Sanofi reported positive Sarclisa data from a registrational test in certain newly-diagnosed multiple myeloma patients, with the company anticipating a US launch as early as this year.
The French drugmaker said the new efficacy data could help set Sarclisa apart from Johnson & Johnson’s Darzalex. Both drugs are CD38 inhibitors, but Darzalex benefits from its first-in-class status and is ahead in both indication tally and sales.
The Phase 3 IMROZ trial tested Sarclisa in combination with bortezomib, lenalidomide and dexamethasone (VRd) versus VRd in 446 people with newly-diagnosed, transplant-ineligible multiple myeloma.
At a follow-up of almost five years, the primary endpoint of median progression-free survival has not yet been reached in the Sarclisa arm, and is around four-and-a-half years in the control arm. The Sarclisa regimen also cut the risk of disease progression or death by around 40% versus VRd (p=0.0005), according to data presented Monday at the American Society of Clinical Oncology annual meeting.
Median PFS for Sarclisa is projected to be seven-and-a-half years, Sanofi’s global head of oncology development and pediatric innovation Peter Adamson told Endpoints News in an interview ahead of the confab. Given that the patients enrolled had a median age of 72 years, the Phase 3 results suggest that a cure could be a “realistic vision” for multiple myeloma, Adamson said.
“We still have a long way to go, don’t get me wrong, but when we are looking at outcomes that are measured in years — and seven and a half years estimated in this case — I think it begins to set the stage for where our scientific advances have taken us,” he said.
The Sarclisa-VRd regimen also saw 55.5% of trial patients achieve minimal residual disease (MRD) negative complete responses, meaning no disease was detected. Although comparing across trials is risky, these results suggest that Sarclisa could be differentiated from Darzalex in terms of depth of response, Adamson said. In its registrational trial, Darzalex plus lenalidomide and dexamethasone saw 36.1% of patients under 75 years achieve MRD-negativity.
Sanofi’s regimen is under priority review with the FDA, whose decision is expected by Sept. 27. There were no new safety signals for Sarclisa in the study.
The company said it anticipates launching Sarclisa in its new setting “as early as 2024 in the US,” with rollout in other key countries to follow in 2025 and continue through 2026.
Sarclisa is already approved for relapsed and refractory multiple myeloma, but a label expansion to the earlier setting could significantly boost its market prospects. There are more than 18,000 new cases diagnosed worldwide every year, and an estimated 50-60% of them are deemed transplant-ineligible, according to Sanofi.
But Darzalex is several years ahead in the market, having received a US approval in combination with lenalidomide and dexamethasone for the same newly-diagnosed multiple myeloma patients back in 2019.
With seven different multiple myeloma indications on Darzalex’s label versus Sarclisa’s one, Darzalex is further ahead in sales. In 2023, Darzalex made $9.74 billion in sales while Sarclisa pulled €381 million ($413 million).