Published on March 24, 2021
Could Umbralisib Improve Indolent Non-Hodgkin Lymphoma Care?
Umbralisib (Ukoniq), an oral therapy, has delivered promising results for some patients with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL), according to a recent study published in the Journal of Clinical Oncology (JCO).
Indolent means slow-growing, but targeted treatment options for this type of lymphoma are limited, and it tends to recur (relapsed iNHL) or become resistant to treatment over time (refractory iNHL). The UNITY-NHL trial looked at umbralisib as a novel treatment option to manage three common iNHL subtypes: marginal zone lymphoma (MZL), follicular lymphoma (FL) and small lymphocytic lymphoma (SLL).
About the Umbralisib Study
The phase IIb study included 208 patients with relapsed or refractory iNHL who had received prior
treatments, including one or more anti-CD20-based therapies. CD-20 is a biomarker and a target for B-cell lymphomas.
Study participants were given 800 mg of umbralisib orally once daily until disease progression, unacceptable toxicity or study withdrawal occurred. The primary endpoint (i.e., the main goal of the study) was the overall response rate. Secondary endpoints included time to response, duration of response, progression-free survival (PFS) and safety.
Side Effects of Umbralisib
“Umbralisib affects the B cells and lymphocytes [that] are important for driving inflammation. So, if you alter inflammation responses, you may have side effects,” said Dr. Felipe Samaniego, a professor in the Department of Lymphoma/Myeloma, Division of Cancer Medicine, at MD Anderson Cancer Center in Houston. Dr. Samaniego’s team reported the findings in JCO.
One side effect of umbralisib was diarrhea, which occurred in fewer than 10% of individuals, and, in most cases, was short-lived, according to Dr. Samaniego. To mitigate digestive problems, patients either took a break from the medicine (without losing any benefits from the therapy), or they took steroids for a brief period of time.
The second side effect observed in some patients was low neutrophil counts, which increases the risk of infections.
What’s the trade-off? Patients have to decide for themselves when weighing the risks versus benefits of any type of treatment.
The Future of Umbralisib
Nearly 50% of patients had a response, which is promising. The median follow-up happened around 27.7 months to track efficacy, and 21.4 months to evaluate safety. The overall response rate was 47.1%, and tumor reduction occurred in 86.4% of patients. The median time to response was 2.7 to 4.6 months.
The U.S. Food and Drug Administration (FDA) has approved umbralisib for marginal zone lymphoma and follicular lymphoma, and Dr. Samaniego is looking ahead to the next phase of clinical trials, that will combine umbralisib with other agents to achieve a higher response rate.
“Umbralisib is combined with ublituximab, an anti-CD20 monoclonal antibody. It’s a good partner drug,” Dr. Samaniego said of a new study his team is working on. “This is very exciting because we personally take care of these patients at MD Anderson on this trial and they are doing very well."
Beyond that, other trials are being conducted that aim to reduce the side effects of umbralisib. Research scientists like those on Dr. Samaniego’s team will continue to focus on targeted therapies that have the potential to have bigger advantages for patients than broad-spectrum chemotherapies down the road.
Dr. Samaniego’s team has several active clinical trials that are currently enrolling patients. To find out more, talk to your doctor or use the MD Anderson clinical trial search tool. With more knowledge, there can be more hope.
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- Fowler NH, Samaniego F, Jurczak W, et al. Umbralisib, a Dual PI3Kδ/CK1ε Inhibitor in Patients With Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. Published online March 08, 2021.
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