Phase 3 FORTITUDE-101 Study

Key Takeaway: Amgen has completed the final analysis of the Phase 3 FORTITUDE-101 trial for bemarituzumab in gastric cancer. While the interim analysis showed significant survival benefits, the final results indicated a reduced effect. Zai Lab plans to wait for the FORTITUDE-102 trial results before proceeding with regulatory filings, expected by mid-2026.
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POSITIVE FACTORS

  • Bemarituzumab showed significant improvement in overall survival at interim analysis.
  • Results will be presented at a major medical meeting, indicating ongoing interest.
  • Zai Lab is strategically awaiting further trial results before regulatory filing.

CONCERNS & RISKS

  • The survival benefit observed in interim analysis has attenuated in the final analysis.
  • Regulatory filing is delayed pending results from FORTITUDE-102 trial.

BiopharmaWatch Analysis

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Best trade, last catalyst
+104%
120-day peak, hindsight
Typical move
8.5%
average across 4 past catalysts
Cash runway
~164 mo
Low dilution risk
Lead asset
ZL-1211
Phase 1 · Advanced Solid Tumor

Full Press Release Details

According to Amgen, Zai Lab’s partner and study sponsor, 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. 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. Data readout from FORTITUDE-102 is anticipated by the end of 2025 or the first half of 2026.Please refer to Amgen’s public statements made during the Wells Fargo Healthcare Conference on September 3, 2025. The link is provided below:https://event.webcasts.com/starthere.jsp?ei=1731776&tp_key=346b98b330&tp_special=8For more information, please contact:Investor Relations:Christine Chiou / Lina Zhang+1 (917) 886-6929 / +86 136 8257 6943christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.comMedia:Shaun Maccoun/ Xiaoyu Chen+1 (857) 270-8854 / +86 185 0015 5011shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com

Frequently Asked Questions

What is the FORTITUDE-101 trial about?

The FORTITUDE-101 trial evaluates bemarituzumab combined with chemotherapy for gastric cancer.

What were the results of the FORTITUDE-101 trial?

The interim analysis showed significant survival benefits, but the final analysis indicated reduced effects.

When will the results of FORTITUDE-102 be available?

Data from the FORTITUDE-102 trial is expected by late 2025 or early 2026.

What is Zai Lab's next step after FORTITUDE-101?

Zai Lab plans to wait for FORTITUDE-102 results before filing for regulatory approval.

Last updated: Sep 4, 2025