Abstract CT232: Safety, efficacy, and tolerability of FHND9041 capsules as first-line treatment in patients with EGFR sensitive mutations or second/third-line treatment in patients with T790M+ advanced non-small cell lung cancer (NSCLC): results from a phase I/II single-arm, multi-center, open-label study

Abstract Background: FHND9041 is a third-generation EGFR inhibitor independently developed by Nanjing Chuangte Pharmaceutical Technology Co., Ltd. It irreversibly binds to EGFR protein, and demonstrates strong inhibitory effect on EGFR T790M mutations as well as EGFR sensitive mutations. This is the first single-arm, multi-center, open-label phase I/II study of FHND9041 capsule, which evaluates the safety, tolerability and preliminary efficacy of FHND9041 capsule in initial treatment of NSCLC with EGFR sensitive mutations or treatment of T790M+ advanced NSCLC who progressed after prior EGFR-TKI therapy. Methods: 124 subjects tested for EGFR mutations and eligible for evaluation were randomized to dose groups of 40 mg, 80 mg (first-line treatment or second/third-line treatment with T790M+), 120 mg and 180 mg. The primary endpoint is objective response rate (ORR), and key secondary endpoints are progression-free survival (PFS), disease control rate, duration of response, and safety. Results: The ORR of FHND9041 capsule 80 mg (recommended phase 2 dose, RP2D) is 71.43% in patients newly diagnosed of NSCLC with EGFR sensitive mutations, and 63.64% in patients with T790M+ NSCLC who had progressed after prior EGFR-TKI therapy. No DLT occurred in all dose groups, 40 mg, 80 mg and 120 mg, which demonstrated satisfactory tolerability and safety of FHND9041. Detailed efficacy data of each dose group is shown in the table below. Conclusion: FHND9041 capsule 80 mg shows significant antitumor activity with favorable efficacy and safety profile in patients for both initial treatment and treatment of T790M+ NSCLC who progressed after prior therapy. For futher research of the capsule, a multicenter, randomized, positive-controlled phase III clinical research is ongoing with recommended dose of 80 mg. Group Dosage(mg) Evaluable Subjects(n) ORR% Second/Third-line T790M+ 40mg 3 33.33 80mg 39 63.64 120mg 42 58.33 180mg 3 100.00 First-line 80mg 37 71.43 Citation Format: Yongqiang Zhu, Minghong Shang, Jia Wang, Nong Yang, Xiaorong Dong. Safety, efficacy, and tolerability of FHND9041 capsules as first-line treatment in patients with EGFR sensitive mutations or second/third-line treatment in patients with T790M+ advanced non-small cell lung cancer (NSCLC): results from a phase I/II single-arm, multi-center, open-label study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr CT232.