Sanofi makes ‘best-in-class’ claim for Sarclisa in myeloma

Armed with new  phase 3 clinical results, Sanofi says its multiple myeloma drug Sarclisa should be considered the “treatment of choice” among CD38-targeting therapies, throwing down a gauntlet to Johnson & Johnson’s Darzalex.

The French drugmaker has reported the data from the IKEMA trial in relapsed multiple myeloma, after teasing a positive result last month. Sarclisa (isatuximab) reduced the risk of disease progression or death by 47% compared to standard care with Amgen's Kyprolis (carfilzomib) and dexamethasone in the study.

There was no difference between the two groups on the overall response rate which was 86.6% and 82.9%, respectively, but Sarclisa was more likely to lead to a complete response – a 39.7% chance versus 27.6% for standard care.

The depth of the responses seen – with undetectable levels of myeloma cells in early 30% of patients treated with Sarclisa – means that the drug “has the potential to become the anti-CD38 of choice for the treatment of multiple myeloma”, according to Sanofi’s head of R&D John Reed.

IKEMA involved 302 patients who had received between one and three prior myeloma therapies, with progression-free survival the primary endpoint. At the data cut-off, the median PFS was 19.2 months for patients on Kyprolis/dexamethasone, but had not yet been reached for the Sarclisa group.

Sarclisa was approved by the FDA in March as a third-line treatment for multiple myeloma, becoming the first direct rival to J&J’s Darzalex (daratumumab), which made almost $3bn in sales last year.

Darzalex is used across a range of myeloma indications, including first-line use in transplant eligible patients, and is still growing at a healthy lick five years after launch, rising 49% to $937m in the first quarter of this year.

Sanofi’s drug has a shorter infusion time – two hours instead of several hours with J&J’s drug – and according to the French drugmaker also has a better safety profile because it binds to a different part of the CD38 molecule.

It is planning to move the drug into earlier lines of therapy as well, and revealed new first-line data at an ASCO satellite event that showed a 100% overall response rate, with a complete response in almost two-thirds of patients.

The problem for Sanofi is that J&J has already upped the ante in the class with the FDA approval of Darzalex Faspro, which can be administered by subcutaneous injection in a matter of minutes. The drug has also been recommended for approval by the EMA’s human medicines committee, the CHMP.

Meanwhile, the IV formulation of Darzalex still has the considerable advantage of being well-established in the market and already a cornerstone of multiple myeloma therapy. Analysts at Jefferies said recently they don’t think Sarclisa will catch Darzalex when it comes to annual sales, but could still become a $1bn-plus product.