On Thursday, Sanofi SA (NASDAQ:SNY) released results from the IRAKLIA phase 3 study evaluating the non-inferiority of Sarclisa (isatuximab) subcutaneous formulation via an on-body delivery system (OBDS) versus weight-based dosed Sarclisa IV in combination with pomalidomide and dexamethasone (Pd) in adult patients with relapsed or refractory multiple myeloma. 

The trial demonstrated that Sarclisa SC, in combination with pomalidomide and dexamethasone (Pd), met its co-primary endpoints of non-inferior objective response rate and observed concentration before dosing (C trough) at steady state.

Also Read: Sanofi’s 340B Credit Proposal Draws Federal Warning For Statutory Violation

Key secondary endpoints were also achieved, including very good partial response, the incidence rate of infusion reactions, and C trough at cycle 2.

The study is ongoing, and the full results will be presented at a forthcoming medical meeting.

Additional studies evaluating Sarclisa SC formulations across different combinations and lines of therapy are ongoing.

The safety and efficacy of Sarclisa SC and the enFuse device have not been evaluated by any regulatory authority outside of their approved indications. Regulatory submissions in the US and in the EU are planned during the first half of 2025.

In September, the FDA approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment option for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant.

In August, Sanofi released new results from the GMMG-HD7 phase 3 study of Sarclisa in combination with lenalidomide, bortezomib, and dexamethasone (RVd) versus RVd induction followed by post-transplant re-randomization to Sarclisa plus lenalidomide versus lenalidomide maintenance in transplant-eligible newly diagnosed multiple myeloma patients.

The data show that Sarclisa, combined with RVd during induction therapy, significantly prolonged progression-free survival, resulting in a statistically significant and clinically meaningful reduction in disease progression or death compared to RVd induction regardless of the maintenance regimen.

Price Action: SNY stock closed at $49.23 on Wednesday.

Read Next:

• Medicare To Cover Eli Lilly’s Weight Loss Drug Zepbound For Obstructive Sleep Apnea Treatment

Image by HJBC via Shutterstock

Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market.

Get the latest stock analysis from Benzinga?

This article Sanofi's Blood Cancer Drug's New Subcutaneous Formulation Hits Primary Goal In Late-Stage In Multiple Myeloma originally appeared on Benzinga.com

© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.