Revlimid Study Discontinuation: What does it mean?
Many of you have heard the news that Celgene's ORIGIN study was discontinued after the FDA placed it on clinical hold on July 12, 2013. This Phase III study was designed to evaluate the safety and efficacy of Revlimid (lenalidomide) vs chlorambucil as a single agent in previously untreated elderly patients with CLL. The study had an imbalance of deaths in the lenalidomide arm vs. the chlorambucil arm, leading Celgen to discontinue the study. Since the study discontinuation, the CLL patient community has been buzzing about what the study discontinuation means.
This discontinued study, also referred to as the CLL-008 trial, enrolled 450 patients in over 26 countries. The patients had a substantial number of comorbidities such as diabetes, congestive heart failure and renal impairment. In fact, this study enrolled patients who were unable to be treated with more aggressive standard chemo-immunotherapies such as regimens containing fludarabine and bendamustine.
Many patients have asked if they should come off lenalidomide treatment. Our strong advice is not to arbitrarily stop taking lenalidomide without talking to your doctor. Many clinical studies have shown that lenalidomide is effective in the treatment of CLL, although the agent is formally approved by the FDA for certain patients with multiple myeloma, myelodysplastic syndroms and mantle cell lymphoma. See these two journal articles for information on studies of lenalidomide in elderly patients: Lenalidomide induces long-lasting responses; Lenalidomide as initial therapy. Celgene reports that all of its other company-sponsored CLL clinical trials with lenalidomide are continuing.
According to Dr. Michael Keating, CLL Global President and CEO, the relevance of the Celgene study discontinuation is of very limited consequence to patients in the United States and Europe. The care of patients and access to technology in many of the countries in which the study was conducted is not at the level that you would anticipate in the United States and Western Europe.
Keating also noted that the patients included in the study were elderly, including a substantial number of patients over the age of 80. For the "super elderly", previous studies already demonstrated that caution is needed when treating patients over the age of 75.
It is unfortunate, Keating continued, that patients who have already made such a long-term time and personal commitment to the protocol are having their treatment discontinued even if they were tolerating it well and benefitting from it.