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News
Cullinan Therapeutics has initiated an NDA submission to the FDA for zipalertinib combined with platinum-based chemotherapy as a frontline treatment for NSCLC patients with EGFR exon 20 insertion mutations. Backed by phase 3 REZILIENT3 trial data, the combo cut the risk of disease progression or death by 50% and extended median PFS by 6 months compared to chemotherapy alone. The submission is being reviewed under the FDA's Real-Time Oncology Review program.
Cullinan Therapeutics has kicked off a new drug application (NDA) submission to the FDA for zipalertinib plus platinum-based chemotherapy as a first-line treatment for patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations — a rare and historically difficult-to-treat molecular subgroup. The filing is being processed under the FDA's Real-Time Oncology Review (RTOR) program, with full submission expected by end of 2026.
The application is anchored by data from the phase 3 REZILIENT3 trial, presented at the IASLC 2026 World Conference on Lung Cancer. The combination slashed the risk of progression or death by 50% versus chemotherapy alone, with a median PFS of 14.5 months vs. 8.5 months. Response rates were also markedly higher with the combo (65% vs. 40.3%), and the PFS benefit held even in patients with brain metastases.
By the Numbers:
Why it matters: EGFR exon 20 insertions account for 5–10% of EGFR mutations in NSCLC and have limited targeted therapy options. If approved, zipalertinib — an oral pill — could offer patients a more convenient and highly effective frontline alternative to existing IV-based regimens.
