Malene bekrefter at dette er en mulighet:
Q: “(…) Have you considered to open another arm in Paradigme, or a new study, combining Betalutin and Rituximab in the Paradigme population (Ritux refractory patients)?”
A: "The Archer-1 study was primarily designed to measure the safety and tolerability of the Betalutin plus 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.
The recruitment of patients in the study, following the completion of the first cohort, has been slower than expected, and this prompted the company’s decision to pause, after the first two cohorts will be fully enrolled, to decide what is the best way forward, in particular regarding the clinical development strategy to secure a 2L FL label extension.
As outlined during the recent Quarterly Call, we are keen on reviewing the data on the combination once the second cohort is enrolled. We are still behind the rationale for this combination, for the very reasons you highlight in your message, and may consider future exploratory studies in an anti-CD20 refractory patient population."
Merk at hun ikke svarer på om det kan være aktuelt å gjøre en utvidelse av Paradigme.
Vil anta at ballen nå ligger hos FDA og at de sammen med pre-kliniske studier og “immunological tests” fra Archer vil vurdere hensiktsen med å åpne en et større og bredere studie ala fase 3-studien med Lenalidomide+Rituximab, men hvor også Rituximab/anti-CD20-refraktære pasienter også inkluderes. Åpenbart forsøker de å unngå en ny Paradigme, hvor man ikke kommer i mål pga strenge inklusjonskriterier.