Det er normalt for et fase 3 /pivotalt studie innen onkologi å måtte ha 300 til 400 pasienter inkludert, med surrogatendepunkter kan man komme under 150 i spesielle tilfeller.
Men å signere en avtale med BP trengs noen gangsvært få pasienter, særlig hvis resultatene er svært gode.
Følgende link fra endpoint News i går viser det.
https://endpts.com/jj-fronts-new-cancer-drug-pact-with-500m-in-cash-for-argenxs-aml-antibody/
“Early Monday the pharma giant announced that it was paying Belgium’s argenx $500 million — $300 million as an upfront and $200 million for equity — to grab the worldwide commercial rights to cusatuzumab (ARGX-110) to treat acute myeloid leukemia and high-risk myelodysplastic syndromes. The deal also comes with $1.3 billion in milestones.”
"The Belgian biotech flagged stellar — but very early-stage — data for this drug in the lead-up to ASH last week. In the Phase I portion of the study researchers tracked a 92% response rate and a stunning 42% complete response with minimal residual response among 12 patients.
That’s all very promising, but it also covers only 12 patients. J&J will also now co-develop the drug with argenx, throwing its ambitious oncology R&D group into the fray."