Medically reviewed by Dr. Brian Koffman
The Bottom Line:
Long-term use of lenalidomide was safe and did not increase the risk of infections or secondary cancers in patients with high-risk CLL.
Who Performed the Research and Where Was it Presented:
Dr. Kerry Rogers from the Ohio State University and colleagues presented the results at the American Society for Hematology (ASH) Annual Meeting 2023.
Background:
Lenalidomide is an immunotherapy with promising efficacy for high-risk chronic lymphocytic leukemia (CLL) in clinical trials. It has immunomodulatory effects that were hypothesized to improve immune function in patients with untreated early-stage CLL. A phase 2 clinical trial gave lenalidomide to high-risk CLL patients who did not yet need treatment and looked at lenalidomide’s effects on vaccine response. While the use of lenalidomide did not improve vaccine responses, patients continued to receive treatment with lenalidomide. This study looks at the long-term outcomes of those patients who received early treatment with lenalidomide.
Methods and Participants:
This was a phase 2 clinical trial that enrolled adult patients with CLL who had high-risk features, including deletion 17p, deletion 11q, complex karyotype, or unmutated IGHV status. Patients had not received any prior therapies and did not meet the iwCLL 2008 treatment criteria. They received lenalidomide starting at 2.5 mg daily and increasing to 5 mg as tolerated.
Results
- Forty-nine patients enrolled in the study, and the average age was 59 years.
- The median follow-up time was 4.6 years, and the median time on lenalidomide treatment was 3.7 years.
- The median time for starting lenalidomide to needing subsequent therapy was 4.4 years.
- The median progression-free survival after starting lenalidomide was 5.7 years.
- It was estimated that 74% of patients would be alive after eight years.
- Patients with CLL are prone to developing skin cancers, and in this study, 15 patients developed non-melanoma skin cancers.
- Cases of other types of second cancers were infrequent. One patient developed lung cancer, one patient developed melanoma, and one patient developed squamous cell carcinoma.
- Patients with CLL are also more likely to develop infections because they are immunosuppressed, and 88% of patients experienced an infection at some point during this study.
- 95% of these infections were mild or moderate in severity.
Conclusion:
Long-term use of lenalidomide was safe and did not increase the risk of infections or secondary cancers in patients with high-risk CLL. It is hard to say how effective it was because everyone in the study received lenalidomide (so there is no group to compare with). It was given before patients had clinical symptoms that would typically warrant treatment. Lenalidomide could potentially be used as a maintenance therapy after fixed-duration treatments or as part of combination therapy in high-risk patients with CLL.
Lenalidomide is a very active therapy for CLL. Its immune-modulating effects are complex, and higher doses have caused severe complications and even deaths in past CLL trials, so this study is reassuring.
Links and Resources:
Watch the interview on the abstract here:
You can read the ASH abstract here: Extended Follow up of a Phase 2 Study of Early Intervention with Lenalidomide in Patients with High-Risk Chronic Lymphocytic Leukemia.
Take care of yourself first.
Ann Liu, PhD
