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Sanofi’s Sarclisa, chasing Darzalex, brings the heat with big myeloma combo win

Sanofi has a big job ahead as it goes after Johnson & Johnson blockbuster Darzalex in the multiple myeloma field. But the French drugmaker’s contender, Sarclisa, is coming full-force, backed by big new combo data.

Adding the drug to a combination of Amgen’s Kyprolis and steroid dexamethasone cut relapsed myeloma patients’ risk of disease progression or death by 47% over the Kyprolis-dexamethasone regimen alone, the French drugmaker said Tuesday.

Patients in the phase 3 study’s control arm went a median 19.15 months without their disease worsening, but the median for Sarclisa patients hadn’t been reached at the time of the analysis, Sanofi said. And the drug’s benefits stayed consistent across patient subgroups, too.

Cutting risks by 47% over a standard-of-care regimen is no small feat; last September, a combination of Darzalex, Kyprolis and dexamethasone posted a 37% reduction in the risk of disease progression or death in the same population, although differences in study design make cross-trial comparisons problematic.

Still, “these results suggest the potential of Sarclisa to become a new standard of care in the relapsed multiple myeloma setting,” Philippe Moreau, M.D., of the University Hospital of Nantes’ department of hematology, said in a statement.

The results mark the second big win for Sarclisa, which in March won its first green light—and the first go-ahead for a wholly-owned Sanofi oncology med in a decade. That nod came on the back of data showing it could slash the risk of disease progression or death by 40% when added to Bristol-Myers Squibb’s Pomalyst and dexamethasone in patients who had tried at least two other therapies.

But while the company is riding high on Sarclisa’s success, if it wants to really take the fight to fellow CD-38 antibody Darzalex, it’ll have to score some wins in previously untreated patients. Two years back, J&J’s $3 billion seller made history by becoming the first-ever monoclonal antibody to snag an approval in first-line patients, and since then, it’s bagged two more.

Sanofi figures it’s up to the challenge, though. “We believe Sarclisa has the potential to become the anti-CD38 of choice for the treatment of multiple myeloma,” R&D Chief John Reed, M.D., Ph.D., said in a statement. “We look forward to seeing the results from future clinical trials to understand the impact of Sarclisa in earlier stages of disease.”