ArriVent BioPharma’s stock has dropped 46% after a Phase III trial of its non-small cell lung cancer (NSCLC) candidate failed to meet its primary endpoint.
In the FURVENT trial (NCT05607550), firmonertinib was investigated as a monotherapy in patients with previously untreated, locally advanced or metastatic non-squamous NSCLC harbouring EGFR exon 20 insertion mutations.
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The study did not meet its primary endpoint of progression-free survival (PFS) by blinded independent central review (BICR). Median PFS came in at 11 months in the 240mg cohort, 8.4 months in the 160mg cohort, and 9.5 months in the control group – the latter received platinum-based chemotherapy with pemetrexed, the current first-line standard of care (SoC).
Clinical benefit was observed with secondary endpoints such as PFS by investigator’s assessment and confirmed objective response rate by BIC, and while not mature, a trend toward an improvement in overall survival (OS) was also observed, the company stated.
The safety profile observed in FURVENT was consistent with previous clinical studies of firmonertinib, with no new safety signals identified.
Dr Bing Yao, CEO of ArriVent, said: “While the safety profile observed with firmonertinib was consistent with previous clinical studies, FURVENT did not show a meaningful improvement in PFS over chemotherapy by BICR in this study. We are deeply grateful to the patients, investigators and clinical teams who made this program possible and are evaluating the full FURVENT dataset as we determine the most appropriate development path for firmonertinib.”
After the data was revealed, the company’s stock dropped significantly at market open, from $28.46 at market close on 5 October to $12.09 at market open on 6 October. It did increase slightly during the day before closing at $15.09, a 46.98% drop day-on-day. ArriVent, listed on the Nasdaq exchange, has a market cap of $744.05m.
Firmonertinib is an oral, brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor that acts against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations. ArriVent’s drug gained approval in China for first-line NSCLC in March 2021.
It has also been granted US Food and Drug Administration (FDA) Breakthrough Therapy Designation for the treatment of patients with previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations and orphan drug designation for its use in NSCLC with EGFR mutations or human epidermal growth factor receptor 2 (HER2) mutations or HER4 mutations.
Beyond the FURVENT trial, the drug is also in a second global Phase III study in first-line NSCLC patients with EGFR PACC mutations (ALPACCA; NCT07185997).
This disappointment for ArriVent comes just weeks after Johnson & Johnson announced that Rybrevant (amivantamab-vmjw) plus chemotherapy has been linked to the longest median OS seen in a Phase III trial in the same patient population.
The OS data build on the primary PAPILLON analysis shared in October 2023, which demonstrated a statistically significant and clinically meaningful 60% improvement in progression-free survival (PFS), meeting the trial’s primary endpoint. Median PFS in the triplet arm of the trial was 11.4 months, while it was just 6.7 months in the doublet arm.
EGFR Ex20ins mutations account for approximately 12% of all EGFR mutations and have been historically difficult to treat with targeted medicines.
Historically, median OS has ranged from 16 to 24 months, with five-year survival reported at just 8%.
According to a GlobalData report, the NSCLC therapeutics market across the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan) was valued at $24.1bn in 2022 and is forecast to reach $56.5bn by 2032, reflecting a CAGR of 8.9% during the forecast period.
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