FHND9041 / Sino Biopharm - LARVOL DELTA

Phase I/II Study of FHND9041 in Advanced NSCLC Patients Progressed After Prior EGFR-TKI Therapy [WITHDRAWN] (ESMO 2025) - No abstract available

Clinical • Metastases • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase I/II Study of FHND9041 in T790M-Positive Advanced NSCLC Patients Progressed After Prior EGFR-TKI Therapy (IASLC-WCLC 2025) - "Across both 80 mg and 120 mg expansion cohorts, no treatment-related deaths were reported and grade ≥3 TRAEs were observed in 14.3% of patients (16/112). Conclusions : FHND9041 showed durable efficacy and a favorable safety profile in patients with EGFR T790M-positive NSCLC who progressed after EGFR-TKI treatment, supporting its further development as a potential treatment option."

Clinical • Metastases • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

Comprehensive first-in-human phase I/II study of FHND-9041 in patients with EGFR-mutated advanced non-small cell lung cancer. (PubMed, Lung Cancer) - "FHND-9041 exhibits favorable safety and efficacy profile, supporting its further clinical development for EGFR-mutated advanced NSCLC."

Journal • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Effect of CYP3A4 inhibitor and induction on the pharmacokinetics and safety of FHND9041, a novel EGFR T790M inhibitor, in healthy Chinese. (PubMed, BMC Pharmacol Toxicol) - "Co-administration with Rifampicin significantly reduced the exposure of FHND9041. Therefore, it is recommended to avoid co-administration of FHND9041 with Rifampicin and other potent CYP3A4 inducers. Conversely, co-administration with Itraconazole significantly increased the total exposure of FHND9041. Caution is advised when FHND9041 is co-administered with Itraconazole or other strong CYP3A4 inhibitors. Close monitoring of tolerability during co-administration is essential, and dose reduction may be necessary if required. FHND9041 capsules demonstrated good safety and tolerability when used alone or in combination with strong CYP3A4 inhibitors or inducers."

Journal • PK/PD data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Tyrosinase

FHND9041 Versus Afatinib for Non-small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=350 | Enrolling by invitation | Sponsor: Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.

New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Helpful: First-in-Human Phase I/II Study of FHND-9041 in Patients With EGFR Mutated Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=124 | Completed | Sponsor: Yongchang Zhang

Metastases • New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

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 (AACR 2023) - "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.GroupDosage(mg)Evaluable Subjects(n)ORR%Second/Third-line T790M+40mg333.3380mg3963.64120mg4258.33180mg3100.00First-line80mg3771.43"

Clinical • Metastases • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR