Efficacy

Tazverik (Tazemetostat) Efficacy in Lymphoma

Tazverik (tazemetostat) is an oral, selective inhibitor of the EZH2 enzyme, which has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of certain types of lymphoma. Specifically, it is indicated for adult patients with relapsed or refractory follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies. It is also indicated for the treatment of adult patients with relapsed or refractory FL who have no satisfactory alternative treatment options, regardless of EZH2 mutation status.

The efficacy of Tazverik in treating lymphoma was demonstrated in a multicenter, single-arm trial, where patients with relapsed or refractory FL received Tazverik monotherapy. The results showed a meaningful proportion of patients achieving an objective response rate (ORR), which is a measure of the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. The duration of response (DOR) in responders was also notable, with some patients maintaining response for a significant period.

Brukinsa (Zanubrutinib) Efficacy in Lymphoma

Brukinsa (zanubrutinib) is a Bruton's tyrosine kinase (BTK) inhibitor used in the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy. Zanubrutinib has been granted accelerated approval by the FDA based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. The efficacy of Brukinsa was evaluated in a single-arm clinical trial and a randomized controlled trial comparing it with another BTK inhibitor.

In the single-arm trial, patients with relapsed or refractory MCL treated with Brukinsa demonstrated a high ORR, with a majority of patients showing a partial or complete response to the treatment. The randomized controlled trial further supported the efficacy of Brukinsa, with results indicating a similar ORR when compared to the control BTK inhibitor, but with a suggestion of a better side effect profile. The DOR for patients responding to Brukinsa was also significant, with many patients experiencing sustained responses.