Aliqopa (copanlisib) is an injectable medicine being developed by Bayer. The U.S Food and Drug Administration (FDA) recently granted Aliqopa accelerated approval to treat adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.

In addition to follicular lymphoma, Aliqopa is also being investigated in other relapsed or refractory lymphomas, head and neck carcinomas and breast cancer, alone or in combination with other drugs.

How Aliqopa works

Follicular lymphoma is a slow-growing, non-Hodgkin type of lymphoma that originates in the B-cells at the lymph nodes. B-cells are a type of immune system cells that are responsible for combating infections or threats against the body through the production of antibodies.

In patients with follicular lymphoma, the cancer often comes back even after multiple treatments, with the rate and duration of the response usually decreasing with each therapy.

Aliqopa is a kinase inhibitor. It works by inhibiting the phosphatidylinositol-3-kinases (PI3Ks), PI3K-alpha and PI3K-delta, present in cancerous B-cells. The PI3K pathway is involved in cell growth, survival, and metabolism, and its dysregulation plays an important role in follicular lymphoma. By blocking PI3Ks pathway, Aliqopa inhibits tumor cell growth and survival.

Aliqopa in clinical trials

The safety and effectiveness of Aliqopa monotherapy were evaluated in a Phase 1 study (NCT02155582) in patients with advanced solid tumors or non-Hodgkin’s lymphoma (NHL). The trial’s results showed that Aliqopa was well-tolerated and demonstrated encouraging antitumor activity.

The FDA based its approval of Aliqopa on data from the Phase 2 CHRONOS-1 trial (NCT01660451) designed to evaluate the efficacy and safety of the drug in people with follicular B-cell NHL who had relapsed disease following at least two prior systemic therapies. The trial measured the number of patients who experienced complete or partial shrinkage of their tumors after treatment (overall response rate). The results showed that 59 percent of patients had a complete or partial response for a median 12.2 months, having a favorable impact in the treatment of disease-related symptoms.

Bayer is currently performing a Phase 3 trial (NCT02369016) called CHRONOS-2 to confirm the benefits of Aliqopa in patients with follicular and other types of B-cell indolent NHL who are refractory to treatment with Rituxan (rituximab).

In addition, two Phase 3 studies, CHRONOS-3 (NCT02367040) and CHRONOS-4 (NCT02626455), are currently recruiting patients to examine Aliqopa in combination with other cancer therapies to treat further NHL.

Apart from NHL, Aliqopa is also being evaluated in a Phase 1 trial (NCT02705859) to treat breast cancer, as well as a Phase 1/2 trial (NCT02822482) to treat head and neck carcinomas. Both studies are now recruiting patients.

Other details

While the drug is considered safe, it does cause some adverse effects. The most common of these are nausea, high blood sugar and blood pressure, decreased general strength and energy, diarrhea, and lower urinary tract infections, in addition to the typical treatment-related loss of white blood cells and platelets.


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