MULTIPLE MYELOMA

Karyopharm Therapeutics has announced that a rolling submission of an FDA new drug application has been completed for selinexor as a treatment for patients with penta-refractory multiple myeloma, based on results from part 2 of the phase IIb STORM trial.

Treatment with chimeric antigen receptor B-cell maturation antigen T cells induced substantial antitumor activity in patients with heavily treated relapsed/refractory multiple myeloma, according to results from a first-in-human clinical trial.

Sagar Lonial, MD, professor and chair, Department of Hematology & Medical Oncology, Emory University School of Medicine, chief medical officer, Winship Cancer Institute of Emory University, discusses the results from 2 large phase III trials presented earlier this year for triplet regimens including pomalidomide in multiple myeloma.

Treatments for Relapsed and Refractory Multiple Myeloma

In an interview with&nbsp;<em>Targeted Oncology</em>, Paul G. Richardson, MD,&nbsp;clinical program leader and director of Clinical Research in the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute,&nbsp;discussed the results from the OPTIMISMM trial. He also shared his insight on the significance of these findings and what he expects to see in the future for this patient population.

Sagar Lonial, MD, details&nbsp;optimal sequencing techniques for patients with relapsed/refractory myeloma in a presentation during the 2018 Pan Pacific Lymphoma Conference.

Sham Mailankody, MBBS,&nbsp;discusses current treatment options and shifting preferences, especially toward triplet combinations, as well as emerging immunotherapy treatment options.

Sarah Holstein, MD, PhD,&nbsp;discusses new approaches to induction therapy for patients with multiple myeloma.

In topline findings from the phase III TOURMALINE-MM3 study, maintenance treatment with the proteasome inhibitor ixazomib improved progression-free survival compared with placebo in adult&nbsp;patients with multiple myeloma who responded to high-dose therapy and autologous stem cell transplant.

Paul G. Richardson, MD, clinical program leader and director of Clinical Research in the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute, discusses results from the phase III OPTIMISMM trial comparing treatment regimens for relapsed/refractory multiple myeloma. This data compares a regimen of pomalidomide, bortezomib, and dexamethasone versus bortezomib and dexamethasone alone.&nbsp;

Elotuzumab&nbsp;(Empliciti) added to&nbsp;pomalidomide (Pomalyst) and&nbsp;dexamethasone reduced the risk of disease progression by 46% in patients with relapsed/refractory multiple myeloma compared with&nbsp;pomalidomide and dexamethasone alone,&nbsp;according to findings from the phase II ELOQUENT-3 trial presented at the 2018 EHA Congress.

In an&nbsp;analysis of patients with relapsed/refractory multiple myeloma enrolled on the phase Ib MMY1001 trial, daratumumab (Darzalex) was shown to be safe and effective when added to the backbone of carfilzomib (Kyprolis) and dexamethasone. These findings, which were presented&nbsp;during the 2018 ASCO Annual Meeting, signaled promising efficacy in patients who are refractory to lenalidomide (Revlimid), according to lead study author Ajai Chari, MD.

The FDA approved several indications in the month of June, including venetoclax (Venclexta) in chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL), the combination of binimetinib (Mektovi) plus encorafenib (Braftovi) in melanoma, and bevacizumab (Avastin) in ovarian cancer. The FDA also accelerated approvals for pembrolizumab (Keytruda) in cervical cancer and in primary mediastinal large B-cell lymphoma, while also granting a priority review to glasdegib for acute myeloid leukemia.

Noa Biran, MD, physician, Multiple Myeloma Division, John Theurer Cancer Center, discusses the rationale for selecting stem cell transplant as treatment over a chemotherapy regimen for patients with multiple myeloma.

A supplemental new drug application adding overall survival data from the phase III ASPIRE trial to the label&nbsp;for carfilzomib (Kyprolis) has been approved by the FDA, according to Amgen, the manufacturer of the proteasome inhibitor.&nbsp; Carfilzomib is approved&nbsp;for use in patients with relapsed or refractory multiple myeloma.

Noopur S. Raje, MD, a medical oncologist at Massachusetts General Hospital, discusses chimeric antigen receptor T-cell therapy in patients with multiple myeloma. This therapy has been an exciting advancement in both hematology as well as solid tumors, she notes.

Rafael Fonseca, MD, recently shared the treatment considerations and decisions he makes when treating patients with multiple myeloma. Fonseca, professor of medicine, chair, Department of Internal Medicine, Mayo Clinic, explained how he would treat these patients based on case scenarios during a <em>Targeted Oncology </em>live case-based peer perspectives presentation.

An FDA analysis of data from 2 randomized clinical trials investigating pembrolizumab in multiple myeloma showed inconsistent results regarding the relationship between immune-related adverse events and objective responses. The KEYNOTE-183 and KEYNOTE-185 trials were reviewed during the 2018 ASCO Annual Meeting.

Patients with relapsed/refractory t(11;14) multiple myeloma achieved high rates of responses when venetoclax was added to the combination of carfilzomib and dexamethasone, according to findings from an ongoing phase II study presented during the 2018 ASCO Annual Meeting.

According to the phase III ARROW study, a prolonged progression-free survival was found when carfilzomib was administered with a new dosing schedule of 70 mg/m²&nbsp;once weekly with&nbsp;dexamethasone compared to the standard of care, a twice-weekly schedule, in patients with relapsed/refractory multiple myeloma.