Here is the Celgene/Revlimid maintenance study I referenced at the end of my article about new, promising anti-multiple myeloma therapies I wrote earlier today:
Continuous treatment with REVLIMID® for Patients with Multiple Myeloma Following Autologous Stem Cell Transplant evaluated by Intergroup Phase III Study (CALGB 100104)
Patients Receiving Continuous Daily Treatment with Lenalidomide Experienced a 60% reduction in the Risk of Disease Progression or Death Compared to Placebo
Patients in Continuous Therapy Arm Also Had a Statistically Significant Median Progression-Free Survival of 42.3 Months Compared to 21.8 for Placebo
December 5, 2010 – Celgene International today announced that data from a National Cancer Institute-sponsored clinical study were presented by representatives of a network of researchers led by the Cancer and Leukemia Group B (CALGB) at the 52nd Annual Aeeting of the American Society of Hematology.
In this Phase III, controlled, double-blind, multi-centre study, newly diagnosed multiple myeloma patients who achieved at least stable disease (SD) following autologous stem cell transplant (ASCT) were randomized to receive continuous daily treatment with REVLIMID® lenalidomide 10 (escalation or reduction to 5 or 15 mg as needed; n=231) or placebo (n=229) until relapse. The independent Data and Safety Monitoring Committee report of a planned interim analysis in November 2009 led to the announcement the study had met its primary endpoint and should be halted early and unblinded in December 2009. The data are from a third interim analysis of this study.
The median follow-up was 17.5 months from ASCT. Patients receiving continuous lenalidomide following ASCT experienced a 60% reduction in the risk of disease progression or death when compared to patients receiving placebo (p < 0.0001).
The median time to progression (TTP) was significantly higher for the lenalidomide arm at 42.3 months versus the estimated median TTP of 21.8 months for the placebo arm.
Significant improvements in TTP were observed in the lenalidomide arm regardless of disease volume (expressed by beta-2 microglobulin). Patients who received prior thalidomide or lenalidomide induction therapy also experienced clinically significant improvements in TTP from lenalidomide continuous therapy.
As of December 17, 2009 there had been 13 deaths in the lenalidomide arm compared to 24 deaths in the placebo arm – resulting in a difference in overall survival (p<0.052). According to the study, as of November 2010, a statistical difference between the two arms may no longer be present due to approximately 78% (86/110) of patients in the placebo arm crossing over to active treatment with lenalidomide (p<0.078).
The most common grade 3-4 adverse events experienced by patients receiving lenalidomide or placebo in the study were neutropenia (43% 89/208 vs. 9% 17/197), thrombocytopenia (13% 26/208 vs. 4% 7/197) and infections (16% 33/208 vs. 5% 11/197). There were no grade 5 haematologic adverse events. The rate of grade 5 non-haematologic adverse events was similar between the two arms of the study (1% 3/208 vs. 2% 3/197).
The CALGB 100104 data are from an investigational study. REVLIMID® does not have marketing approval for the initial treatment of patients with multiple myeloma.
Note the third to last paragraph. 13 deaths are 13 too many. But much better than 24! More telling is the last sentence of the same paragraph: “According to the study, as of November 2010, a statistical difference between the two arms may no longer be present due to approximately 78% (86/110) of patients in the placebo arm crossing over to active treatment with lenalidomide (p<0.078).” That means doctors felt it was in the best interest for all of the patients to start using maintenance therapy. They were convinced!
No time for comment or editorial here… I will keep throwing examples of significant and/or controversial new research from these ASH meetings out to you. We will have plenty of time to debate the risk, rewards, benefits and cost of this stuff after the dust settles and we move into the new year.
Feel good and keep smiling! Pat