Efficacy

Efficacy of Poteligeo (Mogamulizumab) in Treating Lymphoma

Poteligeo (mogamulizumab-kpkc) is an immunotherapy drug specifically 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 evaluated in a pivotal clinical trial known as the MAVORIC study, which was a phase 3 clinical trial comparing mogamulizumab to vorinostat in patients with relapsed or refractory MF and SS. The results demonstrated that mogamulizumab significantly improved progression-free survival (PFS) compared to vorinostat, with a median PFS of 7.6 months for mogamulizumab-treated patients versus 3.1 months for those receiving vorinostat.

The overall response rate (ORR) for mogamulizumab was also higher compared to vorinostat. In the trial, the ORR for mogamulizumab was 28% versus 4.8% for vorinostat. Additionally, the duration of response (DOR) was longer in the mogamulizumab group, with some patients maintaining a response for over three years. These results support the use of mogamulizumab as an effective treatment option for patients with MF and SS who have previously received systemic therapy.

Efficacy of Epkinly (Epcoritamab-bysp) in Treating Lymphoma

As of the knowledge cutoff date, Epkinly (epcoritamab-bysp) is an investigational bispecific antibody targeting CD3 on T-cells and CD20 on B-cells. It is designed to engage the body's immune system to fight against malignant B-cells. While epcoritamab has shown promise in early clinical trials, it is important to note that as of the knowledge cutoff date, epcoritamab has not yet been approved by the FDA or any other regulatory agencies for the treatment of lymphoma or any other condition.

In the available clinical trial data, epcoritamab has demonstrated efficacy in patients with relapsed or refractory non-Hodgkin lymphoma (NHL), including those with diffuse large B-cell lymphoma (DLBCL). Early phase clinical trials have reported encouraging response rates, with a significant proportion of patients achieving partial or complete responses. The ongoing trials are aimed at further evaluating the efficacy and safety profile of epcoritamab in a larger cohort of patients. As such, the final assessment of epcoritamab's efficacy for the treatment of lymphoma will depend on the outcomes of these clinical trials and subsequent regulatory review.