The primary endpoint was Independent Review Committee-assessed ORR.
Serious adverse reactions were reported in 44 (26%) patients. The most frequent serious adverse reactions that occurred were pneumonia (8%), pneumonitis (5%) and hyperglycemia (5%). Adverse reactions resulted in dose reduction in 36 (21%) and discontinuation in 27 (16%) patients. The most frequently observed adverse drug reactions (=20%) in copanlisib-treated patients were: hyperglycemia (54%), leukopenia (36%), diarrhea (36%), decreased general strength and energy (36%), hypertension (35%), neutropenia (32%), nausea (26%), thrombocytopenia (22%), and lower respiratory tract infections (21%).1 The safety data reflect exposure to copanlisib in 168 adults with follicular lymphoma and other hematologic malignancies treated with copanlisib 60 mg or 0.8 mg/kg equivalent in clinical trials. Patients with small lymphocytic leukemia, lymphoplasmacytic lymphoma / Waldenstrom's macroglobulinemia and marginal zone lymphoma were also enrolled in the study and included in the safety analysis.
About Follicular Lymphoma
FL is the most common indolent form of B-cell NHL, accounting for approximately 20 to 30 percent of all NHLs.2,4 FL is typically a slow-growing, or indolent, form of NHL, in which the cancer cells grow in a circular pattern in lymph nodes.3 Often, FL presents with no obvious symptoms of the disease at diagnosis; however, some common symptoms may include enlarged lymph nodes in the neck, armpits, abdominal area or groin, fatigue, shortness of breath, night sweats or unexplained weight loss.5 Relapse is common, although remission may last for years.
About Aliqopa
Aliqopa is an inhibitor of PI3K with inhibitory activity predominantly against PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells.1 The PI3K pathway is involved in cell growth, survival and metabolism, and its dysregulation plays an important role in FL. Aliqopa has been shown to induce tumor cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines. Aliqopa inhibits several key cell-signaling pathways, including B cell receptor signaling, CXCR12 mediated chemotaxis of malignant B cells, and NF?B signaling in lymphoma cell lines.1 Aliqopa is administered as a 1-hour intravenous infusion on days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule. Treatment should be continued until disease progression or unacceptable toxicity.
The broad clinical development program for copanlisib also includes ongoing Phase III studies in indolent NHL (iNHL) patients who have relapsed or are refractory to prior therapies. The CHRONOS-3 Phase III study is eva luating copanlisib in combination with rituximab in relapsed iNHL and the CHRONOS-4 Phase III study is eva luating copanlisib in combination with standard immunochemotherapy in relapsed iNHL. More information about these trials can be found at www.clinicaltrials.gov.
Important Safety Information
Infections: Serious, including fatal, infections occurred in 19% of 317 patients treated with ALIQOPA monotherapy. The most common serious infection was pneumonia. Monitor patients for signs and symptoms of infection and withhold ALIQOPA for Grade 3 and higher infection.
Serious pneumocystis jiroveci pneumonia (PJP) infection occurred in 0.6% of 317 patients treated with ALIQOPA monotherapy. Before initiating treatment with ALIQOPA, consider PJP prophylaxis for populations at risk. Withhold ALIQOP |
