Nordic Nanovector, a biotechnology company focusing on the development of novel targeted therapeutics in haematology and oncology, announces updated results of its ongoing Phase 1/2 study with Betalutin® in relapsed non-Hodgkin lymphoma (NHL) patients.
Betalutin® was generally well tolerated and showed a 63.2% Overall Response Rate (ORR) including 31.6% Complete Response (CR) among 21 patients with previously treated CD37+ NHL patients. This data include two additional patients whose efficacy data has become available following submission of the abstract.
The data being presented in the poster at AACR are from the ongoing Phase 1/2 single dose, open label, dose-finding study investigating three dose levels of Betalutin® in 21 patients with relapsed CD37+ NHL, 19 with Follicular Lymphoma and two with Mantle Cell Lymphoma, previously treated with one to eight treatment regimens. One patient recruited into the study had transformed disease and was excluded from the response rate calculation.
The updated data in the poster confirm the favourable safety profile of Betalutin® and its promising efficacy as a single agent in patients who have failed many prior regimens, characterised by a sustained duration of response.
Key conclusions from the update include:
• Betalutin® is well tolerated, with a predictable and manageable safety profile: most adverse events are haematological in nature, and all have been transient and reversible
• Betalutin® delivers a highly favourable response rate (best response) in this heavily pre-treated patient population (Overall Response Rate 63.2% and Complete Response 31.6%)
• The median Duration of Response (DoR) has not yet been reached. Clinical responses observed are sustained, with DoR exceeding 12 months in most responders
Luigi Costa, Nordic Nanovector’s Chief Executive Officer, commented: “These new data continue to confirm Betalutin’s efficacy potential and favourable safety profile. In addition, Duration of Response (DOR) in patients who responded to treatment with Betalutin® has further improved confirming the product’s potential to become a significant treatment of NHL. These encouraging results support the continued clinical development of Betalutin®. We are pleased with the progress that we are making in executing our revised Phase 1/2 study and look forward to confirming the optimal dosing regimen for the pivotal Phase 2 study, PARADIGME, expected in Q1 2017.”