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Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
Results from the Phase III POLLUX trial with Janssen’s Darzalex showed that the drug was effective at reducing disease progression in patients with relapsed or refractory multiple myeloma.
Results from Phase III POLLUX trial with Janssen’s Darzalex (daratumumab) in combination with lenalidomide, and dexamethasone was released in the Oct 6, 2016 issue of the New England Journal of Medicine (NEJM). Results from the trial, which was funded by Janssen, show the combination of drugs was efficacious at treating relapsed or refractory multiple myeloma. FDA granted the drug breakthrough therapy designation in July 2016.
The POLLUX trial showed that treatment with daratumumab, lenalidomide, and dexamethasone found a 92.9% overall response rate. The drugs were “associated with a 63% lower risk of disease progression or death than lenalidomide and dexamethasone alone among patients with multiple myeloma who had received one or more lines of therapy previously.” Researchers also saw promising results in the CASTOR trial, another Phase III trial that examined the daratumumab in combination with bortezomib and dexamethasone. During an American Society of Clinical Oncology (ASCO) meeting in June 2016, study authors said the drug should be a new standard of care for multiple myeloma. Results from the POLLUX and CASTOR trials were presented during the 21st Annual Congress of the European Hematology Association. Both trials showed the drug assisted in reducing disease progression or death.
In an editorial published in the same issue of NEJM, S. Vincent Rajkumar, MD and Robert A. Kyle, MD, both doctors at the Mayo Clinic, commented on the development of new monoclonal antibodies as treatments for multiple myeloma. Since 2013, FDA has approved six new drugs for the treatment of this type of cancer, pomalidomide, carfilzomib, panobinostat, ixazomib, elotuzumab, and daratumumab, the authors report. While the doctors agreed that the approval of new drugs is positive, they note “the rapid pace of these advances has left us without clear comparative data for making informed decisions.”
Rajkumar and Kyle say the CASTOR and POLLUX trials display “unprecedented” reductions in disease progression for this stage of the multiple myeloma, and that the three-drug combination of daratumumab, lenalidomide, and dexamethasone is “a clear standout.” But they also comment that it will be a challenge preventing unnecessary use of daratumumab, since the drug is used in combination with other treatments.
Rajkumar and Kyle also said it is important to consider that many of the patients treated in the POLLUX trial did not have previous exposure to lenalidomide, which the study authors noted as a limitation in their research. This contrasts the significant number of patients with relapsed myeloma in the United States that have already been treated with lenalidomide, which the doctors said could have an impact on the overall generalizability of the trial.