On 14th September 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to copanlisib for the treatment of adult patients with relapsed Follicular Lymphoma (FL) who have received two or more systemic therapies.
The accelerated approval for Bayer’s PI3K inhibitor is based on findings from the single-arm, phase II CHRONOS-1 trial (NCT01660451), which included 104 FL patients who had experienced relapse after at least two previous systemic therapies. Results of this pivotal trial were presented during the 14th International Conference on Malignant Lymphoma (ICML) by Martin Dreyling from the University Hospital of Munich, Germany; click here to read more on this abstract presentation.
- Copanlisib 60mg on days 1, 8, and 15 of a 28-day cycle; intermittent schedule until PD or unacceptable toxicity
- ORR = 59% (95% CI, 49–68%); CR = 14%
- Median DoR = 12.2 months
- Most frequent AEs (>20%) = decreased strength and energy (36%), diarrhea (36%), hyperglycemia (54%), hypertension (35%), leukopenia (36%), lower respiratory tract infections (21%), nausea (26%), neutropenia (32%), and thrombocytopenia (22%)
- SAEs were experienced by 26%
- The most common SAEs = hyperglycemia (5%), pneumonia (8%), and pneumonitis (5%)
- AEs lead to: dose reduction in 21% of pts; treatment discontinuation in 16% of pts
Professor Anas Younes from Memorial Sloan Kettering Cancer Center, and Co-Chair of the Lymphoma Hub Executive Steering Committee, said in the press release: “When treating patients with relapsed Follicular Lymphoma, two factors for physicians involve lessening tumor burden and reducing adverse events (AEs) patients may experience from treatments. Therapies need to be both effective and tolerable.” Professor Younes went on to say “The PI3K pathway is activated in many tumor types, including lymphoma, and targeting PI3K therapeutically is a very important strategy in this area of disease. Copanlisib has a safety and efficacy profile that is a welcome advance for both doctors and patients in third-line Follicular Lymphoma.”
Copanlisib has also been awarded Orphan Drug Designation by the FDA for patients with Marginal Zone Lymphoma (MZL).