- Results from a Phase 3 study showed treatment with Sanofi's experimental anti-CD38 therapy helped to extend progression-free survival in patients with multiple myeloma, the French pharmaceutical giant said Tuesday.
- Sanofi plans to submit the therapy, isatuximab, to U.S. and European regulators in the first half of 2019 for potential approval as a third-line therapy for relapsed or refractory multiple myeloma, a company spokesperson said in an emailed statement. The pharma aims to progressively expand the drug's indication into earlier treatment settings over the next few years.
- Detailed results weren't disclosed, although the company said isatuximab hit the trial's primary goal of showing a PFS improvement in patients who had already received two or more anti-myeloma therapies. Additional results will be presented at a future medical meeting, Sanofi stated.
Isatuximab's success in Phase 3 comes about a month after Sanofi chose to narrow an ongoing R&D collaboration with Regeneron in oncology, aiming to more independently advance its cancer plans.
Positive data give Sanofi a wholly-owned drug to tout, even as it continues to work with the New York biotech elsewhere in the red-hot research field.
Through its partnership with Regeneron, the French pharma holds rights to an approved immunotherapy in Libtayo (cemiplimab). While that drug represents a backbone asset for both companies, each still lags well behind immuno-oncology leaders like Merck & Co., Bristol-Myers Squibb and Roche.
If approved, isatuximab would help Sanofi challenge Johnson & Johnson's Darzalex (daratumumab), another anti-CD38 already on the market for multiple myeloma. Darzalex posted worldwide sales of $2 billion last year, up from $1.2 billion a year prior.
Sanofi's pivotal trial, dubbed ICARIA, enrolled 307 patients with relapsed or refractory multiple myeloma who had undergone multiple previous treatments. Isatuximab was tested in combination with pomalidomide and low-dose dexamethasone.
ICARIA is the first of four Phase 3 multiple myeloma studies to read out for Sanofi's therapy. The others will test isatuximab combinations, working toward building evidence supportive of a first-line indication.
Sanofi has previously outlined a timeline for further submissions, setting 2020 as a goal to file isatuximab in first- to third-line relapsed or refractory multiple myeloma.
In 2021, the company anticipates filing isatuximab in the first-line setting for newly diagnosed, transplant ineligible cases — and then adding transplant eligible cases in 2022 or later.