Nordic Nanovector has announced plans to discontinue the Phase IIb PARADIGME clinical trial of Betalutin (177Lu lilotomab satetraxetan) in third-line relapsed and anti-CD20 refractory follicular lymphoma (3L R and R FL).
The board of directors decided to discontinue the trial after a thorough review and independent data analysis of the trial as well as a subsequent request for talks with the regulatory agency.
With the latest development, the trial will not further enrol subjects.
So far, the PARADIGME trial enrolled 109 participants. The company will discontinue the trial in a structured manner to guarantee that the patients receive the best care throughout this time.
Even though Betalutin showed a favourable safety profile and positive signs of efficacy in some trial subjects at a chosen dose of 15MBq/kg following a pre-dose of 40mg lilotomab (40/15), the board believes that the observed profile does not completely meet the goals of the trial.
In the trial, only one in three subjects showed a response to the therapy and the average response duration was nearly six months.
Due to this, the board believes that the shown profile is no longer competitive enough to allow the marketing of Betalutin for the third line relapsed and refractory FL indication for the timeframe that is financially and commercially sensible for Nordic Nanovector.
The company will seek possible collaborations and consult the US Food and Drug Administration (FDA) to hold talks to determine whether Betalutin can be assessed in an alternative setting.
In addition, Nordic Nanovector will shift the focus of its efforts and resources on the development of its pipeline of CD37-targeting products.
The board also plans to restructure the company soon to lower the costs where required to offer support for activities linked to the development of its pipeline.
Nordic Nanovector CEO Erik Skullerud: Our focus will now shift to our pipeline of other CD37-targeting assets, which give us multiple shots on goal, including Humalutin Alpha37, a portfolio of fully humanised anti-CD37 antibodies and the CD37 CAR-T.
“We look forward to communicating our development plans for these assets in more detail in the coming months.”