Cullinan Therapeutics to present new results from REZILIENT1 trial

Cullinan Therapeutics (CGEM), Taiho Pharmaceutical and Taiho Oncology announced new results from the pivotal Phase 2b cohorts of the REZILIENT1 trial, a Phase 1/2 clinical trial of zipalertinib monotherapy in patients with advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations who have received prior therapy. These data will be presented on Sunday, June 1 at the American Society of Clinical Oncology annual meeting as an oral presentation. As of the December 2024 data cutoff, 244 patients were enrolled in REZILIENT1 and received at least one dose of 100 mg zipalertinib. The overall efficacy population consisted of all patients who received at least one dose of 100 mg zipalertinib and had approximately 8 months of minimum follow-up at data cutoff. Patients had received a median of 2 prior therapies, and 39% of patients had a history of brain metastases. With median follow-up of 9.3 months, zipalertinib demonstrated: In the overall efficacy population, confirmed overall objective response rate was 35% with median duration of response of 8.8 months; in patients with prior platinum-based chemotherapy only, ORR was 40% with mDOR of 8.8 months, consistent with REZILIENT1 Phase 1/2a results; in patients with prior chemo and amivantamab, ORR was 30% with mDOR of 14.7 months; in patients with prior chemo and amivantamab, ORR was 24% with mDOR of 8.5 months and in patients with brain metastases, the ORR was 31% with mDOR of 8.3 months. The safety analysis population included all REZILIENT1 patients who received at least one dose of 100 mg zipalertinib. The results showed that zipalertinib demonstrated a manageable safety profile in this heavily pre-treated patient population, consistent with previously reported data. The most common treatment-related adverse events were paronychia, rash, dermatitis acneiform, dry skin, diarrhea and stomatitis. The majority of TRAEs were grade 1 or 2. The most common grade 3 TRAEs were anemia, pneumonitis and rash, increased alanine aminotransferase, diarrhea, and decreased platelet count.