MULTIPLE MYELOMA

In September 2019, the FDA approved new treatment options for patients with endometrial carcinoma, prostate cancer, and multiple myeloma. The FDA also expanded the indication for the Cologuard noninvasive screening test for colorectal cancer. During the month there were 2 breakthrough therapy designations, 2 fast track designations, 1 orphan drug designation, and 1 priority review granted.

The discussion about the pros and cons of a 4-drug regimen for patients with multiple myeloma was highlighted during the 2019 Debates and Didactics in Hematology and Oncology conference.

The combination of daratumumab plus bortezomib, thalidomide, and dexamethasone (VTD) has been approved by the FDA for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant.

Selinexor plus lenalidomide and dexamethasone, an all-oral triplet, was found to be highly active in patients with relapsed or refractory multiple myeloma, according to results of the multi-arm STOMP study that were presented during the 17th International Myeloma Workshop. The regimen is also well tolerated and especially active in patients who did not receive lenalidomide prior to the trial.

The combination of carfilzomib, dexamethasone, and daratumumab led to a 37% reduction in the risk of progression or death compared with carfilzomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma in the phase III CANDOR trial. According to a press release from Amgen, this met the primary endpoint of progression-free survival for the trial.

Simon J. Harrison, MD, gives key takeaways from his presentation on the ICARIA-MM study, which he recently presented at the 2019 International Myeloma Workshop.<br /> &nbsp;

The combination of melflufen and dexamethasone showed antitumor activity in patients with relapsed or refractory multiple myeloma, both in those with and those without extramedullary disease, according to data from the phase II HORIZON study presented&nbsp;at the 17th International Myeloma Workshop.

The GRIFFIN study showed that the addition of daratumumab to bortezomib, lenalidomide, and dexamethasone, improved stringent complete response in transplant-eligible patients with newly diagnosed multiple myeloma without affecting stem cell mobilization or hematopoietic reconstitution, according to results presented at the 17th International Myeloma Workshop.

Novel agent iberdomide in combination with&nbsp;dexamethasone was safe and demonstrated antitumor activity in patients with relapsed/refractory multiple myeloma who were heavily pretreated, according to findings from a phase Ib/IIa trial presented at&nbsp;the 17th International Myeloma Workshop.

In an interview with&nbsp;<em>Targeted Oncology</em>&nbsp;during the 17th IMW Scientific Program, Simon J. Harrison, MBBS, PhD, discussed the subgroup findings from the ICARIA-MM study in relapsed/refractory multiple myeloma.

Paul G. Richardson, MD, clinical program leader and director of clinical research of the Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute and RJ Corman Professor of Medicine, Harvard School of Medicine, discusses the interesting safety and efficacy profiles of the HORIZON trial.

The addition of isatuximab to&nbsp;carfilzomib, lenalidomide, and dexamethasone led to a response rate in all 10 patients included in a safety run-in cohort&nbsp;of the phase II, multicenter GMMG-CONCEPT trial.

Daratumumab in combination with&nbsp;bortezomib, thalidomide, and dexamethasone demonstrated benefit compared with VTd alone in subgroup analyses of patients with high-risk multiple myeloma from the&nbsp;phase III CASSIOPEIA trial.

Sagar Lonial, MD, discusses how phase III trials should be designed in the United States for patients with multiple myeloma in the early-relapse setting.

During a&nbsp;Targeted Oncology&nbsp;case-based peer perspectives presentation, Ajai Chari, MD, discussed with a group of physicians the treatment options available to patients with relapsed multiple myeloma. Chari explained the various treatment options and the supporting data based around a case scenario of a patient with multiple myeloma who relapses.

Belantamab mafodotin, an investigational antibody&ndash;drug conjugate, demonstrated a clinically meaningful overall response rate among patients with relapsed multiple myeloma in early results from the DREAMM-2 trial, according to a press release from GlaxoSmithKline. This met the primary endpoint of the pivotal phase II trial.

Selinexor plus dexamethasone induced objective responses and a significant overall survival among heavily pretreated patients with multiple myeloma, according to results from the phase IIb STORM trial published in&nbsp;<em>The New England Journal of Medicine.</em>

The addition of novel agents and combinations to the treatment of multiple myeloma, along with improvements in personalized therapy based on genetic profiles of individual patients, are propelling care forward with their potential for prolonging survival and deepening responses beyond those from the current standards of care.<br /> &nbsp;

In an interview with <em>Targeted Oncology&nbsp;</em>following a presentation at the Charlotte Plasma Cell Disorder Congress, Cesar Rodriguez Valdes, MD explained how small molecules fit into the myeloma treatment and notes the ongoing research that shows promise for the next class of small molecules in the future.<br /> &nbsp;

Peter Voorhees, MD, discusses the latest data for the use of pomalidomide-containing regimens for the treatment of patients with relapsed/refractory multiple myeloma. He highlights data from 2 randomized clinical trials that demonstrated an improvement in responses with pomalidomide-based triplets.

In an interview with <em>Targeted Oncology</em>, Noopur Raje, MD, director, Center for Multiple Myeloma, Massachusetts General Hospital, talked through the current options for the treatment of patients with relapsed/refractory multiple myeloma and the clinical trial data that will shape the future of the field.

A Biologics License Application was submitted to the FDA seeking approval for a new subcutaneous formulation of daratumumab in select patients with multiple myeloma.

Phillipe Moreau, MD, discusses the results from the randomized, open-label, multicenter phase III CASSIOPEIA trial. The results of the trial led to&nbsp;a priority review designation from the FDA for the combination of daratumumab plus bortezomib, thalidomide, and dexamethasone for patients with treatment-na&iuml;ve multiple myeloma who are candidates for autologous stem cell transplant.

The FDA has accepted and is reviewing a Biologics License Application (BLA) for isatuximab as a potential treatment for patients with relapsed or refractory multiple myeloma. A target action date of April 30, 2020 has been set by the agency.¹<br /> &nbsp;

The 4-drug regimen of daratumumab in combination with bortezomib, lenalidomide, and dexamethasone induced a high percentage of stringent complete responses compared with VRd alone in patients with newly diagnosed multiple myeloma who are eligible for high-dose chemotherapy and an autologous stem cell transplantation, according to topline results of the GRIFFIN trial. This met the primary endpoint of the phase II trial.