Dive Brief:

• An experimental lung cancer treatment from ArriVent BioPharma failed its main goal in a late-stage study, sending its shares down more than 50% in pre-market trading Tuesday. 
• ArriVent has been evaluating its therapy, furmonertinib, as a first-line therapy in people whose lung tumors harbor a rare genetic alteration known as an “EGFR exon 20 insertion mutation.” ArriVent’s drug didn’t meaningfully delay tumor progression compared to chemotherapy in that study, though, falling short of its primary objective. CEO Bing Yao said the company will evaluate the data to determine the next steps for furmonertinib. 
• The drug is currently approved in China for certain lung cancers, where it’s sold by original developer Allist Pharmaceuticals. Success in the study would’ve opened up a market opportunity for ArriVent and enabled it to challenge multiple other approved and emerging lung cancer treatments aimed at EGFR exon 20 insertion mutations. 

Dive Insight:

While exon 20 insertion mutations in the EGFR gene are rare, affecting up to 10% of non-small cell lung tumors, they’re nonetheless a popular target among drugmakers.

Johnson & Johnson’s Rybrevant and Takeda’s Exkivity were the first marketed treatments specifically targeting those alterations. Exkivity, however, was withdrawn and Rybrevant is an intravenously administered biologic, leaving opportunities for others with superior options.  

Multiple companies are trying to fill that need, among them AstraZeneca — which just agreed to pay up to $1.5 billion for rights to a marketed therapy from Dizal Pharma — and a partnership between Taiho Oncology and Cullinan Therapeutics. The latter recently set the bar higher for ArriVent, posting a victory in first-line disease and an effect on tumor progression that surpassed historical benchmarks. 

ArriVent has hoped furmonertinib, a pill, could stand out as well. The company tested its drug as a monotherapy against chemo, rather than as part of a combination regimen. That strategy could’ve led to a regimen with fewer side effects, analysts have noted. 

In a note to investors last month, Jefferies analyst Roger Song wrote that his team was looking to see a three-month improvement over chemotherapy in progression-free survival. ArriVent instead reported a 1.5-month benefit, with the highest dose of its therapy delaying tumor progression by a median 11 months, versus 9.5 months for those receiving chemotherapy. The results missed statistical significance. 

A “trend” toward a survival benefit was observed, according to ArriVent. No new safety signals were identified.