Dutch immunology company argenx SE (ARGX) Tuesday announced that its ADVANCE-SC study of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with primary immune thrombocytopenia or ITP did not meet primary or secondary endpoints.
ADVANCE-SC is the second of two registrational trials conducted as part of the ongoing ITP development program for VYVGART. It enrolled 207 adult patients with chronic and persistent ITP.
The topline results from the study evaluating VYVGART Hytrulo indicated that it failed to meet the primary endpoint of a sustained platelet count response in chronic ITP patients.
The secondary endpoints, including additional endpoints on International Working Group or IWG responder status and mean platelet count change from baseline, were also not met.
The company noted that VYVGART Hytrulo was well-tolerated in ADVANCE-SC. The observed safety and tolerability profile was consistent with ADVANCE-IV and the confirmed safety profile of VYVGART and VYVGART Hytrulo.
Additional analyses of the dataset are ongoing. The company will present the full results of the trial at an upcoming medical meeting and in a peer-reviewed publication.
Luc Truyen, Chief Medical Officer of argenx, said, "This is not the outcome we had hoped for patients, but setbacks are part of pioneering a new class of medicines and these data will provide insights into the broader understanding of FcRn and ITP. … We remain committed to the ITP patient community who urgently needs additional treatment options to manage this challenging disease, and continue to move forward in our deeper analysis of these results."
The company had reported results from the first study in the ITP registrational program, ADVANCE-IV, in May 2022. The study met its primary and key platelet-derived secondary endpoints.
Argenx noted that ADVANCE-IV formed the basis of the regulatory submission for approval of VYVGART IV for ITP in Japan. A decision is expected in the first quarter of 2024 in the country.
VYVGART is currently being evaluated in 13 severe autoimmune diseases, including the registrational ADDRESS study for pemphigus from which topline results are expected around year-end 2023.
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