Nordic Nanovector will present new data from the Phase 1/2 trial (NCT01796171) of its investigational treatment Betalutin for relapsed or treatment-resistant non-Hodgkin’s lymphoma at the International Conference on Malignant Lymphoma, taking place June 14-17 in Switzerland.
Titled “LYMRIT 37-01: Updated results of a phase I/II study of 177Lu-lilotomab satetraxetan, a novel CD37-targeted antibody- radionuclide-conjugate in relapsed NHL patients,” the poster will be presented by the study’s principal investigator Dr. Arne Kolstad, who is also a senior consultant in medical oncology and radiation therapy at Oslo University Hospital, Norwegian Radium Hospital in Norway.
The company has not given any indication of the nature of the data to be presented at the lymphoma meeting, but stated that the presentation will include updated analyses.
Betalutin, also known as 177Lu-satetraxetan-lilotomab, is an antibody against the protein CD37, attached to a radioactive compound. According to the company, the treatment is the first of a new generation of antibody-radionuclide-conjugates (ARCs), currently in clinical trials.
This approach is a bit like localized radiotherapy, but with radiation administered from the inside of the body. CD37 is a molecule found on the surface of tumor cells. When the antibodies bind to the tumor, it becomes irradiated in a local and specific manner.
The trial, called LYMRIT 37-01, is an open-label study in which all patients receive Betalutin. Patients are divided into four groups that receive increasing doses of the treatment. The study also explores different pre-dosing treatments with Rituxan (rituximab) or a CD37 antibody.
The main objective of the Phase 1 part of the treatment is to evaluate Betalutin’s safety and the maximum tolerable dose, while the Phase 2 part will focus more on the treatment’s effectiveness.
Nanovector already released data of efficacy in December 2016, when researchers presented data at the ASH Annual Meeting. At the time, the analysis included data from 35 patients, who had an overall response rate of 63 percent, and 29 percent achieved a complete response.
Safety data also spoke in favor of the treatment. Side effects were both predictable and manageable. The most common side effects were transient and reversible decreased blood cell counts.
The highest dose group did not experience toxicity that could limit the use of higher doses, and in December, researchers announced that the results allowed for testing of a higher dose than initially planned.
Betalutin is also under scrutiny in another Phase 1 trial, called LYMRIT 37-05 (NCT02658968). The study, which is currently recruiting participants, will focus on patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
LYMRIT 37-05 has a similar setup to the earlier LYMRIT 37-01 study. Patients will receive increasing doses of Betalutin, and no control group is included. In March 2017, the first patients in the trial received the treatment.
The trial plans to enroll up to 24 patients in the U.S., Germany, Italy, Spain, and the U.K.