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J&J unit reports positive phase 3 data for multiple myeloma drug

Johnson & Johnson unit Janssen Research & Development LLC's phase 3 studies showed that Darzalex in combination with bortezomib and dexamethasone, or lenalidomide and dexamethasone, improved progression-free survival and the overall response rate for previously treated patients with multiple myeloma, regardless of cytogenetic risk.

Darzalex in combination with bortezomib and dexamethasone significantly reduced the risk of disease progression or death by 55% in patients with high-risk cytogenetics compared to bortezomib and dexamethasone alone. The combination resulted in an overall response rate of 82% versus 62% with very good partial response or better achieved in 64% versus 35% patients, and complete response or better achieved in 34% versus 9% patients.

In patients with standard cytogenetic risk, the addition of Darzalex reduced the risk of disease progression or death by 74%. The combination regimen resulted in an overall response rate of 85% compared to 64%, with very good partial response or better achieved in 64% versus 26% of patients, and complete response or better achieved in 28% versus 8% of patients treated with the combination versus bortezomib and dexamethasone, respectively. The median duration of follow-up was 19.4 months.

Darzalex in combination with lenalidomide and dexamethasone reduced the risk of disease progression or death by 47% in patients with high-risk cytogenetics compared to lenalidomide and dexamethasone alone. The combination regimen resulted in an overall response rate of 85% versus 67%, with very good partial response or better achieved in 64% versus 31% patients, and complete response or better achieved in 38% versus 6% patients.

In patients with standard cytogenetic risk, the addition of Darzalex reduced the risk of disease progression or death by 70%. The combination regimen resulted in an overall response rate of 95% versus 82%, with very good partial response or better achieved in 85% versus 55% patients, and complete response or better achieved in 58% versus 27% patients treated with the combination regimen versus lenalidomide and dexamethasone alone. The median duration of follow-up was 25.4 months.

A cohort in a phase 1b study showed that the overall safety profile of Darzalex in combination with carfilzomib, lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma was consistent with the known safety profiles of Darzalex and carfilzomib, lenalidomide and dexamethasone, respectively.

Treatment with this combination regimen yielded promising results with an overall response rate of 100%, with 91% achieving very good partial response or better and 43% achieving complete response or better, after a short-term follow-up.

In August 2012, Janssen Biotech Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize the drug. Darzalex is commercialized in the U.S. by Janssen Biotech Inc.