EHA 2023 – Roche heads to regulators with its Soliris challenger

Several developers are coming after Astrazeneca’s blockbuster Soliris/Ultomiris franchise in paroxysmal nocturnal haemoglobinuria, and Roche today presented positive data at the European Hematology Association conference from two pivotal trials of its subcutaneous contender crovalimab. Like Astra’s MAbs crovalimab is a C5 inhibitor, and the Swiss developer hopes to make a convenience argument with once-monthly subcutaneous administration. While intravenous Soliris is given every two weeks, Ultomiris, also intravenous, can be stretched out to every eight weeks, although complex loading dose schedules, also seen with crovalimab, make such comparisons less than straightforward. Either way, crovalimab showed itself to be non-inferior to Soliris in Commodore-2 in treatment-naive PNH, meeting its two co-primary efficacy endpoints of transfusion avoidance and control of haemolysis, with what appears to be a similar adverse event profile. Commodore-1, a switching study, “supported the favourable benefit-risk profile of crovalimab”, Roche said. Though data have only just been presented Roche is already heading to regulators. PNH is getting crowded: Novartis has also said that it intends to file its oral project iptacopan this half, and of course Astra is not standing still, releasing data on danicopan, an oral factor D inhibitor, at EHA today.

Commodore 2 (NCT04434092) data in paroxysmal nocturnal haemoglobinuria
  Crovalimab 680-1020mg SC q 4wk Soliris 900mg IV q 2wk
N* ~137 ~67
Haemolysis control rate from wks 5 to 25 (%)  79.3 79.0
Transfusion avoidance from baseline to wk 25 (%) 65.7 68.1
Improvement in FACIT-Fatigue score from baseline to wk 25 (points) 7.8 5.2
Adverse events (%) 78 80
     Serious infections (%) 3 7
     Infusion-related reactions (%) 16 13
     Adverse event leading to treatment discontinuation (%)* ~0.7 ~1.5
*Vantage calculations. Both arms included IV (Soliris) or IV/SC (crovalimab) loading doses until wk 5. Source: company release. 

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