Innlegg fra 13 juli i år:
Ser ut til at det blir totalt 6 og ikke 9 pasienter.
Svar fra Malene hvor jeg spør om dette:
Many thanks for your mail and your continued support.
The Archer-1 study was primarily designed to measure the safety and tolerability of the Betalutinplus rituximab combination, and secondarily to capture preliminary data on its efficacy hence confirm in the clinical setting the synergistic effect which was earlier observed in preclinical models, so as to support a subsequent phase 3 study targeted to a 2L label extension. The study also included a series of immunological tests, the results of which may help elucidate the combined mechanism of action. There are three patients in a cohort. We stated at the Q1 that we are still missing two patients in cohort number two.
The recruitment of patients in the study, following the completion of the first cohort, has been slower than expected despite the good data from the first cohort. We are still behind the rationale for this combination, but has taken a decision to pause, after the first two cohorts when fully enrolled, to decide what is the best way forward, in particular regarding the clinical development strategy to secure a 2L FL label extension.
Have a good evening,
Malene
