The Withdrawal of Copanlisib: A Blow to the PI3K Inhibitor Class

Bayer’s follicular lymphoma drug, copanlisib (Aliqopa), is set to be withdrawn from the U.S. market due to a failed confirmatory study and discussions with the FDA. The phase III study, known as CHRONOS-4, was a requirement for the accelerated approval of the PI3K inhibitor. Unfortunately, the addition of copanlisib to standard immunochemotherapy did not lead to an improvement in progression-free survival (PFS) for relapsed follicular lymphoma patients when compared to immunochemotherapy alone. As a result, the company has advised against prescribing copanlisib to new patients.

While new patients will no longer have access to copanlisib, Bayer has expressed its commitment to finding alternative access options for current patients who have responded well to the treatment and have the support of their treating physicians. Recognizing that there may be no suitable alternatives available for these patients, Bayer aims to ensure that they can continue to receive the drug.

The withdrawal of copanlisib is part of a broader trend in the FDA’s crackdown on PI3K inhibitors. Drugs such as umbralisib (Ukoniq) and idelalisib (Zydelig) have already been removed from the market or had their indications withdrawn due to safety concerns and potential overall survival (OS) issues observed in confirmatory trials. In fact, the FDA’s Oncologic Drugs Advisory Committee unanimously voted that future applications for PI3K inhibitors in hematologic cancers must be supported by randomized trial data.

Copanlisib received accelerated approval from the FDA in 2017 for patients with relapsed follicular lymphoma who had previously undergone at least two systemic therapies. The approval was based on promising tumor shrinkage data from the phase II CHRONOS-1 trial, where the PI3K inhibitor demonstrated response rates of 59% and complete responses in 14% of patients. The median duration of response was 12.2 months.

In the subsequent phase III CHRONOS-3 trial, the addition of copanlisib to rituximab did improve PFS in relapsed indolent non-Hodgkin’s lymphoma, including patients with follicular lymphoma. The results showed a median PFS of 21.5 months for the combination arm compared to 13.8 months for the rituximab-only arm (HR 0.52, 95% CI 0.39-0.69, P


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