In the currently mismatched CD38 antibody race, Sanofi’s Sarclisa has delivered a pivotal trial win, which might help the lagging follower level the playing field a little.
Using Sarclisa on top of Takeda’s Velcade, Bristol Myers Squibb’s Revlimid and the steroid dexamethasone (VRd), significantly reduced the risk of disease progression or death versus VRd alone in patients with newly diagnosed multiple myeloma not eligible for transplant, Sanofi said Thursday.
Sanofi’s phase 3 IMROZ readout comes as Sarclisa’s in-class rival, Johnson & Johnson’s Darzalex, is sharing a positive phase 3 for its VRd combo in transplant-eligible patients at the upcoming American Society of Hematology annual meeting.
Still, the J&J data don’t prevent Sanofi from claiming the first phase 3 win for an anti-CD38 antibody with VRd in transplant-ineligible patients.
Results from the IMROZ trial will be shared at a future medical meeting and will support a regulatory filing, Sanofi said. A potential submission for IMROZ is expected in 2024, according to a Sanofi R&D update Thursday. The timeline for IMROZ has been delayed as Sanofi once targeted a readout by the end of 2021.
As the later CD38 drug to reach the market, Sarclisa lags behind Darzalex by a large margin by both the breadth of their indications and sales. Without any front-line nod, Sarclisa brought in 278 million euros ($300 million) sales in the first nine months of 2023. By comparison, J&J recorded nearly $7.2 billion in sales from Darzalex.
In the first-line transplant-ineligible setting, Darzalex has boasted an FDA approval in combination with Rd–without Velcade–since mid-2019. The J&J drug became the first antibody approved for these patients in 2018 as part of a regimen that also includes Velcade, melphalan and prednisone.
As for the first-line transplant-eligible population, the Darzalex-VRd combo cut the risk of progression or death by 58% compared with VRd alone, according to an abstract published ahead of the ASH 2023 meeting.
Sanofi is also gunning for a potential regulatory submission in 2025 for Sarclisa-VRd in first-line transplant-eligible myeloma patients based on data from the phase 3 GMMG-HD7 trial, which is being conducted solely in Germany, according to the R&D update Thursday. That timeline was also pushed back from a previous goal of 2024.
At ASH 2021, investigators of GMMG-HD7 reported that 50.1% of patients who got the Sarclisa combo achieved very low levels of minimal residual disease known as MRD negativity in the blood system after induction therapy, compared with 35.6% for RVd.
Sanofi is currently under pressure with growth now heavily driven by the immunology blockbuster Dupixent. The company in October unveiled a cost-cutting plan, which includes spinning off its consumer health franchise, pipeline reprioritization and an annual savings goal of 700 million euros.