ArriVent BioPharma (NASDAQ: AVBP) announced encouraging additional follow-up proof-of-concept data from its global Phase 1b FURTHER trial of first-line firmonertinib monotherapy in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) P-loop alpha-C helix-compressing (PACC) mutations.
The company also provided a clinical development update on the firmonertinib program for the treatment of ECFR PACC-mutant NSCLC.
“We are encouraged by the strong progression-free survival and durable systemic responses with long term firmonertinib treatment in frontline patients with EGFR PACC mutant NSCLC. Moreover, the generally well-tolerated safety profile is consistent with what has been clinically established,” Bing Yao, Ph.D., chairman and CEO of ArriVent, said. “We believe these Phase 1b findings support the advancement of firmonertinib towards a registration study for EGFR PACC mutant NSCLC, with potential for accelerated approval. We expect to enroll the first patient in the second half of 2025 in our randomized, global pivotal ALPACCA Phase 3 trial.”
Stuart Lutzker, M.D., Ph.D., co-founder and president of R&D of ArriVent, added, “Patients with PACC mutant NSCLC represent an underserved population. We believe the interim median progression free survival of 16 months observed in the FURTHER study is clinically meaningful, and together with the compelling CNS activity and favorable safety profile underscore the potential of firmonertinib to address unmet needs across patients with PACC mutations as a once daily oral, chemo-free monotherapy.”
