ArriVent BioPharma said its experimental therapy furmonertinib failed its main goal in a late-stage study as first-line treatment for people whose lung tumors carry an EGFR exon 20 insertion mutation, a rare genetic alteration affecting up to 10 percent of non-small cell lung tumors. Shares fell more than 50 percent in premarket trading Tuesday, erasing more than half of the company’s value.
The details explain the reaction. Jefferies analyst Roger Song had written last month that his team was looking for a three-month improvement in progression-free survival over chemotherapy. ArriVent reported a 1.5-month benefit: the highest dose delayed tumor progression by a median of 11 months versus 9.5 months for chemotherapy, missing statistical significance. A “trend” toward a survival benefit was observed, and no new safety signals were identified. CEO Bing Yao said the company will evaluate the data to determine next steps for furmonertinib.
The drug is approved in China for certain lung cancers, where it is sold by original developer Allist Pharmaceuticals, so a U.S. first-line approval was the prize. It also represented a strategic bet: ArriVent tested the drug as a monotherapy against chemotherapy rather than as part of a combination, hoping for a regimen with fewer side effects. The bar was recently raised by a partnership between Taiho Oncology and Cullinan Therapeutics, which posted a first-line victory that surpassed historical benchmarks. AstraZeneca, meanwhile, just agreed to pay up to $1.5 billion for rights to a marketed therapy from Dizal Pharma in the same space.