NEWTOWN SQUARE, PA — ArriVent BioPharma, Inc. (Nasdaq: AVBP) has shared encouraging interim results from its Phase 1b FURTHER trial, which investigates firmonertinib as a first-line monotherapy for non-small cell lung cancer (NSCLC) patients with EGFR PACC mutations. The findings highlight firmonertinib’s potential to address a critical gap in the treatment of this underserved population.
The study reported a median progression-free survival (mPFS) of 16 months for patients treated with firmonertinib at 240 mg, as assessed by blinded independent central review (BICR). Notably, the trial also demonstrated strong central nervous system (CNS) activity, with 41% of CNS-evaluable patients achieving a confirmed complete response and 53% achieving an overall response.
“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. Furthermore, the generally well-tolerated safety profile is consistent with what has been clinically established,” said Bing Yao, Ph.D., Chairman and Chief Executive Officer of ArriVent. “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.”
Additionally, firmonertinib demonstrated a manageable safety profile over a median follow-up period of 12.5 months. The most common treatment-related adverse events (TRAEs) included diarrhea, hepatic enzyme elevation, rash, stomatitis, and dry skin, consistent with earlier findings in the same drug class.
Dr. Stuart Lutzker, Co-Founder and President of R&D at ArriVent, underscored the significance of the results. “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.”
The company plans to build on these findings with its upcoming ALPACCA Phase 3 trial, which is set to begin in the latter half of 2025. This global pivotal study is designed with regulatory input to potentially facilitate both accelerated and full approval of firmonertinib in first-line PACC patients.
Firmonertinib, an oral and highly brain-penetrant EGFR inhibitor, addresses both classical and uncommon mutational variants of EGFR. With robust CNS penetration and dual pathway inhibition, the therapy is positioned to be a game-changer for patients facing limited treatment options due to uncommon mutations like PACC.
Lung cancer remains the leading cause of cancer-related deaths worldwide, with non-small cell lung cancer accounting for 85% of all cases. Patients with PACC mutations, representing approximately 12% of all EGFR mutations, face particularly poor survival outcomes with current therapies.
By advancing firmonertinib into late-stage clinical trials, ArriVent continues to demonstrate its commitment to addressing unmet medical needs in oncology and offering hope to patients with the most challenging diagnoses.
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