The U.S. Food and Drug Administration (FDA) granted accelerated approval to Aliqopa® (copanlisib), an intravenously administered pan-class I phosphatidylinositol 3-kinase (PI3K) inhibitor, for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies.
Follicular lymphoma is the most common indolent (slow-growing) form of non-Hodgkin’s lymphoma (NHL), which is a type of cancer originating in immune cells referred to as B-cells. Follicular lymphoma accounts for approximately one in five cases of NHL, and is considered incurable with standard treatment options. In the United States, it is estimated that more than 14,000 new cases of follicular lymphoma will be diagnosed in 2017.
Aliqopa inhibits several key cell-signaling pathways, including B-cell receptor (BCR) signaling, CXCR12 mediated chemotaxis of malignant B cells, and NFκB signaling in lymphoma cell lines leading to cancer cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines.
The approval was based on data from the phase II, single-arm CHRONOS-1 trial, which enrolled 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed after at least two prior treatments. Patients received Aliqopa 60 mg intravenously on days 1, 8, and 15 of a 28-day cycle.
Sixty-one patients responded to treatment, with 15 patients (14%) achieving a complete response, for an overall response rate of 59 percent, and a median duration of response of 12.2 months with some patients with sustained responses greater than 22 months.
The most frequently reported serious adverse events (AEs) were pneumonia (8%), pneumonitis (5%), and hyperglycemia (5%). The most common AEs (occurring in ≥20% of patients) were hyperglycemia, diarrhea, decreased general strength and energy, hypertension, leukopenia or neutropenia, nausea, lower respiratory tract infections, and thrombocytopenia.
Copanlisib was previously granted priority review and orphan-drug designation.
Sources: FDA press release, September 14, 2017; Bayer press release, September 14, 2017.
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