The final analysis of the Italian FIL-MOGA study showed an objective response lasting at least 4 months in 47% of patients and identified the measure as a surrogate for survival outcomes.
Mogamulizumab (Poteligeo) generated responses persisting for at least 4 months in nearly half of patients with previously treated mycosis fungoides (MF) or Sézary syndrome (SS) who received the agent in routine clinical practice, according to the final analysis of the real-world FIL-MOGA study conducted by the Italian Lymphoma Foundation (FIL) and presented at the
Findings showed that mogamulizumab (n = 93) generated an objective response lasting at least 4 months (ORR4) in 47% of patients (95% CI, 37%-58%). At a median follow-up of 35 months, an additional 10% of patients achieved responses lasting less than 4 months, and 42% had no response. ORR4 was more commonly observed in patients with SS at diagnosis, whereas the lowest response rates occurred in patients with stage IIB tumor-stage MF. Stage IV disease was associated with higher odds of achieving ORR4 vs early-stage disease (OR, 3.94; 95% CI, 1.40-11.1). Compartment-specific objective response rates were 50% in the skin and 64% among patients with B2 blood involvement.
Best global objective response rates were 29% at 1 month, 38% at 4 months, and 58% at any time.
Failure to achieve ORR4 was associated with a higher risk of death (HR, 2.92; 95% CI, 1.50-5.57), disease progression (HR, 3.25; 95% CI, 1.91-5.54), and earlier initiation of the next systemic therapy (HR, 3.53; 95% CI, 1.72-7.26). The median overall survival (OS) for the entire cohort was 37 months, and the 2-year OS rate was 72%. Notably, the 2-year OS rates were 76% among patients who achieved ORR4 vs 60% among those who did not.
“In this Italian experience, mogamulizumab showed meaningful real-world effectiveness with response rates varying according to [disease] stage,” lead study author Gabriele Roccuzzo, MD, of the University of Turin in Italy, said in a presentation of the data. “ORR4 consistently and independently stratified OS, progression-free survival [PFS], and time to next treatment [TTNT], supporting its value as a dynamic response end point in real-world studies and not just in clinical trials.”
Key Takeaways From the FIL-MOGA Analysis
In the United States,
Mogamulizumab became reimbursable in Italy at the end of 2020 for the treatment of MF and SS following at least 1 prior systemic therapy.1 FIL-MOGA was a multicenter observational study that enrolled patients from 18 Italian centers between January 2021 and December 2023, with a data cutoff of November 2025.
The primary end point was the proportion of patients achieving ORR4, along with its association with OS, PFS, and TTNT.
Of 100 enrolled patients, 98 were eligible. The median age was 63 years, 53% were female, and 71% had received at least 2 prior systemic therapies. The median baseline modified Severity Weighted Assessment Tool (mSWAT) score was 77 (range, 3-152), and 57% of patients had elevated lactate dehydrogenase levels. Disease stages comprised IB (10%), IIA (6%), IIB (10%), III (22%), IVA1 (26%), IVA2 (17%), and IVB (5%). Among patients on treatment, the median number of cycles was 33 (range, 17-60).
Skin-related adverse effects occurred in 33% of patients, and infections were reported in 29%, all of which were grade 1 to 3. In an exploratory analysis of allogeneic transplantation, 13 patients proceeded to hematopoietic stem cell transplantation, 11 of whom achieved a complete response, supporting a role for mogamulizumab as a bridge to transplant.
