Updated results to be presented at ASH in December
Our portfolio company Nordic Nanovector will present updated results from the phase I/II trial of Betalutin in non-Hodgkin lymphoma in a poster at the American Society of Hematology (ASH) meeting, 9-12 December 2017 in Atlanta, US.
The dataset includes 55 evaluable patients. Data from patients receiving the two most promising dosing regimens in the phase II expansion cohorts – Arm 1 (15 MBq/kg Betalutin® after 40 mg lilotomab pre-dosing) and Arm 4 (20 MBq/kg Betalutin® after 100 mg/m2 lilotomab) – are described and will be updated at the congress.
The data continue to highlight the encouraging clinical profile of single-agent Betalutin® therapy in iNHL patients, particularly in those with follicular lymphoma (FL), the primary NHL population for which Betalutin® is being developed. These data will continue to mature up until presentation in December.
Key facts are:
Single-agent Betalutin® is highly active and well tolerated in recurrent iNHL:
• 64% Overall Response Rate (ORR) and 24% Complete Responses (CR) in the 55 evaluable iNHL patients
• 81% ORR (CR 28%) in 21 FL patients in Arm 1 (of 32 iNHL patients evaluated); median duration of response (DoR) of 15 months in FL patients
• No unexpected safety findings, the safety profile is both predictable and manageable
Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, commented:
“These data are very encouraging for a primarily elderly, heavily pre-treated patient population, especially for those with relapsed FL, where the greatest need exists. The data from Arm 4, while so far evaluable in only six patients (50% ORR, CR 17%) are also very encouraging and we look forward to seeing how these data evolve with a larger patient population. These data from both arms of the study are enabling us to refine the design of the pivotal Phase 2 PARADIGME trial, which we expect to initiate this year.”
Luigi Costa, Chief Executive Officer of Nordic Nanovector, added:
“We are very excited with these results, which support the strategy course we undertook when we decided to explore alternative dosing regimens. These data strengthen our confidence in the potential of Betalutin® to be an attractive therapeutic option with the convenience of being a one-time treatment. We now have two promising dosing options, and as a result we have further strengthened the development path for Betalutin®. We are also very encouraged that Betalutin® treatment consistently demonstrates a highly competitive profile when compared to other therapies in development or recently approved for FL.”
Abstract and poster details
The ASH annual meeting is the premier event for scientific exchange in the field of haematology, attracting more than 20,000 attendees from all over the world. Typically, more than 5,000 scientific abstracts are submitted each year, and more than 3,000 abstracts are accepted for oral and poster presentations through an extensive peer review process.
The abstract is now available online.
Abstract 2769 Abstract title: 177Lu-Lilotomab Satetraxetan, a Novel CD37-Targeted Antibody-Radionuclide Conjugate in Relapsed Non-Hodgkin’s Lymphoma (NHL): Updated Results of an Ongoing Phase I/II Study (LYMRIT 37-01) Authors: Kolstad, A et al.
- Session Name: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II
- Date: Sunday, December 10, 2017
- Presentation Time: 6:00 PM – 8:00 PM
- Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2, Atlanta, GA, USA
About Nordic Nanovector:
Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The company aspires to become a leader in the development of targeted therapies for haematological cancers.
Nordic Nanovector’s lead clinical-stage candidate is Betalutin®, a novel CD37-targeting Antibody-Radionuclide-Conjugate (ARC) designed to advance the treatment of non-Hodgkin Lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 20 billion by 2024.
The Company aims to rapidly develop Betalutin®, alone and in combination with other therapies, for the treatment of major types of NHL, targeting first regulatory submission in relapsed/refractory follicular lymphoma in 1H 2019. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.
The Company is also advancing a pipeline of ARCs and other immunotherapies for multiple cancer indications.