After a Phase III trial did not meet its primary endpoint, Bayer will voluntarily withdraw Aliqopa (copanlisib) from the U.S. market following discussions with the FDA.
Pictured: Bayer headquarters in New Jersey/iStock, JHVEPhoto
Bayer is voluntarily taking one of its drugs out of the U.S. market after it failed to reach a primary endpoint in a Phase III trial, the company announced on Monday.
The company’s decision to voluntarily withdraw the NDA for the kinase inhibitor Aliqopa (copanlisib), designed to treat adults with follicular lymphoma who have received two prior therapies, was made following discussions with the FDA.
According to Bayer, the drug was given accelerated approval in September 2017 based on Phase II data from its Chronos-1 trial. However, the FDA had required a “clinical benefit” in the Chronos-4 study, which investigated Aliqopa in combination with chemotherapy in relapsed indolent non-Hodgkin’s lymphoma.
In the trial, Aliqopa failed to meet the primary endpoint of progression-free survival benefit against standard immunochemotherapy. Bayer did not post the full details of the study but did say it “intends to publish the results of Chronos-4 in a timely manner.”
The company added that it is currently “exploring access options” for those taking the drug and who have responded well to its treatment, but no new patients should be prescribed Aliqopa. Bayer also asked that those patients being treated with the drug consult with their healthcare provider.
Aliqopa, a PI3K inhibitor, had previously shown some positive signs. In 2021, the Phase III Chronos-3 trial showed “significant improvements” in progression-free survival in a combination of Aliqopa and rituximab, or Rituxan. The combo had a median progression-free survival rate of 21.5 months versus 13.8 months in patients treated with only Rituxan and a placebo, netting a p-value of p=000002.
However, according to MedPage Today, the trial’s overall survival data did not significantly benefit the overall population or the follicular lymphoma subgroup. The report also said that the FDA reviewers “expressed concern” over an “early dip” in the survival curve for those taking the combination.
Bayer’s decision to withdraw Aliqopa from the U.S. market comes as the company is struggling financially. After posting that its cash flow was “unacceptable” in the third quarter of 2023, Bayer chose to reduce part of its workforce, including removing parts of its management structure. The company is also considering a complete separation of its crop science business or consumer health business.
PI3K inhibitors have also been on the FDA’s radar. Last year, amid “concerning” patient survival data and toxicities, an FDA advisory committee recommended shuttering single-arm clinical studies of PI3K inhibitors. The adcomm also recommended using randomized clinical trials to help mitigate safety concerns.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
