MULTIPLE MYELOMA

Treatment of Multiple Myeloma with High-Risk Cytogenetics

Deepu Madduri, MD, assistant professor at Mount Sinai Hospital, discusses the biggest challenge oncologists currently face since the introduction of novel agents to the field of multiple myeloma. 

A look back at all the FDA news that happened in the month of August 2018, including several new approvals, a priority review, breakthrough therapy designations, and more in a variety of cancer types.

Noopur Raje, MD, discusses the latest treatment advances in multiple myeloma, including the promising results seen with the anti-BCMA CAR T-cell therapy bb2121 in patients with relapsed/refractory disease.

FDA approval is being sought for a once-weekly dosing option of carfilzomib for use in combination with dexamethasone as a treatment for patients with relapsed/refractory multiple myeloma. Amgen, the manufacturer of the proteasome inhibitor, announced the submission of a supplemental new drug application seeking this approval today.

In an interview with&nbsp;<em>Targeted Oncology&nbsp;</em>during the2nd Annual Live Medical Crossfire: Hematologic Malignancies meeting, Alexander M. Lesokhin, MD, assistant attending physician in the Department of Medicine and Myeloma Service at Memorial Sloan Kettering Cancer Center, discussed the current treatment landscape of multiple myeloma and where he predicts the field will be in the next decade. He also shared his thoughts on the current research in CAR T-cell therapy.

A supplemental biologics license application for elotuzumab<em>&nbsp;</em>has been granted a priority review by the FDA&nbsp;for use in combination with pomalidomide and low-dose dexamethasone as a treatment for patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, including lenalidomide and a proteasome inhibitor.<br /> &nbsp;

Karyopharm Therapeutics has announced that a rolling submission of an FDA new drug application has been completed for&nbsp;selinexor as a treatment for patients with penta-refractory multiple myeloma,&nbsp;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 &amp; 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.