Sanofi's Darzalex rival hits the mark in phase 3 trial

Johnson & Johnson’s Darzalex multiple myeloma drug has just become a blockbuster – but it could face competition from a rival from Sanofi that has just checked out in a phase 3 trial.

Developed in partnership with Danish biotech Genmab, Darzalex (daratumumab) is approved in four different multiple myeloma indications, including as a monotherapy or in combination with chemotherapy in relapsed disease.

This has accelerated sales to just over $1.2 billion in 2018, an increase of 36% compared with full year 2017.

Now Sanofi wants to compete in the lucrative indication with a drug that has an identical mechanism of action, targeting the CD38 surface receptor that is uniformly expressed on multiple myeloma cells.

Sanofi expects to file results of the ICARIA-MM trial, which tested isatuximab added to pomalidomide and low-dose dexamethasone in relapsed or refractory disease, with regulators later this year.

The international trial involving 307 patients compared the isatuximab combination with pomalidomide (Celgene’s Imnovid) and low-dose dexamethasone alone, which is still standard of care in the indication.

At the moment Darzalex is only approved on the basis of a small trial in this use, and the greater certainty offered by a phase 3 success could help Sanofi’s marketing efforts should the regulators such as the FDA decide to approve isatuximab.

The French drugmaker did not reveal details of the trial’s findings, but will announce them at a forthcoming medical meeting.

Sanofi has several other trials ongoing, including in combination with standard therapies in newly diagnosed and relapsed/refractory disease.

John Reed, head of R&D at Sanofi, said: "We are excited by these results, which represent significant progress in our ambition to extend the lives of multiple myeloma patients.

"We look forward to engaging with regulatory authorities with the goal of bringing this potential new treatment to patients as quickly as possible."