ArriVent reports 16-month progression-free survival for lung cancer drug

NEWTOWN SQUARE, Pa. - ArriVent BioPharma, Inc. (NASDAQ:AVBP), a clinical-stage biotech company with a market capitalization of $863 million, announced follow-up data from its Phase 1b FURTHER trial showing 16.0 months median progression-free survival for patients treated with firmonertinib 240 mg in non-small cell lung cancer (NSCLC) with EGFR PACC mutations. According to InvestingPro data, analysts maintain a strong buy consensus with price targets ranging from $36 to $45.

The data revealed robust central nervous system (CNS) activity, with 41% complete response and 53% overall response rate in CNS evaluable disease patients, according to blinded independent central review.

The company reported that the majority of patients treated with the 240 mg dose remain on the study after one year, with a 14.6-month median duration of response. The drug demonstrated a 68.2% confirmed overall response rate at the 240 mg dose level.

ArriVent described firmonertinib’s safety profile as "generally well-tolerated and manageable," with common treatment-related adverse events including diarrhea, hepatic enzyme elevation, rash, stomatitis, and dry skin.

The company plans to advance firmonertinib to a global Phase 3 trial called ALPACCA, with enrollment of the first patient expected in the second half of 2025. The trial is designed to enable potential for both accelerated and full approval.

"Patients with PACC mutant NSCLC represent an underserved population," said Stuart Lutzker, Co-Founder and President of R&D at ArriVent, in the press release statement.

Firmonertinib is an oral EGFR inhibitor that previously received FDA Breakthrough Therapy Designation for treatment of previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations.

EGFR PACC mutations represent approximately 12% of all EGFR mutations in NSCLC, which is the predominant subtype of lung cancer, accounting for about 85% of all cases globally. Despite current losses, ArriVent’s stock has shown strong momentum with a 40% return over the past year. InvestingPro subscribers can access 8 additional key insights about the company’s financial health and growth prospects.

In other recent news, ArriVent BioPharma has seen significant developments surrounding its lead drug candidate, firmonertinib. H.C. Wainwright analyst Robert Burns raised the price target for ArriVent BioPharma to $40, citing promising clinical trial results for firmonertinib in treating non-small cell lung cancer (NSCLC) patients with EGFR PACC mutations. The drug demonstrated a confirmed objective response rate (ORR) of 63.6% at the 240mg dose, outperforming existing treatments. In addition, ArriVent BioPharma has appointed Dr. Merdad Parsey to its Board of Directors as the company prepares for the potential registration of firmonertinib. Dr. Parsey brings extensive experience in global clinical development, having held significant roles at Gilead Sciences and Genentech. ArriVent’s Chairman and CEO, Bing Yao, highlighted Dr. Parsey’s expertise as a valuable addition to the company’s leadership. The company is also advancing its antibody drug conjugate (ADC) pipeline, aiming to address unmet medical needs in cancer care. These recent developments underscore ArriVent’s strategic efforts to strengthen its position in the biopharmaceutical industry.

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