J&J, Genmab strengthen case for Darzalex in frontline multiple myeloma with fresh slate of PhIII data
J&J and Genmab offered a snapshot of the Phase III data that got Darzalex its priority review for frontline use late last week, highlighting how adding the blockbuster multiple myeloma drug to a chemotherapy regimen improved the complete response rate. The partners are now ready to expound on the full extent of that benefit with some numbers on progression-free survival.
The results of the CASSIOPEIA study were published in The Lancet amid a flood of data from ASCO, where Sanofi also delineated a case for its rival anti-CD38 therapy, isatuximab, by comparing a combo with pomalidomide and dexamethasone against the chemo/corticosteroid alone.
“There is a need for new treatment options for newly diagnosed patients, potentially including this combination therapy with daratumumab,” said Philippe Moreau, primary investigator and head of the hematology department at the University Hospital of Nantes, France, in a statement. “This study adds to the growing body of evidence for daratumumab in the frontline setting.”
As previously reported, the group receiving Darzalex plus the standard of care VTD — Velcade(bortezomib), thalidomide and dexamethasone — notched a stringent complete response rate of 29% 100 days after their autologous stem cell transplant, versus 20% in the VTD arm (odds Ratio = 1.60; p<0.0010).
Furthermore, DARZALEX-VTD increased the rate of very good partial response or better (83% versus 78%, p<0.0239) and complete response or better (39% versus 26%, p<0.0001).
Then there’s the second, ongoing part of the 1085-patient study measuring PFS in the patients who show at least a partial response, the median for which has not been reached in either arm. But the 18-month PFS rate for the combo group was 93% — a significant improvement from VTD’s 85% according to J&J. Hazard ratio came in at 0.47 with p<0.0001.
As J&J and Genmab await a decision on their sBLA in September, Sanofi has a foot in US and EU regulators’ door for isatuximab’s first approval. Their drug scored a clear win on progression-free survival for relapsed or refractory patients, with 11.53 months for the combination of isatuximab and pom-dex compared to 6.47 months for pom-dex alone. The p-value was 0.001.
The combination also scored a 60% overall response rate, compared to 35% for pom-dex alone — also statistically significant.
Sanofi R&D chief John Reed contends that their drug, a late-stage favorite in his plan to revamp the pharma giant’s oncology group, “has features that differentiate it from daratumumab.” For instance, it directly induces apoptosis in myeloma cells, hitting the tumor microenvironment.
Expect aggressive moves into frontline and second-line territory to follow, Reed told Endpoints News at ASCO as he envisions a $3 billion market opportunity. But J&J and an almost public Genmab are coming to the defense prepared.