Contact Information

Website: https://www.aliqopa-us.com/

Currently Enrolling Trials

The drug is being pulled from the market in November of 2023 after failing to reach endpoints in a confirmatory trial.

General Information

Aliqopa (copanlisib) is a kinase inhibitor with activity predominantly against the PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells.

Aliqopa is specifically indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.

Aliqopa is supplied as a solution for intravenous infusion. The recommended dose is 60 mg administered as a 1-hour intravenous infusion on Days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (three weeks on and one week off). Continue treatment until disease progression or unacceptable toxicity.

Clinical Results

FDA Approval

Aliqopa was granted accelerated approval based on data from the open-label, single-arm Phase II CHRONOS-1 trial investigating Aliqopa in 104 adults with follicular B-cell non-Hodgkin's lymphoma (NHL) who had relapsed disease following at least two prior systemic therapies. Treatment with copanlisib resulted in an ORR of 59%, with 14% of patients achieving a complete response, and a median duration of response of 12.2 months.

Side Effects

Adverse effects associated with the use of Aliqopa may include, but are not limited to, the following:

hyperglycemia
diarrhea
decreased general strength and energy
hypertension
leukopenia
neutropenia
nausea
lower respiratory tract infections
thrombocytopenia

Mechanism of Action

Aliqopa (copanlisib) is a kinase inhibitor with activity predominantly against the PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells. Copanlisib has been shown to induce tumor cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines. Copanlisib 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.