Photo by Larry Young
SAN FRANCISCO—Results of a phase 2 trial suggest lenalidomide may be a treatment option for patients with relapsed adult T-cell leukemia-lymphoma (ATLL).
Lenalidomide produced a 42% overall response rate (ORR) in this trial, and patients had a “favorable” median overall survival, according to Kisato Nosaka, MD, PhD, of the National Center for Global Health and Medicine in Tokyo, Japan.
He noted, however, that the survival data are still immature and may have been confounded by subsequent therapies.
Dr Nosaka presented these results at the 8th Annual T-cell Lymphoma Forum. The study was sponsored by Celgene K.K.
The trial included 26 Japanese patients with relapsed ATLL. Fifty-eight percent of patients had the acute subtype, 27% had the lymphoma subtype, and 15% had the unfavorable chronic subtype.
The patients’ median age was 68.5 (range, 53-81), and 65% of patients were 65 or older. Fifty percent of patients had an ECOG performance status of 0, 35% had a status of 1, and 15% had a status of 2.
Most patients had a low-risk simplified ATL-PI score (65%), but 35% had an intermediate-risk score. Fifteen percent had bone marrow involvement.
The median number of prior treatment regimens was 2 (range, 1-4). Forty-two percent of patients had prior mogamulizumab, and 35% had received LSG15 or modified LSG15.
Patients received lenalidomide at 25 mg per day, given continuously until disease progression or intolerability.
Safety
The median duration of treatment was 3.7 months (range, 0.4 to 18.3 months). There were no deaths during treatment or for 28 days after.
Nine patients (35%) experienced serious adverse events (AEs), but only 1 serious AE occurred in more than 1 patient. Two patients had serious thrombocytopenia.
The most frequent AEs were thrombocytopenia (77%), neutropenia (73%), lymphopenia (69%), and increased C-reactive protein (42%). The most frequent grade 3 or higher AEs were neutropenia (65%), leukopenia (38%), and lymphopenia (38%).
Response and survival
The median follow-up was 3.9 months. The ORR was 42%, including 5 complete responses/unconfirmed complete responses and 6 partial responses. Eight patients (31%) had stable disease, and 7 (27%) progressed.
Dr Nosaka noted that responses occurred in all disease subtypes and at all disease sites. The ORR was 33% (5/15) for the acute subtype, 50% (2/4) for the unfavorable chronic subtype, and 57% (4/7) for the lymphoma subtype.
The ORR was 31% (5/16) at the target lesion, 60% (6/10) in the peripheral blood, and 75% (6/8) for PGA (Physician’s Global Assessment of Clinical Condition, used to assess skin lesions).
Dr Nosaka also pointed out that the ORR was higher in patients who did not receive prior mogamulizumab (60%) than in patients who did (18%). However, he said the number of patients was too small for a definitive conclusion to be reached.
Similarly, the ORR was higher for patients in the low-risk simplified ATL-PI risk group than for those in the intermediate-risk group—53% and 22%, respectively.
Among the 11 responders, the median duration of response was not reached (range, 0.5 months to not reached). The mean duration of response was 5.2 months (range, 0 to 16.6 months).
The median progression-free survival was 3.8 months (range, 1.9 months to not reached). The median overall survival was 20.3 months (range, 9.1 months to not reached).
The overall survival was longer for patients in the low-risk ATL-PI group than the intermediate-risk group—not reached and 10.1 months, respectively (P=0.03).
In closing, Dr Nosaka said these results support lenalidomide as a possible treatment option for patients with relapsed/recurrent ATLL.
