Patients with relapsed or recurrent T-cell leukemia/lymphoma (ATLL) may benefit from Revlimid (lenalidomide) monotherapy, according to results of a Phase 2 trial.
The study, “Multicenter Phase II Study of Lenalidomide in Relapsed or Recurrent Adult T-Cell Leukemia/Lymphoma: ATLL-002,” published in the Journal of Clinical Oncology, shows that Revlimid has promising anti-tumor activity and a good safety profile in this patient population.
Adult T-cell lymphoma/leukemia is a rare but aggressive hematological disease, caused by infection with the human T-lymphotropic virus type 1 (HTLV1). Treating ATLL is still a challenge. Aggressive chemotherapy regimens induce overall response rates of about 70 percent, but most patients — 90 percent — relapse within months of completing therapy.
In a prior Phase 1 trial (NCT01169298), Revlimid demonstrated preliminary anti-tumor activity in patients with relapsed ATL, at a maximum tolerated dose of 25 mg per day.
To determine the clinical efficacy and safety profile of Revlimid monotherapy in this patient population, Takashi Ishida, MD, with the department of medical oncology and immunology at Nagoya City University Graduate School of Medical Sciences in Japan, and colleagues conducted a small Phase 2 trial (NCT01724177).
The study enrolled 26 people, ages 53 to 83, who relapsed or had cancer recurrence after previously achieving stable disease. Patients had three distinct disease subtypes — acute ATLL, lymphoma, and unfavorable chronic ATLL — and received 25 mg Revlimid daily until disease progression or unacceptable toxicity.
After a median follow-up of 3.9 months, the overall response rate for patients with acute ATLL, lymphoma, and chronic unfavorable ATLL was 33%, 57%, and 50%, respectively, which accounted for a cumulative overall response rate of 42 percent (11 patients). Among the responders, four achieved a complete response and one patient achieved an unconfirmed complete response.
The tumor control rate for the entire cohort, which is defined as stable disease or better, was 73%, with a median time to response of 1.9 months and time to progression of 3.8 months. Despite the low rate seen in progression-free survival, patients demonstrated a median overall survival of 20.3 months from the start of Revlimid treatment.
Revlimid was well-tolerated, with the most common Grade 3 or higher adverse events being reduced numbers of platelets, or specific subsets of immune cells. Serious adverse events were observed in nine patients, and all but two were resolved.
Although the study describes a relatively small trial, “on the basis of these promising results, further investigations of lenalidomide in ATL and other T-cell neoplasms are warranted,” Ishida and colleagues wrote.
Revlimid, an immunomodulatory drug, is FDA-approved to treat certain patients with multiple myeloma, transfusion-dependent anemia due myelodysplastic syndromes, and mantle cell lymphoma.
ATLL represents 1% to 2% of T-cell lymphomas in the United States and Europe.