FDA rejects Summit Therapeutics' Ivonescimab cancer drug

The US Food and Drug Administration has rejected Summit Therapeutics' Ivonescimab, a cancer drug invented by Akeso, a company based in Zhongshan, China. Summit, which is based in Miami, said on Sunday that the FDA determined that substantial evidence of effectiveness is not established and that the drug did not significantly add to survival rates.

The FDA decision

The FDA issued a complete response letter for the biologics license application covering Ivonescimab with platinum-based chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer whose disease progressed after an EGFR tyrosine kinase inhibitor. The application had a Nov. 14 FDA goal date.

According to Summit, the FDA said effectiveness was not established without a statistically significant overall survival benefit, and a progression-free survival benefit alone did not support approval. The HARMONi trial met its progression-free survival endpoint, but overall survival trended positive without reaching statistical significance. Summit cited a post-hoc hazard ratio of 0.76 with longer follow-up.

On safety, 16 patients (7.3%) on Ivonescimab discontinued because of treatment-related adverse events, against 5.0% in the placebo-plus-chemotherapy arm. Treatment-related deaths numbered four (1.8%) in the Ivonescimab arm and five (2.3%) in the chemotherapy-alone arm.

Company and deal background

In 2022, Akeso licensed the drug to Summit in a deal worth up to $5bn. AstraZeneca invested $2bn in Summit in September as part of a collaboration agreement, giving the pharmaceutical company an 11 per cent equity stake.

Summit said it will keep evaluating the drug in other cancers and is running several additional global Phase 3 studies. The release did not say whether Summit will resubmit or meet with the FDA.

"We are disappointed for patients and their families awaiting additional treatment options in this setting," Robert Duggan, Summit's co-chief executive, said in a statement.

Broader context

The study submitted to the FDA comprised 62 per cent Asian patients and 38 per cent western people. TD Cowen said in a research report on Sunday that the patient mix may have influenced the FDA's decision-making, noting that the agency has previously rejected Chinese clinical studies as not representative of the US population.

Akeso is seen as a leader in China's booming biotech sector. Its shares are down 27 per cent so far in 2026. US lawmakers and regulators are increasingly nervous about China's growing biotech industry. In August, Republicans and Democrats in Congress called on the FDA to stop using drug trial data from China for new clinical trials or drug applications unless the agency has inspected the trial site in the past 12 months.

---

Sources

• ft.com: FDA rejects cancer drug invented in China in blow to Beijing’s biotech sector
• mlq.ai: FDA rejects Summit Therapeutics and Akeso's lung cancer drug ivonescimab, saying it needs an overall survival benefit | MLQ.ai
• briefs.co: FDA Rejects Summit's Ivonescimab for EGFR Lung Cancer
• tradersunion.com: Summit Therapeutics cancer drug rejection raises risks for China biotech expansion

This article was drafted with AI assistance and checked against the sources above. Company claims are reported as claims. Cover image is AI-generated.