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The FDA granted accelerated approval to Aliqopa in September 2017 for the treatment of adults with relapsed follicular lymphoma previously treated with at least two prior systemic therapies.
Bayer is voluntarily withdrawing a new drug application for copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma previously administered at least two prior systemic treatments.1
The FDA granted accelerated approval to Aliqopa in September 2017 after findings from the Phase 2 CHRONOS-1 study (NCT01660451) showed promising results. In the trial, Aliqopa was found to produce an objective response rate (ORR) of 58.7%, with a complete response (CR) rate of 14.4%, a partial response rate of 44.2%, and estimated median duration of response (DOR) of 12.2 months.2
In terms of safety, the combination was consistent with findings on the individual drugs that were previously been published, with no new safety signals identified.3
As part of the accelerated approval, Bayer was required to confirm the clinical benefit of the drug in the Phase 3 CHRONOS-4 study (NCT02626455).1
In the Phase 3 portion of the trial, Aliqopa combined with chemoimmunotherapy regimens failed to meet the primary endpoint, as it did not significantly improve progression-free survival (PFS) compared with standard chemoimmunotherapy alone in patients with relapsed follicular lymphoma.
“Bayer is exploring access options for patients currently receiving Aliqopa who have experienced a favorable response to treatment, whose treating physician supports continuing treatment with Aliqopa, and for whom there may be no suitable alternative treatments available,” the company stated in a press release.1 “Patients currently being treated with Aliqopa should consult their healthcare provider. No new patients should be prescribed Aliqopa.”
In the CHRONOS-4 trial, patients were enrolled with histologically confirmed relapsed indolent non-Hodgkin lymphoma, with subtypes of follicular lymphoma grades 1, 2, or 3A and small lymphocytic lymphoma with an absolute lymphocyte count of less than 5 x 109/L.
Enrollment criteria included administration of at least one and up to three lines of prior therapy, including a rituximab (Rituxan)-based chemoimmunotherapy regimen and alkylating agents.
Patients were excluded if they had histologically confirmed follicular grade 3B or transformed disease or chronic lymphocytic leukemia; if they developed resistance to Rituxan, Rituxan biosimilars, or an anti-CD20 monoclonal antibody such as obinutuzumab (Gazyva); a history of or concurrent interstitial lung disease; lymphomatous involvement of the central nervous system; or known HIV infection.
Patients were randomly assigned to receive Aliqopa combined with standard chemoimmunotherapy or chemoimmunotherapy alone, comprised of Rituxan plus bendamustine (R-B) and Rituxan plus cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone (R-CHOP).
Phase 3 of the trial was to include approximately 520 patients, with Aliqopa analyzed at the recommended Phase 2 dose of 60 mg plus R-B. Patients were administered a maximum of six cycles of treatment.
In the Phase 3 portion, the efficacy endpoints included ORR, DOR, CR rate, time to disease progression, time to next treatment, overall survival, time to improvement in disease-related physical symptoms, time to deterioration in disease-related physical symptoms, treatment-emergent adverse effects, and disease control rate.
In the press release, Bayer said that results from CHRONOS-4 will be published “in a timely manner.”1
Aliqopa is currently approved in the United States, China, and Taiwan as a monotherapy for the treatment of adults with relapsed follicular lymphoma.
1. Bayer provides update on Aliqopa (copanlisib). News release. Bayer. November 13, 2023. Accessed November 13, 2023. https://finance.yahoo.com/news/bayer-provides-aliqopa-copanlisib-150000518.html
2. FDA grants accelerated approval to copanlisib for relapsed follicular lymphoma. FDA. September 14, 2017. Accessed November 13, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-copanlisib-relapsed-follicular-lymphoma
3. Aliqopa (copanlisib) in combination with rituximab meets primary endpoint in patients with relapsed indolent non-Hodgkin’s lymphoma. News release. Bayer. October 14, 2020. Accessed October 14, 2020. https://bit.ly/3dqGE2m.