The FDA has granted Bayer’s copanlisib a Priority Review designation for its New Drug Application (NDA) to treat relapsed or refractory follicular lymphoma patients who have received at least two prior therapies.
A Priority Review means that the FDA will review the drug within 6 months instead of the standard 10 months. (compared to 10 months under standard review).
Approximately 1 in 5 people with a lymphoma in the U.S. have follicular lymphoma. The term follicular means that the cells tend to grow in a circular pattern in lymph nodes.
Copanlisib is a pan-Class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms.
The NDA for copanlisib includes data from the Phase II open-label, single-arm CHRONOS-1 study evaluating patients with relapsed or refractory indolent non-Hodgkin's lymphoma (iNHL). In that study involving 142 patients, 73.2% of patients had follicular lymphoma. Other subtypes in the study included marginal zone, SLL, and lymphoplasmacytic lymphoma (LHL)/Waldenstrom macroglobulinemia (WM).
Data from the CHRONOS-1 study was presented at the American Association for Cancer Research (AACR) Annual Meeting 2017 and data from just the subset of patients with follicular lymphoma will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2017 in June.
In the CHRONOS-1 data presented at AACR, patients with iNHL received copanlisib (60 mg) on days 1, 8, and 15, repeated every 28 days until disease progression or development of unacceptable toxicity. All of the patients had prior exposure to rituximab and one or more alkylating agents, and 60.6% had disease that was refractory to the last regimen received. The primary endpoint was objective response by central review after a minimum of 16 weeks of treatment. Secondary endpoints included PFS, duration of response, overall survival, safety, and quality of life. Data analysis included 142 patients who had a median age of 63.
Patients remained on treatment for a median duration of 22 weeks, during which time they received a median of 5.5 cycles of therapy and 96% of planned copanlisib doses. The overall response rate was 59.2%, including 12.0% with a complete response. The study population had a median PFS of 11.2 months (95% CI, 8.1-24.2).
The most common adverse events (all grades) were hyperglycemia (48.6%), hypertension (28.9%), and decreased neutrophil count (24.6%).
Dreyling M, Santoro A, Mollica L, et al. Copanlisib in patients with relapsed or refractory indolent B-cell lymphoma: primary results of the pivotal CHRONOS-1 study. Presented at: 2017 AACR Annual Meeting; April 1-5, 2017; San Washington, DC. Abstract CT149.