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Showing 3351 - 3400Updated Follow-up of ZUMA-1 Confirms Benefit of CAR T-Cell Therapy in Aggressive B-Cell Lymphoma
POSITIVE DATA about chimeric antigen receptor (CAR) T-cell therapy in lymphoma continue to accrue. Long-term follow-up of the pivotal ZUMA-1 trial shows that patients with refractory diffuse large B-cell lymphoma (DLBCL) continue to have durable responses to the CD19-directed CAR T-cell therapy...
ICER Releases Draft Evidence Report on CAR T-Cell Therapy for B-Cell Cancers
On December 19, the Institute for Clinical and Economic Review (ICER) released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta). The draft report, along with draft voting...
FDA Accepts sNDA for Osimertinib in First-Line Treatment of EGFR-Mutated NSCLC
On December 18, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for the use of osimertinib (Tagrisso)—a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central...
Phase I Study Finds ERK1/2 Inhibitor Safe and Active in Advanced Solid Tumors
Ulixertinib (BVD-523) is an ERK1/2 kinase inhibitor with potent preclinical activity in BRAF- and RAS-mutant cell lines. Now, a multicenter phase I study investigating its safety and efficacy in the treatment of patients with advanced solid tumors has found that ulixertinib to have an acceptable...
ASH 2017: Acalabrutinib Demonstrates Activity in Relapsed or Refractory Mantle Cell Lymphoma
At the 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Wang et al presented results from the open-label, single-arm phase II ACE-LY-004 clinical trial, which served as the basis for the recent U.S. Food and Drug Administration (FDA) accelerated approval of acalabrutinib...
Study Suggests Racial Differences in Lung Tumor Biology
According to research by the American Cancer Society, lung cancer is the second most common cancer in men and women in the United States and is the leading cause of cancer-related death. In addition, among all populations, African Americans tend to have the highest lung cancer incidence and...
Andrew D. Zelenetz, MD, PhD, and Sattva S. Neelapu, MD, on NHL: Results From the ZUMA-1 Trial
Andrew D. Zelenetz, MD, PhD, of Memorial Sloan Kettering Cancer Center, and Sattva S. Neelapu, MD, of The University of Texas MD Anderson Cancer Center, discuss long-term study findings on axicabtagene ciloleucel in patients with refractory aggressive non-Hodgkin lymphoma (Abstract 578).
ASH 2017: JULIET Trial: 6-Month Analysis of Tisagenlecleucel in Relapsed/Refractory DLBCL Shows Sustained Responses
Six months after receiving a single dose of tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy that targets CD-19, high response rates persist among adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), according to findings reported by Schuster et al at...
ASH 2017: ZUMA-1: Responses to CAR T-Cell Therapy Still Strong After 1 Year in Patients With Refractory NHL
Among 108 patients with fast-growing and refractory aggressive non-Hodgkin lymphoma (NHL), more than half were still alive at least a year after receiving a single infusion of a CAR T-cell therapy called axicabtagene ciloleucel that targets the CD-19 protein frequently found on cancerous lymphoma...
Watch for More From ASH 2017
Phase III ASPIRE Trial of Carfilzomib in Relapsed Multiple Myeloma Overall survival results from the phase III ASPIRE trial will be detailed for the first time in an oral presentation by Stewart et al on Monday, December 11. The addition of carfilzomib to lenalidomide and...
FDA Announces Approval, CMS Proposes Coverage of Diagnostic Test for Cancer Biomarkers
On November 30, the U.S. Food and Drug Administration (FDA) approved CDx (F1CDx), a breakthrough-designated, next-generation sequencing–based in vitro diagnostic test that can detect genetic mutations in 324 genes and 2 genomic signatures in any solid tumor type. The Centers for Medicare &...
Partial-Breast and Reduced-Dose Radiotherapy After Breast-Conserving Surgery
The UK IMPORT LOW phase III trial has shown noninferiority in local relapse for partial-breast and reduced-dose vs standard whole-breast radiotherapy after breast-conserving surgery in early breast cancer. These study results were reported by Charlotte E. Coles, PhD, of the University of...
Living a Full Life With Stage IV Non–Small Cell Lung Cancer
The discovery of my non–small cell lung cancer (NCSLC) in 2005 was serendipitous and completely unexpected. A never smoker and physically active my whole life, the only hint something might be amiss was a slight tickle in my throat, which I’m not even sure was related to my cancer diagnosis. In...
Future Directions for CAR T-Cell Therapy
Chimeric antigen receptor (CAR) T-cell therapy burst upon the scene as an innovative approach to the treatment of hematologic malignancies, mainly for patients who have exhausted all other treatment options. Recently two CAR T-cell products were approved by the U.S. Food and Drug Administration...
Olaparib Tablets for Maintenance Treatment in Ovarian Cancer
On August 17, 2017, olaparib -(Lynparza) in tablet form was granted regular approval for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.1,2 Olaparib...
Immunotherapy Has Indelibly Changed the Treatment Paradigm in Urothelial Carcinoma
Cisplatin-based combination chemotherapy is the preferred first-line therapy for metastatic urothelial cancer and the only treatment shown to improve survival in patients with previously untreated disease for many years. This chemotherapy also has proven to be beneficial in the neoadjuvant and...
Immunotherapy Plus Chemotherapy in Non–Small Cell Lung Cancer: Despite the Failure of Ipilimumab, Guarded Optimism Persists
Ipilimumab (Yervoy) is a fully human monoclonal antibody that inhibits cytotoxic T-lymphocyte–associated protein 4 (CTLA-4) and was the first checkpoint inhibitor approved after showing survival benefit in metastatic melanoma.1 Indeed, in the first-line setting for metastatic melanoma, ipilimumab ...
Follicular Lymphoma: Is the Road to Cure Paved With Gallium?
The roadside along the path to curing follicular lymphoma is riddled with the debris of failed cytotoxic regimens. For decades, clinical trials unsuccessfully pitted various chemotherapy combinations against each other. It took but a single, noncytotoxic molecule, rituximab (Rituxan), to forever...
Vemurafenib in Erdheim-Chester Disease
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 6, 2017, vemurafenib (Zelboraf) was granted...
Cancer and Obesity: Not Such a Linear Relationship
Obesity has been established as a strong risk factor for the development of cancer. African Americans and Hispanics are particularly at risk, and their access to health care is often poor. How do racial and ethnic disparities in the development of obesity as well as access to care intersect to...
Caring for the Frail, Older Patient With Cancer: Four Practical Approaches
Cancer may be a disease of aging, but data suggest that older patients with cancer are undertreated, especially with respect to chemotherapy. One analysis showed that approximately 40% of patients in their 70s—and 60% of patients in their 80s—do not receive adjuvant therapy after surgery for colon...
Expert Point of View: Michael Boyer, MBBS, PhD
Formal discussant of this trial, Michael Boyer, MBBS, PhD, a medical oncologist at Sydney Cancer Centre, Royal Prince Alfred Hospital, Camperdown, Australia, was enthusiastic about these results, with the caveat that overall survival data are needed. “Unresectable stage III non–small cell lung...
Durvalumab Therapy Improves Outcomes in Patients With Unresectable Stage III NSCLC
The PACIFIC study showed that the addition of the programmed cell death ligand 1 (PD-L1) inhibitor durvalumab (Imfinzi) following chemoradiotherapy for patients with unresectable stage III non–small cell lung cancer (NSCLC) dramatically improved progression-free survival compared with placebo....
CAR T-Cell Therapy Makes Further Inroads in Lymphoma and Myeloma
With the recent U.S. Food and Drug Administration (FDA) approvals of two chimeric antigen receptor (CAR) T-cell products, this novel approach seems to be moving into the mainstream. The approvals were tisagenlecleucel (also known as CTL019; Kymriah) for the treatment of pediatric B-cell acute...
Evidence-Based Support for Triplet Therapies in Multiple Myeloma
Over the past 15 years, multiple myeloma has garnered among the highest number of regulatory approvals by the U.S. Food and Drug Administration (FDA) for the management of all phases of the disease. This fast-expanding repertoire of treatment options has pushed the median survival of multiple...
SABCS 2017: Increasing the Dose Intensity of Chemotherapy May Lower the Risk of Breast Cancer Recurrence and Death
Increasing the dose intensity of chemotherapy—by either shortening the intervals between the cycles or by sequential administration instead of concurrent administration of the drugs—reduced the risk of early-stage breast cancer recurrence and death compared with standard chemotherapy...
Patients With HIV-Associated Lymphoma Can Safely Continue Antiretroviral Therapy During Chemotherapy
Patients with human immunodeficiency virus (HIV) who are treated with combination antiretroviral therapy (cART) can safely undergo chemotherapy to treat associated lymphomas at the same time, researchers from the AIDS Malignancy Consortium have found. These findings were published by Tan et al in...
Combination Therapy for Previously Untreated Stage IV NSCLC
As reported in The Lancet Oncology by Herbst et al, the phase III SWOG S0819 trial showed no overall benefit of adding cetuximab (Erbitux) to carboplatin/paclitaxel both with and without bevacizumab (Avastin) in patients with previously untreated stage IV non–small cell lung cancer (NSCLC). A ...
FDA Announces Approval, CMS Proposes Coverage of First Breakthrough-Designated Test to Detect Extensive Number of Cancer Biomarkers
On November 30, the U.S. Food and Drug Administration (FDA) approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next-generation sequencing–based in vitro diagnostic test that can detect genetic mutations in 324 genes and 2 genomic signatures in any solid tumor type. The ...
Urban American Indian and Alaskan Natives May Have Lower Survival Rates Following Invasive Prostate and Breast Cancers
Compared with the non-Hispanic white (NHW) population, the urban American Indian and Alaskan Native (AIAN) community was more likely to have lower survival rates following invasive prostate and breast cancer, according to a new study by Emerson et al in Cancer Research. “It’s been...
Comparison of EGFR Inhibitors in Untreated Advanced EGFR-Mutant NSCLC
As reported in The New England Journal of Medicine by Soria et al, the phase III FLAURA trial has shown a significant progression-free survival benefit with the third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) osimertinib (Tagrisso) vs standard EGFR TKIs in...
Adjuvant Chemotherapy With or Without Monoclonal Antibody in Resected NSCLC
The phase III E1505 trial has shown no benefit of adding bevacizumab (Avastin) to adjuvant therapy in early-stage resected non–small cell lung cancer (NSCLC). These results were reported by Wakelee et al in The Lancet Oncology. Study Details In the open-label trial, 1,501 patients from...
FDA Approvals in November 2017: Novel Drugs, New Indications
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) approved a number of novel drugs and new indications in November 2017. Several of them are listed here. Fulvestrant/Abemaciclib Combination in Breast Cancer ON NOVEMBER 15 , the FDA approved fulvestrant (Faslodex) in combination with abemaciclib...
Nivolumab in Hepatocellular Carcinoma Previously Treated With Sorafenib
ON SEPTEMBER 22, 2017, nivolumab (Opdivo) was granted accelerated approval for treatment of hepatocellular carcinoma in patients previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data APPROVAL WAS based on findings in a 154-patient subgroup of the CheckMate 040 trial consisting...
Recent Study Findings in Hematologic Malignancies
HERE IS A BRIEF LOOK at the study findings and clinical implications of several recent and important clinical trials in neoplastic hematology. Attention is focused on clonal myeloid disorders, acute lymphoblastic leukemia, lymphoma, and plasma cell dyscrasias. Clonal Myeloid Disorders STUDY:...
Health-Care Access Unlikely to Explain Racial/Ethnic Disparities in Breast Cancer Outcomes
Even with equivalent access to care, black patients with breast cancer may fare worse than white patients with breast cancer, according to Lawrence H. Kushi, ScD, Director of Scientific Policy at the Kaiser Permanente Northern California Division of Research in Oakland. “Accounting for...
Reports From JCO and JOP
Staying up-to-date with peer-reviewed oncology literature is a daunting task. To assist readers, The ASCO Post has summarized a number of studies recently published in the Journal of Oncology Practice (JOP) and the Journal of Clinical Oncology (JCO). Survival as Quality Metric in Cancer Care In a...
Genomic Profiling With Multidisciplinary Collaboration: Improving Breast Cancer Outcomes Through Timely Chemotherapy Initiation
As reviewed in this issue of The ASCO Post, Losk and colleagues from Dana-Farber/Brigham and Women’s Cancer Center report their institution’s implementation of a protocol of surgeon-initiated genomic profiling of estrogen receptor–positive tumors in women with early breast cancer that resulted in ...
Palliative Care Intervention Reduces Total Health-Care Costs in Patients With Advanced Cancer
A matched case-controlled study among Medicare beneficiaries with metastatic lung, colorectal, breast, and prostate cancers has found that palliative care consultation significantly reduced total health-care costs following intervention. According to data presented at the 2017 Palliative and...
Johns Hopkins Researcher Awarded $300,000 to Investigate Genetics of Lung Cancer
The Bonnie J. Addario Lung Cancer Foundation (ALCF) and the International Association for the Study of Lung Cancer (IASLC) announced they have awarded $300,000 in research funding to a Johns Hopkins University investigator studying the genetics of lung cancer. According to the organizations, Johns ...
Pembrolizumab in Advanced Gastric Cancer
On September 22, 2017, pembrolizumab (Keytruda) was granted accelerated approval for treatment of recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma with tumors expressing programmed cell death ligand 1 (PD-L1), as determined by a U.S. Food and Drug...
A Pioneer in Bloodless Transplant Discusses Advances in Blood Management
Bloodless stem cell transplantation, performed without the transfusion of allogeneic blood or blood products, has numerous clinical advantages, especially among populations of patients who prefer, for religious or other reasons, no blood methods of medical and surgical treatment. Patricia A. Ford, ...
FDA Approves CAR T-Cell Therapy for Adults With Certain Types of Large B-Cell Lymphoma
ON OCTOBER 18, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment....
Patient-Reported Outcomes With Immunotherapy vs Chemotherapy in Advanced NSCLC
Pembrolizumab (Keytruda) treatment was associated with improved or maintained health-related quality of life vs platinum-based chemotherapy in the phase III KEYNOTE-024 trial in advanced programmed cell death ligand 1 (PD-L1)–positive non–small cell lung cancer (NSCLC). These findings...
ESMO Asia 2017: FLAURA Trial: Osimertinib Improves Progression-Free Survival in Asian Patients With EGFR-Mutated NSCLC
Osimertinib (Tagrisso) improves progression-free survival compared to standard first-line therapy in Asian patients with EGFR-mutated non–small cell lung cancer (NSCLC), according to the Asian subset analysis of the FLAURA trial presented at the European Society for Medical Oncology (ESMO)...
Brigatinib in Crizotinib-Pretreated Metastatic ALK-Positive Non–Small Cell Lung Cancer
On April 28, 2017, brigatinib (Alunbrig) was granted accelerated approval for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who have had disease progression on or are intolerant to crizotinib (Xalkori).1,2 Supporting Efficacy...
Dabrafenib and Trametinib in BRAF V600E–Mutant Metastatic NSCLC
On June 22, 2017, regular approvals were granted to dabrafenib (Tafinlar) and trametinib (Mekinist) given in combination for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by a U.S. Food and Drug Administration (FDA)-approved...
Unraveling PD-L1 Assays in NSCLC: Are They Interchangeable?
With the availability of at least five checkpoint inhibitors to treat non–small cell lung cancer (NSCLC) and other solid tumors, appropriate patient selection for these expensive treatments remains key. The hope is that testing the level of programmed cell death ligand 1 (PD-L1) expression in tumor ...
Copanlisib in Relapsed Follicular Lymphoma
On September 14, 2017, copanlisib (Aliqopa) was granted accelerated approval for treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.1,2 Supporting Efficacy Data Approval was based on durable responses observed in a multicenter phase ...
Axicabtagene Ciloleucel for Large B-Cell Lymphoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 18, 2017, the chimeric antigen receptor (CAR)...
