Taiho Oncology and Cullinan Therapeutics Present Data on Zipalertinib at the IASLC 2025 World Conference on Lung Cancer

Core Insights - Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. announced new data from the REZILIENT1 and REZILIENT2 trials of zipalertinib, an oral EGFR tyrosine kinase inhibitor for advanced or metastatic non-small cell lung cancer (NSCLC) [1][26] - The data will be presented at the IASLC 2025 World Conference on Lung Cancer, highlighting the importance of addressing unmet medical needs in specific patient populations [1][4] REZILIENT1 Trial Summary - The REZILIENT1 trial focuses on patients with NSCLC harboring EGFR exon 20 insertion mutations who have been previously treated with amivantamab [2][5] - As of June 2025, 84 patients were enrolled, with a median of 3 prior lines of therapy; 54.8% had a history of brain metastases [5] - The confirmed objective response rate (ORR) was 27.4% with a median duration of response (mDOR) of 8.5 months, and the disease control rate (DCR) was 84.5% [7] - In patients who received prior amivantamab only, ORR was 31.5% with mDOR of 9.5 months [7] - Zipalertinib demonstrated a manageable safety profile with no new safety signals; the most common treatment-emergent adverse events included paronychia (41.7%) and anemia (38.1%) [8][9] REZILIENT2 Trial Summary - The REZILIENT2 trial evaluates zipalertinib in patients with uncommon non-exon 20 insertion EGFR mutations [3][10] - As of March 2025, 40 patients were enrolled, with a median of 2 prior lines of therapy; 30% had a history of brain metastases [10] - The overall efficacy population showed a confirmed ORR of 30% with a mDOR of 7.75 months and a DCR of 70% [17] - The most common treatment-related adverse events were paronychia (47.5%) and dermatitis acneiform (37.5%); most were grade 1 or 2 [11][12] Zipalertinib Overview - Zipalertinib is an orally available small molecule designed to target activating mutations in EGFR, specifically ex20ins mutations, while sparing wild-type EGFR [15] - It has received Breakthrough Therapy Designation from the FDA and is currently investigational [15][16] - The drug is being developed by Taiho Oncology, Inc. in collaboration with Cullinan Therapeutics, Inc. [16]