Phase 3 Trial Shows Superior Survival With Rilertinib for EGFR-Mutated NSCLC

Rilertinib showed significantly longer progression-free survival (PFS) compared with gefitinib to treat EGFR-mutated non-small cell lung cancer (NSCLC), according to results of a phase 3 trial presented at the IASLC 2024 World Conference on Lung Cancer.

Rilertinib is a novel, oral EGFR tyrosine kinase inhibitor (TKI). For this double-blind trial, patients with locally advanced or metastatic EGFR-mutated NSCLC at 31 sites were randomized to rilertinib (n=162) or another EGFR-TKI, gefitinib (n=83), once daily for 21-day cycles. Treatment continued until disease progression or withdrawal.

PFS, the primary endpoint, was significantly longer in the rilertinib treatment group (hazard ratio, 0.46; 95% CI, 0.33–0.65; P<.0001). The median PFS was 19.3 months in the rilertinib group (95% CI, 15.2–22.3) and 9.8 months in the gefitinib group (95% CI, 7.1–12.6).

Rates of response and disease control were similar between groups. The objective response rate was 72.8% and 78.3% in the rilertinib and gefitinib groups, respectively. The disease control rates were 93.8% and 97.6%, respectively. The median duration of response was longer in the rilertinib group, at 20.7 months (95% CI, 14.1–23.4) compared with 11.1 months (95% CI, 6.9–12.6) with gefitinib.

Regarding safety outcomes, grade ≥3 treatment-related adverse events occurred in 17.3% of the rilertinib group and 22.9% of the gefitinib groups. Serious treatment-related adverse events were reported in 6.2% of patients treated with rilertinib and 9.6% of patients treated with gefitinib. There were no deaths due to treatment-related adverse events in either group.

“Rilertinib is a well-tolerated third-generation EGFR-TKI that demonstrated superior efficacy compared with gefitinib in first-line treatment for patients with EGFR mutation-positive NSCLC, along with an acceptable safety profile without new signals,” the investigators summarized. “Rilertinib could serve as a new treatment option for this population.”

Reference

Zhou C, Xiong F, Wu F. Phase III Study of Rilertinib Versus Gefitinib as First-Line Therapy for Patients with Locally Advanced or Metastatic EGFR-Mutated NSCLC. Abstract OA02.04A. Presented at the IASLC World Conference on Lung Cancer; September 7-10, 2024; San Diego, California.