MULTIPLE MYELOMA

A look back at all the FDA news in oncology from the month of January 2019, including several new approvals, breakthrough therapy designations, and a partial clinical hold.

FDA approval is being sought for the combination of daratumumab with lenalidomide and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem-cell transplant. Genmab, which co-develops daratumumab with Janssen Biotech, announced that a supplemental Biologics License Application has been initiated with the FDA.

In an interview with <em>Targeted Oncology</em>, Robert M. Rifkin, MD, highlighted the results of a trial evaluating the safety of split-dosing administration of daratumumab in patients with multiple myeloma.

Maria-Victoria Mateos, MD, PhD, discusses updated findings from the ALCYONE trial in patients with newly diagnosed multiple myeloma.&nbsp;

David M. Siegel, MD, PhD, discusses one of the biggest dilemmas to arise recently in the treatment of multiple myeloma.

Cristina Gasparetto, MD, discusses findings from an ongoing trial of&nbsp;selinexor, daratumumab, and dexamethasone in patients with multiple myeloma

C. Ola Landgren, MD, PhD,&nbsp;discusses the role of MRD negativity and the emergence of CAR T-cell therapy in multiple myeloma.

Several oncology experts discuss the FDA approvals they found most significant in 2018.

During a <em>Targeted Oncology </em>case-based peer perspectives program, Keith Stewart, MB, ChB, discussed his clinical considerations for the management of multiple myeloma, especially in light of new data from the 2018 ASH Annual Meeting that could be reaching the clinic soon.

In an interview with&nbsp;<em>Targeted Oncology&nbsp;</em>during the 2018 ASH Annual Meeting<em>,&nbsp;</em>Peter Voorhees, MD, discussed the safety and efficacy findings from the safety run-in cohort and the next steps for the Griffin study.

Peter Voorhees, MD, investigator, department of hematologic oncology &amp; blood disorders, Levine Cancer Institute/Atrium Health, discusses the rationale for adding daratumumab to triplet regimen bortezomib, lenalidomide, and dexamethasone in patients with multiple myeloma.

Although there were a variety of encouraging data presented at the 2018 ASH Annual Meeting, CLL and multiple myeloma undoubtedly ruled the day, according to poll results. As these topics heated up on Twitter, a few experts took a moment to discuss their thoughts on some of the top abstracts that were presented.

Ajai Chari, MD, discusses the biggest challenge in treating patients with multiple myeloma.

Each of the many BCMA-targeted CAR T cells in development demonstrate a different efficacy and safety profile, and each have different constructs. None of the agents have reached the FDA yet, but data for many of the agents were presented at the 2018 ASH Annual Meeting.

A look back at all the FDA news that happened in the month of November 2018, including several new approvals, priority reviews, a fast track designation, and an accelerated approval, across a variety of cancer types.

According to the phase III MAIA trial, triplet regimen&nbsp;daratumumab, lenalidomide, plus dexamethasone reduced risk of disease progression or death by 44%&nbsp;in newly diagnosed patients with multiple myeloma who were not candidates for high-dose chemotherapy and autologous stem-cell transplant, compared to patients who received&nbsp;lenalidomide plus dexamethasone.

An overall response rate of 26.2% was induced by selinexor, an oral XPO1 inhibitor,&nbsp;combination in heavily pretreated patients with penta-refractory multiple myeloma. According to the findings from part 2 of the pivotal STORM trial, selinexor is now the first investigational oral therapy to show activity in these patients.

Initial results from a phase I study showed an objective response rate of 83.3% had been achieved in&nbsp;heavily pretreated patients with relapsed/refractory multiple myeloma who had been treated with the anti-BCMA CAR T-cell therapy bb21217.

Maria-Victoria Mateos, MD, PhD, discusses the key takeaways from the phase III ALCYONE trial looking at bortezomib, melphalan, and prednisone in combination with daratumumab in patients with newly diagnosed multiple myeloma who are transplant ineligible.

According to findings from the phase III TOURMALINE-MM3, a 39% improvement in progression-free survival was demonstrated with 2-year maintenance therapy with ixazomib compared with placebo for patients with newly diagnosed multiple myeloma who had previously achieved a partial response with&nbsp;an induction therapy of a proteasome inhibitor and/or an immunomodulatory agent&nbsp;following autologous stem cell transplant.

Peter M. Voorhees, MD, investigator, department of hematologic oncology &amp; blood disorders, Levine Cancer Institute/Atrium Health, discusses efficacy and updated safety findings of a safety run-in cohort from the phase II Griffin trial, a randomized study of daratumumab, bortezomib, lenalidomide, and dexamethasone (Dara-Vrd) versus Vrd in patients with newly diagnosed multiple myeloma eligible for high-dose therapy and autologous stem cell transplantation, during the 2018 ASH Annual Meeting.

In a study of transplant-eligible patients with newly diagnosed multiple myeloma, daratumumab added to bortezomib, lenalidomide, and dexamethasone induced at least a very good partial response in all patients, including a complete response in 63% of patients, at the end of consolidation therapy.<br /> &nbsp;

During a&nbsp;<em>Targeted Oncology&nbsp;</em>case-based peer perspectives program, Sikander Ailawadhi, MD, reviewed with other physicians his clinical considerations for the management of multiple myeloma. Ailawadhi discussed his treatment options and other factors that go into his decision making with the group during the meeting based on a case scenario of a patient with high-risk, transplant-ineligible multiple myeloma.

During a <em>Targeted Oncology </em>live case-based peer perspective presentation, Ajai Chari, MD, spoke on the treatment options and considerations he makes when treating patients with relapsed/refractory multiple myeloma.

Ajai Chari, MD, discusses the rationale for using combination therapy in patients with multiple myeloma.&nbsp;