INDUCE-3
INDUCE-3: a randomized phase II/III study of first-line feladilimab plus pembrolizumab in patients with recurrent/metastatic head and neck squamous cell carcinoma
Phase 2/3N = 315NCT04128696
- Population
- First-line PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma
- Design
- Randomised (1:1), double-blind, adaptive phase 2/3 study (a 2-in-1 design with an option to expand the phase 2 study into a phase 3 confirmatory study) in first-line PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma. Feladilimab (an ICOS agonist) 24 mg plus pembrolizumab 200 mg, or placebo plus pembrolizumab 200 mg, every 3 weeks for up to 35 cycles. Primary endpoints were overall survival and investigator-assessed progression-free survival. An independent data monitoring committee recommended stopping accrual after review of unblinded interim data in 140 patients, when prespecified futility criteria were met, and the study did not proceed to the phase 3 expansion. The paper presents efficacy data without P values because no hypothesis testing was planned at this interim analysis.
- Primary endpoint
- OS, PFS
- Arms
- Feladilimab plus pembrolizumab (experimental, n = 157): Feladilimab 24 mg plus pembrolizumab 200 mg every 3 weeks
- Placebo plus pembrolizumab (control, n = 156): Placebo plus pembrolizumab 200 mg every 3 weeks
- People
- Rischin D, senior author Le Tourneau C
OSHR 1.51 (95% CI 0.99–2.29)PFSHR 1.40 (95% CI 1.05–1.86)Δ ORR−5.3 points
Show the numbers
| Endpoint | Analysis | Feladilimab plus pembrolizumab | Placebo plus pembrolizumab | Effect |
|---|---|---|---|---|
| OSModified intention-to-treat (mITT) population: all randomised patients who received the study intervention, excluding those first dosed or randomised after the date immediate discontinuation was requested (n = 313 of 315 enrolled) | interimmedian follow-up 6.28 monthsRischin 2026 | — | — | HR 1.51 (95% CI 0.99–2.29)Adjusted hazard ratio, feladilimab plus pembrolizumab versus placebo plus pembrolizumab; no P value (no hypothesis testing planned at this interim analysis). Events: 54 (34%) vs 38 (24%). Median OS was 44.1 weeks (95% CI 35.9 to not applicable) with feladilimab plus pembrolizumab and not reached with placebo plus pembrolizumab; weeks are not converted to months here. |
| PFSModified intention-to-treat (mITT) population: all randomised patients who received the study intervention, excluding those first dosed or randomised after the date immediate discontinuation was requested (n = 313 of 315 enrolled) | interimmedian follow-up 6.28 monthsRischin 2026 | — | — | HR 1.40 (95% CI 1.05–1.86)Adjusted hazard ratio. Median PFS was 10.1 weeks (95% CI 9.1 to 15) with feladilimab plus pembrolizumab versus 16 weeks (95% CI 14.3 to 26.1) with placebo plus pembrolizumab; weeks are not converted to months here. |
| ORRModified intention-to-treat (mITT) population: all randomised patients who received the study intervention, excluding those first dosed or randomised after the date immediate discontinuation was requested (n = 313 of 315 enrolled) | interimmedian follow-up 6.28 monthsRischin 2026 | 19.7% (13.8–26.8%) | 25% (18.4–32.6%) | Secondary endpoint: investigator-assessed best response without confirmation of complete or partial response (not required in the adaptive decision-making). Estimated difference -5.3 percentage points (95% CI -14.6 to 4). |
| Endpoint | Analysis | Feladilimab plus pembrolizumab | Placebo plus pembrolizumab | Effect |
|---|---|---|---|---|
| OSModified intention-to-treat (mITT) population: all randomised patients who received the study intervention, excluding those first dosed or randomised after the date immediate discontinuation was requested (n = 313 of 315 enrolled) | interimmedian follow-up 6.28 monthsRischin 2026 | — | — | HR 1.51 (95% CI 0.99–2.29)Adjusted hazard ratio, feladilimab plus pembrolizumab versus placebo plus pembrolizumab; no P value (no hypothesis testing planned at this interim analysis). Events: 54 (34%) vs 38 (24%). Median OS was 44.1 weeks (95% CI 35.9 to not applicable) with feladilimab plus pembrolizumab and not reached with placebo plus pembrolizumab; weeks are not converted to months here. |
| PFSModified intention-to-treat (mITT) population: all randomised patients who received the study intervention, excluding those first dosed or randomised after the date immediate discontinuation was requested (n = 313 of 315 enrolled) | interimmedian follow-up 6.28 monthsRischin 2026 | — | — | HR 1.40 (95% CI 1.05–1.86)Adjusted hazard ratio. Median PFS was 10.1 weeks (95% CI 9.1 to 15) with feladilimab plus pembrolizumab versus 16 weeks (95% CI 14.3 to 26.1) with placebo plus pembrolizumab; weeks are not converted to months here. |
| ORRModified intention-to-treat (mITT) population: all randomised patients who received the study intervention, excluding those first dosed or randomised after the date immediate discontinuation was requested (n = 313 of 315 enrolled) | interimmedian follow-up 6.28 monthsRischin 2026 | 19.7% (13.8–26.8%) | 25% (18.4–32.6%) | Secondary endpoint: investigator-assessed best response without confirmation of complete or partial response (not required in the adaptive decision-making). Estimated difference -5.3 percentage points (95% CI -14.6 to 4). |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 1.51 | 0.99–2.29 |
| PFS | 1.4 | 1.05–1.86 |