May 24, 2011 — Maintenance therapy with lenalidomide (Revlimid) after stem cell transplantation for multiple myeloma is now showing a benefit in overall survival, according to data from the latest update of the phase 3 clinical trial conducted by the Cancer and Leukemia Group (CALGB). The study also showed an extended time to progression.
Results of the fifth interim analysis of the CALGB ECOG BMT-CTN 100104 trial showing data out to a median of 18 months were presented in Paris, France, at the 13th International Myeloma Workshop by principal investigator Philip McCarthy Jr, MD, director of the Blood & Marrow Transplant Program at Roswell Park Cancer Institute in Buffalo, New York.
In this latest analysis, there continued to be a significantly longer time to progression in the patients who received lenalidomide therapy when compared with placebo.
As of April 17, 2011, 69 of the original 231 lenalidomide patients experienced an event — disease progression or death — compared with 116 of the original 229 patients randomized to placebo (P < .0001), for a 56% reduction in the risk for disease progression in the lenalidomide arm (hazard ratio, 0.44; 95% confidence interval, 0.32 – 0.60).
With regard to overall survival, patients receiving continuous lenalidomide therapy demonstrated an overall survival rate of 90% at more than 2 years after transplantation, compared with 83% for patients receiving placebo (P = .018).
Practice Changing
This is a practice-changing finding, Dr. McCarthy told Medscape Medical News.
There is a marked benefit in delaying disease progression in patients who receive lenalidomide maintenance therapy, and there appears to be an overall survival benefit," he said. "We hope these results will allow patients and their physicians the option to prolong response to initial therapy and prevent disease recurrence."
Last year, Dr. McCarthy presented the 12-month median follow-up results at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting. As reported by Medscape Medical News at that time, patients who received lenalidomide had a 58% reduction in their risk for relapse. After 12 months of follow-up, only 13.8% of patients in the lenalidomide group had disease progression, compared with 27.8% of patients in the placebo group.
Additional evidence for the benefit of maintenance lenalidomide was also presented by French researchers at the 2010 ASCO meeting, as reported by Medscape Medical News
Michel Attal, PhD, professor of hematology at Purpan Hospital in Toulouse, France, presented interim results of a phase 3 trial conducted in 614 patients that showed that lenalidomide maintenance reduced the risk for relapse by 54%. The 3-year progression-free survival was 68% with maintenance lenalidomide, compared with 35% with placebo.
Long-Awaited Data
"We have been waiting on this data for a very long time," Joseph Mikhael MD, consultant haematologist and associate professor at the Mayo Clinic College of Medicine in Scottsdale, Arizona, told Medscape Medical News.
"That there is a prolonged progression-free survival is not surprising," said Dr. Mikhael, who was not involved in the study and is a spokesperson for the American Society of Hematology. "Some people have gone to the extreme of claiming that they should never have set progression-free survival as an endpoint to close the study because we knew that was going to happen anyway. But nonetheless, essentially 20 more months of progression-free survival compared with placebo is an important finding.
"What was different about the study now presented at Paris...is that there is potentially an overall survival benefit," Dr. Mikhael said.
He cautioned that the overall survival result is preliminary. "We don't have an objective measure to say that Revlamid maintenance, when compared to not giving Revlamid, means that people lived 6 months or 8 months or even 6 days longer," he said. "We still don't know that. So I would say that although it appears to improve overall survival, we need more maturity in the data to conclude that."
Other considerations are a potential increased risk for secondary cancers from lenalidomide and the cost of the drug — currently estimated at approximately $7000 per month, Dr. Mikhael pointed out.
"We still have to look at every patient individually and decide if the risk benefit for going on maintenance is worth it, as opposed to saying everybody en masse should get maintenance after transplant," he said.
G. L. Phillips MD, director of the Blood & Marrow Transplant Program at the University of Rochester Wilmot Cancer Center in New York, agrees with that view.
"I believe that giving the maintenance therapy is a good thing, but not everybody believes that. There are risks and benefits to all therapies, and there is concern that there might be an increase in secondary malignancies with Revlamid," Dr. Phillips told Medscape Medical News.
This study definitely lends weight to giving lenalidomide as maintenance, he agreed. "We still have to follow patients up for fairly long periods of time. We won't have an answer tomorrow."
Dr. McCarthy reports having served as a consultant or adviser for Celgene (manufacturer of lenalidomide) and several other companies. Dr. Phillips has disclosed no relevant financial relationships.
Results of the fifth interim analysis of the CALGB ECOG BMT-CTN 100104 trial showing data out to a median of 18 months were presented in Paris, France, at the 13th International Myeloma Workshop by principal investigator Philip McCarthy Jr, MD, director of the Blood & Marrow Transplant Program at Roswell Park Cancer Institute in Buffalo, New York.
In this latest analysis, there continued to be a significantly longer time to progression in the patients who received lenalidomide therapy when compared with placebo.
As of April 17, 2011, 69 of the original 231 lenalidomide patients experienced an event — disease progression or death — compared with 116 of the original 229 patients randomized to placebo (P < .0001), for a 56% reduction in the risk for disease progression in the lenalidomide arm (hazard ratio, 0.44; 95% confidence interval, 0.32 – 0.60).
With regard to overall survival, patients receiving continuous lenalidomide therapy demonstrated an overall survival rate of 90% at more than 2 years after transplantation, compared with 83% for patients receiving placebo (P = .018).
Practice Changing
This is a practice-changing finding, Dr. McCarthy told Medscape Medical News.
There is a marked benefit in delaying disease progression in patients who receive lenalidomide maintenance therapy, and there appears to be an overall survival benefit," he said. "We hope these results will allow patients and their physicians the option to prolong response to initial therapy and prevent disease recurrence."
Last year, Dr. McCarthy presented the 12-month median follow-up results at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting. As reported by Medscape Medical News at that time, patients who received lenalidomide had a 58% reduction in their risk for relapse. After 12 months of follow-up, only 13.8% of patients in the lenalidomide group had disease progression, compared with 27.8% of patients in the placebo group.
Additional evidence for the benefit of maintenance lenalidomide was also presented by French researchers at the 2010 ASCO meeting, as reported by Medscape Medical News
Michel Attal, PhD, professor of hematology at Purpan Hospital in Toulouse, France, presented interim results of a phase 3 trial conducted in 614 patients that showed that lenalidomide maintenance reduced the risk for relapse by 54%. The 3-year progression-free survival was 68% with maintenance lenalidomide, compared with 35% with placebo.
Long-Awaited Data
"We have been waiting on this data for a very long time," Joseph Mikhael MD, consultant haematologist and associate professor at the Mayo Clinic College of Medicine in Scottsdale, Arizona, told Medscape Medical News.
"That there is a prolonged progression-free survival is not surprising," said Dr. Mikhael, who was not involved in the study and is a spokesperson for the American Society of Hematology. "Some people have gone to the extreme of claiming that they should never have set progression-free survival as an endpoint to close the study because we knew that was going to happen anyway. But nonetheless, essentially 20 more months of progression-free survival compared with placebo is an important finding.
"What was different about the study now presented at Paris...is that there is potentially an overall survival benefit," Dr. Mikhael said.
He cautioned that the overall survival result is preliminary. "We don't have an objective measure to say that Revlamid maintenance, when compared to not giving Revlamid, means that people lived 6 months or 8 months or even 6 days longer," he said. "We still don't know that. So I would say that although it appears to improve overall survival, we need more maturity in the data to conclude that."
Other considerations are a potential increased risk for secondary cancers from lenalidomide and the cost of the drug — currently estimated at approximately $7000 per month, Dr. Mikhael pointed out.
"We still have to look at every patient individually and decide if the risk benefit for going on maintenance is worth it, as opposed to saying everybody en masse should get maintenance after transplant," he said.
G. L. Phillips MD, director of the Blood & Marrow Transplant Program at the University of Rochester Wilmot Cancer Center in New York, agrees with that view.
"I believe that giving the maintenance therapy is a good thing, but not everybody believes that. There are risks and benefits to all therapies, and there is concern that there might be an increase in secondary malignancies with Revlamid," Dr. Phillips told Medscape Medical News.
This study definitely lends weight to giving lenalidomide as maintenance, he agreed. "We still have to follow patients up for fairly long periods of time. We won't have an answer tomorrow."
Dr. McCarthy reports having served as a consultant or adviser for Celgene (manufacturer of lenalidomide) and several other companies. Dr. Phillips has disclosed no relevant financial relationships.
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