Efficacy

Ukoniq (Umbralisib) Efficacy in Treating Lymphoma

Ukoniq (umbralisib) is a medication that 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 marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. Umbralisib is a PI3K delta inhibitor that works by blocking a protein involved in the growth and survival of tumor cells.

The efficacy of Ukoniq was evaluated in a multicenter, open-label, single-arm trial for patients with MZL and FL. The overall response rate (ORR) was a primary endpoint, with duration of response (DOR) being an important secondary endpoint. For patients with MZL, the ORR was reported to be approximately 49%, with a median DOR not reached at the time of data cutoff, indicating that the response was durable for a significant period. In patients with FL, the ORR was around 43%, with a median DOR that was also not reached, suggesting sustained efficacy in a substantial portion of patients.

Brukinsa (Zanubrutinib) Efficacy in Treating Lymphoma

Brukinsa (zanubrutinib) is another medication that has been approved by the FDA for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy. Zanubrutinib is a Bruton's tyrosine kinase (BTK) inhibitor that helps to block the BTK protein, which plays a role in the growth and expansion of cancerous cells. The approval of Brukinsa was based on overall response rate, including complete and partial responses, as observed in clinical trials.

The efficacy of Brukinsa was assessed through a multicenter, single-arm trial that involved adult patients with MCL who had received at least one prior therapy. The trial demonstrated an ORR of 84%, with a complete response rate of 59%. The median DOR was not reached in the study, suggesting that the responses were durable. Zanubrutinib has been shown to be effective in inducing a high rate of response in patients with relapsed or refractory MCL, offering a promising treatment option for this challenging condition.