Short answer
Cullinan Therapeutics, Inc. (CGEM) filed an 8-K current report with the SEC on September 14, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.1). Phase 3 REZILIENT3 results for zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion-positive NSCLC.
Cullinan Therapeutics, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Phase 3 REZILIENT3 results for zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion-positive NSCLC
- Comparator: chemotherapy alone, providing pivotal efficacy data for a targeted lung-cancer treatment
- Cullinan and Taiho issued the September 13, 2026 announcement, signaling a material clinical-development update
- Full trial results and outcomes available in furnished Exhibit 99.1
Item 8.01 · Other Events
- Phase 3 REZILIENT3 met its interim PFS endpoint in first-line EGFR ex20ins NSCLC
- Median PFS 14.5 months versus 8.5 months; hazard ratio 0.50, P=0.00015
- Objective response rate 65.0% versus 40.3%, with response duration 14.2 versus 9.9 months
- Overall survival signal immature at 30% maturity; death hazard ratio 0.72 with continued follow-up
- Grade ≥3 adverse events 87.1% versus 54.4%, primarily hematologic toxicity at 58.6% versus 28.7%
Item EX-99.1 · Exhibit EX-99.1
- Phase 3 REZILIENT3 achieved primary PFS endpoint, strengthening zipalertinib’s path toward first-line EGFR exon 20 insertion NSCLC approval
- Median PFS 14.5 vs 8.5 months; HR 0.50, 95% CI 0.34–0.73, P=0.00015
- Response rate 65.0% vs 40.3%, with median response duration 14.2 vs 9.9 months
- Overall-survival signal encouraging but immature: HR 0.72 at 30% event maturity, with follow-up ongoing
- Grade ≥3 adverse events 87.1% vs 54.4%, primarily hematologic events, highlighting combination-therapy tolerability risk
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
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