Positive Interim Data for Firmonertinib in NSCLC Study

By Tamara Parker • Monday, June 23 10:03 • Permanent Link

Arrivent Biopharma, Inc. has announced positive interim data from the global phase 1b study for firmonertinib monotherapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR PACC mutations. The median progression-free survival (MPFS) with firmonertinib 240 mg was reported to be 16.0 months by blinded independent central review (BICR) in first-line patients. The study also revealed robust central nervous system (CNS) activity, with 41% confirmed complete response (CR) and 53% confirmed overall response (ORR) in CNS evaluable disease patients.

The company plans to advance firmonertinib into a global pivotal phase 3 study, named ALPACCA, and expects to enroll the first patient in the second half of 2025. Firmonertinib, an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor, has demonstrated favorable outcomes in the interim data.

In addition to the MPFS, the interim data also highlighted a 14.6 months median duration of response with firmonertinib 240 mg, along with 68.2% and 43.5% confirmed ORR at 240mg and 160mg dose levels, respectively. Furthermore, the study reported that 41% of CNS evaluable disease patients achieved confirmed CR, and 53% achieved confirmed ORR.

The safety profile of firmonertinib remained consistent with no new safety signals, and the most frequent treatment-related adverse events included diarrhea, hepatic enzyme elevation, rash, stomatitis, and dry skin. Arrivent Biopharma believes that the phase 1b findings support the advancement of firmonertinib towards a registration study for EGFR PACC mutant NSCLC, with potential for accelerated approval.

Regarding the development update for firmonertinib, the ALPACCA (FURMO-006) study is set to be the first randomized global phase 3 trial in first-line NSCLC patients across PACC mutations. The trial design enables the potential for both accelerated and full approval, and firmonertinib 240 mg has been selected as the optimal dose for pivotal phase 3 development. The enrollment of the first patient in ALPACCA is anticipated in the second half of 2025.

Today the company's shares have moved 1.33% to a price of $25.22. For the full picture, make sure to review ArriVent BioPharma's 8-K report.

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