Summit Therapeutics Inc. said US regulators declined to approve its lung cancer medicine, setting back its quest to challenge the standard of care with a drug first pioneered in China.
The biotech firm had sought approval for the treatment's use in a small subtype of advanced non-small cell lung cancer after prior treatment with drugs targeting EGFR, a protein that can drive the growth of tumor cells. The Food and Drug Administration's decision is also a blow for Summit's Chinese partner Akeso Inc., which first developed the drug, ivonescimab, and markets it in China.
The FDA issued a so-called Complete Response Letter saying that it can't approve Summit's application in its present form because the drug didn't help patients live longer in a statistically significant way. While it kept cancer from getting worse, this alone isn't sufficient to warrant approval, the company said in a statement on Sunday.
“We are disappointed for patients and their families awaiting additional treatment options in this setting,” Summit's Chief Executive Officer Bob Duggan said in the statement. The company will continue to study the drug's effect on other types of cancer, he said.
“Our mission remains to improve outcomes for patients facing significant unmet needs, which is work worth doing,” Duggan said.
Ivonescimab is the most advanced dual-action cancer immunotherapy drug. Like traditional immunotherapies, it unleashes patients' immune systems to attack cancer, but it also targets a driver of tumor blood-vessel growth.
The FDA decision focused on a relatively niche population: patients whose lung cancer is driven by mutations in the gene known as EGFR and for whom a common first-line treatment didn't work or stopped working. Summit had previously estimated that more than 14,000 US patients would be eligible for treatment every year, while Bloomberg Intelligence analyst Javier Manso Polo has predicted just $230 million in potential sales by 2035.
The rejection could have wider reverberations. Summit's China-originated drug took on symbolic significance after garnering international attention in 2024, when Summit and its partner Akeso said it beat Merck & Co's Keytruda, the world's top-selling cancer drug, in a late-stage clinical study in China. Its promise inspired a series of licensing deals involving similar drugs from China.
Since then, ivonescimab has become a barometer for the broader Chinese biotech industry. Sunday's setback means investors will have to wait longer for proof that success in China can be replicated globally.
Summit sought FDA clearance for the EGFR subtype — which has eluded Merck's Keytruda — despite being warned by regulators that it didn't have strong enough data.
Expectations for approval were “minimal,” Jefferies analysts wrote in a Oct. 27 note.
The company has ambitions beyond this initial setting, currently running several more global Phase 3 studies to prove ivonescimab's effects in other cancer types, including studies pitting it directly against Keytruda.
In September, AstraZeneca Plc announced a $2 billion investment in Summit to collaborate on ivonescimab and combine it with AstraZeneca's other medicines, underscoring its potential across a range of cancers.
If the ongoing studies succeed, analysts estimate that the drug could bring in $3.8 billion in total sales by 2030, according to BI. Akeso stands to earn low double-digit royalties from US product sales.
(This story has not been edited by NDTV staff and is auto-generated from a syndicated feed.)
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