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Showing 5451 - 5500FDA Pipeline: Priority Review in Lung Cancer, Breakthrough Therapy Designation in Head and Neck Cancer, and More
This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to brigatinib for the treatment of ALK-positive lung cancer and Breakthrough Therapy designation to a potential first-in-class oral antagonist of inhibitors of apoptosis proteins for the treatment of head and neck...
2020 Head and Neck Cancers Symposium: Adjuvant Everolimus for Advanced Head and Neck Cancer
The mTOR inhibitor everolimus may extend progression-free survival for patients with advanced head and neck cancer who are at high risk for recurrence after standard treatment. Patients enrolled in a randomized phase II trial who received the agent were more likely to be cancer-free 1 year after...
Abbreviated Breast MRI vs Digital Breast Tomosynthesis Screening in Women With Dense Breasts
As reported in JAMA by Christiane K. Kuhl, MD, PhD, and colleagues, the ECOG-ACRIN EA1141 trial has shown that abbreviated breast magnetic resonance imaging (MRI) was associated with a significantly higher invasive breast cancer detection rate vs digital breast tomosynthesis among women with dense...
2020 Head and Neck Cancers Symposium: Nivolumab With or Without Ipilimumab for the Neoadjuvant Treatment of Patients With Oral Cavity Cancer
Results from a new clinical trial suggest that neoadjuvant immunotherapy for oral cavity cancers may elicit tumor regression, which could provide long-term benefit for patients. Findings were presented by Jonathan D. Schoenfeld, MD, MPH, of Dana-Farber/Brigham and Women's Cancer Center, and...
2020 Head and Neck Cancers Symposium: Pembrolizumab Plus Radiotherapy for Platinum-Ineligible Patients With Locally Advanced HNSCC
A new phase II trial has found that the combination of radiation therapy and pembrolizumab led to improved survival outcomes and acceptable toxicity for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). The combination therapy may offer a new treatment option for...
FDA Approves Neratinib/Capecitabine for Pretreated Patients With Metastatic HER2-Positive Breast Cancer
On February 25, the U.S. Food and Drug Administration (FDA) approved neratinib (Nerlynx), a tyrosine kinase inhibitor, in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2–based regimens in the...
Physical Activity and Quality of Life in African American Cancer Survivors
New research suggests that regular exercise may improve the well-being of African American cancer survivors, but most survivors do not meet current recommendations for physical activity. The findings were published by Jennifer Beebe-Dimmer, MPH, PhD, and colleagues in the journal Cancer. Because...
Preliminary Study Finds ASCO Decision Aid May Improve Quality of Serious Adverse Events Reporting
Sponsors of clinical trials conducted under investigational new drug applications are required by the U.S. Food and Drug Administration (FDA) to report serious adverse events that are unexpected and suspected to be related to the drug. However, contrary to FDA guidance, investigators often send...
The EHE Foundation Receives $450,000 Award From the Chan Zuckerberg Initiative
The EHE Foundation announced it will receive a $450,000 award from the Chan Zuckerberg Initiative (CZI) to drive progress toward treatments and a cure for epithelioid hemangioendothelioma (EHE), a rare vascular cancer diagnosed in about 20 individuals per year. The award recognizes The EHE...
Dana-Farber Cancer Institute to Establish Riney Family Multiple Myeloma Initiative
Dana-Farber Cancer Institute will establish the Riney Family Multiple Myeloma Initiative to help improve outcomes and accelerate understanding of the underlying biology for the most challenging types of myeloma. The initiative is being established with a $16.5 million gift from Paula and Rodger...
Eileen Smith, MD, Named Chair, Department of Hematology & Hematopoietic Cell Transplantation at City of Hope
Eileen Smith, MD, Medical Director of City of Hope’s Alpha Stem Cell Clinic, Associate Director of the Clinical Research Program, Clinical Professor in the Department of Hematology & Hematopoietic Cell Transplantation, has been appointed the new Chair of the Department of Hematology &...
Update on Project Facilitate at the Oncology Center of Excellence
OCE Insights is an occasional department developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Mitchell Chan, PharmD, BCPS, Regulatory Project Manager; Tamy Kim, PharmD, Associate Director of Regulatory ...
Prevent Cancer Foundation Awards $1.1 Million in Cancer Research and Global Grants
The Prevent Cancer Foundation® has announced the funding of eight new United States–based researchers and four new cancer prevention and early detection projects in low- or middle-income countries. Research grants and fellowships awarded this year will increase cancer prevention and early detection ...
Immunogenomic Profiling of Osteosarcoma
Comprehensive profiling of tumor samples taken from patients with osteosarcoma showed that multiple factors contribute to the traditionally poor responses observed with immune checkpoint inhibitor treatment in patients with this malignancy, according to new research published by Wu et al in Nature...
PSA-Stratified Screening for Prostate Cancer
Previous studies have shown that men with low prostate-specific antigen (PSA) levels (< 1.0 ng/mL) between ages 44 to 60 have a very low risk of developing prostate cancer in the future. A study published by Heijnsdijk et al in JNCI: Journal of the National Cancer Institute investigated benefits ...
Drug Repository Programs Address High Costs, Access, and Waste Issues When Appropriately Implemented
On February 19, 2020, ASCO issued a news release about a position statement on state drug repository programs, outlining the Society’s support for drug repository programs solely for oral medications provided they are maintained within a closed system. The Society also makes recommendations to help ...
FDA Pipeline: Priority Reviews in Lung Cancers, Lymphoma
This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for non–small cell and small cell lung cancers, as well as for diffuse large-B cell lymphoma (DLBCL); Breakthrough Therapy designation to an antibody-drug conjugate for bladder cancer; and a double Fast...
New Center for Indigenous Cancer Research at Roswell Park Has Regional Focus, Global Reach
Growing up on the Seneca Nation in Western New York, Rodney Haring, PhD, MSW, learned the concept of “The Good Mind,” largely from the matrilineal voices in his community. He calls this philosophy, which is one of the shaping principles of the Haudenosaunee people, “a strength from awareness of...
Quality of Life With Tisagenlecleucel Therapy for Relapsed or Refractory DLBCL
Adult patients with diffuse large B-cell lymphoma (DLBCL) whose disease was effectively treated with the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel showed sustained and clinically meaningful improvement in a variety of self-reported quality-of-life measures, according to...
Nicholas D. James, PhD, MBBS, on Adding Abiraterone to Hormone Therapy in Prostate Cancer: STAMPEDE Trial on Cost-Effectiveness
Nicholas D. James, PhD, MBBS, of The Institute of Cancer Research in London, discusses the health economics of adding abiraterone to first-line, long-term hormone therapy in prostate cancer, and what it means for long-term survival, quality-adjusted survival, and cost-effectiveness (Abstract 204).
Highlights From ASH 2019 Included New Data in Leukemia, Lymphoma, and Multiple Myeloma
The ASH 2019 Annual Meeting & Exposition featured countless important sessions and lectures. It would be impossible to attend all the symposia, oral presentations, poster presentations, and special events. Below, we have selected some presentation highlights to supplement our coverage of the...
Expert Point of View: Javier Pinilla-Ibarz, MD, PhD
Javier Pinilla-Ibarz, MD, PhD, Moffitt Cancer Center, Tampa, Florida, commented on this study: “ELEVATE TN compared front-line treatment with acalabrutinib alone or in combination with obinutuzumab vs obinutuzumab/chlorambucil and showed that a second-generation Bruton’s tyrosine kinase (BTK)...
Pivotal Trial Evaluates Second-Generation BTK Inhibitor Alone and in Combination With Obinutuzumab for First-Line Treatment of CLL
The second-generation Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib, alone, or in combination with obinutuzumab significantly improved progression-free survival compared with a standard combination of obinutuzumab/chlorambucil in treatment-naive patients with chronic lympocytic leukemia...
Bruton’s Tyrosine Kinase Inhibitor Yields High Overall Response Rates in del(17p) CLL and SLL
In findings of the SEQUOIA trial and updated results of the AU-003 trial,1,2 zanubrutinib, a Bruton’s tyrosine inhibitor (BTK), was shown to produce high overall response rates for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), even in the presence of...
Expert Point of View: Thierry Facon, MD, and Michael Jain, MD, PhD
Thierry Facon, MD, of Lille University Hospital in France, and Michael Jain, MD, PhD, of Moffitt Cancer Center, Tampa, were interviewed by The ASCO Post on the second-generation chimeric antigen receptor (CAR) T-cell products for treating multiple myeloma. According to Dr. Facon, essentially...
Next-Generation BCMA-Targeted CAR T-Cell Therapies for Relapsed or Refractory Multiple Myeloma Explored in Early-Phase Trials
Two novel dual-target chimeric antigen receptor (CAR) T-cell strategies are yielding early and durable responses for patients with relapsed or refractory multiple myeloma, as well as potentially less cytokine-release syndrome and neurotoxicity compared with first-generation CAR T-cell products,...
Combination Brentuximab Vedotin, Nivolumab Explored in First-Line, Salvage Therapies for Patients With Hodgkin Lymphoma
Two separate studies are investigating brentuximab vedotin plus nivolumab combination therapy for adults with Hodgkin lymphoma: one as first-line therapy and another as salvage therapy for relapsed/refractory classic disease, according to data presented at the 2019 Annual Meeting & Exposition...
Early Data Suggest Efficacy of Innovative CAR NK-Cell Therapy for B-Cell Malignancies
FT596, a novel off-the-shelf chimeric antigen receptor natural killer cell (CAR-NK) product, was as effective as existing CAR T-cell platforms in killing cancer cells in vivo, and the combination of FT596 plus rituximab killed lymphoma cancer cells that were no longer responding to CAR T-cell...
Bispecific Antibody Shows Activity in Post–CAR T-Cell Therapy for Non-Hodgkin Lymphoma
Mosunetuzumab, an investigational bispecific antibody, demonstrated activity in preliminary studies of patients with non-Hodgkin lymphoma (NHL), including those who are refractory to or relapsed after third-line chimeric antigen receptor (CAR) T-cell therapy. With further study, mosunetuzumab,...
Expert Point of View: Howard J. Weinstein, MD, and Robert A. Brodsky, MD
Commenting on the Children’s Oncology Group AALL1331 study, Howard J. Weinstein, MD, Chief of Pediatric HematologyOncology at Massachusetts General Hospital for Children and Harvard Medical School in Boston, said: “These are very promising results for children, adolescents, and young adults who...
Blinatumomab Post-reinduction Consolidation Improves Event-Free, Overall Survival vs Chemotherapy in Young Patients With B-Cell ALL
Among children, adolescents, and young adults with B-cell acute lymphoblastic leukemia (ALL), the bispecific T-cell engager blinatumomab improved event-free survival and overall survival, compared with standard chemotherapy, as post-reinduction consolidation therapy at first relapse prior to...
Expert Point of View: Basem M. William, MD, MRCP (UK), FACP, and Caron Jacobson, MD
Basem M. William, MD, MRCP (UK), FACP, Director of the T-Cell Lymphoma Program and Member of the Blood and Marrow Transplant Program at The Ohio State University Comprehensive Cancer Center, Columbus, said many of the new-generation bispecific antibodies are “highly promising.” He said they “are...
Will Bispecific Antibodies Compete With CAR T-Cell Therapy in Lymphoma?
Are second-generation bispecific antibodies the next big thing in lymphoma? Studies of these drugs were among the highlights of the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition. Years ago, the bispecific T-cell engager blinatumomab validated the concept of bispecific...
Ziad Bakouny, MD, on Sarcomatoid and Rhabdoid RCC: Potential Determinants of Poor Prognosis and Treatment Response
Ziad Bakouny, MD, of Dana-Farber Cancer Institute, discusses two types of renal cell cancer that are associated with poor prognosis. Because recent early data suggest these tumors respond well to immune checkpoint inhibitors, the authors characterized the tumors in an integrative molecular and...
Toni K. Choueiri, MD, on COSMIC-313: Cabozantinib in Combination With Nivolumab/Ipilimumab in RCC
Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, describes a currently recruiting phase III study (COSMIC-313) of cabozantinib in combination with nivolumab and ipilimumab vs nivolumab/ipilimumab for patients with previously untreated advanced renal cell carcinoma of intermediate or poor risk ...
Hannah L. Rush, MBChB, on Prostate Cancer: Comparing Quality of Life in Patients Receiving Docetaxel or Abiraterone
Hannah L. Rush, MBChB, of the Clinical Trials Unit at University College London, discusses an analysis of the STAMPEDE trial, which showed that patients treated with abiraterone had higher scores in global quality of life as well as in the physical, social, and role function domains and lower...
Nizar M. Tannir, MD, on Nivolumab/Ipilimumab vs Sunitinib in Advanced Kidney Cancer
Nizar M. Tannir, MD, of The University of Texas MD Anderson Cancer Center, discusses overall survival and an independent review of response in CheckMate 214 with 42-month follow-up, using first-line nivolumab plus ipilimumab vs sunitinib in patients with advanced renal cell carcinoma (Abstract 609).
Thomas Powles, MD, PhD, on Adding Radiation to Immunotherapy for RCC: Improving Systemic Control Through Local Therapy
Thomas Powles, MD, PhD, of Queen Mary University of London, summarizes two papers on metastatic renal cell carcinoma for which he was the discussant: nivolumab in combination with stereotactic body radiotherapy in pretreated patients, and combining dual immune checkpoint inhibition with...
Karim Fizazi, MD, PhD, on Prostate Cancer: Pain and Quality of Life in Patients Receiving Cabazitaxel vs Abiraterone or Enzalutamide
Karim Fizazi, MD, PhD, of the Institut Gustave Roussy, discusses results from the CARD study, which showed that cabazitaxel improved pain, time to pain progression, and symptomatic skeletal events, as well as quality of life in patients with metastatic castration-resistant prostate cancer. The...
Nicholas D. James, PhD, MBBS, on Bladder Cancer: Cetuximab With Chemoradiotherapy
Nicholas D. James, PhD, MBBS, of The Institute of Cancer Research in London, discusses results from a phase I/II feasibility study that showed the combination of cetuximab, chemoradiation, fluorouracil, and mitomycin yields high bladder cancer control rates with acceptable toxicity and quality of...
Maha Hussain, MD, on Next-Generation Sequencing of Prostate Tumor Tissue: Results From the PROfound Study
Maha Hussain, MD, of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, discusses the first phase III clinical trial to demonstrate the feasibility of tissue-based genomic testing to preselect men with metastatic castration-resistant prostate cancer for targeted treatment...
Neeraj Agarwal, MD, on Castration-Resistant Prostate Cancer: Results From the COSMIC-021 Study of Cabozantinib and Atezolizumab
Neeraj Agarwal, MD, of the University of Utah Huntsman Cancer Institute, discusses trial findings that showed the combination of cabozantinib and atezolizumab had a tolerable safety profile and showed activity in men with metastatic disease. Further evaluation of cabozantinib and atezolizumab is...
Toni K. Choueiri, MD, on an HIF2A Inhibitor for Advanced Clear Cell RCC
Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, discusses findings from a phase I/II trial that found MK-6482 was well tolerated and demonstrated activity in heavily pretreated patients with clear cell renal cell carcinoma (Abstract 611).
David P. Dearnaley, MD, on Prostate Cancer: Conventional vs Hypofractionated High-Dose Radiotherapy
David P. Dearnaley, MD, of The Institute of Cancer Research and Royal Marsden NHS Foundation Trust, discusses 8-year outcomes of the phase III CHHiP trial, which showed that modest hypofractionation is noninferior to conventional fractionation in localized prostate cancer, with no increase in side...
Ziad Bakouny, MD, on Metastatic Kidney Cancer: Defining the Role of Cytoreductive Nephrectomy
Ziad Bakouny, MD, of Dana-Farber Cancer Institute, discusses the controversial and ill-defined role of cytoreductive nephrectomy in treating patients with metastatic renal cell carcinoma who have received targeted therapies or immune checkpoint inhibitors (Abstract 608).
Julie N. Graff, MD, on Castration-Resistant Prostate Cancer: Results From KEYNOTE-199 on Pembrolizumab Plus Enzalutamide
Julie N. Graff, MD, of Oregon Health & Science University and Knight Cancer Institute, discusses study findings that show pembrolizumab plus enzalutamide after progression on enzalutamide produced clinical activity and can lead to durable responses, with a manageable safety profile. The phase...
Diagnostic and Treatment Technology Disparities Among Patients With Colorectal Cancer
In a study published by Frankenfeld et al in Cancer Epidemiology, researchers found racial disparities in how the presence of cancer-related diagnostic and treatment technology is related to colorectal cancer patient outcomes in Georgia. The findings suggest that the hospital capacity and...
Proteomic Analysis of Endometrial Cancer
A comprehensive molecular study of endometrial cancer published by Dou et al in Cell has further defined the contributions of key genes and proteins to the disease. The overview suggests new treatment approaches that could be tailored for each patient, as well as potential biologic targets for...
Syed A. Hussain, MD, on Muscle-Invasive Bladder Cancer: NEO-BLADE Trial of Nintedanib Plus Chemotherapy
Syed A. Hussain, MD, of the University of Sheffield, discusses phase II findings comparing nintedanib or placebo in combination with gemcitabine and cisplatin in locally advanced muscle-invasive bladder cancer. The data showed that adding nintedanib was safe and well tolerated, with a significant...
Jonathan E. Rosenberg, MD, on Locally Advanced or Metastatic Urothelial Carcinoma: Enfortumab Vedotin Plus Pembrolizumab
Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discusses study results which showed that, in first-line cisplatin-ineligible patients with metastatic urothelial carcinoma, enfortumab vedotin/pembrolizumab demonstrated activity and durability, with a manageable safety profile...
