Bayer's Copanlisib for Injection Lyophilized Powder Nominated for Priority Review in China

On April 7, the CDE website indicated that Bayer’s copanlisib lyophilized powder for injection was proposed for inclusion in the priority review program. The marketing application for this product was accepted by the CDE on March 10, making it the first PI3K inhibitor submitted for market approval in China.

Copanlisib is an intravenously administered phosphatidylinositol 3-kinase (PI3K) inhibitor that exhibits inhibitory activity against both the PI3K-α and PI3K-δ isoforms expressed in malignant B cells, inducing tumor cell death through apoptosis and inhibition of malignant B-cell proliferation.

In October 2020, Bayer announced the results of the Phase 3 CHRONOS-3 clinical trial. The trial evaluated the efficacy of copanlisib in combination with rituximab for the treatment of relapsed indolent non-Hodgkin lymphoma (iNHL). The analysis demonstrated that the combination therapy met its primary endpoint of significantly prolonging progression-free survival (PFS). Meanwhile, the safety and tolerability profile observed in the trial was generally consistent with previously published data on the individual components of the combination, with no new safety signals identified.

Copanlisib was first granted accelerated approval by the FDA in September 2017 for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. The accelerated approval for this indication was based on results from the open-label, single-arm Phase II CHRONOS-1 study, which demonstrated an overall response rate (ORR) of 59%, including a complete response (CR) rate of 14%. Updated results following a 2-year follow-up showed an ORR of 59% in the follicular lymphoma population, with a CR rate of 20%.

In addition, Copanlisib is currently being evaluated in the CHRONOS-4 study (China Clinical Trial Registry Number: CTR20160362), a Phase III clinical trial investigating its combination with standard immunochemotherapy for the treatment of relapsed indolent non-Hodgkin lymphoma (iNHL). The first patient was enrolled in July 2017. Patient recruitment is currently ongoing in China.

In China, the most advanced development progress for this target is Bayer's Copanlisib. Novartis's Alpelisib and Buparlisib, as well as Roche's Taselisib and GDC-0077, are all in Phase III clinical trials. Domestic companies such as Chia Tai Tianqing, Innovent Biologics, Hutchison China MediTech, and CSPC Pharmaceutical Group have also entered the field, with their candidates currently in Phase I/II clinical trials.

Sources: PharmCube, Pharma First Time