Efficacy

Efficacy of Beleodaq (belinostat) in Lymphoma

Beleodaq (belinostat) is a histone deacetylase inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This approval was based on the results of a multicenter, single-arm clinical trial that demonstrated the efficacy of belinostat in this patient population. In the trial, belinostat showed an overall response rate (ORR) of 25.8%, with 10.8% of patients achieving a complete response and 15% achieving a partial response. The median duration of response was reported to be 13.6 months, indicating a potential for long-term benefit in some patients.

While Beleodaq has shown efficacy in PTCL, its effectiveness in other types of lymphoma has not been established through pivotal clinical trials. It is important to note that the safety and efficacy of belinostat beyond the approved indication have not been systematically evaluated and should be considered investigational.

Efficacy of Zynlonta (loncastuximab tesirine-lpyl) in Lymphoma

Zynlonta (loncastuximab tesirine-lpyl) is an antibody-drug conjugate specifically indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The FDA approval of Zynlonta was supported by the results of a pivotal phase 2 clinical trial, LOTIS-2, which demonstrated significant efficacy in this patient population. The trial reported an ORR of 48.3%, with 24.1% of patients achieving a complete response and 24.1% achieving a partial response. The median duration of response for those who achieved a complete response was not reached, suggesting a durable response in a subset of patients.

The efficacy of Zynlonta in other lymphoma subtypes or as a front-line treatment has not been established. As with any medication, the use of loncastuximab tesirine-lpyl should be guided by its approved indication, and any off-label use should be approached with caution and based on the best available scientific evidence. It is also important to consider the safety profile of the drug when evaluating its use for individual patients.