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Showing 13001 - 13050FDA Approves New Pembrolizumab Dosing Regimen
On April 28, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new dosing regimen for pembrolizumab (Keytruda)—400 mg every 6 weeks—across all currently approved adult indications, in addition to the current 200 mg every 3 weeks dosing regimen. The approval was based on...
Recent FDA Oncology/Hematology Approvals
The U.S. Food and Drug Administration (FDA) had a very busy 10 or so days, so this week, we’ll go over five recent oncology and hematology approvals the Agency issued, in bladder cancer, breast cancer, bile duct cancer, and leukemia.
AACR 2020: Cell-Free DNA Liquid Biopsy May Provide an Early Detection Test for Patients With Suspected Cancer
The Circulating Cell-free Genome Atlas Study is a large multicenter, case-controlled, observational study of 15,254 participants, 56% with cancer and 44% without cancer, with longitudinal follow-up to support the development of a cell-free DNA (cfDNA) multicancer early detection test. In this phase ...
AACR 2020: Study Finds Vape Shops Are Mostly Concentrated in Low-Resource, Minority Communities
An analysis investigating the socioecologic context of tobacco and vape shops in Los Angeles has found that vape shops are more likely to be concentrated in low-resource communities. The communities also tended to have higher concentrations of minority residents and fewer tobacco and vaping sales...
AACR 2020: Continuous vs Intermittent Dabrafenib/Trametinib Dosing in Patients With BRAF-Mutated Melanoma
A randomized clinical trial offers evidence that a combination of two targeted melanoma drugs, when given continuously, improves progression-free survival when compared with intermittent treatment, according to study results presented by Algazi et al at the American Association for Cancer Research...
Prognosis of Patients With Cancer and COVID-19: Outcomes From a Center in New York City
A group of clinicians from New York City sought to determine if patients with cancer and COVID-19 in the United States have a poor prognosis. In an article published as a pre-proof in Annals of Oncology, Miyashita et al analyzed the electronic medical records from the Mount Sinai Health System, and ...
ASCO Shares New Clinical Trial Data, Initiatives, and Path Forward for Post–COVID-19 Cancer Care Delivery System
ASCO (the Society) and its affiliate organization the Association for Clinical Oncology (the Association) recently announced the results of a survey that tracked the initial impact of the COVID-19 pandemic on cancer clinical trials, highlighted a new research initiative to address the data gap on...
Jacek Jassem, MD, PhD, on Fighting COVID-19 and Cancer: The View From Poland
Jacek Jassem, MD, PhD, of the Medical University of Gdansk, and an international editor on The ASCO Post Editorial Board, talks about the situation in Poland, how his institution is coping, and the adjustments the staff has made to deliver quality cancer care. Filmed April 17, 2020.
Paolo A. Ascierto, MD, on Cancer Treatment During the COVID-19 Pandemic: The View From Southern Italy
Paolo A. Ascierto, MD, of the Istituto Nazionale Tumori in Naples, Italy, talks about minimizing risks for patients with cancer, prioritizing surgery and other treatments for melanoma, and the state of clinical trials. Filmed April 17, 2020.
Hypercoagulability in Critically Ill Patients With COVID-19: Where Do We Stand?
“Life is short, art long, opportunity fleeting, experience treacherous, judgment difficult.” ―Hippocrates The ASCO Post is pleased to present Hematology Expert Review, an ongoing feature that occasionally quizzes readers on issues in hematology. In this installment, Drs. Abutalib and Connors...
Long-Term Outcomes With Triplet Induction and Risk-Adapted Maintenance Therapy for Newly Diagnosed Multiple Myeloma
As reported by Joseph et al in the Journal of Clinical Oncology, follow-up in a large cohort of patients with newly diagnosed multiple myeloma indicates good long-term outcomes with consecutive treatment with lenalidomide/bortezomib/dexamethasone (RVD) induction therapy and risk-adapted maintenance ...
AACR 2020: ctDNA May Be a Prognostic Biomarker of Disease Recurrence in Patients With Lung Cancer
The TRACERx study investigated phylogenetic tracking and minimal residual disease (MRD) detection using circulating tumor DNA (ctDNA) profiling following resection in patients with stage I to III non–small cell lung cancer (NSCLC). Investigators found that ctDNA is an adjuvant biomarker capable of...
AACR 2020: Final Overall Survival Results From the Phase III EMBRACA Trial
New data from the phase III EMBRACA trial showed the poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib did not produce a statistically significant overall survival benefit for patients with locally advanced or metastatic HER2-negative germline BRCA-mutated breast cancer. Most patients...
Factors Potentially Associated With Progression of Advanced Small-Bowel Neuroendocrine Tumors After Multimodal Surgical Therapy
In a single-institution analysis reported in the journal Pancreas, Khetan et al found that age at diagnosis, perineural invasion, and elevated preoperative chromogranin levels may be associated with an increased risk of disease progression in patients with advanced grade 1 or 2 small-bowel...
ASCO, Conquer Cancer Honor Leaders in Cancer Care With 2020 Special Awards
ASCO and Conquer Cancer, the ASCO Foundation®, are proud to recognize the winners of ASCO’s 2020 Special Awards and Conquer Cancer’s Women Who Conquer Cancer Mentorship Awards. The recipients of these awards have worked to transform cancer care around the world. David A. Karnofsky Memorial Award...
Isatuximab-irfc for Previously Treated Multiple Myeloma
On March 2, 2020, the CD-38-directed cytolytic antibody isatuximab-irfc (Sarclisa) was approved for use in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.1,2...
Robert L. Coleman, MD, Named Chief Scientific Officer for the US Oncology Network
On March 31, 2020, the US Oncology Network (The Network) named cancer researcher Robert L. Coleman, MD, FACOG, FACS, as its new Chief Scientific Officer. In this role, Dr. Coleman will be the senior-most clinician scientist on The US Oncology Network leadership. Dr. Coleman, who most recently...
NCI Awards $14.5 Million Grant for Immunotherapy Research
A team led by Pawel Kalinski, MD, PhD, of Roswell Park Comprehensive Cancer Center, has earned a 5-year, $14.5 million award from the National Cancer Institute (NCI) to expand a promising immunotherapy platform. Funded through the NCI’s Program Project Grant, this 5-year grant will fund five...
Smilow Cancer Hospital and Yale Cancer Center Appoint Deputy Chief Medical Officer
Mehra Golshan, MD, MBA, FACS, has been appointed the inaugural Deputy Chief Medical Officer for Surgical Services at Smilow Cancer Hospital and Yale Cancer Center, Professor of Surgery at Yale School of Medicine, and Interim Director of the Breast Center at Smilow Cancer Hospital. As Deputy Chief...
AMA Highlights Mental Health Resources for Physicians During COVID-19 Pandemic
Earlier this month, the American Medical Association (AMA) announced resources available to help physicians cope with increased levels of distress and anxiety during the coronavirus disease 2019 (COVID-19) pandemic. These resources build on the AMA’s efforts to ensure physicians and other...
Virtual Appointments Help Patients With Cancer Continue Care During COVID-19 Health Crisis
Texas Oncology recently announced a major expansion of its telemedicine services to allow patients to schedule virtual visits with more than 400 physicians and 150 advanced practice providers throughout the statewide cancer care practice. Through this expanded approach, launched earlier this month, ...
FDA Accelerates Development of Novel Therapies for COVID-19
The U.S. Food and Drug Administration (FDA) has implemented a program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency’s disposal to bring new...
Adapting Adjuvant Endocrine Therapy by Patient Age and Risk
The individualization and optimization of adjuvant endocrine therapy for breast cancer are important and not always simple. Guidance on this issue was offered at the 2020 Miami Breast Cancer Conference by Joyce O’Shaughnessy, MD, the Celebrating Woman Chair in Breast Cancer Research at Baylor...
21-Gene Assay Recurrence Score and Risk of Locoregional Recurrence in Hormone Receptor–Positive, Node-Positive Breast Cancer
A retrospective analysis from the Southwest Oncology Group S8814 trial, reported by Wendy A. Woodward, MD, PhD, of the Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, and colleagues in JAMA Oncology,1 showed that a low 21-gene assay recurrence score was...
Radon Exposure: A Leading Environmental Cause of Cancer Mortality in the United States
The Environmental Protection Agency (EPA) has concluded that about 21,000 people die each year of lung cancer related to radon gas exposure, making it the second leading cause of lung cancer death in the United States. Although the EPA and various other organizations, including the National Radon ...
PD-1 Inhibition in Mismatch Repair–Deficient/Microsatellite Instability–High Cancers Other Than Colorectal Cancer
Mismatch repair (MMR)-deficiency and consequently high DNA microsatellite instability (MSI-H) are associated with high tumor mutational burden. A high mutational load increases the potential number of neoantigens that can be presented by the tumor cell and recognized by host lymphocytes. Detection...
NCI-MATCH Subprotocol Finds Nivolumab Active in Mismatch Repair–Deficient Cancers Other Than Colorectal Cancer
In a study (NCI-MATCH trial subprotocol, arm Z1D) reported in the Journal of Clinical Oncology, Nilofer S. Azad, MD, of Johns Hopkins Medicine Sidney Kimmel Comprehensive Cancer, and colleagues found that nivolumab was active in mismatch repair (MMR)-deficient noncolorectal cancers.1 As stated by...
Actively Recruiting Clinical Trials Studying Multiple Myeloma
This Clinical Trials Resource Guide lists six actively recruiting clinical trials that focus on treating multiple myeloma. These studies, ranging from phase I to phase III, are evaluating the safety and efficacy of vaccines, cytotoxic T lymphocytes, and drug treatment regimens. Some studies center ...
Addition of Isatuximab to Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma
As reported in The Lancet by Michel Attal, MD, of the Institut Universitaire du Cancer Toulouse Oncopole, France, and colleagues, the phase III ICARIA-MM trial has shown that the addition of the CD38-targeted antibody isatuximab to pomalidomide and low-dose dexamethasone significantly improved...
Gut Bacterial Diversity: A Marker or Driver of Outcomes After Hematopoietic Cell Transplantation?
Previous single-center studies have linked the gut microbiota (via stool sample analysis) to outcomes after hematopoietic cell transplantation (HCT), such as overall mortality, transplant-related mortality, graft-vs-host disease, and graft-vs-host–related mortality.1-4 Although intriguing, these...
Selected ASH Abstracts on Novel Treatments for Non-Hodgkin Lymphomas
To complement The ASCO Post’s continued comprehensive coverage of the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel therapies for patients with non-Hodgkin lymphomas (NHLs). For full...
Expert Point of View: John M. Carethers, MD, and Joseph J. Y. Sung, MD, PhD
Session moderators for the CheckMate 142 presentation at the Gastrointestinal Cancers Symposium were John M. Carethers, MD, the John G Searle Professor (and Chair) of Internal Medicine at the University of Michigan, Ann Arbor, and Joseph J. Y. Sung, MD, PhD, the Mok Hing You Professor of Medicine...
How CRISPR-Cas9 Gene Editing May Improve the Effectiveness of Cellular Therapeutics in Patients With Cancer
The results from the first in-human phase I clinical trial in the United States evaluating CRISPR-Cas9–edited T cells in patients with advanced cancer has shown that the therapy is both feasible and safe, representing a big step forward in the potential of using gene editing to boost the natural...
CheckMate 142 Updated Analysis: First-Line Nivolumab Plus Low-Dose Ipilimumab in MSI-H/dMMR Metastatic Colorectal Cancer
As a first-line regimen for patients with metastatic colorectal tumors that are microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR), the combination of nivolumab and low-dose ipilimumab yielded an objective response rate of 64%, a complete response rate of 9%, and a disease...
ASCENT Study Halted: Efficacy Shown Across Multiple Study Endpoints in Triple-Negative Breast Cancer
The phase III confirmatory ASCENT study of the antibody drug-conjugate sacituzumab govitecan will be stopped based on efficacy across multiple study endpoints following unanimous recommendation from the independent data safety monitoring committee, according to a news release issued earlier this...
Beyond CDK4/6 Inhibitors: What Subsequent Treatment Is Best?
Inhibitors of cyclin-dependent kinases 4 and 6 (CDK4/6) have changed the natural history of hormone receptor–positive metastatic breast cancer. While median progression-free survival on these drugs is approximately 27 months, the disease eventually progresses and clinicians must choose a subsequent ...
More Antibody-Drug Conjugates on the Horizon for Breast Cancer
Novel antibody-drug conjugates that target actionable cell-surface markers in metastatic breast cancer will soon expand the utility of the class that already includes ado-trastuzumab emtansine (T-DM1), according to two speakers at the 2020 Miami Breast Cancer Conference. These new agents were...
Do HIV Positivity and Autoimmune Disease Preclude Treatment With Checkpoint Inhibitors?
Can patients with cancer and preexisting autoimmune disorders safely benefit from immunotherapy? The answer has been unclear, with only retrospective studies and anecdotal reports guiding oncologists. This subpopulation of patients has largely been excluded from clinical trials out of concerns over ...
What’s the Current Status of Neoadjuvant Immunotherapy?
For several tumor types, can the successes achieved with immunotherapy in the metastatic and adjuvant settings be replicated in the neoadjuvant setting? An explosion in clinical trials—with more than 300 listed on ClinicalTrials.gov—point to “yes.” “The neoadjuvant use of immunotherapy is of great ...
Expert Point of View: Dana E. Rathkopf, MD
Study discussant Dana E. Rathkopf, MD, Director of Clinical Research, Prostate Cancer, at Memorial Sloan Kettering Cancer Center, New York, began her presentation by noting that the “complicated” landscape of metastatic prostate cancer can be approached like a chess game. She used a chess analogy...
Upfront Apalutamide Delays Time to Second Progression in Metastatic Castration-Sensitive Prostate Cancer
The addition of apalutamide to androgen-deprivation therapy (ADT) reduced the risk of second disease progression or death (PFS2) by 34% vs ADT alone in patients with metastatic castration-sensitive prostate cancer, in a post hoc analysis of the phase III TITAN trial presented at the 2020...
Merry-Jennifer Markham, MD, FACP, FASCO, Rose From Humble Beginnings to a Leadership Role in Oncology
Merry-Jennifer Markham, MD, FACP, FASCO, grew up in Fort White, Florida, a rural speck on the map in the northern part of the state. Fort White is home to the Ichetucknee River and Springs, a crystal-clear natural wonder known only to the locals until 1972, when it was declared a National Natural...
Free Practice Resource: Cancer.Net Patient Referral Cards From ASCO
Patients and caregivers are always looking for trusted online information on cancer topics. Display these free referral cards in your practice to encourage your patients to visit ASCO’s patient information website, Cancer.Net, where they will find authoritative, oncologist-approved information...
Better Mental Health Screening Needed for Survivors of Head and Neck Cancer
The threat posed by head and neck cancer extends well beyond the physical disease, according to research presented at the 2020 Multidisciplinary Head and Neck Cancers Symposium.1,2 The pair of studies underscored the high costs of survivorship, including elevated rates of chronic pain, substance...
ASCO Resources on COVID-19 for the Oncology Community
The worldwide spread of the novel coronavirus (COVID-19) presents unprecedented challenges and uncertainty to the cancer care delivery system. ASCO has been actively monitoring and responding to the pandemic to ensure that accurate information is readily available to clinicians and their patients. ...
Conquer Cancer Researchers Remember Jane C. Wright, MD, FASCO
It’s 1964 in Chicago. Seven forward-thinking oncologists gather to brainstorm what will become the American Society of Clinical Oncology (ASCO). Among the group is Jane C. Wright, MD, FASCO, the only woman and African American among ASCO’s founders. It’s time for the 2011 ASCO Annual Meeting in...
Study Finds Chemoradiation Plus Bevacizumab Safe and Feasible in Locally or Regionally Advanced Nasopharyngeal Cancer
The addition of bevacizumab to the current standard of care of chemoradiation therapy is safe and feasible for the treatment of locally or regionally advanced nasopharyngeal cancer, according to data presented at the 2020 Multidisciplinary Head and Neck Cancers Symposium.1 “I’m pleased to report...
FDA’s Draft Guidance Will Improve Evidence Base for Older Adults With Cancer
ASCO commends the U.S. Food and Drug Administration (FDA) for releasing draft guidance that encourages inclusion of older adults in clinical trials of drugs for the treatment of cancer. The guidance emphasizes the importance of including adults aged 75 or older in clinical trials to better enable...
Expert Point of View: Charu Aggarwal, MD, MPH
Charu Aggarwal, MD, MPH, Leslye M. Heisler Assistant Professor for Lung Cancer Excellence at the Perelman Center for Advanced Medicine, University of Pennsylvania, underscored the paucity of treatment options for metastatic head and neck squamous cell carcinoma. “Even though pembrolizumab is...
Pembrolizumab Plus Cetuximab Shows Antitumor Activity in Squamous Cell Head and Neck Cancer
The first trial to evaluate anti–programmed cell death protein 1 (PD-1) blockade combined with epidermal growth factor receptor (EGFR) inhibition in head and neck squamous cell carcinoma demonstrates promising activity of the drug combination in patients with platinum-refractory or -ineligible...
