Argenx goes small with next Vyvgart trial
Last month Argenx promised a smaller, sleeker second attempt with Vyvgart in immune thrombocytopenia, and details have just emerged of a planned phase 3 trial that looks like just that. As previously disclosed, the latest study, called Advance-Next, will test an intravenous formulation of the FcRn antagonist – following last year’s failure with a subcutaneous version. What’s new is the primary endpoint, detailed in a recently revealed clinicaltrials.gov listing. While the previous Advance and Advance-SC trials evaluated sustained platelet response with Vyvgart versus placebo, Advance-Next will test disease control. Both endpoints require patients’ platelet counts to rise to 50×109/l or more, but disease control appears slightly less stringent. ITP is caused by low platelet levels that can lead to bruising and bleeding. Enrolment criteria also look simpler in Advance-Next: patients are merely required to have a mean platelet count of less than 30x109/l at baseline, while Advance specified two such platelet counts, and Advance-SC three. And Advance-Next also asks for a documented response to a prior therapy. Despite Argenx’s efforts to speed things along, however, data from Advance-Next still look a while away: the study isn’t set to complete until June 2028, according to clinicaltrials.gov.
Pivotal Vyvgart trials in immune thrombocytopenia
| Trial | Formulation | N | Primary endpoint | Time frame | Result |
|---|---|---|---|---|---|
| Advance | IV | 131 | Sustained platelet count response, defined as platelet counts of ≥50x109/l on at least four of the six visits between week 19 and week 24 | During weeks 19 -24 | Success (22%, vs 5% for placebo) |
| Advance-SC | SC | 207 | Fail (14%, vs 16% for placebo) | ||
| Advance-Next | IV | 63 | Disease control, defined as the number of cumulative weeks during the double-blinded treatment period with platelet counts of at least ≥50×109/l | Up to 24 weeks | To start Oct 2024 |
Source: OncologyPipeline.
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