News

Chimeric antigen receptor T cells have hit the prime time, with 2 FDA approvals already for this class of cellbased therapy. Undoubtedly this will be a game changer for patients with B-cell malignancies who have a small number of treatment options; however, questions regarding the realworld application of CAR T-cell therapies remain.

The objective response rate with neoadjuvant nivolumab (Opdivo) plus ipilimumab (Yervoy) was almost tripled compared with nivolumab alone in patients with high-risk resectable melanoma, according to preliminary findings from a phase II study presented during the 32nd SITC Annual Meeting.

Alectinib (Alecensa) has received FDA approval for the frontline treatment of patients with ALK-positive metastatic non–small cell lung cancer, Genentech, the manufacturer of the second-generation ALK inhibitor, announced today.

Vemurafenib (Zelboraf) has been granted approval by the FDA&nbsp;as a treatment for patients with <em>BRAF</em> V600-mutated Erdheim-Chester disease (ECD). This is the first approved therapy for this rare blood disorder.

Brentuximab vedotin&nbsp;(Adcetris) has been submitted for FDA approval in combination with Adriamycin, vinblastine, dacarbazine for the frontline treatment of patients with&nbsp;advanced classical Hodgkin lymphoma.&nbsp;Seattle Genetics,&nbsp;the company developing brentuximab vedotin, recently announced the submission of a&nbsp;supplemental new drug application for the&nbsp;CD30-targeted antibody-drug conjugate.

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.

According to 10-year results from the TEAM study,

Although the addition of pazopanib (Votrient) to gemcitabine in the second-line treatment of&nbsp;patients with metastatic or relapsed uterine or soft tissue leiomyosarcomas demonstrated disease control in the majority of patients,&nbsp;statistical endpoints were not met in the&nbsp;phase II UNICANCER SARCOMA 11 study, according to results reported at the 2017 ESMO Congress.

Acalabrutinib (Calquence) received an accelerated approval from the FDA for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least 1 prior regimen.

In a presentation during the 2017 International Liver Cancer Association Annual Conference, Amit G. Singal, MD, discussed data surrounding the use of direct acting antivirals, a novel and completely oral hepatitis C therapy, which has been associated with a high response rate.

A supplemental biologics application for bevacizumab (Avastin) has been accepted by the FDA for the first-line treatment of advanced ovarian cancer, according to Genentech, the manufacturer of the&nbsp;angiogenesis inhibitor.

Intravenous rolapitant (Varubi) has received FDA approval for&nbsp;use in combination with other antiemetic agents to treat delayed chemotherapy-induced nausea and vomiting in adults, according to TESARO, the manufacturer of the agent.

Peter R. Dottino, MD, discusses&nbsp;the utilization of molecular methods to identify ovarian cancer following treatment with chemotherapy, and how this type of research impacts the field going forward.

Researchers in the Perelman School of Medicine at the University of Pennsylvania evaluated the genetic profiles of 160 breast and ovarian cancers associated with germline mutations in&nbsp;<em>BRCA1 </em>and <em>BRCA2&nbsp;</em>and determined that there is a relationship between the genetics of <em>BRCA 1/2 </em>mutations and the risk of resistance to platinum-based chemotherapy.&nbsp;

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.

Coordinating appointments between the physician office suite and infusion center improved dramatically with the use of a scheduling optimization tool at the Cowell Family Cancer Center in Traverse City, Michigan. Specifically, the investigators observed a 6% reduction in median office-visit time and a 43% reduction in patient wait time in the infusion chair before infusion began.

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>.

According to data from the phase II OMS-I102 trial presented at the 2017 World Congress of Melanoma, the&nbsp;immune stimulator ImmunoPulse IL-12 induced promising activity when added to pembrolizumab (Keytruda) in patients with melanoma who have been identified as unlikely responders to&nbsp;anti&ndash;PD-1 therapies.

According to data presented&nbsp;at the 2017 World Congress of Melanoma, the combination of&nbsp;nivolumab (Opdivo) and ipilimumab (Yervoy) induced a 3-year relapse-free survival rate of 71% in the adjuvant treatment of patients with high-risk resected stage IIIC/IV melanoma, but it was also associated with significant toxicity.&nbsp;

Medical oncologist Linda T. Vahdat, MD, MBA, has been appointed the new chief of medical oncology and clinical director of cancer services at Norwalk Hospital. The new position comes as a result of a new collaboration between Memorial Sloan Kettering Cancer Center and Norwalk Hospital in Norwalk, Connecticut.

The combination of&nbsp;dabrafenib and trametinib has been granted a breakthrough therapy designation by the FDA for the adjuvant treatment of patients with stage III melanoma with a <em>BRAF V600</em> mutation following complete resection.

Four researchers from the Dana-Farber Cancer Institute are joining the Parker Institute for Cancer Immunotherapy as a result of a collaboration between the 2 institutions: W. Nick Haining, BCh, BM; Catherine Wu, MD; Philip Kranzusch, PhD; and F. Stephen Hodi, Jr., MD.

A supplemental New Drug Application for olaparib (Lynparza) has been granted a priority review by the FDA for the&nbsp;treatment of patients with germline <em>BRCA</em>-positive, HER2-negative metastatic breast cancer who have previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic settings,&nbsp;AstraZeneca and Merck, the co-developers of the PARP inhibitor, recently announced.

The CD19-directed CAR T-cell therapy&nbsp;axicabtagene ciloleucel (axi-cel; Yescarta) has been approved by the FDA for the treatment of adults with relapsed or refractory non-Hodgkin lymphoma (NHL), based on complete remission (CR) rate results from the phase II ZUMA-1 trial.

Based on positive progression-free survival results from the PACIFIC trial, a supplemental biologics license application for durvalumab (Imfinzi) for the treatment of patients with stage III, unresectable non&ndash;small cell lung cancer has been granted a priority review by the FDA.

Abemaciclib (Verzenio) failed to meet its primary endpoint of improving overall survival versus erlotinib (Tarceva) in patients with&nbsp;<em>KRAS</em>-mutated, advanced non&ndash;small cell lung cancer who progressed after platinum-based chemotherapy, according to topline results from the phase III JUNIPER trial.

Osimertinib (Tagrisso) has been granted Breakthrough Therapy Designation by the FDA for the&nbsp;first-line treatment of patients with metastatic <em>EGFR </em>mutation-positive non-small cell lung cancer (NSCLC).

Based on data from the phase III MONARCH 3 trial, a new drug application for abemaciclib (Verzenio) has been granted a priority review by the FDA for&nbsp;use in combination with an aromatase inhibitor for the frontline treatment of women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.