The European Medicines Agency‘s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Celgene‘s Revlimid (lenalidomide) and Pomalyst (pomalidomide, marketed as Imnovid in Europe) as combination therapies with Velcade (bortezomib) and dexamethasone for adult patients with multiple myeloma.
In the case of Revlimid, the triple drug combination (RVd) was recommended for patients who had not been treated previously and were not eligible for stem cell transplantation. The triple combination with Pomalyst (PVd) was recommended for patients who had been treated previously with at least one therapy regimen, including Revlimid.
“The CHMP positive opinions for our IMiD [immunomodulatory] combinations, RVd and PVd represent very good news for patients with multiple myeloma in Europe,” Nadim Ahmed, president, Hematology/Oncology for Celgene, said in a press release. “We look forward to potential EMA approvals, which would make these new triplet regimens available to patients, as we aim to improve patient outcomes across multiple stages of their disease.”
The CHMP recommendation for Revlimid was based on promising data from SWOG S0777, a randomized, open-label, Phase 3 clinical trial (NCT00644228) designed to test the effectiveness of the Revlimid combination in untreated adult patients with multiple myeloma.
The study enrolled 525 patients who were assigned randomly to the triple combination treatment administered in eight cycles of 21 days, or the double combination of Revlimid and dexamethasone given in six cycles of 28 days.
The trial’s data showed that Velcade prolonged patients’ lives without signs of disease worsening (42 months vs. 30 months) and overall survival (89 months vs. 67 months) compared to those who were treated only with the Revlimid and dexamethasone therapy.
Likewise, the rates of overall and complete responses were higher in patients receiving the Revlimid combination, compared to those in the control group — 82% vs. 72% for overall response, and 16% vs. 8% for complete response.
The CHMP recommendation for Pomalyst was based on promising data from OPTIMISMM, a randomized, open-label, Phase 3 clinical trial (NCT01734928) designed to evaluate the effectiveness of the Pomalyst combination therapy in adult patients with multiple myeloma who had received at least one prior treatment regimen, including Revlimid.
The study enrolled 559 patients who receive either the triple Pomalyst combination treatment, or the double combination of Velcade and dexamethasone. Most patients in the trial failed to respond to their last anti-myeloma treatment, including 70% who were refractory (resistant) to Revlimid.
The trial’s data showed the triple Pomalyst combination therapy significantly increased the time patients lived without disease progression compared to those in the control group (11.2 months vs. 7.1 months), effectively reducing the risk of disease progression by 39%.
The final decision from the European Commission regarding the approval of both triple combination therapies should be announced in two months.