Sanofi flashes more PhIII data on new multiple myeloma drug, setting up battle with Darzalex
Two months after nabbing their first approved cancer drug in a decade, Sanofi announced new late-stage data burnishing the drug’s efficacy in another combination for multiple myeloma.
In a 302-person Phase III trial, investigators combined the new drug, known as Sarclisa, with Amgen’s Kyprolis and showed that the cocktail was more effective than Kyprolis alone. Although Sanofi did not release data, they said the independent review board had stopped it after the combo showed “significantly prolonged progression-free survival.”
“This is the second positive phase 3 trial for Sarclisa, further supporting the potential our medicine has to improve outcomes for patients struggling with relapsed multiple myeloma,” Sanofi R&D chief John Reed said in a statement.
The trial result gives an additional boost to Sanofi as they take on J&J, whose Genmab-developed Darzalex has been the market leader for third-line multiple myeloma patients — and some earlier stage patients — since its approval in 2015. Last year, Amgen released data that a similar combo of Kyprolis and Darzalex led to a 37% reduction in risk of death or disease progression in the same set of patients. Both drugs work by the same mechanism, targeting the CD38 receptor that’s over-expressed on multiple myeloma cells.
On March 2, FDA approved Sarclisa well ahead of an April PDUFA, a recognition of the tests Sanofi had already run on its first prospective cancer approval since 2010. In a Phase III trial testing Sarclisa in combination with Bristol Myers Squibb’s Pomalyst against Pomalyst alone, the Sarclisa patients had a progression-free survival of 11.5 months, compared to 6.5 months for the Pomalyst patients.
Although the FDA approval came for third-line patients, the new trial tested the drug in patients who had gone through one to three lines of therapies, potentially pointing to the drug’s efficacy in earlier stage patients. In all trials, the drug was also given with dexamethasone, a chemotherapy given to most multiple myeloma patients.
Although the potential sales for an effective multiple myeloma drug are significant — J&J earned a hair under $3 billion last year from Darzalex, although that includes other indications — Sanofi faces a difficult launch as they look to market the new drug during a pandemic. Their Q1 earnings showed €1 million in sales through one month.