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Merck & Co. and Daiichi Sankyo have withdrawn an approval application in the U.S. for a lung cancer drug at the center of a multibillion-dollar alliance the companies formed two years ago.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.
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We are grateful to the study participants, their families and caregivers, the study investigators and staff, our research partners, and the Vera team for their ongoing commitment and dedication to this important research,' said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. 'Vera aspires to evolve the practice of kidney medicine with the hope that, one day, patients may no longer face a future of dialysis or transplantation. Vera is poised for potential commercial launch of atacicept in 2026 and to pursue development in additional indications in other autoimmune kidney diseases and beyond.' 'Patients with IgA nephropathy, as well as their families and care partners, suffer from clinical uncertainty and the horrible outcome of kidney failure. In addition to clinical signs and symptoms, IgAN has a devastating impact on quality of life and mental wellbeing. 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Investors Dial-in: 1-877-425-9470 Int'l Investors Dial-in: 1-201-389-0878 Conference ID: 13754147 Webcast: The live webcast will be available on the Company's Investor Calendar, with the recording and presentation available immediately following the event. References1. Barratt J, et al. JASN 2024 About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN, other autoimmune kidney diseases and lupus nephritis. 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Words such as 'anticipate,' 'believe,' 'expect,' 'plan,' 'potential' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary or interim results may not be predictive of final study results, risks and uncertainties associated with Vera's business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera's filings with the Securities and Exchange Commission. 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Keytruda's a top seller now because it produced dramatic overall survival results, compared to the standard treatments of its time. The lack of convincing overall survival data so far for ivonescimab severely reduces the odds that it will go on to produce blockbuster sales in the places where Summit Therapeutics has a license to sell it. Despite the obvious challenges ahead, expectations are still sky-high. Drugmaker stocks tend to trade at mid-single-digit multiples of trailing annual sales. Summit has no sales, as ivonescimab is the only candidate in its pipeline. Despite the lack of options and an uncertain path forward, the stock finished May with a market cap above $13.5 billion. If ivonescimab goes on to produce sales anywhere near Keytruda's, investors who bought Summit Therapeutics at recent prices could reap enormous gains. 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Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of May 19, 2025 Cory Renauer has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Summit Therapeutics. The Motley Fool has a disclosure policy. Is Beaten-Down Summit Therapeutics Stock a Bad-News Buy? was originally published by The Motley Fool Sign in to access your portfolio
