ASH 2025 | Tafasitamab with lenalidomide in patients with relapsed central nervous system lymphoma

So the rationale for this study is the application of this anti-CD19 monoclonal antibody tafasitamab which has enhanced ADCC as well as we anticipate probably has increased penetration across the blood-brain barrier because of the presence of vascular pericytes, which are a component of the blood-brain barrier, which have been shown to express CD19, which is a surprising finding. It may account for some of the neurologic symptoms associated with CD19 targeting T-cell engagers as well as CAR T-cells, ICANS. So for this reason, we’ve been treating patients with highly refractory primary and secondary CNS lymphomas with tafasitamab, generally in combination with lenalidomide. In this phase one study, which is based upon positive responses seen in several patients, two of whom were described in a British Journal of Haematology paper published a few years ago by our group, we have now evaluated 10 patients on this phase one trial looking at three different dose levels of lenalidomide, 10 milligrams per day, 15 milligrams per day, and now up to 20 milligrams per day, and have observed responses in most of the patients, many of whom have highly refractory disease, previously refractory to lenalidomide and rituximab, generally about a 90% response rate, and encouragingly, about half the patients have been on study for approximately six months or longer with two patients currently on study enjoying complete responses without significant toxicity. We have seen one DLT at the 20 milligram dose level. We are still looking to identify the MTD, to be applied in combination with tafasitamab in this highly refractory patient population that’s difficult to treat because of age and comorbidities.

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