Dr Jacobs on the Preliminary Efficacy of TNB-486 in R/R Follicular Lymphoma

Ryan Jacobs, MD, hematologist and medical oncologist, Levine Cancer Institute, Atrium Health, discusses early responses with the novel CD19 and CD3 bispecific T-cell engager TNB-486 in relapsed and refractory follicular lymphoma, according to data from a phase 1 study (NCT04594642).

There is a lack of treatment options for patients with follicular lymphoma who do not respond to standard CAR T-cell therapy or CD20 bispecific T-cell engagers. As this disease is associated with decreased progression-free survival and a high likelihood of relapse, there is a great need for novel agents that are accessible, tolerable, and effective.

A phase 1 study was designed to assess the ability of the novel bispecific T-cell engager TNB-486 to successfully bolster T-cell–mediated immune responses in this population, Jacobs begins. Patients were given fixed doses of TNB-486 escalating from 0.03 mg to 2.4 mg, he details. The agent was administered intravenously every 2 weeks in 28-day cycles for up to 2 years.

Interim results from the dose-escalation portion of the study were presented at the 2023 EHA Congress and showed that the 11 efficacy-evaluable patients who received at least 2.4 mg of TNB-486 had an overall response rate (ORR) of 91%. This was comprised entirely of complete responses (CRs), Jacobs reports. Moreover, patients with CD20-negative disease, those who had received a prior CD20-directed therapy, and patients who experienced lymphoma progression within 24 months (n = 5) had a CR rate of 100%. These data are promising, as the phenotype is traditionally associated with worse patient outcomes, Jacobs notes.

Additionally, patients who received prior CD19-directed therapies as well as bispecific T-cell engagers also responded to TNB-486, Jacobs states.

The dose-escalation portion of this study is ongoing and aims to identify a recommended phase 2 dose for the agent.