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Showing 7301 - 7350CMS Finalizes Decision to Cover CAR T-Cell Therapy for Medicare Beneficiaries
On August 7, the Centers for Medicare & Medicaid Services (CMS) finalized the decision to cover U.S. Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T-cell therapy among recipients of Medicare benefits. FDA-approved CAR T-cell therapies are approved to...
Polatuzumab Vedotin-piiq for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
On June 10, 2019, the CD79b-directed antibody-drug conjugate polatuzumab vedotin-piiq was granted accelerated approval for use in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified,...
COTA Signs Research Collaboration Agreement With FDA
COTA, Inc, a precision medicine technology company, announced that it has signed a 2-year Research Collaboration Agreement with the U.S. Food and Drug Administration (FDA) Information Exchange and Data Transformation (INFORMED) Program, the Agency’s data science and technology incubator that...
Treatment Update on Selected Non-Hodgkin Lymphomas
As part of The ASCO Post’s coverage of the 2019 ASCO Annual Meeting, featured here are four abstracts from different clinical trials evaluating newer treatments for Waldenström’s macroglobulinemia and T-cell lymphomas. Waldenström’s Macroglobulinemia ABSTRACT 7509: Outcomes with bendamustine plus ...
Maintenance Bevacizumab, Pemetrexed, or Both in Advanced Nonsquamous NSCLC
In the phase III ECOG-ACRIN 5508 trial, reported in the Journal of Clinical Oncology by Ramalingam et al, maintenance pemetrexed or bevacizumab was associated with no significant improvement in overall survival vs the bevacizumab control group alone, and was associated with greater toxicity in...
Pembrolizumab in Metastatic Small Cell Lung Cancer
On June 17, 2019, pembrolizumab was granted accelerated approval for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.1,2 Supporting Efficacy Data Approval was based...
Preserving Sexuality and Restoring Sexual Function in Male and Female Cancer Survivors
Intimacy changes after a cancer diagnosis. Both male and female survivors can experience significant sexual dysfunction, pain with sex, loss of desire, and a slew of other clinical and psychological sequelae. To make matter worse, sexual function is often not discussed by patients and their...
Atezolizumab Combined With Chemotherapy in First-Line Extensive-Stage Small Cell Lung Cancer
On March 18, 2019, atezolizumab was approved for use in combination with carboplatin and etoposide in the first-line treatment of adult patients with extensive-stage small cell lung cance (SCLC).1,2 Supporting Efficacy Data Approval was based on findings in the phase III double-blind IMpower133...
Novel Therapeutics on the Horizon for Treating Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy-induced peripheral neuropathy is a major clinical problem, and better therapies are needed for both its treatment and prevention. According to Charles Loprinzi, MD, a medical oncologist at the Mayo Clinic in Rochester, Minnesota, to devise better preventive and treatment approaches,...
Notable Presentations at ASCO 2019 Included Studies in Sarcoma, Lymphoma, Myeloma, and Breast and Kidney Cancers
The 2019 ASCO Annual Meeting featured a wealth of presentations on important topics. In addition to our regular news coverage of the meeting, we present below some highlights of other studies that add to our knowledge base for treatment of various cancers. Olaratumab in Soft-Tissue Sarcoma...
Gender Equity
Diversity, inclusion, and gender equality were prevalent themes for 2019 that ran throughout the ASCO Annual Meeting. From the first year that featured free onsite child care for attendees, to a session on “Establishing a Mutually Respectful Environment in the Workplace,” as well as a Plenary...
How an Innovative AI-Based Smartphone Application Is Addressing Patients’ Palliative Care Needs
GUEST EDITOR Addressing the evolving needs of cancer survivors at various stages of their illness and care, Palliative Care in Oncology is guest edited by Jamie H. Von Roenn, MD, FASCO. Dr. Von Roenn is ASCO’s Vice President of Education, Science, and Professional Development. During the 2019...
BEACON CRC: Encorafenib/Binimetinib/Cetuximab Improves Survival in BRAF V600E–Mutated Metastatic Colorectal Cancer
The three-drug combination of encorafenib (a BRAF inhibitor), binimetinib (a MEK inhibitor), and cetuximab (an EGFR inhibitor) significantly improved overall survival in patients with BRAF-mutated metastatic colorectal cancer, according to the results of the phase III BEACON CRC clinical trial....
Ibrutinib/Rituximab vs Standard Chemoimmunotherapy in Previously Untreated CLL
In an interim analysis of the phase III E1912 trial reported in The New England Journal of Medicine, Shanafelt et al found that ibrutinib/rituximab improved progression-free and overall survival vs standard chemoimmunotherapy in patients 70 years old or younger with previously untreated chronic...
Tumor-Associated Antigen Cytotoxic T Cells in Relapsed or Refractory Solid Tumors
In a phase I trial reported in the Journal of Clinical Oncology, Hont et al found that treatment of relapsed or refractory solid tumors with ex vivo expanded autologous multiantigen-associated specific cytotoxic T cells—or, tumor-associated antigen cytotoxic T cells—was safe and showed...
Post Hoc 5-Year Follow-up of Pembrolizumab vs Ipilimumab in Advanced Melanoma
In a post hoc 5-year follow-up of the KEYNOTE-006 trial reported in The Lancet Oncology, Robert et al found that pembrolizumab maintained overall and progression-free survival benefits over ipilimumab in patients with advanced melanoma. In the primary analysis from the trial, both pembrolizumab...
Adjuvant Radiotherapy After Radical Prostatectomy vs Radical Prostatectomy Alone in Patients With Positive Margins or Extracapsular Extension
In patients with prostate cancer with surgical positive margins or extracapsular extension of their disease, the risk of disease recurrence postprostatectomy is higher than in cases where the cancer cells are confined within the prostate. The Finnish FinnProstataX study investigated...
Survey Finds Majority of Americans Are Unfamiliar With Cutaneous Squamous Cell Carcinoma
Nearly-three quarters of Americans are not familiar with cutaneous squamous cell carcinoma, the second most common type of cancer in the United States, according to a new survey conducted by The Harris Poll on behalf of The Skin Cancer Foundation. Cutaneous squamous cell carcinoma is more common...
Durvalumab With or Without Tremelimumab in Metastatic Pancreatic Cancer
In the first stage of a phase II trial reported in JAMA Oncology, O’Reilly et al found poor activity of durvalumab with or without tremelimumab in metastatic pancreatic ductal adenocarcinoma. Owing to the lack of efficacy, study expansion was not pursued. The lead-in open-label safety ...
Palbociclib Plus Cetuximab in Platinum- and Cetuximab-Resistant HPV-Unrelated Head and Neck Cancer
In a phase II study reported in The Lancet Oncology, Adkins et al found that the combination of the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib and the EGFR inhibitor cetuximab showed activity in patients with either platinum- or cetuximab-resistant human papillomavirus...
Pazopanib in Advanced Extraskeletal Myxoid Chondrosarcoma
Findings from a cohort of a phase II study reported by Stacchiotti et al in The Lancet Oncology indicated activity of the antiangiogenic agent pazopanib in advanced extraskeletal myxoid chondrosarcoma. As noted by the investigators, this rare sarcoma has low sensitivity to cytotoxic chemotherapy,...
FDA Approves Pembrolizumab for Some Patients With PD-L1–Positive Esophageal Cancer
On July 30, the U.S. Food and Drug Administration (FDA) approved the programmed cell death protein 1 inhibitor pembrolizumab (Keytruda) as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express programmed ...
Overall Survival With the Addition of Ribociclib to Endocrine Therapy in Advanced HR-Positive, HER2-Negative Breast Cancer
As reported in The New England Journal of Medicine by Im et al, an interim analysis of the phase III MONALEESA-7 trial has shown an overall survival benefit with the addition of the cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor ribociclib to endocrine therapy in pre- or perimenopausal women...
Post Hoc Updated Survival Analysis of Adjuvant Chemoradiotherapy vs Radiotherapy in High-Risk Endometrial Cancer
As reported in The Lancet Oncology by de Boer et al, a post hoc updated survival analysis of the phase III PORTEC-3 trial has shown a significant overall survival benefit of adjuvant chemoradiotherapy vs radiotherapy alone in women with high-risk endometrial cancer. A benefit in failure-free...
Rituximab Maintenance in Previously Untreated Follicular Lymphoma: 9-Year Follow-up
As reported in the Journal of Clinical Oncology by Bachy et al, 9-year follow-up of the phase III PRIMA trial indicated a maintained progression-free survival benefit of maintenance rituximab vs observation following first-line induction therapy for follicular lymphoma. As in the prior reports from ...
Five-Year Survival in Heavily Pretreated Patients Receiving Nivolumab Monotherapy
As reported by Topalian et al in JAMA Oncology, long-term follow up of patients from a phase I expansion cohort study indicated 5-year overall survival rates of 34.2%, 27.7%, and 15.6% among patients who received nivolumab monotherapy for advanced melanoma, renal cell carcinoma (RCC), and...
Erdafitinib in FGFR-Altered Advanced Urothelial Carcinoma
As reported in The New England Journal of Medicine by Loriot et al, the fibroblast growth factor receptor 1-4 tyrosine kinase inhibitor erdafitinib showed activity in FGFR-altered advanced urothelial carcinoma. Study Details The study enrolled patients from sites in 14 countries between May...
ARCHES: Enzalutamide Plus ADT in Metastatic Hormone-Sensitive Prostate Cancer
As reported in the Journal of Clinical Oncology by Armstrong et al, findings from the phase III ARCHES trial have shown significant improvement in radiographic progression-free survival with enzalutamide plus androgen-deprivation therapy (ADT) vs placebo plus ADT in men with metastatic...
FDA Pipeline: Label Update for Durvalumab in NSCLC; Applications Accepted in Epithelioid Sarcoma, AML
Recently, the U.S. Food and Drug Administration (FDA) approved the inclusion of overall survival from the PACIFIC trial in the U.S. prescribing information for durvalumab and accepted applications for a new drug in the treatment of epithelioid sarcoma and two orphan drugs in the treatment of acute...
Pembrolizumab After Stereotactic Body Radiotherapy in Advanced NSCLC
In a Dutch phase II study reported in JAMA Oncology, Theelen et al found that although use of stereotactic body radiotherapy prior to pembrolizumab increased the objective response rate vs pembrolizumab alone in metastatic non–small cell lung cancer (NSCLC), the difference did not meet study...
ASCO, Conquer Cancer Congratulate 2019 Grant and Award Recipients
Conquer Cancer®, the ASCO Foundation, presented more than $7 million in grants and awards to exceptional oncology researchers at the 2019 ASCO Annual Meeting. ASCO and Conquer Cancer congratulate the recipients and offer their profound thanks to those who generously supported these awards. Visit...
Parental Treatment Refusals: What Your Responsibilities Are When Mom and Dad Decline Cancer Treatment for a Child
In April 2019, a 3-year-old boy, Noah McAdams, missed the third round of chemotherapy for his acute lymphoblastic leukemia. His parents wanted instead to focus on alternative remedies of cannabidiol oil, alkaline water, mushroom tea, and herbal extracts. The sheriff was summoned; Noah’s parents...
Is It Time to Reevaluate the P Value in Biomedical Research?
Developed in 1925 by British statistician Sir Ronald Fisher, the P value is a measure that is ever-present in abstracts and studies, a small statistical tool that has enormous power to aid research being published in the literature or support drug approval. Over the past several years, however, a...
Brief Update on Clinical Trials of New Treatments in Gastrointestinal Cancers
The 2019 ASCO Annual Meeting provided attendees with an abundance of clinically relevant abstracts in gastrointestinal cancers. Briefly featured here are clinical trial updates on pembrolizumab in the second-line treatment of hepatocellular carcinoma (KEYNOTE-240 trial), laparoscopic vs open...
Two Investigational Agents Demonstrate Safety, Efficacy in Lung Cancer
A handful of investigational drugs in early-phase trials always create a buzz at ASCO Annual Meetings. Two that garnered attention this year, and could eventually change outcomes in the clinic, are the first-in-class KRAS inhibitor AMG 510 and the ROS1 inhibitor repotrectinib. Should late-phase...
Update on Newer Treatments in Non-Hodgkin Lymphomas
As part of The ASCO Post’s coverage of the 2019 ASCO Annual Meeting, featured here are summaries of five abstracts of different clinical trials evaluating newer treatments for follicular and marginal zone lymphomas as well as diffuse large B-cell lymphoma. Follicular and Marginal Zone Lymphomas...
FDA Expands Indication for Pembrolizumab to Metastatic Small Cell Lung Cancer
ON JUNE 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the anti– programmed cell death protein 1 (PD-1) therapy pembrolizumab (Keytruda) as monotherapy for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based...
FDA Grants Accelerated Approval to Selinexor in Combination With Dexamethasone in Pentarefractory Multiple Myeloma
On July 3, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two ...
Study Highlights on Novel Agents and Supportive Care Strategies in Prostate Cancer
In addition to our regular coverage of major news stories from the 2019 ASCO Annual Meeting, here is an additional roundup of important studies related to prostate cancer. ARAMIS: Darolutamide and Quality of Life Darolutamide, a next-generation androgen receptor antagonist, significantly prolonged...
Is Heterogeneity Within HER2-Positive Tumors Clinically Relevant?
Breast cancers that display heterogeneity of HER2 expression may represent a distinct subset of HER2-positive breast cancer that is associated with lower rates of pathologic complete response, according to a phase II study from Dana-Farber Cancer Institute. This trial evaluated HER2 heterogeneity...
Two Pivotal Studies in Breast Cancer Report Further Analyses
At the 2019 ASCO Annual Meeting, two pivotal breast cancer trials reported final or additional analyses: one confirmed the negative results seen in earlier reports,1 and the other supported a new survival benchmark.2 KRISTINE: Neoadjuvant T-DM1/Pertuzumab Sara A. Hurvitz, MD, of the David Geffen...
No Man Is an Island: Reflections From an ASCO IDEA Recipient
IT WAS a chilly Chicago morning, and I was sitting at the lobby of my hotel when I saw a smiling gentleman cheerfully waving at me from his car. It was Lawrence H. Einhorn, MD, picking me up for our drive to Indiana. I was one of the recipients of the ASCO International Development and Education...
Becoming Acquainted With Cancer
Just weeks after my wedding in late summer of 2017, I had a sudden bout of abdominal pain so severe that it sent me to the emergency room. I was just 29 years old and in great physical shape. In the emergency room, a physician examined me and was about to release me with a prescription for a...
Expert Point of View: Vernon K. Sondak, MD
Commenting for The ASCO Post, melanoma expert Vernon K. Sondak, MD, Chair of the Department of Cutaneous Oncology at Moffitt Cancer Center, Tampa, maintained that the association between immunotherapy-related toxicity and better outcomes is not yet clear. He first noted the impact of novel...
Activity of a MEK 1/2 Inhibitor in Select Pediatric Brain Cancers
In a phase II trial reported in The Lancet Oncology, Jason Fangusaro, MD, and colleagues found that the MEK1/2 inhibitor selumetinib was active in pediatric patients with recurrent, refractory, or progressive pilocytic astrocytoma with common BRAF aberrations and neurofibromatosis type 1...
Study Finds Immune-Related Adverse Events Herald Benefit With Adjuvant Pembrolizumab in Melanoma
In the EORTC 1325/KEYNOTE-054 trial of adjuvant pembrolizumab in patients with stage III melanoma, recurrences were reduced by 44% in the immunotherapy arm, vs placebo, but this benefit increased to a 63% reduction in risk among patients developing an immune-related adverse event on treatment.1...
Active Regimen for High-Risk and Older Patients With Previously Untreated Chronic Lymphocytic Leukemia
In a single-center phase II trial reported in The New England Journal of Medicine, Nitin Jain, MD, and colleagues found that the combination of ibrutinib and venetoclax was highly active in previously untreated high-risk and older patients with chronic lymphocytic leukemia (CLL). In the study, 80 ...
Active Surveillance for Early-Stage Prostate Cancer Requires Active Participation by Patient and Clinician
Active surveillance of patients with early-stage prostate cancer “is tackling the problem of overtreatment” and, with rigorous monitoring, “is safe and allows us to treat only patients who need treatment when their cancer progresses,” Ronald C. Chen, MD, MPH, affirmed in an interview with The ASCO...
Radiofrequency Ablation vs Minimally Invasive Surgery for Small Hepatocellular Carcinoma
In a retrospective analysis published by Si et al in Surgical Endoscopy, researchers found minimally invasive surgery led to higher survival and lower local recurrence in patients with small hepatocellular carcinoma vs radiofrequency ablation, whereas radiofrequency ablation was associated with...
Physicians and the Threat of Nuclear War
The Hippocratic Oath calls on physicians to “use treatment to help the sick according to my ability and judgment,” but not all versions of the oath call on us to prevent disease. Here we urge our colleagues to acknowledge that additional mandate and renew their commitment to preventing what could ...
