New triplet combination was of Revlimid and Imnovid was approved by the European Commission for the treatment of patients with multiple myeloma.
As per the approval, Revlimid in combination with bortezomib and dexamethasone was indicated for the treatment of patients with multiple myeloma as first-line treatment.
Imnovid in combination with bortezomib and dexamethasone was indicated for the treatment of patients with multiple myeloma as first-line therapy.
First-line therapy was important in the treatment of multiple myeloma as later lines of treatment has less fast remission.
The approval is based on SWOG S0777 and OPTIMISMM
SWOG S0777:
Phase 3 study compared Revlimid, bortezomib and dexamethasone combination was compared with lenalidomide and dexamethasone alone in a newly diagnosed with multiple myeloma (ndMM) who were not intending on immediately receiving ASCT. Patients have indicated both the treatments in the ratio of 1:1. The main efficacy endpoint was progression-free survival. It was 42 months in Revlimid, Bortezomib and dexamethasone combination where it was 30 months in Lenalidomide and dexamethasone combination. Complete response was observed within 52 months in Revlimid, bortezomib, and dexamethasone whereas it was 38 months in lenalidomide and dexamethasone combination.
OPTIMISMM:
Phase 3 study compared pomalidomide in combination with bortezomib and dexamethasone with lenalidomide and dexamethasone alone. The target population was patients with an early line of therapy in patients with relapsed and refractory multiple myeloma. Patients were randomized for 1:1 to receive both the treatments. 11.2 progression-free survival was reported in pomalidomide in combination with bortezomib and dexamethasone and 7.1 months in bortezomib and dexamethasone. Neutropenia, thrombocytopenia, and infections were the adverse events observed.