Nordic Nanovector: Single administration Betalutin® is effective and well-tolerated in R/R iNHL patients: 6 month follow-up data presented at ASH
- Overall response rate (ORR) of 61% and complete response (CR) rate of 28% in 74 patients with indolent non-Hodgkin’s lymphoma (iNHL)
- Highly active in follicular lymphoma (FL) patients with ≥2 prior therapies (n=37) (ORR 70% CR 32%), and rituximab-refractory FL (n=21) (ORR 62% CR 19%)
- Durable responses, especially for patients with a CR (20.7 months)
- Promising response rates (ORR and CR) for dosing regimens being evaluated in pivotal Phase 2b PARADIGME study
- Well tolerated with predictable and manageable safety profile
- Conference call/audio cast to discuss results to be held Monday 3 December at 8.00 AM CET
Oslo, Norway, 2 December 2018
Nordic Nanovector ASA (OSE: NANO) announces that updated results from its LYMRIT 37-01 Phase 1/2 clinical study of Betalutin® (177Lu-lilotomab-satetraxetan) in patients with relapsed/refractory indolent non-Hodgkin’s lymphoma (R/R iNHL) have been presented 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 2 November 2018) includes 74 evaluable patients; all patients received Betalutin® as a single administration and have six or more months of follow-up.
Lisa Rojkjaer, MD, Chief Medical Officer of Nordic Nanovector, commented: “We are very pleased with the clinical data, which continue to support our decision to compare two promising dose regimens in the pivotal Phase 2b PARADIGME trial. The efficacy and safety profile of Betalutin®, the duration of response and the convenience of a single administration underscore the potential of Betalutin® for the treatment of patients with advanced-stage follicular lymphoma.”
The conclusions from the updated study results are that a single administration of Betalutin® is well-tolerated and continues to demonstrate encouraging anti-tumour activity in recurrent iNHL, especially in follicular lymphoma (FL) patients, the primary NHL population for which Betalutin® is being developed. Key results are:
|Patients||Number of patients (n)||Overall Response Rate (ORR)||Complete Responses (CR)|
|All iNHL patients||74||61 %||28 %|
|FL patients||57||65 %||28 %|
|3L FL patients (≥2 prior therapies)||37||70 %||32 %|
|FL patients in Arm 1
(40 mg lilotomab followed by 15 MBq/kg Betalutin®)
|25||64 %||32 %|
|FL patients in Arm 4
(100 mg/m2 lilotomab followed by 20 MBq/kg Betalutin®)
|16||69 %||25 %|
|RTX refractory FL, ≥2 prior therapies||21||62 %||19 %|
The median follow-up time for all patients was 18.4 months (range 3.2-61.6 months). The median duration of response (mDoR) was 9.0 months for all patients and 20.7 months for those with a CR. Twenty-five patients (34%) have remained free of disease progression for 12 months or more. Follow-up for duration of response is on-going.
Betalutin® therapy was well tolerated with no unexpected safety findings and most common adverse events were predictable and manageable.
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.
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.
The abstract is available at http://www.hematology.org/Annual-Meeting/and the poster has been published on the Nordic Nanovector website in the section: /what-we-do/scientific-publications/scientific-posters.
Conference call/audio cast details:
Nordic Nanovector will host a conference call, 3 December 2018, at 08:00 CET. A question and answering session will follow the presentation. The conference call presentation will be available at: http://www.nordicnanovector.com/investors-and-media/reports-and-presentations/presentations
To participate in the call either:
Press crtl+click on the link https://bit.ly/2AzfKlS or paste it into your browser
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Use the manual dial-in numbers and participant passcode: 332692 (note that this connection might take more time):
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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.
Betalutin® is a tumour-seeking anti-CD37 antibody (lilotomab) conjugated to a low-intensity radionuclide (lutetium-177). It has shown promising efficacy and safety in the first part of the Phase 1/2 LYMRIT 37-01 clinical study in relapsed/refractory follicular lymphoma (R/R FL). A global, randomised Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to anti-CD20 immunotherapy (including rituximab, RTX) is currently on-going.
Betalutin® is also being investigated in the Phase 1b Archer-1 study in combination with RTX in second-line FL patients, and in the Phase 1 LYMRIT 37-05 study in patients with R/R diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin’s lymphoma (NHL).
Betalutin® has been granted Fast Track designation in the US and Promising Innovative Medicine (PIM) Designation in the UK for the treatment of patients with R/R FL. Betalutin® also received Orphan Drug designations for FL in both the USA and Europe in 2014.
Betalutin® is selective for CD37, which is highly expressed on the surface of B-cell non-Hodgkin's lymphoma (NHL) cells. When bound to CD37 on tumour cells, Betalutin® is internalised, causing DNA damage and cell death.
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; 69% ≥ 65); the median number of prior therapies was 3 (range 1-9); 48 pts (65%) received 2 or more prior therapies.
For further information, please contact:
Malene Brondberg, VP Investor Relations and Corporate Communications
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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 28.7 billion by 2026. 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
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.
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