Study suggests an approximately 2.5-year survival increase compared with placebo or no maintenance in patients with multiple myeloma.
Findings from a meta-analysis suggested significant overall survival (OS) benefits in multiple myeloma patients who received investigational maintenance treatment with lenalidomide (Revlimid) capsules following autologous stem cell transplant (ASCT).
The meta-analysis was conducted to evaluate patient level data from 1209 patients in 3 randomized, controlled, phase 3 studies: CALGB (Alliance) 100104, IFM 2005-02, GIMEMA-RVMM-PI-209.
The studies compared Revlimid maintenance in 605 participants to either placebo or no maintenance (n=604), which revealed that Revlimid maintenance treatment after ASCT reduced the risk of disease progression or death by about 50%, meeting the primary study endpoint.
The results of the meta-analysis revealed that median OS had not been reached for patients who received Revlimid maintenance at the median follow-up of 80 months, compared with 86 months in the control arm [95% CI: HR 0.74 (0.62-0.89); p=0.001]. This showed a 2.5-year benefit of Revlimid maintenance.
“The results of this meta-analysis reinforce the long-term benefit that lenalidomide maintenance therapy has demonstrated in myeloma patients who receive an autologous stem cell transplant within the large, phase 3 studies individually,” said Antonio Palumbo, lead investigator of the GIMEMA study.
The hazard ratios in each of the studies favored Revlimid maintenance treatment. In the Revlimid arm, pooled data showed a hazard ratio of 2.03 (95% CI: 1.14-3.61) for the risk of developing a hematologic secondary primary malignancy (SPM), while the risk of developing a solid tumor SPM had a hazard ratio of 1.71 (95% CI: 1.04-2.79).
Hematologic SPMs found in the CALGB (Alliance) 100104 study totaled 15 for the Revlimid arm and 8 for the control arm. In the IFM 2005-02 study, there were 21 for Revlimid and 9 for the control, and none for either arm in the GIMEMA-RVMM-PI-209 study.
For the solid tumor SPMs, there were 17 totaled for the Revlimid arm and 10 for the control arm in the CALGB (Alliance) 100104 study, 21 for Revlimid and 13 for control in the IFM 2005-02 study, and 5 for Revlimid and 2 for the control in the GIMEMA-RVMM-PI-209 study.
“Lenalidomide has consistently demonstrated improvement in progression-free survival in this setting,” said Michel Attal, lead investigator of the IFM study. “The improved overall survival shown by this meta-analysis further supports the positive benefit-risk ratio observed in the individual phase 3 studies.”