Efficacy

Aliqopa (Copanlisib) Efficacy in Lymphoma

Aliqopa (copanlisib) is a kinase inhibitor specifically targeting PI3K, with predominant activity against PI3K-alpha and PI3K-delta isoforms expressed in malignant B-cells. It has been approved by the FDA for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. The efficacy of Aliqopa in lymphoma was primarily shown in a single-arm, multicenter clinical trial that included 104 patients with follicular lymphoma who had relapsed following at least two prior treatments. The overall response rate (ORR) was observed to be significant, with a considerable proportion of patients achieving partial or complete response to the therapy.

The duration of response (DOR) for patients treated with Aliqopa also demonstrated positive outcomes. In the pivotal trial, the median DOR was not reached at the time of data cut-off, indicating that the duration of response could be substantial for those who respond to treatment. These results suggest that Aliqopa offers a promising treatment option for patients with relapsed follicular lymphoma, particularly for those who have limited treatment options due to the refractory nature of their disease.

Ezharmia (Valemetostat Tosilate) Efficacy in Lymphoma

Ezharmia (valemetostat tosilate) is an investigational, orally administered, selective inhibitor of EZH1 and EZH2 methyltransferase activity. EZH1/2 are part of the polycomb repressive complex 2 (PRC2), which is known to play a role in the pathogenesis of various cancer types, including lymphomas. As of the knowledge cutoff date, valemetostat tosilate is still under clinical investigation and has not been approved for the treatment of lymphoma by regulatory authorities. However, early clinical trials have shown promise in the treatment of certain types of lymphoma, such as adult T-cell leukemia/lymphoma (ATL) and peripheral T-cell lymphoma (PTCL).

In these early clinical studies, valemetostat tosilate has demonstrated a manageable safety profile and encouraging signs of efficacy in patients with relapsed or refractory non-Hodgkin lymphoma, including ATL and PTCL. The ORR and DOR in these studies, although preliminary, indicate that valemetostat tosilate could potentially offer a novel mechanism of action for the treatment of lymphoma. Ongoing clinical trials continue to evaluate the efficacy and safety of valemetostat tosilate in a larger cohort of patients with different subtypes of lymphoma.