Among patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), early phase 2 trial data suggest that zilovertamab vedotin (ZV) may have antitumor activity, according to research presented at the ASCO Annual Meeting 2023.

ZV is an antibody-drug conjugate that targets ROR1, a protein known to be expressed in DLBCL. For the single-arm phase 2 waveLINE-004 study (ClinicalTrials.gov Identifier: NCT05144841), researchers evaluated the safety and efficacy of ZV among patients with relapsed or refractory DLBCL. At the ASCO 2023 meeting, researchers presented early results from waveLINE-004.

Overall, 40 patients have been enrolled and treated on this study. In this cohort, at baseline, the median age was 68 years, 73% of patients were male sex, 40% of patients had received 2 prior therapy lines, and 28% of patients had received chimeric antigen receptor (CAR) T-cell therapy.


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The median time from first dose to data cutoff was 2.6 months. At time of cutoff, 17 patients were ongoing on treatment.

Analysis showed that the overall response rate was 30% (95% CI, 11.9-54.3) and the disease control rate was 55% (95% CI, 31.5-76.9). There were 2 patients who had a complete response, whereas 4 patients had a partial response and 5 patients had stable disease.

Any-grade adverse events were noted in 70% of patients, including grade 3-4 events in 40% of patients. There was 1 patient who discontinued treatment because of diabetic ketoacidosis.

“Early results show that ZV had clinically meaningful antitumor activity in [patients] with [relapsed/refractory] DLBCL,” the authors noted in their poster presentation. “Additionally, the safety profile was manageable and consistent with other monomethyl auristatin E-containing agents.”

Enrollment in waveLINE-004 is ongoing.

Disclosures: This research was supported by Merck. Please see the original reference for a full list of disclosures.

Reference

Ozcan M, Lee ST, Mensah F, et al. Zilovertamab vedotin (MK 2140) in relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Early results from the phase 2 waveLINE-004 study. ASCO 2023. June 2-6, 2023. Abstract 7531.