Bayer launched a breakthrough therapy AliqopaTM (Copanlisib) for the treatment of Marginal Zone Lymphoma (MZL).
Aliqopa (Copanlisib) is an intravenous phosphatidylinositol-3-Kinase (PL3K) inhibitory activity predominantly against the PL3K-alpha and PL3K-delta isoforms expressed in malignant B cells.
Breakthrough therapy is intended to increase the development and review of drug candidates that treat serious or life-threatening diseases or conditions, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies.
Based upon the data from the pivotal Phase II CHRONOS-1 study, the therapy received the U.S. Food and Drug Administration (FDA) approval. Bayer, the manufacturer of the PI3K inhibitor. In a subgroup of 23 patients with MZL, the overall response rate (ORR) was 69.6 per cent (n = 16) in the primary analysis. A follow-up analysis at 18 months showed an ORR of 78.3 per cent (n = 18) in these patients.
Patients received copanlisib at 60 mg on days 1, 8, and 15, repeated every 28 days until disease progression or development of unacceptable toxicity.
Across patient subgroups, 80.3 per cent of them have advanced disease stage (III or IV) at the enrollment. Follicular lymphoma was dominant lymphoma for 73.2 per cent of the study population.
Safety data for the MZL subgroup showed that the most common (≥20 per cent) all-grade treatment-emergent adverse events (TEAEs) were hyperglycemia and fatigue (47.8 per cent), hypertension and diarrhea (43.5 per cent), nausea (26.1 per cent), and pyrexia and cough (21.7 per cent). The most common grade 3 TEAEs were hypertension (39.1 per cent) and hyperglycemia (34.8 per cent).
The compound is currently not approved by the European medicines agency (EMA) or other authorities of the US.