Celgene has unveiled a meta-analysis of pooled data from three late-stage studies showing a significant overall survival (OS) benefit in patients newly diagnosed with multiple myeloma receiving Revlimid as maintenance therapy following autologous stem cell transplantation (ASCT).
The meta-analysis pooled data from 1,208 patients newly diagnosed in multiple myeloma who underwent ASCT in three randomised, controlled Phase III studies (CALGB 100104, IFM 2005-02, GIMEMA RVMM-PI-209).
The findings, published as a Rapid Communication in the Journal of Clinical Oncology, show that Revlimid (lenalidomide) maintenance therapy cut the risk of death by 25 percent versus placebo/observation.
The seven-year survival rate was 62 percent with Revlimid maintenance versus 50 percent in the control group, while median progression-free survival was 52.8 months for the treatment group and 23.5 months for the control arm.
Also, no new safety signals were reported, but discontinuation rates due to treatment-emergent adverse events were 29.1 percent with Revlimid and 12.2 percent in the control group, the most commonly reported in the treatment group being haematological, including neutropenia and thrombocytopenia.
Revlimid is approved for use across the multiple myeloma spectrum, including as combination therapy for the treatment of patients not eligible for transplant who are newly diagnosed or those have received at least one prior therapy. It was cleared by European regulators in February this year as maintenance therapy following ASCT.
Findings of the pooled analysis “reinforce the body of evidence” that resulted in the drug approval in the post -ASCT maintenance setting, noted Professor Michel Attal, executive director of the Institut Universitaire du Cancer Toulouse Oncopole and Institut Claudius Regaud, France, and senior author on the paper.
“Achieving remission and maintaining long-term disease control are critical aims when treating newly diagnosed patients. In this context, Revlimid has been shown to delay disease progression, prolong the time before the next line of treatment is needed, and ultimately extend survival. It can therefore now be considered a standard of care for these patients,” he said.
Around 39,000 people are diagnosed with multiple myeloma and 24,000 die from it in Europe every year.