Sylvester Study Leads to Updated National Guidelines for Follicular Lymphoma Treatment

A treatment regimen for a form of lymphoma tested by researchers at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, is now codified in an influential set of clinical guidelines.

The guidelines were released Feb. 10 by the National Comprehensive Cancer Network (NCCN), a nonprofit alliance of cancer centers.

The new guidelines greenlight a combination of two drugs, rituximab and loncastuximab tesirine (Zynlonta), for third-line and subsequent therapy in patients with classic follicular lymphoma.

“With this combination, the patient is able to receive a very effective therapy for only six months, when other options require a longer treatment period,” said Juan Alderuccio, MD, a hematologist and lymphoma specialist at Sylvester.

Dr. Alderuccio, who is also an associate professor of medicine at the Miller School, initiated a phase 2 clinical trial testing the drug combination.

A New Combination for Follicular Lymphoma

Follicular lymphoma is a common form of non-Hodgkin lymphoma, and a slow-growing disease with a relatively high response rate to first-line therapy.

Patients with disease refractory to treatment or who relapse within 24 months after initial therapy, however, represent a high-risk group associated with shorter survival. New therapeutic options for these patients have become available in the last few years, including CAR T cell therapy and treatment with drugs called bispecific antibodies.

In the recent study, Dr. Alderuccio and his colleagues tested another potential option: the combination of rituximab and loncastuximab.

Rituximab is known to mediate an immune attack on lymphoma cells by binding to a target on B cells, which malfunction in the disease. Loncastuximab binds to a different B cell target and delivers a toxin that kills the cells.

The study assessed the drug combination in 39 patients with relapsed or refractory disease who also presented with a high tumor burden or fast progression.

Getting the Green Light

Together, the combination of the two drugs appeared to be highly effective.

After 12 weeks, the treatment yielded an overall response rate of 97% and a complete response rate of 67%. Some patients continued to improve, leading to a complete response rate of 76.9% at 21 weeks. That rate is comparable to or higher than that seen historically with other treatments. Patients also had a low burden of side effects and required a relatively short course of treatment.

The ongoing study was published Dec. 7 in Lancet Haematology.

Based on these data and newer findings from the study, the NCCN listed loncastuximab plus rituximab as an option for patients with follicular lymphoma who have failed two or more lines of previous therapy.

Though the NCCN backs the new drug combination, the organization also notes that its use is supported by lower-level evidence than some other interventions. To address this, Dr. Alderuccio and his colleagues are now expanding the study to other cancer centers. Based on their earlier findings, they have also reduced the treatment time for the drugs from 10 to six months. A clinical trial comparing the new regimen against others is also in the early planning stages.

“It’s a career goal to be able to design and conduct a study that favorably impacts patient outcomes,” said Dr. Alderuccio. “Now the treatment is supported by national guidelines and could be considered outside clinical trials. That is highly rewarding.”