Nordic Nanovector have announces initial results from the LYMRIT 37-05 Phase 1 trial investigating Betalutin in patients with relapsed/refractory diffuse large B-cell lymphoma not eligible for stem cell transplantation.
The initial results from the completed Phase I study (n=16 treated with Betalutin) show that Betalutin was well tolerated, with a good safety profile consistent with all previous studies with Betalutin, states the company in a press release. As reported previously, a single, reversible dose-limiting toxicity (DLT) was seen in the last cohort investigating the highest dosing regimen (20 MBq/kg Betalutin and 100 mg/m2 lilotomab), which on review by the Independent Review Committee (IRC) resulted in three additional patients being enrolled. No further DLTs were seen.
Clinical activity of Betalutin was seen in 6 evaluable patients receiving the highest dosing regimen including one complete response and one partial response. The IRC commented that the safety and anti-tumor activity of the highest dosing regimen could be considered for investigation in combination with other therapies used in R/R DLBCL which the company is now evaluating, with an emphasis on combination partners that would not compromise the current safety profile of Betalutin.
“We have also seen clinical activity in DLBCL patients from a single administration of Betalutin and we will now consider the next steps for its development in this large patient population potentially in combination with other therapies.”
“We continue to be very encouraged by the overall safety profile that Betalutin exhibits in even the most fragile and highly pre-treated NHL patients. We have also seen clinical activity in DLBCL patients from a single administration of Betalutin and we will now consider the next steps for its development in this large patient population potentially in combination with other therapies, as part of our overall strategy to develop Betalutin for difficult to treat haematological tumors. Our near-term focus remains very much on completing PARADIGME in 3rd-line follicular lymphoma and delivering top line 3-month data by the end of 2021,” says Peter Braun, Nordic Nanovector CEO.
Photo: Nordic Nanovector