CD38 Inhibitor(Ribon Therapeutics)

Johnson & Johnson’s CD38 inhibitor Darzalex showed a benefit in delaying or preventing disease progression in patients with high-risk smoldering multiple myeloma, a precursor to active multiple myeloma. The primary endpoint of progression-free survival in the Phase 3 Aquila trial was “significantly improved” in patients on Darzalex, earning a p-value of 0.0001: Estimated 60-month progression-free survival rates were 63.1% for the drug versus 40.8% of patients being actively monitored. The overall response rate was 63.4% with J&J’s drug versus 2% with active monitoring, also earning a p-value of 0.0001. There was a “positive trend” in favor of Darzalex for another secondary endpoint, overall survival, with 93% in the Darzalex group and 86.9% in the active monitoring group. There were 41 deaths in the trial: 15 in the treatment group and 26 in active monitoring. Grade 3 or 4 treatment-emergent adverse events were seen in 40.4% of Darzalex patients and 30.1% in the active monitoring group, while 5.7% of patients on Darzalex discontinued due to adverse events. In the abstract the study authors said the “results strongly support the benefit of early intervention with [Darzalex] monotherapy versus active monitoring, the current standard of care” in patients with high-risk smoldering multiple myeloma. Responding to a question from Endpoints News about regulatory plans for Darzalex in high-risk smoldering multiple myeloma, a representative for J&J said the company continues “to work with regulatory authorities worldwide on the DARZALEX clinical development program and potential future indications.” Darzalex already has seven different multiple myeloma indications and $9.74 billion in sales in 2023, and a little over $3 billion in the third quarter of 2024. J&J in September also touted positive data from several late-stage studies with the drug in patients with newly-diagnosed multiple myeloma who had an autologous stem cell transplant. The company filed a supplemental BLA for the drug in combination with chemotherapy to treat patients with newly-diagnosed multiple myeloma who have not had a stem cell transplant. Stay tuned for more coverage of ASH from Endpoints , and sign up for our virtual ASH event here .