Efficacy

Efficacy of Copiktra (Duvelisib) in Treating Lymphoma

Copiktra (duvelisib) is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and it is specifically a dual inhibitor of PI3K-delta and PI3K-gamma. It has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. In addition, it is indicated for adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. The efficacy of Copiktra in lymphoma was demonstrated in clinical trials, where it showed an ability to reduce tumor burden and achieve partial or complete responses in a subset of patients.

In the DUO trial, a pivotal phase III study, duvelisib demonstrated a median progression-free survival (PFS) of 13.3 months for patients with CLL/SLL compared to 9.9 months for those on the comparator arm, ofatumumab. In patients with follicular lymphoma, the DYNAMO study, a single-arm phase II trial, showed an overall response rate (ORR) of 47% with duvelisib monotherapy. These studies highlight the potential of Copiktra to provide clinical benefit in patients with these types of lymphoma who have limited treatment options due to disease refractoriness or relapse.

Efficacy of Columvi (Glofitamab-gxbm) in Treating Lymphoma

Columvi (glofitamab-gxbm) is a novel bispecific monoclonal antibody designed to target CD20 on B-cells and CD3 on T-cells, thereby redirecting T-cells to engage and eliminate B-cell lymphoma cells. As of the knowledge cutoff date, Columvi is an investigational agent and has not yet been approved by regulatory authorities for the treatment of lymphoma or any other indication. However, early clinical trials have shown promising results in terms of its efficacy against B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL) and other non-Hodgkin lymphomas (NHL).

In early-phase clinical studies, glofitamab has been evaluated as a monotherapy and in combination with other agents. Preliminary data suggest that glofitamab can induce rapid and durable responses in patients with relapsed or refractory B-cell lymphomas. For example, in a phase I study, glofitamab demonstrated an ORR of 65.7% with a complete response rate of 49.3% in heavily pretreated relapsed or refractory NHL patients. These results are encouraging and suggest that glofitamab could become an important therapeutic option for patients with aggressive forms of B-cell lymphoma, pending further clinical development and regulatory review.