After 2 years of no new drug approvals for the treatment of patients with multiple myeloma, 2015 brought great strides in the advancement of therapeutic options.
The U.S. Food and Drug Administration (FDA) approved panobinostat in combination with bortezomib and dexamethasone for patients who have received at least 2 prior regimens in early 2015. By the end of the year, the FDA had approved 3 more agents: single-agent daratumumab, elotuzumab in combination with lenalidomide and dexamethasone, and ixazomib in combination with lenalidomide and dexamethasone. It also expanded the indication for carfilzomib from use as monotherapy only to use in combination with lenalidomide and dexamethasone in patients with relapsed disease.
“Following their regulatory approval, there is an increasing use of both daratumumab [and] elotuzumab in relapsed myeloma,” Elisabet E. Manasanch, MD, assistant professor in the Division of Cancer Medicine Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center in Houston, TX, told Cancer Therapy Advisor. “Patients are benefitting from these new therapies in the clinic and we are very excited that this has happened in the field of multiple myeloma.”
Despite the numerous advances in the treatment of multiple myeloma, including both chemotherapy and immunotherapy, within the last year, clinicians should be looking to what is on the horizon.
So, what is there to look forward to now? In this article, Cancer Therapy Advisor takes a look at the various drugs in the pipeline for the treatment of multiple myeloma.
Dr Manasanch, who completed a clinical fellowship in multiple myeloma with the National Institutes of Health and has authored more than 40 peer-review original research articles and abstracts, discussed with Cancer Therapy Advisor the drugs she thinks are the most important in the future of multiple myeloma care, including 4 drugs being studied with diverse regimens in an array of treatment lines and a novel immunotherapy for those with heavily pretreated disease.
Selinexor, a first-in-class SINE XPO1 antagonist, seems to be the most promising drug to keep an eye on, Manasanch said. It is being evaluated in the open-label, single-arm, phase 2 STORM trial in combination with dexamethasone in heavily pretreated patients refractory to bortezomib, lenalidomide, carfilzomib, pomalidomide, and their most recent therapy. Patients receive selinexor 45 mg/m2 orally plus dexamethasone 20 mg, both twice weekly. The primary endpoint is overall response rate and the estimated study completion date is November 2016.1
Researchers are also assessing the drug in combination with dexamethasone and pomalidomide or bortezomib in the phase 1b/2 STOMP trial, as well as with carfilzomib and dexamethasone in a phase 1 trial, both in patients with relapsed/refractory disease.2,3
“Selinexor seems very promising. Dr Christine Chen presented data at the American Society of Hematology meeting in December on a phase 1 study that showed that selinexor was tolerable and identified a dose recommended for phase 2 studies. Preliminary results on efficacy included partial and complete remissions in relapsed/refractory myeloma,” Dr Manasanch said. “These results in a new drug class for myeloma are very encouraging.”
Preliminary findings of that phase 1 study of 8 patients demonstrated a 75% partial response rate or better with no unexpected toxicities with selinexor plus carfilzomib and dexamethasone in highly refractory patients.4