6 days ago
Merck, Daiichi pull approval application for ADC in lung cancer
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Merck & Co. and Daiichi Sankyo have withdrawn an approval application in the U.S. for a lung cancer drug at the center of a multibillion-dollar alliance the companies formed two years ago.
In a short statement Thursday, the companies said they've pulled a Food and Drug Administration submission for an experimental therapy known as patritumab deruxtecan. Merck and Daiichi had been seeking an 'accelerated' approval of the drug in people whose non-small cell lung cancer has a mutation in a gene called EGFR and, last September, reported that it meaningfully delayed tumor progression compared to chemotherapy in a Phase 2 trial.
However, Merck and Daiichi have also found that their drug didn't extend survival, the gold standard for a cancer drug. That finding, as well as subsequent discussions with the FDA, led the companies to withdraw their application, according to their statement.
The companies will present study results at the American Society of Oncology Meeting on Sunday.
This outcome is a 'reminder of how challenging it can be to treat these patients with EGFR-mutated non-small cell lung cancer in the second and later line settings,' said Eliav Barr, the chief medical officer of Merck Research Laboratories, in the statement.
Merck currently draws the bulk of its revenue from the cancer immunotherapy Keytruda, which in recent years became the world's top-selling drug. But Keytruda is poised to lose patent protection later this decade, and Merck has been facing increasing skepticism from analysts and investors about its plans to offset those future losses and grow. The company's share price has fallen nearly 40% over the last 12 months.
One area of research Merck has looked to is antibody-drug conjugates, a type of targeted cancer medicine seen as a potential way to replace traditional chemotherapies. The company formed a pair of alliances with China-based drugmaker Kelun Biotech in 2022 and, a year later, sprung for a collaboration with Daiichi that could potentially be worth as much as $22 billion.
In aligning with Daiichi, Merck may have been spurred on by the success AstraZeneca has had with a similar type of ADC-focused partnership. A 2019 deal between Daiichi and AstraZeneca yielded Enhertu, an ADC that's cleared for use in several cancers and is now a blockbuster medicine. Merck partnered with Daiichi a month after the Japanese company reported Phase 2 data underlying an accelerated approval application for patritumab deruxtecan.
But the companies have faced setbacks since. U.S. regulators rejected their ADC last June due to findings at a manufacturing plant. Now, after pulling their application, Merck and Daiichi are searching for a new path forward.
The companies are 'conducting further biomarker analyses' to better identify lung cancer patients who might benefit from treatment, said Ken Takeshita, Daiichi's global head of R&D, in the statement. 'We remain confident in the broad development of [our drug],' which includes trials across 15 types of cancer, he added.
