Sept 25 (Reuters) – Merck and Daiichi Sankyo have withdrawn their US application seeking accelerated approval for an experimental lung cancer therapy, the companies said on Friday, marking the second pullback under their multibillion-dollar cancer alliance.
The decision followed discussions with the US Food and Drug Administration, which determined that the data from a mid-stage clinical study testing the therapy, ifinatamab deruxtecan, did not satisfy requirements needed to support an early green light.
The therapy was under review to treat adults with an aggressive condition, known as extensive-stage small cell lung cancer, whose disease had worsened after standard chemotherapy.
Ifinatamab deruxtecan belongs to a class of targeted cancer therapies, called antibody-drug conjugates, which work like “guided missiles” by killing tumor cells while leaving healthy ones unharmed.
It is the second of the three “guided missile” therapies, co-developed by Merck and Daiichi under their 2023 partnership worth up to $22 billion, to face a US application withdrawal. Last year, the companies pulled the application for another lung cancer candidate, patritumab deruxtecan, after it failed to extend the lives of patients in a late-stage study.
Ifinatamab deruxtecan, patritumab deruxtecan and a third therapy, raludotatug deruxtecan, are all part of the collaboration.
Despite the setback, the companies said they would continue evaluating ifinatamab deruxtecan. Patient enrollment is nearly complete for a larger, late-stage trial comparing the therapy against other standard chemotherapy options.
The companies plan to use the results from that study to seek approvals from the FDA and other global health regulators.
The therapy is also being evaluated in separate late-stage clinical trials for advanced prostate and esophageal cancers.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Maju Samuel and Shilpi Majumdar)
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