Janssen to Discuss New Combinations of Darzalex and Other Multiple Myeloma Therapies

Janssen Biotech will discuss at a Chicago cancer conference the effectiveness of new multiple myeloma treatment combinations that include its therapy Darzalex (daratumumab).

The United States and European Union approved some combinations of Darzalex and other therapies in 2016, but Janssen wanted to evaluate additional combinations.

Janssen will present its latest clinical-trial findings at the annual meeting of the American Society of Clinical Oncology in June, according to its partner, Genmab, which developed Darzalex. The presentations will cover findings from two Phase 3 trials and a Phase 1b trial.

So far, Darzalex has been approved only for advanced myeloma. The Phase 1b study is important because it is looking at whether a combination of Darzalex, Kyprolis (carfilzomib), Revlimid (lenalidomide) and dexamethasone is an effective and safe treatment for newly diagnosed myeloma.

The study is an open label trial in which all patients receive the treatment.

U.S. and European regulators approved Darzalex, in combination with other therapies, for advanced myeloma patients who failed to responded to previous treatments, or who relapsed after those treatments. The EU approval specifies that the earlier treatments had to have included a proteasome inhibitor and an immunomodulatory drug.

At the Chicago conference, Janssen will update effectiveness and safety findings from its Phase 3 CASTOR and POLLUX trials of patients with relapsed or refractory myeloma. Part of the update will cover the safety of Darzalex combo treatments in patients 75 years and older who were enrolled in the Phase 3 trials.

The CASTOR trial (NCT02136134) is assessing Darzalex in combination with Velcade (bortezomib) and dexamethasone, compared with Velcade and dexamethasone alone. The POLLUX trial (NCT02076009) is evaluating Darzalex in combination with Revlimid and dexamethasone, compared with Revlimid and dexamethasone.

Researchers will also discuss their analysis of published research on myeloma therapies. The review focused on treatments that were effective against myeloma patients’ first relapse.

This part of the research involved the team doing what scientists call a meta-analysis of pooled data from earlier studies. Researchers believe this approach yields the highest degree of evidence in medical science.

“We are very pleased that, once again, a number of abstracts based on exciting work with Genmab’s innovative therapeutic antibody products have been accepted for presentation at the prestigious ASCO conference,” Dr. Jan van de Winkel, chief executive officer of Genmab, said in a press release.

Genmab licensed Darzalex to Janssen in 2012. It turned out to be a good move because Janssen quickly moved the antibody-based treatment through clinical trials to approval.

Darzalex is the subject of nearly 50 clinical trials, including as a treatment for the myeloma-associated disease Amyloid light-chain (AL) amyloidosis (NCT02841033).