CGEM Cullinan

Cullinan (CGEM) to present zipalertinib REZILIENT2 CNS data at ESMO 2026

Cullinan and Taiho will present mature intracranial efficacy results (iORR 30.2%, iDCR 72.1%, median iDoR 9.7 months) from Cohort C of the Phase 2 REZILIENT2 trial of zipalertinib in EGFR-mutated NSCLC patients with active brain metastases at the ESMO Congress on 2026-10-26. The data add to the clinical evidence for the investigational next-generation EGFR inhibitor but do not alter its current regulatory path.

zipalertinib · NCT07128199 registry update

status: ACTIVE_NOT_RECRUITING → RECRUITING; countries: {'total_sites': 252, 'us_sites': 30} → {'total_sites': 253, 'us_sites': 30}

Cullinan Therapeutics initiates NDA for zipalertinib + chemo in 1L EGFR ex20ins NSCLC under FDA RTOR

Cullinan initiated submission of an NDA for zipalertinib in combination with platinum-based chemotherapy for first-line EGFR exon 20 insertion NSCLC under the FDA Real-Time Oncology Review program. Completion of the NDA is expected by year-end 2026, based on positive Phase 3 REZILIENT3 results showing statistically significant PFS improvement.

Cullinan: REZILIENT3 Phase 3 zipalertinib + chemo meets PFS endpoint

The Phase 3 REZILIENT3 trial met its primary endpoint at the planned interim analysis, showing a statistically significant 6-month median PFS benefit (14.5 vs 8.5 months, HR 0.50) for zipalertinib plus chemotherapy versus chemotherapy alone in first-line EGFR ex20ins NSCLC. Objective response rate was also significantly higher (65.0% vs 40.3%). The data were presented in a Presidential Symposium at WCLC 2026.

Cullinan: zipalertinib REZILIENT3 Phase 3 data at IASLC 2026 WCLC Presidential Symposium

The planned interim analysis of the Phase 3 REZILIENT3 trial has been selected for Presidential Symposium presentation at the IASLC 2026 World Conference on Lung Cancer. The session is scheduled for September 14, 2026, in Seoul. The trial met its primary endpoint of progression-free survival in first-line EGFR exon 20 insertion mutation NSCLC.

Cullinan to start registrational Phase 2 of CLN-049 in R/R AML in Q3 2026

After a positive End-of-Phase 1 FDA meeting in July, Cullinan will initiate a potentially registrational Phase 2 study of CLN-049 (FLT3xCD3 TCE) in relapsed/refractory AML in Q3 2026. The study will begin with dose-optimization and seamlessly progress to a single-arm expansion at the RP2D.

Cullinan: FDA accepts zipalertinib NDA, sets PDUFA Feb 27 2027

FDA accepted the NDA for zipalertinib in relapsed EGFR ex20ins NSCLC. A PDUFA target action date of February 27, 2027 was assigned, establishing the regulatory timeline for potential approval.

Cullinan: FDA accepts zipalertinib NDA; PDUFA set for 27 Feb 2027

FDA has accepted the NDA for zipalertinib in EGFR ex20ins-mutated NSCLC after platinum-based chemotherapy. The PDUFA target action date is now fixed at 27 February 2027, establishing a formal regulatory review timeline. The application is supported by Phase 2b REZILIENT1 data showing a 35% confirmed ORR and 8.8-month median DOR.

Cullinan: CLN-978 autoimmune data readouts planned Q2-Q4 2026

The company announced that initial single-dose data from the OUTRACE RA and OUTRACE SLE studies will be shared in Q2 2026, with repeat-dosing data from RA expected in Q3 2026 and Sjögren’s data in Q4 2026. These readouts will be the first company-sponsored clinical data for a CD19 T-cell engager in autoimmune indications.