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Showing 101 - 150New Targets Explored for Bispecific T-Cell–Engaging Antibodies in Myeloma
B-cell maturation antigen (BCMA) is the most frequent target of immunotherapies in relapsed or refractory multiple myeloma, but bispecific T-cell–engaging antibodies with novel targets are also achieving promising results. Studies presented at the 2020 American Society of Hematology (ASH) Annual...
FDA Grants Accelerated Approval to Umbralisib for Treatment of Marginal Zone and Follicular Lymphomas
On February 5, the U.S. Food and Drug Administration granted accelerated approval to umbralisib (Ukoniq), a kinase inhibitor including PI3K-delta and CK1-epsilon, for the following indications: Adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior...
Venetoclax Added to Bortezomib Plus Dexamethasone in Relapsed or Refractory Multiple Myeloma
As reported in The Lancet Oncology by Shaji K. Kumar, MD, of the Division of Hematology, Mayo Clinic, Rochester, and colleagues, the phase III BELLINI trial has shown that the addition of venetoclax to bortezomib/dexamethasone significantly prolonged progression-free survival in patients with...
New Targets Explored for Bispecific T-Cell–Engaging Antibodies in Myeloma
B-cell maturation antigen (BCMA) is the most frequent target of immunotherapies in relapsed or refractory multiple myeloma, but bispecific T-cell–engaging (BiTE) antibodies with novel targets are also achieving promising results. Studies presented at the 2020 American Society of Hematology (ASH)...
Addition of Gemcitabine to Pazopanib for Refractory Soft-Tissue Sarcoma
In the German phase II PAPGEMO trial reported in JAMA Oncology, Hans-Joachim Schmoll, MD, PhD, and colleagues found that the combination of pazopanib and gemcitabine improved 12-week progression-free survival vs pazopanib alone in patients with anthracycline- or ifosfamide-refractory soft-tissue...
Effect of the COVID-19 Pandemic on Lung Cancer Screening
Reporting on how deferred care worsened outcomes for patients with lung cancer when the COVID-19 pandemic first surged in the spring of 2020, Robert M. Van Haren, MD, MSPH, FACS, and colleagues explained that they have identified a framework that could help people with serious health conditions...
Addition of Venetoclax to Bortezomib/Dexamethasone in Relapsed or Refractory Multiple Myeloma: BELLINI Trial
As reported in The Lancet Oncology by Shaji K. Kumar, MD, and colleagues, the phase III BELLINI trial has shown that the addition of venetoclax to bortezomib/dexamethasone significantly prolonged progression-free survival in patients with relapsed or refractory multiple myeloma but was associated...
Tazemetostat in Relapsed or Refractory Follicular Lymphoma
In a phase II trial reported in The Lancet Oncology, Franck Morschhauser, MD, and colleagues found that the oral EZH2 inhibitor tazemetostat produced durable responses in patients with relapsed or refractory follicular lymphoma with or without an EZH2 mutation. As noted by the investigators,...
Tazemetostat in Patients With Advanced Epithelioid Sarcoma and Loss of INI1/SMARCB1
As reported in The Lancet Oncology by Mrinal Gounder, MD, and colleagues, findings in a cohort of a phase II basket trial showed that the oral EZH2 inhibitor tazemetostat produced durable responses in some patients with advanced epithelioid sarcoma with loss of INI1 or SMARCB1 (the gene encoding...
First-Line PD-1 Inhibitor With or Without Chemotherapy vs Chemotherapy Alone in Advanced Gastric Cancer: KEYNOTE-062
As reported in JAMA Oncology by Kohei Shitara, MD, and colleagues, the phase III KEYNOTE-062 trial showed no significant improvement in overall or progression-free survival with first-line pembrolizumab with or without chemotherapy vs chemotherapy alone in patients with PD-L1–positive advanced...
First-Line Pazopanib vs Doxorubicin in Patients Aged 60 or Older With Metastatic Soft-Tissue Sarcoma
In a German Intergroup phase II study reported in the Journal of Clinical Oncology, Grünwald et al found that progression-free survival with first-line pazopanib was noninferior to doxorubicin in patients aged 60 years or older with inoperable metastatic soft-tissue sarcoma. Pazopanib was also...
Avelumab in Maintenance Treatment of Urothelial Carcinoma
On June 30, 2020, avelumab was approved for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.1,2 Supporting Efficacy Data Approval was based on findings in the randomized, multicenter, ...
Comparing Pazopanib to Doxorubicin in Patients Aged 60 and Older With Soft-Tissue Sarcoma
Doxorubicin is a standard of care in patients with advanced inoperable soft-tissue sarcoma. In the EPAZ study, German researchers tested whether pazopanib showed comparable efficacy to doxorubicin in the first-line treatment of elderly patients with soft-tissue sarcoma. Grünwald et al reported in...
Novel Indications and New Drugs for the Treament of Patients With Renal Cell Carcinoma
Pembrolizumab Plus Axitinib: On April 19, 2019, pembrolizumab (Keytruda) was approved for use in combination with the small-molecule tyrosine kinase inhibitor axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma. Approval was based on findings in the phase...
Physicians, New Drugs, and Pharma
The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have approved record numbers of new cancer drugs recently. This is extraordinarily good news for physicians, patients, and drug companies, but it raises important questions as to how effective these drugs are, whether...
Tazemetostat for Adults With Relapsed or Refractory Follicular Lymphoma
On June 18, 2020, the EZH2 inhibitor tazemetostat was granted accelerated approval for the treatment of adults with relapsed or refractory follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test, and who have...
Two Cohort Studies Identify Risk Factors for Mortality in Patients With Cancer and COVID-19
Two studies recently reported in The Lancet have identified risk factors for mortality among patients with cancer and COVID-19.1,2 As reported by Lennard Y.W. Lee, DPhil, of the Institute of Cancer and Genomic Sciences, University of Birmingham, and colleagues,1 a UK prospective cohort study...
In Keynote Lecture, Anthony Fauci, MD, Explores What We Know About COVID-19 and What’s Being Done to Combat It
Kicking off the American Association for Cancer Research (AACR) Virtual Meeting: COVID-19 and Cancer earlier this week, Anthony Fauci, MD, gave the keynote lecture, “Coronavirus Infections: More Than Just the Common Cold.” As Dr. Fauci told listeners, “[COVID-19]—and other infectious...
FDA Approves Maintenance Avelumab for the Treatment of Advanced Urothelial Carcinoma
On June 30, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. JAVELIN Bladder 100 Efficacy of avelumab...
FDA Grants Accelerated Approval to Tazemetostat for Some Patients With Follicular Lymphoma
On June 18, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik), an EZH2 inhibitor, for adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have...
UKCCMP Prospective Cohort Study of COVID-19 Mortality in Patients With Cancer
As reported by Lee et al in The Lancet, a prospective cohort study from the United Kingdom performed by the UK Coronavirus Cancer Monitoring Project (UKCCMP) has found that increased risk of COVID-19 mortality in patients with cancer is associated with such factors as age, sex, and comorbidities,...
Pembrolizumab, Trastuzumab, and Chemotherapy in HER2-Positive Metastatic Esophagogastric Cancer
In a single-center phase II trial reported in The Lancet Oncology, Janjigian et al found that the addition of pembrolizumab to trastuzumab and chemotherapy showed activity in the first-line treatment of HER2-positive metastatic esophagogastric cancer. Study Details The investigator-initiated trial...
Tribute to Bernard Fisher, MD
Bernard Fisher, MD, who died on October 16, 2019, at the age of 101, is recognized today for his groundbreaking research in breast cancer, which ultimately ended the standard practice of performing the Halsted radical mastectomy, a treatment that had been in place for more than 75 years. His...
Ivosidenib Plus Venetoclax With or Without Azacitidine for IDH1-Mutated AML
Combination therapy with the isocitrate dehydrogenase 1 (IDH1) inhibitor ivosenidib plus the BCL2 inhibitor venetoclax with or without the chemotherapeutic agent azacitidine showed activity in patients with IDH1-mutated acute myeloid leukemia (AML) in a phase Ib/II trial. The results of the...
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...
A Message From the FDA OCE for Patients With Cancer and Health-Care Providers on COVID-19
On March 23, the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) issued the following statement: The FDA OCE recognizes that patients with cancer constitute a vulnerable population at risk of contracting the coronavirus disease (COVID-19). While everyone’s daily lives...
Spring 2020 ABIM Maintenance of Certification Exams Canceled
The American Board of Internal Medicine (ABIM) has announced that all spring 2020 maintenance of certification (MOC) assessment administrations are canceled in light of the COVID-19 pandemic. They issued the following communication: As frontline health-care professionals, many board-certified...
Tazemetostat for Advanced Epithelioid Sarcoma
On January 23, 2020, tazemetostat was granted accelerated approval for the treatment of adults and pediatric patients aged 16 and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.1,2 Supporting Efficacy Data Approval was based on the finding of...
Treating Typical Solitary Fibrous Tumor With a Tyrosine Kinase Inhibitor
In a European phase II trial reported in The Lancet Oncology, Martin-Broto et al found that pazopanib showed activity in patients with typical solitary fibrous tumors. The investigators previously reported findings with pazopanib treatment in a cohort of patients in the trial with advanced...
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 ...
Venetoclax Plus Dexamethasone Shows Activity in t(11;14) Multiple Myeloma
In a phase I/II study of patients with advanced multiple myeloma and t(11;14) translocations, the combination of venetoclax and dexamethasone showed strong, durable activity, even in patients refractory to daratumumab, study investigators reported at the 2019 American Society of Hematology (ASH)...
Activity of Anti-BCMA BiTE Molecule AMG 420 in Relapsed or Refractory Multiple Myeloma
In a phase I study reported in the Journal of Clinical Oncology, Max S. Topp, MD, and colleagues found the maximum tolerated dose of the investigational anti–B cell maturation antigen (BCMA) bispecific T-cell engager (BiTE) molecule AMG 420 elicited a high response rate in patients with relapsed or ...
FDA Approves Tazemetostat for Epithelioid Sarcoma
On January 23, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik) for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. “Epithelioid sarcoma accounts...
CancerCare to Provide Support for Patients With Cancer Impacted by the California Wildfires
As many California residents continue to deal with the aftermath of past wildfires and the advent of new ones, CancerCare is now offering a patient assistance program for both emotional and financial support to patients with cancer affected by the California fires. As a leading national nonprofit...
Is Nonmetastatic Castration-Resistant Prostate Cancer a Valid Disease Category?
Does nonmetastatic castration-resistant prostate cancer really exist? Although it is considered a disease category, it turns out that the definition depends on the type of imaging used. Many patients with castration-resistant prostate cancer who were categorized as “nonmetastatic” on conventional...
Activity of Glucocorticoid-Induced TNF Receptor–Related Protein Agonist Alone or With Nivolumab in Advanced Solid Tumors
In a phase I/IIa study reported in JAMA Oncology, Lillian L. Siu, MD, FRCPC, FASCO, and colleagues found no evidence of activity of the glucocorticoid-induced tumor necrosis factor (TNF) receptor–related protein (GITR) agonist antibody BMS-986156 alone or in combination with nivolumab in patients...
ASCO Provides Guidance on Managing Osteoporosis in Cancer Survivors
Cancer survivors are at an increased risk of osteoporotic fractures due to the accelerated loss of bone mineral density as a result of their treatment. Bone loss from cancer therapy is faster and more severe than bone less from aging; rates of bone loss are up to sevenfold higher when they occur...
Affirming Universal Health Care as a Fundamental Human Right
This year’s meeting of the World Cancer Leaders’ Summit: Cancer and Universal Health Coverage, held on October 15–17 in Nur-Sultan, Kazakhstan, brought together more than 350 global health leaders, including ministers of health, first ladies, and industry leaders, from 82 countries to discuss how...
ESMO Congress 2019: Quick Takes From Key Clinical Trials
The ESMO Congress continues to grow as a pivotal platform for research in clinical oncology. At the ESMO Congress 2019, important findings were showcased in more than 2,200 studies, including 93 late-breaking abstracts. The ASCO Post summarized much of that news in separate articles over several...
Hepatic Arterial Infusion of Floxuridine Plus Systemic Gemcitabine/Oxaliplatin for Unresectable Intrahepatic Cholangiocarcinoma
In a single-center phase II trial reported in JAMA Oncology, Andrea Cercek, MD, and colleagues found that hepatic arterial infusion of floxuridine in combination with systemic gemcitabine/oxaliplatin produced high response and disease control rates and was associated with promising overall survival ...
Gene Therapy: A March Forward!
GUEST EDITORS Dr. Abutalib is Associate Director, Hematology and Cellular Therapy Program and Director, Clinical Apheresis Program Cancer Treatment at Centers of America, Zion, Illinois; Associate Professor, Rosalind Franklin University of Medicine and Science; and Founder and Co-Editor of...
Avelumab Plus Axitinib in Advanced Renal Cell Carcinoma
Earlier this year, avelumab was approved for use in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma.1,2 Supporting Efficacy Data Approval was based on findings in the open-label phase III -JAVELIN Renal 101 trial (ClinicalTrials.gov identifier...
Exposure to Secondhand E-Cigarette Aerosols Increasing Among Middle and High School Students
A growing number of middle and high school students are being exposed to secondhand aerosols from electronic cigarettes (e-cigarettes) by living with or being around individuals who are vaping, according to data from a national survey. Such exposure increased rapidly in 2018 compared to the years...
Direct-Acting Antiviral Therapy and Reduced Mortality in Patients With Hepatitis C and a History of Liver Cancer
A study published by Singal et al in Gastroenterology demonstrated that treatment with antiviral therapy for hepatitis C reduced liver-related deaths by nearly 50% in patients with a history of liver cancer. Previous Research The finding builds on a December 2018 study by Singal et al also...
Some Practices May Not Be Subject to USP and Standards
ASCO recently received clarification from the United States Pharmacopeia (USP) around the newly revised USP General Chapter <797> Pharmaceutical Compounding Standards–Sterile Preparations and USP General Chapter <800> Hazardous Drugs–Handling in Health-Care Settings, which become...
Pexidartinib for Tenosynovial Giant Cell Tumor
On August 2, the oral colony-stimulating factor 1 receptor inhibitor pexidartinib was approved for treatment of adult patients with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery.1,2 It is the first...
Pazopanib or Methotrexate/Vinblastine in Progressive Desmoid Tumors
In the French Sarcoma Group noncomparative phase II DESMOPAZ trial reported in The Lancet Oncology, Toulmonde et al found that the oral vascular endothelial growth factor (VEGF) receptor inhibitor pazopanib was active in adult patients with progressive desmoid tumors. As noted by the investigators, ...
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,...
Artificial Intelligence to Guide Management of Pancreatic Cysts
In a proof-of-concept study, an international scientific team has shown that a laboratory test using artificial intelligence tools has the potential to more accurately sort out which people with pancreatic cysts will eventually develop pancreatic cancers. Their findings were published by Springer...
