Otsuka Holdings Co., Ltd.
Zepaleritinib combined with chemotherapy extends progression-free survival as first-line therapy for EGFR Exon 20 insertion-mutant non-small cell lung cancer in the REZILIENT3 Phase III trial, by a median of 6 months
Interim analysis of the REZILIENT3 trial shows that the combination of zepaleritinib and chemotherapy significantly improves progression-free survival (median PFS extended by 6.0 months) in first-line EGFR Ex21ins NSCLC (HR 0.50, P=0.00015). Overall survival interim analysis is immature; safety aligns with known profile. Presentation at WCLC 2026.
Key Figures
- Median progression-free survival: 14.5 months (combination) vs 8.5 months (chemotherapy alone)
- PFS hazard ratio: 0.50 (95% CI 0.34–0.73)
- Objective response rate: combination 65.0% vs 40.3%
- Median duration of response: 14.2 months (combination) vs 9.9 months
- OS hazard ratio: 0.72 (95% CI 0.42–1.23, maturity 30%)
AI要約
Section Heading
This trial enrolled 285 treatment-naïve patients with locoregional advanced or metastatic NSCLC, comparing the combination of zepaleritinib and chemotherapy to chemotherapy alone. Interim analysis showed substantial PFS improvement and high ORR. Safety profile is consistent with known data. Further regulatory discussions will continue to enable rapid patient access.
Section 2 Heading
Planned presentation at WCLC 2026 Presidential Symposium 2. OS maturity is still low and follow-up continues. Acknowledgment of contributions from physicians, patients, and caregivers. Zepaleritinib is positioned as a key growth driver for the company, with exploration of its potential in other treatment lines.
Median PFS Trend (Combination vs Monotherapy)
Otsuka Holdings Co., Ltd.
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