In a nutshell
This study reported the effectiveness and safety outcomes of copanlisib (Aliqopa) and rituximab (Rituxan) combination for the treatment of patients with relapsed indolent (painless) non-Hodgkin lymphoma (NHL). The data showed that this combination improved the outcomes of these patients with manageable side effects.
Non-Hodgkin lymphoma (NHL) is a cancer that starts in white blood cells called lymphocytes. Indolent NHL (iNHL) is a type of NHL that grows and spreads slowly and usually has very few symptoms. A high number of patients with iNHL experience relapse (worsening of the disease) or refractory (not responsive to the treatment) disease. Treatment of iNHL usually involves treatment with rituximab alone or combined with chemotherapy. Rituximab is an immune protein that works by helping the body’s immune system attack cancer cells.
Copanlisib is a targeted therapy that blocks a protein needed for cancer cells to grow and divide. Blocking this protein may stop the growth of cancerous B-cells, eventually leading to cell death. Copanlisib alone has shown to be effective in patients with iNHL that has relapsed. However, whether the combination of copanlisib with rituximab would be effective and safe for the treatment of patients with relapsed iNHL remain under investigation.
Methods & findings
This study involved 458 patients with relapsed B-cell iNHL. The patients were randomly assigned into two groups. Group 1 included 307 patients who received copanlisib plus rituximab. Group 2 included 151 patients who received placebo plus rituximab. The average follow-up time was 19.2 months.
Copanlisib plus rituximab combination significantly improved the survival without cancer worsening by 48% compared to placebo plus rituximab. The average survival without cancer worsening was 21.5 months for patients in group 1 compared to 13.8 months for patients in group 2.
81% of patients in group 1 had a response to treatment compared with 48% in group 2.
More patients in group 1 (56%) had high levels of sugar in the blood compared to group 2 (8%). Also, more patients in group 1 (40%) had high blood pressure compared to 9% in group 2. Serios treatment-related side effects were observed in 47% of patients in group 1 compared to 18% of patients in group 2.
The bottom line
This study concluded that copanlisib plus rituximab treatment improved survival without cancer worsening in patients with relapsed iNHL with manageable side effects.
The fine print
This study received funding from Bayer HealthCare Pharmaceuticals, the manufacturer of copanlisib. The sample size was small and the follow-up time was too short.
Published By :
The Lancet. Oncology
Apr 09, 2021
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