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“I'm excited, particularly because [data for] the combination show it is superior to single-agent durvalumab. [We showed that 9] out of 12 patients had a meaningful response.”
Christiane Querfeld, MD, PhD, director, Cutaneous Lymphoma Program, professor of Dermatology, Division of Dermatology, City of Hope, discusses findings from a randomized phase 2 trial (NCT03011814) evaluating durvalumab (Imfinzi) in combination with lenalidomide (Revlimid) vs single-agent durvalumab in patients with refractory or advanced cutaneous T-cell lymphoma.
In this single-center trial, Querfeld noted that investigators assessed the safety and efficacy of durvalumab in combination with lenalidomide, an immunomodulatory agent, compared with durvalumab monotherapy in heavily pretreated patients with cutaneous T-cell lymphoma. The median follow-up was 14.5 months (range, 0.9-29.7). Patients treated with the combination (n = 13) received a median of 6 treatment cycles (range, 1-17), and those in the monotherapy cohort (n = 12) received a median of 3.5 treatment cycles (range, 2-20).
Results presented at the 2024 ASH Annual Meeting highlighted superior outcomes in the combination arm with an overall response rate (ORR) of 75%, including 4 complete responses (CRs; 33%) and 5 partial responses (PRs; 42%). In contrast, patients in the monotherapy arm achieved an ORR of 42%, consisting solely of PRs.
Progressive disease occurred in 31% of patients in the combination cohort vs 58% in the monotherapy cohort. At the time of data cutoff, 23% and 25% of patients remained on treatment in the combination and monotherapy arms, respectively.
Querfeld notes that the safety profile was manageable in both cohorts. Most treatment-emergent adverse effects (AEs) were grade 1 or 2, he says. Fatigue, thrombocytopenia, diarrhea, and anemia were the most frequently reported AEs, which occurred at higher rates in the combination arm. Immune-related AEs, including hyperthyroidism or hypothyroidism, were observed in 25% of patients in both cohorts. These immune-related AEs were manageable with standard interventions, Querfeld explains. Tumor flare was also reported but did not necessitate treatment discontinuation.
Querfeld concludes these data suggest that combining durvalumab with lenalidomide could provide an effective therapeutic option for patients with refractory or advanced cutaneous T-cell lymphoma.
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