Sanofi takes aim at J&J's myeloma star Darzalex with latest Sarclisa trial win

Sanofi reported positive results that adding Sarclisa could improve on Amgen’s Kyprolis and dexamethasone in relapsed multiple myeloma. (Sanofi)

For Sanofi, a recent FDA nod for Sarclisa marks its return to oncology. Now, the French pharma is touting a clinical victory that puts the drug on track to a new multiple myeloma use.

Adding Sarclisa to Amgen’s Kyprolis and dexamethasone significantly cut the risk of cancer progression or death compared with the Kyprolis-corticosteroid pairing alone in patients with relapsed multiple myeloma, Sanofi said Tuesday.

Details of that win on the trial's primary endpoint—turned up at the trial's first planned interim analysis—are thin right now, but Sanofi expects to include the data in regulatory submissions later this year.

“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 head John Reed said in a statement.

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The new Ikema trial enrolled 302 relapsed multiple myeloma patients who had received one to three prior therapies.

Previously, Sarclisa had shown that it—when used alongside Bristol Myers Squibb’s Pomalyst and dexamethasone—reduced the risk of disease progression or death by 40% versus that pairing alone. The original trial win helped earn Sarclisa its initial FDA green light in early March in relapsed refractory myeloma patients who’ve received at least two prior therapies.

The nod represented Sanofi's first for a wholly owned oncology molecule in 10 years, but the company isn’t pushing for a full launch until after the COVID-19 crisis wanes, CEO Paul Hudson told investors during a conference call in late April.

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The multiple myeloma market is very crowded. Besides chemotherapies and steroids, other standard treatments include Bristol’s Celgene-inherited Revlimid and Takeda’s proteasome inhibitors Velcade and follow-on drug Ninlaro, which are direct competitors to Kyprolis. Karyopharm’s oral drug Xpovio is also eyeing the second-line myeloma setting.

But the more obvious competitor to Sarclisa is Johnson & Johnson’s megablockbuster Darzalex.

Both Sarclisa and Darzalex are CD38 antibodies. Amgen recently unveiled data showing a regimen containing Kyprolis, Darzalex and dexamethasone led to a 37% reduction in the risk of disease progression or death compared with Kyprolis-dexa in relapsed or refractory patients who received one to three prior therapies—the same population included in Sarclisa’s Ikema study.

Darzalex has been steaming ahead, fueled by several go-aheads in new myeloma patients. Last year, Darzalex sales jumped 48% year over year and reached $3 billion.