IMS 2024 – Darzalex fights back against Sarclisa

Sanofi recently gained US approval for its anti-CD38 MAb Sarclisa in a new first-line multiple myeloma niche, but Johnson & Johnson and Genmab aren’t too far behind with Darzalex. Data from J&J’s Cepheus study, presented at the International Myeloma Society annual meeting in Rio de Janeiro on Friday, show subcutaneous Darzalex looking very similar on PFS to intravenous Sarclisa in its analogous Imroz study. Both trials enrolled first-line transplant-ineligible multiple myeloma patients, and tested the anti-CD38 MAb plus Velcade, Revlimid and dexamethasone (VRd), versus VRd alone. Imroz primarily measured PFS, while Cepheus’s primary endpoint was the percentage of patients achieving minimal residual disease status: 61% with Darzalex-VRd, versus 39% with VRd alone. J&J hasn’t yet given details of filing plans for Darzalex in this use. While Sanofi is ahead here, Sarclisa lags well behind Darzalex in terms of sales: in 2023 the products brought in €381m ($425m) and $9.7bn respectively. Sanofi has yet to get a subcutaneous version of Sarclisa to market, but expects results from the Irakalia study of its SC version soon, with a filing slated for next year if positive.

Cross-trial comparison of Darzalex vs Sarclisa in transplant-ineligible 1L multiple myeloma

Note: VRd=Velcade, Revlimid & dexamethasone. Source: IMS 2024 & ASCO 2024.