Sanofi scores with subcutaneous Sarclisa as it plays catch up with J&J Darzalex

 Trailing Johnson & Johnson’s powerhouse Darzalex by roughly five years in its development timeline has made it challenging for Sanofi’s Sarclisa—the only other CD38 antibody on the market for multiple myeloma—to compete in the indication.

But with an on-body delivery system (OBDS) to deliver its subcutaneous (SC) formulation of Sarclisa, Sanofi may be finding the edge it needs.

The company has taken a major step in the development of its OBDS as a phase 3 trial has met its primary co-endpoints, showing non-inferiority to intravenous (IV) Sarclisa. The company reported the trial result in a press release Thursday.

In IRALIA—which Sanofi says is the first ever phase 3 study to evaluate the SC administration of a cancer treatment by way of an OBDS—531 patients with relapsed or refractory multiple myeloma received either Sarclisa SC or Sarclisa IV. Patients in both treatment arms also received pomalidomide and dexamethasone (Pd).

The endpoints on which Sarclisa SC measured up to IV were objective response rate (ORR) and observed concentration before dosing at steady state. The study also hit its key secondary endpoints.

In the SC arm, Sarclisa was administered at a fixed dose weekly for four weeks during the first cycle of treatment and every two weeks for subsequent cycles. In the IV arm, Sarclisa was administered at a weight-based dose via infusions weekly for four weeks during the first cycle and every two weeks for subsequent cycles.

Sanofi said it will reveal detailed results at an upcoming medical conference. The company added that it plans to submit applications for approval in the U.S. and Europe in the first half of this year.

Sanofi’s automated, hands-free OBDS is called enFuse and is produced by Cincinnati-based Enable Injections. The device uses a hidden, retractable needle that is thinner than is commonly used for SC administration, Sanofi said.

The company is currently evaluating Sarclisa SC formulations across different combinations and lines of therapy.

Sarclisa was approved by the FDA in 2020, five years after J&J won its nod for Darzalex. In September of last year, the FDA signed off on Sarclisa—in combination with bortezomib, lenalidomide and dexamethasone (VRd)—to treat first-line patients. The nod came six years after J&J won a comparable approval to treat first-line patients. Additionally, J&J gained an FDA nod for its SC version of Darzalex, which is called Darzalex Faspro, in 2020.

In the first three quarters of 2024, Darzalex generated sales of $8.6 billion, a 19% increase from the same period in 2023. Meanwhile, Sanofi reported (PDF) sales of Sarclisa in the first three quarters of 2024 at $341 million, a 29% increase year-over-year. 

https://www.fiercepharma.com/pharma/sanofi-scores-its-subcutaneous-version-sarclisa-it-plays-catch-johnson-johnsons-darzalex