Bayer has introduced AliqopaTM (Copanlisib), a breakthrough therapy for the treatment of Marginal Zone Lymphoma (MZL).
Aliqopa (Copanlisib) is administered intravenously and exhibits inhibitory activity against phosphatidylinositol-3-Kinase (PL3K), primarily targeting the PL3K-alpha and PL3K-delta isoforms expressed in malignant B cells.
Breakthrough therapy designation aims to expedite the development and review of drug candidates that address serious or life-threatening diseases or conditions. It is granted when preliminary clinical evidence suggests that the drug may provide significant improvement in one or more clinically significant endpoints compared to available therapies.
The therapy received approval from the U.S. Food and Drug Administration (FDA) based on data from the pivotal Phase II CHRONOS-1 study. In the primary analysis, a subgroup of 23 patients with MZL demonstrated an overall response rate (ORR) of 69.6 percent (n = 16). An 18-month follow-up analysis showed an ORR of 78.3 percent (n = 18) in these patients.
Patients received 60 mg of copanlisib on days 1, 8, and 15, repeated every 28 days until disease progression or the development of unacceptable toxicity.
Among the enrolled patients, 80.3 percent had advanced disease stage (III or IV). Follicular lymphoma was the predominant lymphoma type for 73.2 percent of the study population.
Safety data for the MZL subgroup revealed that the most common treatment-emergent adverse events (TEAEs) of any grade (≥20 percent) were hyperglycemia and fatigue (47.8 percent), hypertension and diarrhea (43.5 percent), nausea (26.1 percent), and pyrexia and cough (21.7 percent). The most common grade 3 TEAEs were hypertension (39.1 percent) and hyperglycemia (34.8 percent).
The compound is currently not approved by the European medicines agency (EMA) or other authorities of the US.
