Two new drugs for use in the treatment of hematologic malignancies have been recommended for conditional marketing authorization in Europe.
The drugs are idecabtagene vicleucel (Abecma), for use in multiple myeloma, and tafasitamab (Minjuvi), for use in diffuse large B-cell lymphoma (DLBCL). In both cases, the drug is intended for use in patients with refractory or relapsed disease.
A conditional marketing authorization is granted to a product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The manufacturer is expected to provide comprehensive clinical data at a later stage.
First CAR Therapy for Myeloma
Idecabtagene vicleucel is a genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy and the first cell-based gene therapy for multiple myeloma.
It is intended for use in adult patients with relapsed and refractory multiple myeloma who have received at least three previous therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and who have experienced disease progression.
The product is already approved in the United States for this indication.
The recommendation for a conditional marketing authorization in the European Union was based primarily on the KarMMa study, a phase 2, multicenter, open-label, single-arm clinical trial that investigated the efficacy and safety of idecabtagene vicleucel in 140 adult patients with relapsed or refractory multiple myeloma who had received at least three prior therapies. Within this group, 28 patients received the target dose levels of 150–450 x 106 CAR T cells after undergoing lymphodepleting chemotherapy.
Results showed that about 67% of patients responded to the treatment and that remission was maintained for an average of about 11 months; 30% achieved a complete response.
The main safety concerns cited were cytokine release syndrome, neurologic toxicity, cytopenias, and infections.
Treatment for Lymphoma
Tafasitamab (Minjuvi) is intended for use in the treatment of adult patients with relapsed or refractory DLBCL who are not candidates for autologous stem cell transplant (ASCT). The indication states that it It is to be used in combination with lenalidomide followed by tafasitamab monotherapy.
The drug is already approved in the United States for this indication.
Tafasitamab is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. It mediates B-cell lysis through apoptosis and immune effector mechanism, including antibody-dependent cell-mediated cytotoxicity and antibody-dependent cellular phagocytosis.
The recommendation for a conditional approval in the European Union was based primarily on results from the L-MIND trial, a single-arm, open-label phase 2 study that investigated the combination of tafasitamab and lenalidomide in patients with relapsed or refractory DLBCL who had had at least one but no more than three prior lines of therapy, including an anti-CD20-targeting therapy, and who were not eligible for high-dose chemotherapy or ASCT (Lancet Oncol. 2020:978-988). A total of 48 (60%) of 80 patients who received tafasitamab plus lenalidomide had an objective response; 34 (43%) achieved a complete response, and 14 (18%) achieved a partial response.
The most common reported side effects were infections, neutropenia (including febrile neutropenia), thrombocytopenia, anemia, leukopenia, hypokalemia, decreased appetite dyspnea, cough, diarrhea, constipation, vomiting, nausea, abdominal pain, rash, asthenia, fatigue, oedema peripheral and pyrexia.
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