FDA Says No to Summit's China-Born Lung Cancer Drug: Slowing Tumors Isn't Enough Without Longer Lives

The Food and Drug Administration has turned down ivonescimab, the closely watched lung cancer drug that Summit Therapeutics licensed from China's Akeso, after the medicine failed to show that it helps patients live longer. STAT reported Sunday that the agency sent the two companies a letter saying the drug could not be approved because it did not extend patients' lives, even though reviewers found it slowed the cancer's growth ^[1].

Fierce Pharma reported that the agency issued what is known as a complete response letter for the drug's use in previously treated patients whose non-small cell lung cancer carries an EGFR mutation ^[2]. Bloomberg described the request as covering a small subtype of advanced lung cancer in patients who had already been treated with drugs that target EGFR ^[3]. The decision had been due by Nov. 14.

The Financial Times called the ruling a blow to Beijing's biotech sector and noted that the drug had been seen as a test case for whether a medicine invented in China could pass scrutiny in the United States ^[4].

What the Trial Showed

Summit built its application on HARMONi, a late-stage study of ivonescimab given with chemotherapy to patients with nonsquamous EGFR-mutated lung cancer whose disease had progressed on a third-generation EGFR pill. According to OncLive, patients on the combination went a median of 6.8 months before their cancer worsened, compared with 4.4 months for patients on chemotherapy and placebo, a 48% cut in the risk of progression or death ^[5].

Overall survival, the study's other main goal, was a different story. OncLive reported that the survival result leaned in the drug's favor but did not reach statistical significance, with a p-value of .057 against the usual .05 bar ^[5]. Fierce Pharma reported that the FDA had told Summit in advance that a statistically significant survival benefit would be needed ^[2], and STAT said the rejection was not entirely unexpected for that reason ^[1].

Slowing a tumor matters, and families facing this diagnosis know how precious a few extra months can be. But the FDA's job is to make sure a new drug delivers what its sponsor promises, and for cancer medicines the clearest promise is more time with the people you love. Holding the line on that evidence is not cruelty. It is the protection that patients, doctors and the taxpayers who fund Medicare are counting on when a drug reaches the pharmacy shelf.

A Setback for Summit, Akeso and China's Drug Ambitions

The stakes went well beyond one prescription. Summit agreed in December 2022 to pay Akeso $500 million up front in a deal worth up to $5 billion, gaining rights to the drug in the United States, Canada, Europe and Japan while Akeso kept China and other regions, according to the companies' announcement carried by BioSpace ^[6]. Bloomberg reported that the decision is also a blow for Akeso, which first developed the medicine and already sells it in China ^[3].

Ivonescimab belongs to a new class of drugs that block two cancer pathways at once, PD-1 and VEGF. Fierce Pharma reported that Summit's filing was the first U.S. application for both the drug and the entire class, and that the setback narrows Summit's head start over large drugmakers, including Merck, that are developing rival versions ^[2]. Fierce also reported that Summit had parted ways with its chief commercial officer and several senior marketing leaders in the run-up to the decision ^[2].

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For Americans, the larger question the FT raised is about trust ^[4]. A growing share of new drug candidates now begins in Chinese laboratories, and U.S. companies are paying billions to bring them here. The FDA's answer this weekend was a reminder that where a drug comes from matters less than whether the evidence behind it meets the American standard, the same standard that applies to drugs invented in New Jersey or Massachusetts.

What Comes Next

Summit is not giving up. Fierce Pharma reported that the company said it remains committed to developing ivonescimab and pointed to five positive late-stage studies run by Summit and Akeso ^[2]. Industry attention is now shifting to the drug's trials as a first treatment for lung cancer, Fierce reported ^[2], where a clear survival win would carry far more weight than this narrow application ever could.

The news broke over the weekend, so investors will deliver their first verdict on Summit's shares when markets open Monday. For patients with EGFR-mutated lung cancer whose first treatments have stopped working, the options remain what they were last week. Their doctors, and the families praying alongside them, will be watching for the next round of data.