Efficacy

Efficacy of Poteligeo (Mogamulizumab) in Treating 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 demonstrated in a pivotal clinical trial known as the MAVORIC study, which was a phase 3 trial comparing mogamulizumab to vorinostat in patients with relapsed or refractory MF or SS. The results showed that mogamulizumab significantly improved progression-free survival (PFS) compared to vorinostat. Patients treated with mogamulizumab had a median PFS of 7.6 months, compared to 3.1 months for those treated with vorinostat.

The overall response rate (ORR) for mogamulizumab was also higher than that for vorinostat, with a 28% ORR in the mogamulizumab group compared to a 4.8% ORR in the vorinostat group. Additionally, the duration of response (DOR) was notably longer in patients treated with mogamulizumab, with a median DOR of 14.1 months compared to 9.1 months in the vorinostat group. These results indicate that mogamulizumab can be an effective treatment option for patients with MF or SS who have not responded to previous therapies.

Efficacy of Copiktra (Duvelisib) in Treating Lymphoma

Copiktra (duvelisib) is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and it is FDA-approved for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies, and for relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. The approval for CLL/SLL was based on a randomized, multicenter, open-label phase 3 study known as DUO, which compared the efficacy of duvelisib to ofatumumab in patients with relapsed or refractory CLL/SLL. Duvelisib demonstrated a significant improvement in PFS, with a median PFS of 13.3 months compared to 9.9 months for ofatumumab.

For the treatment of FL, the approval of duvelisib was supported by a single-arm, multicenter phase 2 study, which showed an ORR of 42% with a median DOR of 10 months. These findings suggest that duvelisib provides a benefit for patients with CLL/SLL and FL who have limited treatment options due to the relapsed or refractory nature of their disease. However, it is important to consider the safety profile of duvelisib, as it can be associated with serious adverse events such as infections, diarrhea or colitis, cutaneous reactions, and pneumonitis.