Abstract
The FDA-approved mogamulizumab-kpkc, a CC chemokine receptor type 4 (CCR4)-directed mAb, in August 2018 for treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. Regular approval was based on a randomized, open-label trial that randomized 372 such patients, with a median of 3 prior systemic therapies, to either mogamulizumab-kpkc or vorinostat. Investigator-assessed progression-free survival (PFS) was statistically significantly longer in the mogamulizumab-kpkc arm, which had an estimated median PFS of 7.6 months [95% confidence interval (CI), 5.6-10.2] compared with 3.1 months (95% CI, 2.8-4.0) in the vorinostat arm (HR = 0.53; 95% CI, 0.41-0.69). The confirmed overall response rate was 28% and 5%, respectively (P < 0.001), based on global composite response criteria. Adverse reactions occurring in at least 20% of mogamulizumab-kpkc recipients included rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection. Serious adverse reactions occurred in 36% of patients, most often from infection. The prescribing information includes warnings for dermatologic toxicity, infusion reactions, infections, autoimmune complications, and complications of allogeneic hematopoietic stem cell transplantation, including severe and steroid-refractory graft-versus-host disease.See related commentary by Larocca et al., p. 7272.
Highlights
The prognosis with mycosis fungoides or Sezary syndrome, the main types of cutaneous T-cell lymphoma (CTCL), varies widely and is related to clinical stage [1, 2]
BV vs. control: overall response rate (ORR) lasting 4 mo, 56% vs. 12%, complete response (CR) 16% vs. 2%, progression-free survival (PFS) median 16.7 vs. 3.5 mo, HR 0.27
A sensitivity analysis of investigator-assessed PFS, treating clinical progression as an event, was consistent with the primary analysis (HR 1⁄4 0.61; 95% confidence interval (CI): 0.47–0.78)
Summary
The prognosis with mycosis fungoides or Sezary syndrome, the main types of cutaneous T-cell lymphoma (CTCL), varies widely and is related to clinical stage [1, 2]. Patients with Sezary syndrome, a closely related, rare, and aggressive leukemic variant of mycosis fungoides, have an estimated median overall survival of 3 years [2] In both diseases, pruritus, skin exfoliation, erosion, and superinfection from constant scratching are common, as are opportunistic infections. The basis of approval is a multicenter, open-label, randomized phase III trial (Study 0761-010; NCT01728805) in adults with relapsed or refractory, stage IB-IV mycosis fungoides or Sezary syndrome after at least one prior systemic therapy [17]. The trial was designed to detect a 50% improvement in median PFS from 5.6 months with
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