ASH 2025 | Preliminary findings from a trial of a novel CD30-directed antibody-drug conjugate in R/R lymphomas

This ASH presented the updated preliminary safety, efficacy, and pharmacokinetics data from 35C, which is an investigational antibody-drug conjugate targeting CD30 in relapsed/refractory Hodgkin lymphoma, CD30-positive PTCL, and CD30-positive DLBCL. This antibody-drug conjugate has a camptothecin-derived payload and was very highly active in a very heavily pretreated patient population with a median prior lines of five therapies. So at the time of data analysis, 53 patients were enrolled in the study, majority of Hodgkin lymphoma with 37 patients in this cohort. The drug showed highly promising efficacy in these patients with an overall response rate of 77% and a CR rate of 25% in the overall population and an overall response rate of 85% and a CR rate of 90% in the Hodgkin patients. The safety of the antibody-drug conjugate was very consistent with the camptothecin-derived payload with majority GI toxicities, hematologic, and dermatologic adverse events. The most common high-grade adverse event was neutropenia, but did not lead to any treatment discontinuations or need for primary prophylaxis with GCSF. Of note, there was no evidence of any peripheral neuropathy. Our preliminary results showed over 90% tumor reduction, and exploratory analysis revealed ctDNA reduction in over 90% of patients with over 90% reduction of ctDNA from baseline to cycle 3, day 1 in those patients who achieved a CR. So I think this drug is showing promising efficacy with a safety and well-tolerated toxicity profile in patients with relapsed/refractory Hodgkin lymphoma, CD30-positive PTCL, and CD30-positive diffuse large B-cell lymphoma.

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