MULTIPLE MYELOMA

Chimeric antigen receptor T-cell therapy with bb2121 demonstrated an objective response rate of 94% in patients with&nbsp;relapsed/refractory multiple myeloma, according to findings from a dose-escalation study. The senior study author, James N. Kochenderfer, MD, presented updated findings from the study during the 2017 ASH Annual Meeting, and commented that 89% of patients had a very good partial response or better, and 56% of patients had a complete remission.&nbsp;<br /> &nbsp;

Jesus Berdeja, MD, Director of Multiple Myeloma Research, Sarah Cannon Research Institute, discusses results of a study that explored bb2121, an anti-BCMA CAR T cell therapy, in heavily pretreated patients with relapsed/refractory multiple myeloma during the 2017 ASH Annual Meeting.

Ajai Chari, MD, associate professor, Mount Sinai Hospital, discusses some of the recent clinical trial evidence for early relapsed multiple myeloma and how it can be put into practice.

The partial clinical holds placed on the&nbsp;phase I CheckMate-039 and phase II CA204142 trials in October were lifted today by the FDA. Both trials were exploring&nbsp;nivolumab-based regimens in patients with relapsed/refractory multiple myeloma.

Dan T. Vogl, MD,&nbsp;discusses some of the novel agents being investigated alone and in combination in multiple myeloma. He also highlighted the potential with CAR T-cell therapy in the multiple myeloma paradigm.

Daratumumab (Darzalex) has been submitted for FDA approval for&nbsp;use in combination with bortezomib (Velcade), melphalan and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT).

Three members will lead the American Society of Hematology (ASH) Executive Committee with terms beginning after the 2017 ASH Annual Meeting, which will be held December 9 to 12 in Atlanta, Georgia: Stephanie Lee, MD; Agnes Lee, MD; and Joseph Mikhael, MD.

The anti&ndash;B-cell maturation antigen chimeric antigen receptor T-cell therapy&nbsp;bb2121 has been granted a breakthrough therapy designation by the FDA for previously treated patients with relapsed/refractory multiple myeloma.

Natalie S. Callander, MD, Professor of Medicine, University of Wisconsin Carbone Cancer Center, discusses updates in the treatment of relapsed/refractory multiple myeloma.

Adam Waxman, MD,&nbsp;discusses emerging regimens for patients with multiple myeloma.<br /> &nbsp;

Progression-free survival was extended by 3.6 months with higher-dose, once-weekly carfilzomib (Kyprolis) compared with a lower-dose, twice-weekly regimen in patients with relapsed/refractory multiple myeloma, according to&nbsp;according to phase III results from the ARROW trial.

Understanding genetic abnormalities is key to better improving outcomes in multiple myeloma, particularly for high-risk patients, Shaji K. Kumar, MD, said in his talk at the&nbsp;35th annual CFS.

Vancheswaran Gopalakrishnan, MPH, a post-doctorate fellow in Dr. Jennifer Wargo&#39;s laboratory at The University of Texas MD Anderson Cancer Center, discusses a study that explored the diversity and composition of the gut microbiome in melanoma patients and its influence on response to anti-PD-1 therapy&nbsp;during The Society for Immunotherapy of Cancer (SITC) 32nd&nbsp;Annual Meeting. Dr.&nbsp;Gopalakrishnan completed this study under the mentorship of Dr. Wargo, who was the principal investigator.&nbsp;

The B-cell maturation antigen antibody-drug conjugate&nbsp;GSK2857916 has been granted a breakthrough therapy designation by the FDA for the treatment of patients with relapsed/refractory multiple myeloma,&nbsp;GlaxoSmithKline has announced.

Shaji K. Kumar, MD, professor of medicine, Mayo Clinic, discusses the management of newly diagnosed patients with multiple myeloma.

The treatment approach for patients with relapsed/refractory multiple myeloma should be tailored based on biology of the disease, frailty of the patient, and comorbidities, said Natalie S. Callander, MD, in a presentation at the NCCN 12th Annual Congress: Hematologic Malignancies in San Francisco, California.

According to phase II results from the DSMM XI trial published in the <em>British Journal of Haematology</em>, induction therapy with bortezomib (Velcade), cyclophosphamide, and dexamethasone demonstrated an overall response rate of 85.4%&nbsp;in treatment-na&iuml;ve patients with multiple myeloma.

In patients with newly diagnosed multiple myeloma, maintenance therapy with lenalidomide (Revlimid)&nbsp;induced a survival benefit following autologous stem-cell transplantation, according to results from a meta-analysis published in the <em>Journal of Clinical Oncology</em>.

Robert Z. Orlowski, MD, PhD, recently discussed 2 cases of patients with multiple myeloma, and the treatment considerations and decisions he would make when treating these patients. Orlowski, chairman, ad interim, director of myeloma, and professor of medicine, The University of Texas MD Anderson Cancer Center, discussed these cases during a&nbsp;<em>Targeted Oncology</em>&nbsp;live case-based peer perspectives dinner.

A look back at all the FDA news that occurred in the month of September.

Robert Orlowski, MD, PhD,&nbsp;Florence Maude Thomas Cancer Research&nbsp;professor and chair, ad interim,&nbsp;Department of Lymphoma &amp; Myeloma&nbsp;at&nbsp;The University of Texas MD Anderson Cancer Center, discusses remaining questions with multiple myeloma treatment.

Sundar Jagannath, MDDS, professor, Medicine, Hematology, and Medical Oncology, Mount Sinai Hospital, discusses the STORM and&nbsp;STOMP clinical trials &nbsp;in patients with multiple myeloma.

Multiple trials in Celgene&rsquo;s FUSION program, which is exploring regimens combining the PD-L1 inhibitor durvalumab (Imfinzi) with immunomodulatory and chemotherapy agents across several hematologic malignancies,&nbsp;have been placed on clinical holds by the FDA.

Partial clinical holds have been placed on 3 trials by the FDA, which are assessing nivolumab (Opdivo)-based combinations in patients with relapsed/refractory multiple myeloma.

A look back at all the FDA news that occurred in the month of August.