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Showing 9351 - 9400Investigational in Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination
On April 16, 2018, the U.S. Food and Drug Administration (FDA) issued a draft guidance, “Investigational in Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination,” to describe for sponsors of certain oncology trials an optional streamlined...
AACR 2018: Short-Acting Calcium Channel Blockers Associated With Increased Risk of Pancreatic Cancer in Postmenopausal Women
Calcium channel blockers (CCBs)—specifically the short-acting form of CCBs, which are prescribed to treat high blood pressure—were associated with an increased risk of pancreatic cancer in postmenopausal women, according to a study presented at the American Assocation for Cancer...
AACR 2018: Dual Inhibition of IDO1 and PD-L1 Safe in Patients With Advanced Solid Tumors
Treatment combining the IDO1 inhibitor epacadostat and the programmed cell death ligand 1 (PD-L1) inhibitor durvalumab (Imfinzi) was found to be safe in patients with advanced solid tumors, with safety data similar to treatment with durvalumab alone, according to data presented from the ongoing...
AACR 2018: TLR9 Agonist CMP-001/Pembrolizumab Combination Shows Early Efficacy in Patients With Metastatic Melanoma Resistant to Anti–PD-1
A combination of CMP-001, an intratumoral Toll-like receptor 9 (TLR9) agonist, and pembrolizumab (Keytruda) was well tolerated and had clinical activity in patients with metastatic melanoma resistant to programmed cell death protein 1 (PD-1) checkpoint inhibition, according to preliminary data...
AACR 2018: Prototype Assays Suggest Highly Specific Blood Test to Screen for Cancer Is Feasible
Initial findings from the Circulating Cell-Free Genome Atlas (CCGA) study showed that prototype sequencing assays tested in this analysis may facilitate the development of a highly specific blood test for early cancer detection, according to data presented at the American Association for Cancer...
Enormous Cost of Failure to Screen Heavy Smokers for Lung Nodules
In 2011 the American College of Radiology Imaging Network (ACRIN) group published its publicly funded study of three annual screening chest computed tomography (CT) scans among heavy smokers aged 55 to 74.1 The results remain the first and only screening study for any cancer demonstrating a...
Promise and Challenges of CAR T-Cell Therapy for Diffuse Large B-Cell Lymphoma: ZUMA-1 Trial Results
Advancing therapeutics and augmenting curability in diffuse large B-cell lymphoma (DLBCL) have been very challenging. Although many novel approaches have offered promise and continue to be developed, we have not yet identified a clearly superior approach to R-CHOP (rituximab [Rituxan],...
FDA Approves Nivolumab/Ipilimumab Combination in Intermediate- or Poor-Risk Advanced RCC
On April 16, 2018, the U.S. Food and Drug Administration (FDA) granted approvals to nivolumab (Opdivo) and ipilimumab (Yervoy) in combination for the treatment of intermediate- or poor-risk previously untreated advanced renal cell carcinoma (RCC). CheckMate 214 The approvals were based on...
AACR 2018: Off-the-Shelf, Dual-Targeted CAR T-Cell Product Showed Promising Results in Preclinical Studies
FT819—an off-the-shelf, T-cell receptor–less CD19 chimeric antigen receptor (CAR) T-cell product that could potentially be made more accessible to patients with cancer than conventional CAR T-cell therapies—showed positive results in preclinical specificity, functionality, and...
AACR 2018: Selective Inhibitor Shows Early Promise in Patients With RET-Altered Cancers
BLU-667, a next-generation inhibitor that selectively targets the oncogenic receptor tyrosine kinase RET, was well tolerated and had broad clinical benefit in patients with advanced cancer that had progressed on previous therapies, including multikinase inhibitor therapy. Proof-of-concept data from ...
AACR 2018: Crizotinib Yielded a High Objective Response Rate for Adult Patients With ALK-Positive Inflammatory Myofibroblastic Tumor
Among patients with inoperable, advanced, or metastatic ALK-positive inflammatory myofibroblastic tumor, 50% were confirmed to have partial or complete tumor shrinkage after treatment with the ALK-targeted anticancer therapeutic agent crizotinib (Xalkori), according to data from the phase II EORTC...
AACR 2018: Children With Nonchromosomal Birth Defects May Face Higher Risk of Several Childhood Cancers
Children with nonchromosomal birth defects—such as congenital heart disease—had a significantly higher risk of developing childhood cancer than children who did not have birth defects, according to a study presented at the 2018 American Association for Cancer Research (AACR) Annual...
Wait for Diagnostic Testing and Effect on Outcomes in Patients With Cancer
The longer patients with a positive screening result wait for diagnostic testing, the worse their cancer outcomes may become, according to a literature review of breast, cervical, colorectal, and lung studies published by Doubeni et al in CA: A Cancer Journal for Clinicians led by researchers at...
Epacadostat Combined With Pembrolizumab in Patients With Unresectable or Metastatic Melanoma
On April 6, an external data monitoring committee commented on results from the phase III ECHO-301/KEYNOTE-252 trial of the investigational IDO1 inhibitor epacadostat plus pembrolizumab (Keytruda) in patients with unresectable or metastatic melanoma. The committee determined that the study did not...
FDA Accepts New Drug Application, Grants Priority Review for Duvelisib in CLL/SLL and Follicular Lymphoma
On April 9, the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review a new drug application (NDA) for the oral agent duvelisib, a first-in-class, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. The NDA is seeking full approval for duvelisib in...
Clinical Hold Lifted on U.S. Studies of BPX-501
On April 11, Bellicum Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on studies of BPX-501 in the U.S. The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring...
ELCC 2018: Canadian Study Shows Coordinating Nurses Can Improve Patients’ Quality of Life and Satisfaction During Lung Cancer Treatment
Investing in the continuity of care for lung cancer patients can bring tremendous benefits in terms of patient satisfaction and quality of life. In Quebec, this investment has taken the form of a dedicated role on the medical team: The Pivot Nurse in Oncology (PNO). A study presented by Kassouf et...
ELCC 2018: Second-Line Tyrosine Kinase Inhibitor Therapy Demonstrates Clinical Benefit in EGFR-Mutated NSCLC With Leptomeningeal Metastasis
Erlotinib (Tarceva) or high-dose erlotinib provides benefit in patients with epidermal growth factor receptor (EGFR) mutated non–small cell lung cancer (NSCLC) who develop leptomeningeal metastasis during or after treatment with a tyrosine kinase inhibitor. Findings supporting second-line...
ELCC 2018: Alectinib Provides Longer Symptom Improvement Than Crizotinib in ALK-Positive Lung Cancer
Alectinib provides longer symptom improvement than crizotinib in <em>ALK</em>-positive non–small cell lung cancer (NSCLC), according to results from the ALEX trial presented by Pérol et al at the European Lung Cancer Congress (ELCC) in Geneva, Switzerland (Abstract...
ELCC 2018: Immunotherapy Provides Long-Term Survival Benefit for Patients With Lung Cancer
Further evidence that immunotherapy provides long-term survival benefit for patients with lung cancer was presented by Mazières et al at the European Lung Cancer Congress (ELCC) in Geneva, Switzerland (Abstract 136PD_PR). Researchers presented the 3-year survival results of the randomized...
ESMO Releases Comments on Findings From the Pan-Cancer Atlas
The European Society for Medical Oncology (ESMO) welcomes the latest reports from The Cancer Genome Atlas (TCGA) as a major resource for researchers across the world and calls for increased across-the-board commitment to translate these efforts into medical advances for the benefit of patients with ...
NIH Completes In-Depth Genomic Analysis of 33 Cancer Types
Researchers funded by the National Institutes of Health (NIH) have completed a detailed genomic analysis, known as the Pan-Cancer Atlas, on a data set of molecular and clinical information from over 10,000 tumors representing 33 types of cancer. “This project is the culmination of more than...
Updated ASTRO Guideline for Palliative Radiotherapy in Lung Cancer
The American Society for Radiation Oncology (ASTRO) has issued an update to its clinical guideline for the use of palliative-intent radiation therapy for patients with incurable non–small cell lung cancer (NSCLC). Reflecting new evidence from randomized clinical trials, the guideline now...
Selinexor Receives Fast Track Designation From the FDA in Pentarefractory Multiple Myeloma
On April 10, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to the oral selective inhibitor of nuclear export (SINE) compound selinexor for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy. The FDA’s...
Notch Signaling and Treatment With Vismodegib in Basal Cell Carcinoma
A study by Eberl et al in Cancer Cell has pinpointed a mechanism that controls how basal cell cancers respond to treatment and offers new ideas for controlling this disease. Basal cell carcinomas are incredibly common—somewhere between 1 million to 3 million diagnosed each year—and...
FDA and EMA Accept Regulatory Submissions for Dacomitinib in Metastatic NSCLC With EGFR-Activating Mutations
On April 4, Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) accepted the company’s new drug application and granted Priority Review for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for the first-line treatment of...
FDA Expands Rucaparib Approval to Include Maintenance Treatment of Recurrent Ovarian Cancer
Today, the U.S. Food and Drug Administration (FDA) approved rucaparib (Rubraca) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy. The FDA...
Phase III REACH-2 Study in Hepatocellular Carcinoma Meets Overall Survival Endpoint
Topline results from the phase III REACH-2 study of ramucirumab (Cyramza) as a single agent in the second-line treatment of patients with hepatocellular carcinoma (HCC) were recently announced. The trial met its primary endpoint of overall survival as well as the secondary endpoint of...
FDA Grants Fast Track Designation for TAR-200 in Muscle-Invasive Bladder Cancer
On April 3, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for TAR-200, a gemcitabine-releasing intravesical system (GemRIS), for the treatment of patients with organ-confined or locally advanced muscle-invasive bladder cancer who are unfit for curative-intent therapy....
Conquer Cancer Foundation Sparks Global Oncology Innovation and Partnerships With IIG and IDEA Awards
ASCO’s Conquer Cancer Foundation has announced the recipients of its 2018 International Innovation Grants (IIG) and International Development and Education Awards (IDEA). Both the grant and award support oncology professionals in low-and middle-income countries, investing in either an innovative...
AACR Launches Initiative to Address Cancer Health Disparities in African Americans
THE AMERICAN ASSOCIATION for Cancer Research (AACR) announced the launch of a collaborative initiative known as “2020 by 2020.” The initiative will perform genomic sequencing of both malignant and benign tumor tissues from 2,020 consented African American cancer patients in addition to aggregating...
How to Respond to a Patient’s Discriminatory Request for a Different Clinician
Some patients may make discriminatory requests for a different clinician for their health care.1-5 These individuals may want to avoid treatment with clinicians of a certain race, religion, gender, sexual orientation, or national origin. Oncologists are not exempt from this type of patient...
Is CAR T-Cell Therapy Setting a New Standard of Care in Lymphoma?
Data presented at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition on the longer-term follow-up analysis of results from the ZUMA-1 trial investigating the effectiveness of axicabtagene ciloleucel (Yescarta) in patients with refractory non-Hodgkin lymphoma (NHL) showed...
Maura Dickler, MD, Appointed Vice President of Late Phase Development at Lilly Oncology
ELI LILLY AND COMPANY announced that Maura Dickler, MD, a breast cancer clinical researcher at the Breast Medicine Service at Memorial Sloan Kettering Cancer Center (MSK), will join Lilly Oncology as Vice President of Late Phase Development in early May 2018. Dr. Dickler is currently Section Head ...
Breast Cancer Specialist Hernan Vargas, MD, Joins Virginia Cancer Specialists
VIRGINIA CANCER SPECIALISTS, an affiliate of The US Oncology Network, has announced Hernan Vargas, MD, has joined its practice. Virginia Cancer Specialists is a cancer care and research center in Northern Virginia with more than 40 years of service to patients. Dr. Vargas joins Virginia Cancer...
Frederick M. Schnell, MD, FACP, Named Medical Director of Community Oncology Alliance
THE COMMUNITY ONCOLOGY ALLIANCE announced that Frederick M. Schnell, MD, FACP, has been appointed to the newly created staff position of Medical Director. Dr. Schnell has been a practicing community oncologist for 34 years and most recently Chief Executive Officer at Central Georgia Cancer Care...
2018 Gastrointestinal Cancers Symposium
The 2018 Gastrointestinal Cancers Symposium is supported by ASCO, the American Society of Radiation Oncology, the Society of Surgical Oncology, and the AGA Institute. Over 3,700 physicians, researchers, and allied health-care professionals attended the meeting. Photos by © ASCO/Todd Buchanan ...
FDA Expands Approval of Brentuximab Vedotin in Classical Hodgkin Lymphoma
ON MARCH 20, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris), an antibody-drug conjugate, to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy. Brentuximab vedotin combines an antibody and...
Greater Understanding of Family Dynamics May Help Cancer Teams Guide, Support Patients
WHETHER THEY are parents themselves or dealing with their own parents, patients with cancer often look to their health-care team to help guide these relationships, but data on how best to help are lacking, according to two poster presentations at the 2018 American Psychosocial Oncology Society...
EMA to Review Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma
On April 3, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery....
FDA Accepts BLA for Moxetumomab Pasudotox in Hairy Cell Leukemia
On April 3, the U.S. Food and Drug Administration (FDA) accepted a Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukemia (HCL) who have received at ...
Samuel Waxman Cancer Research Foundation Awards Research Grant to Craig B. Thompson, MD
THE SAMUEL WAXMAN Cancer Research Foundation (SWCRF) will present the 2018 Daid T. Workman Memorial Award to Craig B. Thompson, MD, President and Chief Executive Officer of Memorial Sloan Kettering Cancer Center, at its Breakthroughs Scientific Symposium in late April. The event brings together...
Edward M. Wolin, MD, Named Director of Center for Carcinoid and Neuroendocrine Tumors at Mount Sinai
EDWARD M. WOLIN, MD, an internationally renowned authority on neuroendocrine tumors, has joined the Mount Sinai Health System as Director of the Center for Carcinoid and Neuroendocrine Tumors. This multidisciplinary center includes specialists in gastroenterology, surgical oncology, hepatobiliary...
Destroy Pancreatic Cancer Donates $1 Million for Unique Trial
DESTROY PANCREATIC CANCER, an Atlanta-based nonprofit dedicated to finding better treatments for pancreatic cancer, is donating $1 million for a unique pancreatic cancer clinical trial designed by the nonprofit Translational Genomics Research Institute. Daniel D. Von Hoff, MD, FACP, one of the...
GU Symposium Focuses on Prognostic Model in Urothelial Cancer, Novel Therapies for Prostate and Kidney Cancers
THE 2018 GENITOURINARY Cancers Symposium hosted an international audience of oncologists and other stakeholders to hear about the latest advances in the field. We have included coverage of many of the top news stories from the meeting in previous issues of The ASCO Post. Here are summaries of a few ...
A Tribute to Two Amazing Scientists
Dr. Collins is Director of the National Institutes of Health. Originally posted on March 19, 2018, to the National Institutes of Health (NIH) Director’s Blog (https://directorsblog. nih.gov). OVER THE PAST couple of weeks, we’ve lost two legendary scientists who made major contributions to our...
Comprehensive Genomic-Profiling Assay FoundationOne CDx Is Commercially Available
On March 30, Foundation Medicine announced that FoundationOne CDx, the first U.S. Food and Drug Administration (FDA)-approved comprehensive genomic-profiling assay for all solid tumors incorporating multiple companion diagnostics, is now available in the United States. FoundationOne CDx is a...
EBCC-11: Mastectomy and Axillary Dissection and Neoadjuvant Targeted Treatment in HER2-Positive Breast Cancer
Extensive surgery involving mastectomy and removal of several lymph nodes may be safely avoided for more women with some types of breast cancer if they receive targeted drugs before surgery, according to research presented at the 11th European Breast Cancer Conference (EBCC-11) (Abstract 19). The...
In Remembrance of James F. Holland, MD
The ASCO Post mourns the loss of ASCO Past President James F. Holland, MD, FASCO, on March 22, 2018. Dr. Holland was the Distinguished Professor of Neoplastic Diseases in the Department of Medicine at the Icahn School of Medicine at Mount Sinai in New York. His wife of many years, Jimmie C....
The Clinical Significance of Clinicaltrials.gov
“I think I found the trial that is going to save your life,” Stefanie Joho’s sister said after checking out the ClinicalTrials.gov website. “And sure enough, it did. That is not an exaggeration. That is exactly what happened,” Ms. Joho, a health advocate and consultant based in Philadelphia, told...
