Nordic Nanovector has responded to the glacial pace of enrollment in its phase 2b follicular lymphoma clinical trial. After failing to enroll any patients in May, the Norwegian biotech has decided to conduct a “comprehensive review” of all aspects of the flatlining study.
At one time, Nordic Nanovector expected (PDF) to have data from the PARADIGME trial for its CD37-targeting antibody-radionuclide-conjugate Betalutin in the second half of 2019. The biotech delayed that target to the first half of 2020 before dosing the first patient but, back in the first half of 2018, still expected to get to the data drop in third-line relapsed anti-CD20 refractory patients on existing cash.
Dosing began four years ago, but enrollment has taken much longer than expected, forcing the company to repeatedly push back the timeline and raise cash to keep going. In January, Nordic Nanovector moved the target from the first to the second half of 2022.
At that time, investigators had enrolled 106 patients, still short of the revised target of 120. Two more patients joined the study over the next four months. They were the last patients to enter the clinical trial.
With the trial still stranded 12 patients short of its enrollment target, the board has decided to run “a comprehensive review of all aspects of the PARADIGME study.” An independent panel will analyze the data to protect the integrity of the study and provide information to inform the best path forward. The trial will continue to try to enroll new patients while the review is happening.
By holding the review, the board hopes to “determine the optimal path forward for Betalutin within a timeframe that is financially and commercially viable.” One possibility, not mentioned explicitly in the statement, is that enrollment stops and the available data are used to assess the efficacy of Betalutin. That may be the only viable option given it will take years to complete enrollment at the pace seen in 2022.
The board expects to report the findings of the review by July 20, when Nordic Nanovector is scheduled to release second-quarter results. The review will inform a potential update of guidance on the timing of the much-delayed data.
In the years since Nordic Nanovector embarked on the pivotal trial, competition for later lines of follicular lymphoma has heated up. Epizyme’s Tazverik came to market in 2020, although it has made a slow start commercially, bringing in net sales of just $8.7 million in the first quarter. The clinical pipeline now features candidates such as Regeneron’s CD20xCD3 bispecific odronextamab.