ASCO 2010-LENALIDOMIDE MAINTENANCE FOR MULTIPLE MYELOMA

June 15, 2010 (Chicago, Illinois) — Maintenance therapy with oral lenalinomide (Revlimid) in multiple myeloma patients who had undergone stem cell transplantation has shown a significant reduction in the risk for relapse in 2 separate phase 3 trials — one conducted in the United States and the other in France.

The time to progression of disease "is dramatically increased," and lenalinomide maintenance therapy could become the "new standard of care" for these patients, said Jean-Luc Harousseau, MD, from the Center for Research on Myeloma in Nantes, France. He was speaking at a Highlights of the Day session here at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting, where the latest results from both studies were presented.

The American study was sponsored by the National Cancer Institute and involved 418 patients. Updated results, reported at the meeting by Philip McCarthy Jr, MD, director of the Blood & Marrow Transplant Program at Roswell Park Cancer Institute in Buffalo, New York, show that patients who received lenalinomide had a 58% reduction in their risk for relapse. After 12 months of follow-up, only 13.8% of patients in the lenalinomide group had disease progression, compared with 27.8% of those in the placebo group.

"This study answers important questions. . . . We now know that prolonged maintenance therapy with lenalinomide will delay disease progression compared with placebo," Dr. McCarthy said in a statement. "That's important and welcome news, because so many patients have relapse or progressive disease even after a stem cell transplant," he added.

The other set of results come from an interim analysis of a French study — a phase 3 trial conducted in 614 patients — and were presented at the meeting by Michel Attal, PhD, professor of hematology at Purpan Hospital in Toulouse, France. Those data were highlighted in an ASCO preview presscast, as already reported by Medscape Oncology. They showed that lenalinomide maintenance halved the risk for relapse. The 3-year progression-free survival was 68% with maintenance lenalinomide, compared with 35% with placebo (hazard ratio, 0.46; P < 10–6), reducing the rate of relapse by 54%.

Dr. Harousseau noted that the 2 studies were similar, but the French study used a consolidation phase of therapy before moving on to maintenance with lenalinomide. Both trials showed a significant improvement in time to disease progression, he pointed out, although there are no data available yet for overall survival.

Maintenance therapy for myeloma is already common clinical practice, but questions remain about which agent to use, Douglas Blayney, MD, outgoing president of ASCO, told Medscape Oncology in an interview.

One advantage of lenalinomide is that it is taken orally, whereas one of the alternative therapies — bortezomib (Velcade) — needs to be administered intravenously. Patients who are on maintenance therapy often prefer the oral agent because it helps them feel that they have returned to a "normal life," he explained.

The other agent that has been used for maintenance, and that has shown benefit, is thalidomide, but the peripheral neuropathy associated with this drug makes it "impossible to use in this setting," said Dr. Attal.

The authors of both studies report having served as consultants or advisors for Celgene (manufacturer of lenalinomide) and several other companies.

American Society of Clinical Oncology (ASCO) 2010 Annual Meeting: Abstracts 8017 and 8018. Presented June 6, 2010.