Mogamulizumab-kpkc (Poteligeo) produced an overall survival (OS) benefit in patients with relapsed/refractory mycosis fungoides or Sézary syndrome from the phase 3 MAVORIC trial (NCT01728805) compared with a real-world Australian cohort of patients who received vorinostat (Zolinza), according to findings from unanchored matched adjusted indirect comparisons (MAICs), which were presented at the 6th World Congress on Cutaneous Lymphomas.1
After the mogamulizumab patient cohort data (n = 102) were re-weighted to match the vorinostat patient cohort data, at a data cutoff in 2016, the median OS with mogamulizumab was not reached vs 30.95 months with vorinostat (HR, 0.41; P = .001); at a data cutoff in 2019, the median OS values were the same in both arms (HR, 0.48; P = .02).
Additionally, the adjusted median time to next treatment was numerically longer in the mogamulizumab cohort vs the vorinostat cohort, at 9.13 months vs 5.82 months, respectively (HR, 0.67; P = .2).
“We were happy with that comparison [in] that mogamulizumab [did] improve OS in what we felt was a comparative group,” H. Miles Prince, MBBS, MS, FRACP, FRCPA, AFRCMA, AFRACD, FAHMS, said in an interview with OncLive®.
Prince is the director of the Centre for Blood Cell Therapy at Peter MacCallum Cancer Centre in Melbourne, Australia.
What is important to note about the MAVORIC trial?
The MAVORIC trial enrolled patients with relapsed/refractory mycosis fungoides or Sézary syndrome. Patients were randomly assigned 1:1 to receive mogamulizumab at 10 mg/kg weekly for the first 4-week cycle and every 2 weeks thereafter, or vorinostat at 400 mg daily.2In the trial, mogamulizumab elicited significant benefits in progression-free survival, overall response rate, and quality of life compared with vorinostat. Notably, findings from MAVORIC supported the 2018 FDA approval of mogamulizumab for the treatment of patients with mycosis fungoides or Sézary syndrome who have received 1 or more prior systemic therapies.3
MAIC of Mogamulizumab vs Vorinostat in Relapsed/Refractory Mycosis Fungoides or Sézary Syndrome
- A study using MAICs found that mogamulizumab provided a significant OS benefit for patients with relapsed/refractory mycosis fungoides or Sézary syndrome when compared with a real-world cohort of patients who received vorinostat.
- The MAVORIC trial demonstrated significant benefits in progression-free survival and quality of life with mogamulizumab vs vorinostat, which supported the 2018 FDA approval of mogamulizumab for patients who have received at least 1 prior systemic therapy.
- To address data confounded by the fact that more than 70% of patients in the original trial’s vorinostat arm crossed over to receive mogamulizumab, researchers compared the trial data against a real-world Australian patient database.
However, Prince noted in a presentation of the data that more than 70% of patients in the vorinostat arm of MAVORIC crossed over to receive mogamulizumab when the trial protocol allowed, which confounded the OS comparison between the 2 arms.1
What was the design of the MAIC comparing mogamulizumab vs vorinostat in mycosis fungoides and Sézary syndrome?
To address the confounded data from MAVORIC and further estimate the efficacy of mogamulizumab compared with vorinostat, the present study included real-world data from patients who received vorinostat and were included in an Australian Cutaneous Lymphoma Database (CLD).
Individual patient data from the mogamulizumab arm of MAVORIC on age group, sex, histology, disease stage at the start of treatment, and ECOG performance score were re-weighted to match the baseline characteristics of the real-world vorinostat cohort. Prince noted in the presentation that the only baseline characteristic that was not accurately matched between the 2 arms was months from diagnosis to treatment, which was slightly longer in the MAVORIC cohort, although this difference was not statistically significant. He also explained that the follow-up was longer in the real-world cohort because vorinostat has been commercially available for longer compared with mogamulizumab. All patients across both cohorts had received at least 1 prior systemic therapy.
“The way the field is going is to look at combination therapies, and I think the toxicity profile of drugs like mogamulizumab is so good that it’s easy to combine, so you could combine it with [some] of the new agents that are coming,” Prince concluded in the interview.
References
- Campbell BA, Bhullar H, Jayawardana M, et al. Outcomes in relapsed/refractory mycosis fungoides or Sézary syndrome from the MAVORIC trial mogamulizumab arm versus a real-world Australian cohort receiving vorinostat. Presented at: 6th World Congress on Cutaneous Lymphomas; June 25-27, 2026; Montreal, Quebec, Canada. Abstract 3B.05.
- Kim YH, Bagot M, Pinter-Brown L, et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018;19(9):1192-1204. doi:10.1016/S1470-2045(18)30379-6
- Kyowa Kirin announces FDA approval of Poteligeo (mogamulizumab-kpkc) for the treatment of mycosis fungoides and Sézary syndrome. News release. Kyowa Kirin. August 9, 2018. Accessed June 25, 2026. https://www.kyowakirin.com/media_center/news_releases/2018/e20180809_01.html
