A big drop in efficacy with Argenx’s CD70-targeting antibody cusatuzumab will be a blow for its licensing partner, Johnson & Johnson. The latest cut of the phase II Culminate data released quietly by Argenx today showed a composite complete remission rate of just 40% among 52 newly diagnosed AML patients who were not eligible for intensive chemotherapy, given the MAb in combination with Vidaza. This is a dramatic fall from the 83% figure released at an event held alongside Ash in 2018, when this study's phase I stage had enrolled just 12 subjects. Those earlier, more impressive data had prompted J&J to part with $500m in cash, which given the waning efficacy signal looks rather expensive. Attention now turns the ongoing phase Ib Elevate study, testing cusatuzumab in combination with Vidaza and Roche/Abbvie’s Venclexta. Elevate has a primary completion date in June, according to clinicaltrials.gov.
|Cusatuzumab's waning efficacy in the Culminate trial|
|Dec 2018 data (ph1 dose escalation)|
|Complete remission*||10/12 (83%)||21/52 (40%)|
|*Including complete remission with incomplete haematologic recovery (CRi). Source: company releases.|