Steroids may improve mogamulizumab efficacy for cutaneous T-cell lymphoma
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The combination of mogamulizumab and topical steroids conferred favorable outcomes to patients with previously treated cutaneous T-cell lymphoma, according to study results presented at Society of Hematologic Oncology Annual Meeting.
Patients who received this regimen were more likely to respond to therapy and also achieved longer PFS, an analysis of the randomized phase 3 MAVORIC trial showed.
The open-label MAVORIC trial compared mogamulizumab (Poteligeo, Kyowa Hakko Kirin Co. Ltd.) — a defucosylated monoclonal antibody directed against C-C chemokine receptor 4 — with the histone deacetylase inhibitor vorinostat (Zolinza, Merck) for adults with relapsed or refractory mycosis fungoides or Sézary syndrome.
The analysis included 372 patients with stage IB to stage IVB disease who failed at least one prior systemic therapy. Patients with large cell transformation were excluded.
Researchers randomly assigned half of the patients to mogamulizumab dosed at 1 mg/kg via IV weekly for the first 5 weeks, then every 2 weeks thereafter. The other half of patients received vorinostat dosed at 400 mg daily.
Patients on stable, low-dose corticosteroids for at least 4 weeks prior to their initial study visit were allowed to continue at the same dosage. A similar percentage of patients in the mogamulizumab and vorinostat groups used corticosteroids (68% vs. 66%), and nearly all (98%) steroid-treated patients received corticosteroids.
Patients assigned vorinostat could cross over to mogamulizumab treatment upon disease progression.
Previously reported results showed significantly prolonged median PFS (7.7 months vs. 3.1 months; P < .0001) and a significantly higher ORR (28% vs. 4.8%) among patients assigned mogamulizumab in the intention-to-treat population.
Among patients who received concomitant steroids, results showed longer median PFS (9.4 months vs. 3.1 months) and a higher confirmed ORR (37% vs. 3.3%) with mogamulizumab than vorinostat.
An analysis of confirmed ORR by disease stage among mogamulizumab-treated patients who received concomitant steroids showed response rates of 33.3% (n = 3 of 9) for those with stage IB disease, 28.6% (n = 4 of 14) for stage IIA, 28.6% (n = 4 of 14) for stage IIB, 16.7% (n = 1 of 6) for stage IIIA, 30% (n = 3 of 10) for stage IIIB and 44.4% (n = 32 of 72) for stage IVA.
Researchers also reported higher skin ORR (intention-to-treat, 41.3% vs. 15.6; with steroids, 53.5% vs. 3.3%) and blood ORR (intention-to-treat, 68% vs. 15.6%; with steroids, 73.4% vs. 19.6%) among mogamulizumab-treated patients.
The rates of treatment-emergent adverse events reported among mogamulizumab-treated patients did not vary significantly between those who did or did not receive concomitant steroids. The most common of these events were infusion-related reactions (33.2% for intention-to-treat vs. 34.6% for concomitant steroids), drug eruption (23.9% vs. 27.6%), diarrhea (23.4% vs. 25.2%), fatigue (23.4% vs. 26%), pyrexia (16.8% vs. 15%) and nausea (15.2% vs. 18.1%).
“The majority of patients in MAVORIC received concomitant topical steroids, which likely mirrors clinical practice for patients with mycosis fungoides or Sézary syndrome,” Larisa J. Geskin, MD, associate professor of dermatology at Columbia University Medical Center, said during a presentation. “Patients receiving mogamulizumab plus steroids experienced PFS improvement relative to the intention-to-treat population. ... There was no apparent benefit associated with concomitant steroids for vorinostat treatment. The combination of mogamulizumab and topical steroids may produce outcomes that are superior to mogamulizumab alone.”
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Akilov O, et al. Abstract TCL-127. Presented at: Society of Hematologic Oncology Annual Meeting (virtual meeting); Sept. 9-12, 2020.
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