Efficacy

Efficacy of Poteligeo (mogamulizumab) for Lymphoma

Poteligeo (mogamulizumab) is a monoclonal antibody that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS), which are types of cutaneous T-cell lymphoma (CTCL). The efficacy of mogamulizumab was established in a pivotal clinical trial known as the MAVORIC study. This phase III trial demonstrated that mogamulizumab significantly improved progression-free survival (PFS) compared to vorinostat in patients with MF and SS who had received at least one prior systemic therapy.

In the MAVORIC trial, the median PFS for patients treated with mogamulizumab was markedly longer than for those who received vorinostat. Additionally, a higher proportion of patients treated with mogamulizumab achieved an objective response. The response was also more durable with mogamulizumab, indicating its efficacy in providing not only a higher response rate but also a more sustained treatment effect for patients with these challenging forms of lymphoma.

Efficacy of Ukoniq (umbralisib) for Lymphoma

Ukoniq (umbralisib) is a kinase inhibitor approved by the FDA for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for adult patients with follicular lymphoma (FL) who have received at least three prior systemic therapies. The approval of umbralisib for these indications was based on the results of the UNITY-NHL trial, a single-arm, multi-cohort, open-label, multicenter trial.

In the UNITY-NHL trial, the efficacy of umbralisib was evaluated in patients with relapsed or refractory MZL and FL. The results showed that umbralisib achieved a meaningful overall response rate (ORR) in both MZL and FL patient populations. The duration of response (DOR) for patients who responded to umbralisib treatment was also notable, with many patients maintaining their response for a significant period. This data supports the use of umbralisib as an effective treatment option for patients with MZL and FL who have exhausted other therapies.