Sanofi’s Sarclisa added to standard of care has prolonged survival without worsening of disease in a late-stage study in certain multiple myeloma patients, reinforcing the drug’s potential as a backbone therapy, the company said Thursday.
The investigator-sponsored, open-label Phase 3 trial enrolled 662 people with newly diagnosed multiple myeloma who are eligible for an autologous stem cell transplant. Sarclisa plus lenalidomide, bortezomib and dexamethasone (RVd) showed a “statistically significant and clinically meaningful” improvement in the progression-free survival primary endpoint when given as an induction therapy in comparison with patients who just received RVd.
Thursday’s results add to data unveiled in 2021, which showed the Sarclisa regimen met the trial’s other primary endpoint of minimal residual disease negativity.
Sarclisa was approved for relapsed refractory multiple myeloma in 2020, but Sanofi has been working to expand its label to earlier settings.
A spokesperson told Endpoints News in an email that it could work on filing plans in transplant-eligible patients with the trial sponsor — the German-Speaking Myeloma Multicenter Group, or GMMG — but it would be “premature” to do so before full data are presented. The French pharma said it will present more detailed results at an upcoming medical meeting.
But Johnson & Johnson’s Darzalex is several years ahead, having won US approval in September 2019 in combination with bortezomib, thalidomide and dexamethasone for transplant-eligible patients.
Meanwhile, in newly diagnosed patients who are not eligible for a transplant, Sanofi touted positive Phase 3 data of Sarclisa plus bortezomib, lenalidomide and dexamethasone in this setting in June. Those results put the estimated median PFS at seven-and-a-half years.
But Darzalex is also ahead in this setting. The drug was approved in combination with lenalidomide and dexamethasone for transplant-ineligible newly diagnosed multiple myeloma patients back in June 2019.
Even so, according to Sanofi, if Sarclisa is approved for the transplant-ineligible group, it would be the first drug of its class to be used with bortezomib, lenalidomide and dexamethasone, which is the current standard of care in this setting. The regimen is under FDA priority review with a Sept. 27 deadline.