ArriVent BioPharma Unveils Promising Phase 1b Data for Firmonertinib in Treating NSCLC

ArriVent BioPharma

NEWTOWN SQUARE, PA — ArriVent BioPharma, Inc. (Nasdaq: AVBP) has announced encouraging interim results from its global Phase 1b FURTHER trial, presented at the prestigious IASCLC 2024 World Conference on Lung Cancer. The findings highlight firmonertinib’s potential as a first-line treatment for patients with non-small cell lung cancer (NSCLC) harboring EGFR PACC mutations, a subgroup that has traditionally faced limited treatment options.

Bing Yao, CEO of ArriVent, emphasized the significance of these results: “These compelling dose-dependent interim data are the first to demonstrate robust systemic and CNS anti-tumor activity for firmonertinib in a PACC mutant population.” The trial data suggests that firmonertinib is not only effective systemically but also offers strong central nervous system (CNS) activity, making it a promising candidate for patients with brain metastases.

Dr. Xiuning Le from MD Anderson Cancer Center, a key investigator in the study, expressed optimism about the drug’s performance. He noted that the trial’s findings indicate rapid and potent anti-tumor activity in patients with PACC mutations, similar to previous data for patients with exon 20 insertions. This broad spectrum of efficacy could position firmonertinib as a leading treatment option for these challenging cases.

The interim results reveal a substantial overall response rate (ORR), with 81.8% at the 240mg dose and 47.8% at the 160mg dose, as assessed by blinded independent central review (BICR). Additionally, firmonertinib achieved a CNS confirmed ORR of 46.2% in patients with baseline brain metastases, showcasing its high brain penetrance and potential to address CNS disease effectively.

Firmonertinib was generally well-tolerated, with treatment-related adverse events such as diarrhea, rash, and dry skin being consistent with prior data. Importantly, no treatment discontinuations due to these adverse events were observed, underscoring the drug’s manageable safety profile.

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This pivotal study marks a significant advancement in the treatment landscape for NSCLC patients with EGFR mutations. The promising efficacy and safety profile of firmonertinib provide hope for a chemotherapy-free, oral therapeutic option that could redefine care standards for this underserved patient population. Further updates and detailed analyses are anticipated to advance our understanding of firmonertinib’s potential in clinical oncology.

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