Independent Review Committee Recommends Nordic Nanovector to focus on one dosage arm for the Pivotal PARADIGME Phase 2b Trial in Patients with 3L R/R FL
Oslo, Norway, 6 August 2020
Nordic Nanovector ASA (OSE: NANO) today announces that, following a planned interim analysis of the PARADIGME Phase 2b pivotal trial of Betalutin® in patients with relapsed/refractory follicular lymphoma (FL), the Independent Review Committee (IRC) has recommended Nordic Nanovector to focus on one dosage arm (15 MBq/kg Betalutin® after a pre-dose of 40 mg lilotomab; “40/15”) to completion.
In this very difficult to treat patient population (bulky disease, patients refractory to standard therapies) the interim analysis confirmed activity. Betalutin®, as a single administration, was active (CR, PR and disease control rate) and had a well-tolerated safety and manageable safety profile in both arms. Based on a comprehensive assessment, the interim data set supported the selection of the 40/15 dosage arm which demonstrated consistency across all patient sub-groups. The arm evaluating the regimen of 20 MBq/kg Betalutin® following a pre-dose of 100 mg/m2 lilotomab (“100/20”) will be discontinued.
PARADIGME is the company's ongoing global, randomised Phase 2b trial investigating Betalutin® (177Lu-lilotomab satetraxetan) as a single administration in patients with 3rd-line relapsed / anti-CD-20-refractory FL who have received two or more prior therapies (3L R/R FL). The trial was designed to enrol 130 patients into two arms to compare different dosing regimens.
Jean Pierre Bizzari, MD, Chair of Nordic Nanovector's Clinical Committee, said: "We are very encouraged by the interim results both the activity and the safety profile in this unmet patient population. We believe that the decision to focus on one arm as well as the ongoing implementation of the protocol amendments will significantly support an increase of the enrolment rate to PARADIGME”.
Lars Nieba, interim Chief Executive Officer, commented: “The recommendation from the IRC to advance the 40/15 arm of PARADIGME provides a clear path for Betalutin® late-stage clinical development in patients with FL, especially those who are elderly and fragile and have no or limited treatment options. We will continue to focus on implementing the protocol amendments and other initiatives that will broaden the patient inclusion criteria’s and improve the enrolment rate. We will complete recruitment for the PARADIGME trial as quickly as possible despite the evolving COVID-19 situation. With the timely adoption of our protocol amendments and enrolment initiatives, we are confident that we can announce the three-month top-line data from PARADIGME in 2H 2021, paving the way for a planned regulatory filing with Betalutin®.”
For further information, please contact:
Malene Brondberg, CFO
Cell: +44 7561 431 762
Mark Swallow/Frazer Hall/David Dible (Citigate Dewe Rogerson)
Tel: +44 203 926 8535
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 29 billion by 2026. Nordic Nanovector retains global marketing rights to Betalutin® and intends to actively participate in the commercialisation of Betalutin® in the US and other major 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.
This information is subject to a duty of disclosure pursuant to Sections 4-2 and 5-12 of the Securities Trading Act.