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ICML 2025 | First-in-human Phase I study of DR-01 in patients with R/R cytotoxic T-cell lymphomas
Swaminathan Iyer, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, comments on the efficacy and safety of DR-01, a CD94-targeting monoclonal antibody, in a rare subset of T-cell lymphomas, specifically cytotoxic T-cell lymphomas. Dr Iyer highlights that the antibody has shown a 42% response rate, with durable responses in some patients. This interview took place during the 18th International Conference on Malignant Lymphoma (18-ICML) in Lugano, Switzerland.
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Transcript
So the DR01 is a monoclonal antibody against the target CD94. It’s in a very rare, ultra-rare subset of T-cell lymphomas called cytotoxic T-cell lymphomas. We had an oral presentation where we presented the first-in-human Phase I and the Phase I extension study data in this group of patients. Just by way of background, the cytotoxic T-cell lymphoma is about 3-6% of all T-cell lymphomas. Very rare but very aggressive...
So the DR01 is a monoclonal antibody against the target CD94. It’s in a very rare, ultra-rare subset of T-cell lymphomas called cytotoxic T-cell lymphomas. We had an oral presentation where we presented the first-in-human Phase I and the Phase I extension study data in this group of patients. Just by way of background, the cytotoxic T-cell lymphoma is about 3-6% of all T-cell lymphomas. Very rare but very aggressive. The outcomes are very poor. The one-year survival for hepatosplenic NK T-cell lymphoma and the MEITL, monomorphic epitheliotropic intestinal T-cell lymphoma is less than a year. The refractory extranodal NK T-cell is less than three months. That’s the background, but what unites these histologies is the expression of CD94. So it becomes a good target for this antibody, which works by connecting the Fc gamma receptors like CD16 to the CD94 and causes the lysis of the tumor cells or through fratricide because these are cytotoxic T-cells. There are about 104 patients enrolled. We have 64 patients’ safety data. The safety data looks pretty good. It’s a very well-tolerated monoclonal antibody except for infusion reactions which are seen in the early cohort. It’s sort of like a step-up dosing for bispecific. It has to be given once a week in the first month for the first three weeks and then once a month thereafter. So the reactions that happen are usually the first or the second time around but usually mitigated through supportive care. And the evaluation happens at the beginning of the second cycle. And for the evaluable cohort, we have about 48 patients. And the 48 patients, what we saw was the response rate is actually 42%. We had a dose, since it was a phase one study, we had dose levels 0.3 all the way to 10 mg per kilogram. And we saw a response rate of 42% with 21% CR. In the 1 mg per kilogram group, we saw a CR of 54% with 29% CRs. So even though it’s a first-in-human study, rare subset, we’re seeing responses and they’re also durable responses. We have about four patients who are beyond one year of therapy. One of my patients is post-allo. He’s close to two years on therapy.
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