Trial results for the FORTITUDE-201 study (NCT05267470) investigating bemarituzumab monotherapy and in combination with other anti-cancer therapies, including pembrolizumab, for squamous-cell non-small-cell lung cancer (SqNSCLC) with FGFR2b overexpression were posted on ClinicalTrials.gov on 2025-03-25. The Phase 1 study, which was terminated, primarily assessed safety and tolerability, reporting 0 or 1 dose-limiting toxicity across evaluated arms.
Background
The FORTITUDE-201 study (NCT05267470) was designed to evaluate the safety and tolerability of bemarituzumab, both as monotherapy and in combination with other anti-cancer therapies such as docetaxel, pembrolizumab, carboplatin, and paclitaxel, in patients with squamous-cell non-small-cell lung cancer (SqNSCLC) with FGFR2b overexpression. The study also aimed to determine the recommended Phase 3 dose for bemarituzumab in combination regimens.
Trial design
The FORTITUDE-201 study (NCT05267470) was a Phase 1 clinical trial that enrolled 74 participants with squamous-cell non-small-cell lung cancer. The study investigated bemarituzumab as monotherapy and in combination with other agents, including docetaxel, pembrolizumab, carboplatin, and paclitaxel. The primary objectives were to evaluate the safety and tolerability of bemarituzumab and to determine the recommended Phase 3 dose of bemarituzumab in combination with other anti-cancer therapies.
Key results
The trial results focused on safety and tolerability outcomes. For the primary outcome of "Number of Participants Who Experienced a Dose Limiting Toxicity (DLT): Parts 1 and 4":
- In the 'Part 1: Bemarituzumab Dose 1 With Docetaxel' group, 0 Participants experienced a DLT.
- In the 'Part 1: Bemarituzumab Dose 2 With Docetaxel' group, 1 Participant experienced a DLT.
- In the 'Part 4: Bemarituzumab Dose 2 First-line Combination Therapy' group, 0 Participants experienced a DLT.
Regarding "Number of Participants With Treatment-emergent Adverse Events (TEAEs)", the following counts were reported across different study parts and dose groups:
- For 'Part 1: Bemarituzumab Dose 1 With Docetaxel', 4 Participants experienced TEAEs. (Reported twice with the same value).
- For 'Part 1: Bemarituzumab Dose 2 With Docetaxel', 9 Participants experienced TEAEs, and separately, 5 Participants experienced TEAEs.
- For 'Part 2: Bemarituzumab Dose 2 With Docetaxel', 29 Participants experienced TEAEs, and separately, 16 Participants experienced TEAEs.
- For 'Part 3: Bemarituzumab Dose 1', 25 Participants experienced TEAEs, and separately, 8 Participants experienced TEAEs.
- For 'Part 4: Bemarituzumab Dose 2 First-line Combination Therapy', 4 Participants experienced TEAEs.
What this means
The results from the FORTITUDE-201 Phase 1 trial indicate that bemarituzumab, both as monotherapy and in combination with agents like pembrolizumab, showed a generally manageable safety profile with low dose-limiting toxicities across the evaluated arms. The observed numbers of treatment-emergent adverse events provide initial insights into the safety profile of these regimens in patients with SqNSCLC. The termination of the study suggests that while safety was assessed, further development in this specific context may not be proceeding as initially planned, potentially due to strategic reasons or lack of sufficient efficacy signals, which were not detailed in the posted results.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05267470, titled "A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201)," were posted on 2025-03-25 on clinicaltrials.gov.