Nordic Nanovector Highlights Promising Clinical Results from Phase 1/2 Trial of Betalutin® in Relapsed/Refractory Indolent non-Hodgkin's Lymphoma

OSLO, Norway, Nov 1, 2018 /PRNewswire/ --

• Overall response rates of 69% in Arm 4 (100 mg/m2 lilotomab followed by 20 MBq/kg Betalutin®) and 64% in Arm 1 (40 mg lilotomab followed by 15 MBq/kg Betalutin®) in relapsed/refractory follicular lymphoma patients

• Median duration of response of 13.3 months for all patients (20.5 months for those with a complete response)

• Well tolerated with predictable and manageable safety profile

Nordic Nanovector ASA (OSE: NANO) announces that an abstract reporting updated results from its LYMRIT 37-01 Phase 1/2 clinical study of Betalutin® (177Lu-satetraxetan-lilotomab) in patients with relapsed/refractory indolent non-Hodgkin's lymphoma (iNHL) has been published ahead of its presentation in a poster at the 60th American Society of Hematology (ASH) Annual Meeting & Exposition (1-4 December 2018 in San Diego, CA, USA).

The published dataset (as of 22 June 2018) includes 74 evaluable patients; all patients received Betalutin® as a single administration and have six or more months of follow-up. The complete dataset will be presented at ASH.

The conclusions from the updated study results are that Betalutin® is well-tolerated and has promising anti-tumour activity in recurrent iNHL, especially in follicular lymphoma (FL) patients. Key results are:

The median duration of response (mDoR), when treated with a single administration of Betalutin®, was 13.3 months for all patients (20.5 months for those with a CR) based on a median follow-up of 9.1 months (range 4.9-49.5 months). Twenty-six patients (35%) have remained free of disease progression for more than 12 months.

Betalutin® therapy was well tolerated with no unexpected safety findings and the safety profile is both predictable and manageable.

The data continue to highlight the encouraging clinical profile of single-agent Betalutin® therapy in iNHL patients, particularly in those with FL, the primary NHL population for which Betalutin® is being developed.

Two recommended Phase 2 doses were identified from this study and are now being compared in the pivotal, randomised Phase 2b PARADIGME trial in relapsed, anti-CD20 refractory FL patients who have received two or more prior therapies.

Arne Kolstad, lead investigator of LYMRIT 37-01 and senior consultant in medical oncology and radiotherapy, Oslo University Hospital Radiumhospitalet, said: "Patients with relapsed/refractory follicular lymphoma have a need for effective treatment options that improve their quality of life, especially elderly patients. The clinical profile that Betalutin® is consistently showing in this patient population is very encouraging."

Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, commented: "We are very pleased with the clinical data. The results from Arm 4 further support the decision to compare the 100 mg/m2 lilotomab + 20 MBq/kg Betalutin® dosing regimen from Arm 4 with the 40 mg lilotomab + 15 MBq/kg regimen from Arm 1 in the pivotal phase 2b PARADIGME trial. The emerging data on the durability of the responses together with the safety profile of Betalutin® and the convenience of a single administration underscore the potential of Betalutin® for the treatment of patients with advanced-stage follicular lymphoma."

Poster details

Abstract 2879 

Abstract title:  LYMRIT 37-01: A phase I/II study of 177Lu-lilotomab satetraxetan (Betalutin®) antibody-radionuclide-conjugate (ARC) for the treatment of relapsed non-Hodgkin's lymphoma (NHL) - Analysis with 6-month follow-up

Authors: A. Kolstad, A et al.

Session Name:  623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II

Date:  Sunday, 2 December 2018

Presentation Time:  6:00 PM - 8:00 PM Pacific time

Location:  San Diego Convention Center, Hall GH

The abstract is available at http://www.hematology.org/Annual-Meeting/ and the poster will be published on the Nordic Nanovector website to coincide with the session.

About ASH

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.

About LYMRIT 37-01

LYMRIT 37-01 is a Phase 1/2 dose-escalation study to determine the safety, pharmacokinetics and preliminary efficacy of a single dose of Betalutin® in patients with relapsed iNHL, and to establish a recommended Phase 2 dose for the global, randomised Phase 2b PARADIGME trial.

LYMRIT 37-01 recruited 74 pts [57 follicular (FL), 7 mantle cell (MCL), 9 marginal zone (MZL), 1 small lymphocytic (SLL)] at 13 sites between December 2012 and February 2018. Median age was 68 years (range 38-87; 55% ≥ 65); the median number of prior therapies was 3 (range 1-9); 48 pts (65%) received 2 or more prior therapies.

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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 designed to advance the treatment of non-Hodgkin's 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. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets. Further information can be found at www.nordicnanovector.com

Forward-looking statements

This press release contains certain forward-looking statements. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on Nordic Nanovector's business, financial condition and results of operations. The terms "anticipates", "assumes", "believes", "can", "could", "estimates", "expects", "forecasts", "intends", "may", "might", "plans", "should", "projects", "targets", "will", "would" or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statements. These forward-looking statements are not historic facts. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in the forward-looking statements. Factors that could cause these differences include, but are not limited to, risks associated with implementation of Nordic Nanovector's strategy, risks and uncertainties associated with the development and/or approval of Nordic Nanovector's product candidates, ongoing and future clinical trials and expected trial results, the ability to commercialise Betalutin®, technology changes and new products in Nordic Nanovector's potential market and industry, Nordic Nanovector's freedom to operate (competitors patents) in respect of the products it develops, the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions, and legislative, regulatory and political factors. No assurance can be given that such expectations will prove to have been correct. Nordic Nanovector disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

This information is subject to a duty of disclosure pursuant to Section 5-12 of the Securities Trading Act.

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SOURCE Nordic Nanovector