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Showing 16051 - 16100ICER Releases Draft Evidence Report on CAR T-Cell Therapy for B-Cell Cancers
On December 19, the Institute for Clinical and Economic Review (ICER) released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta). The draft report, along with draft voting...
Nivolumab for Adjuvant Treatment of Melanoma Granted Regular Approval by FDA
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to the anti–programmed cell death protein 1 (PD-1) monoclonal antibody nivolumab (Opdivo) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes, or in patients with...
FDA Grants Regular Approval to Pertuzumab for Adjuvant Treatment of HER2-Positive Breast Cancer
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. APHINITY...
Sexual Problems and Cancer: ASCO Clinical Practice Guideline Adaptation of CCO Guideline
As reported in the Journal of Clinical Oncology by Jeanne Carter, PhD, of Memorial Sloan Kettering Cancer Center, and colleagues, ASCO has issued a clinical practice guideline adaptation of the Cancer Care Ontario (CCO) guideline on interventions to address sexual problems in people with cancer....
BTK Inhibitor in Relapsed or Refractory Mantle Cell Lymphoma
A phase II study (ACE-LY-004) reported in The Lancet by Wang et al showed durable responses with the Bruton tyrosine kinase inhibitor acalabrutinib (Calquence) in patients with relapsed or refractory mantle cell lymphoma. The study supported the recent approval of acalabrutinib in this setting....
FDA Approves Cabozantinib for First-Line Treatment of Advanced Renal Cell Carcinoma
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to cabozantinib (Cabometyx) for treatment of patients with advanced renal cell carcinoma (RCC). The FDA previously approved cabozantinib in 2016 for treatment of patients with advanced RCC who have received...
FDA Grants Accelerated Approval to Bosutinib for Treatment of Newly Diagnosed Philadelphia Chromosome–Positive CML
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bosutinib (Bosulif) for treatment of patients with newly diagnosed chronic-phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML). BFORE Trial Approval was based on data from ...
California Trends in Cancer Survival by Health Insurance Status
A study using California Cancer Registry data showed that survival improvements in patients with cancer between 1997 and 2014 have largely been limited to those with private or Medicare insurance. These findings were reported in JAMA Oncology by Libby et al. Study Details The study involved...
Combination Agent in Asian Patients With Previously Treated Metastatic Colorectal Cancer
In the Asian phase III TERRA trial, trifluridine/tipiracil (Lonsurf) produced a significant improvement in overall survival vs placebo among patients with metastatic colorectal cancer refractory or intolerant of standard chemotherapies with or without exposure to biologic therapies. These findings...
FDA Accepts sNDA for Osimertinib in First-Line Treatment of EGFR-Mutated NSCLC
On December 18, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for the use of osimertinib (Tagrisso)—a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central...
Howard A. ‘Skip’ Burris III, MD, FACP, FASCO, Elected ASCO President for 2019–2020 Term
Howard A. “Skip” Burris III, MD, FACP, FASCO, a long-time member and volunteer, has been elected to serve as the President of ASCO for the term beginning in June 2019. He will take office as President-Elect during the ASCO Annual Meeting in Chicago in June 2018. Additionally, five...
Study Finds Racial Disparities in Treatment of Clinically Significant Prostate Cancer
In a study reported in the Journal of Oncology Practice, Bickell et al found underuse of treatment for clinically significant prostate cancer was infrequent among white and black patients at two New York City hospitals, but black men accounted for nearly all such underuse of treatment. As noted by...
CAR T-Cell Therapy in Refractory B-Cell Lymphomas
As reported at the recent American Society of Hematology Annual Meeting & Exposition and in The New England Journal of Medicine, Schuster et al found that chimeric antigen receptor (CAR) T-cell therapy produced responses in a high proportion of patients with B-cell lymphomas refractory to or...
Updated Data in KEYNOTE-061: Pembrolizumab in Previously Treated Gastric or Gastroesophageal Junction Adenocarcinoma
The phase III KEYNOTE-061 trial investigating pembrolizumab (Keytruda) as a second-line treatment for patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma did not meet its primary endpoint of overall survival (OS) (hazard ratio [HR] = 0.82, 95% confidence interval [CI] = ...
Nearly 100 Leading Cancer Researchers and Physician-Scientists Urge Congress to Reach a Bipartisan Budget Agreement and Invest in Medical Research
On December 6, the American Association for Cancer Research (AACR) delivered a letter from the current AACR President and Past Presidents—as well as Fellows of the AACR Academy that include 18 Nobel Laureates—to urge leaders in the House and Senate to “move quickly to finalize a...
FDA Accepts sNDA for Rucaparib in Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
On December 5, Clovis Oncology announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for rucaparib (Rubraca) and granted Priority Review status to the application, with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018. In...
Updated SCOUT Trial Data Demonstrate Response to Larotrectinib in TRK Fusion Cancers
At the Special Conference on Pediatric Cancer Research, convened in Atlanta by the American Association for Cancer Research, investigators announced updated clinical data from the larotrectinib (LOXO-101) pediatric phase I SCOUT trial. Bayer and Loxo Oncology are jointly developing larotrectinib,...
Does Warfarin Have Anticancer Potential in Persons Older Than Age 50?
A Norwegian population–based cohort study indicated that the use of warfarin was associated with a reduced risk of cancer overall and site-specific cancers among patients aged > 50 years. The findings were reported in JAMA Internal Medicine by Haaland et al. As noted by the investigators,...
Phase I Study Finds ERK1/2 Inhibitor Safe and Active in Advanced Solid Tumors
Ulixertinib (BVD-523) is an ERK1/2 kinase inhibitor with potent preclinical activity in BRAF- and RAS-mutant cell lines. Now, a multicenter phase I study investigating its safety and efficacy in the treatment of patients with advanced solid tumors has found that ulixertinib to have an acceptable...
FDA Accepts sBLA for Nivolumab Plus Ipilimumab in Intermediate- and Poor-Risk Patients With Advanced Renal Cell Carcinoma
On December 13, the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) for priority review of nivolumab (Opdivo) plus ipilimumab (Yervoy) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma. The FDA also previously...
ASH 2017: Acalabrutinib Demonstrates Activity in Relapsed or Refractory Mantle Cell Lymphoma
At the 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Wang et al presented results from the open-label, single-arm phase II ACE-LY-004 clinical trial, which served as the basis for the recent U.S. Food and Drug Administration (FDA) accelerated approval of acalabrutinib...
ASH 2017: ALCANZA Trial: Brentuximab Vedotin in CD30-Expressing Cutaneous T-Cell Lymphoma
Updated results from the phase III ALCANZA clinical trial evaluating brentuximab vedotin (Adcetris) in CD30-expressing cutaneous T-cell lymphoma (CTCL) were presented by Horwitz et al at the 59th American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 1509). The presentation...
Primary Tumor Location and Outcomes in Stage III Colon Cancer According to RAS- and BRAF-Mutation Status
In a study in the PETACC-8 trial population reported in JAMA Oncology, Taieb et al found that the risk of recurrence in patients with stage III colon cancer differed for the primary tumor location according to RAS- and BRAF-mutation status. Study Details A total of 2,559 patients were...
Anti–PD-L1 Antibody in Advanced Urothelial Carcinoma After Platinum Failure
As reported in The Lancet Oncology by Patel et al, the anti–programmed cell death ligand 1 (PD-L1) antibody avelumab (Bavencio) produced durable responses in patients with locally advanced or metastatic urothelial carcinoma after failure of platinum-based therapy in two expansion cohorts of...
ASH 2017: Low–Molecular-Weight Heparin/Edoxaban vs Dalteparin for VTE Associated With Cancer
People with cancer face an increased risk for venous thromboembolism (VTE). Under current guidelines, cancer patients who develop VTE are prescribed low–molecular-weight heparin, an anticoagulant that must be injected under the skin daily for several months. While effective, this regimen can...
ASH 2017: HERCULES Trial: Caplacizumab Shows Dramatic Improvements for Acquired Thrombotic Thrombocytopenic Purpura
In a phase III trial, patients with acquired thrombotic thrombocytopenic purpura (TTP), a rare blood clotting disorder, who received the investigational drug caplacizumab showed significant improvements in the time it took to normalization of their platelet count compared to those receiving a...
Number of Metastatic Lymph Nodes and Survival in Hypopharyngeal/Laryngeal Cancer
A study using National Cancer Database data has shown that the number of metastatic nodes is a primary independent factor associated with an increased mortality risk in patients with hypopharyngeal and laryngeal cancers. The study was reported in JAMA Oncology by Ho et al. Study Details The study ...
Prognostic Factors in Stage III Favorable-Histology Wilms Tumor
An analysis from the Children’s Oncology Group Study AREN0532 reported in the Journal of Clinical Oncology by Fernandez et al showed that positive lymph nodes and loss of heterozygosity (LOH) at chromosome 1p or 16q are associated with poorer event-free survival in patients with stage III...
Hormonal Contraception and Breast Cancer Risk
As reported in The New England Journal of Medicine by Mørch et al, a Danish study has shown that the risk of breast cancer is increased in hormonal contraception users vs nonusers, with the absolute increase in risk being small. Study Details The study assessed the association between the...
ASH 2017: MURANO Trial: Venetoclax Found Superior to Standard Chemotherapy When Combined With Rituximab in CLL
In the phase III MURANO trial, treatment with the targeted cancer drug venetoclax (Venclexta) in combination with rituximab (Rituxan) more than doubled the likelihood that patients with chronic lymphocytic leukemia (CLL) would survive for 2 years without cancer progression, compared to treatment...
ASH 2017: ALCYONE Trial: Adding Daratumumab to Bortezomib, Melphalan, and Prednisone in Multiple Myeloma
The first randomized trial to evaluate the use of a monoclonal antibody for treating newly diagnosed multiple myeloma showed that adding the drug daratumumab (Darzalex) to one of the standard treatment regimens reduced the likelihood of disease progression or death by 50%. The regimen also induced...
ASH 2017: People Aged 75 Years and Older Are Underrepresented in Blood Cancer Clinical Trials
In the first comprehensive analysis of clinical trial enrollment among older adults with blood cancers, researchers from the U.S. Food and Drug Administration (FDA) found significant gaps in participation among those aged 75 and older when considered against the incidence of these malignancies in...
Novel Clinical-Genomic Risk Group Classification for Localized Prostate Cancer
As reported in the Journal of Clinical Oncology, Spratt et al have developed an integrated clinical-genomic risk classifier for predicting distant metastasis in patients with localized prostate cancer. The classifier uses National Comprehensive Cancer Network® (NCCN) risk categories and risk...
Prevalence of Prior Cancer in Patients With Newly Diagnosed Cancer
In a study using Surveillance, Epidemiology, and End Results (SEER) data reported in JAMA Oncology, Murphy et al found that among persons newly diagnosed with cancer, 25% of those aged ≥ 65 years and 11% of those aged < 65 years had a history of a prior primary cancer. Prevalence of Prior...
BELLE-3 Trial: Combination Therapy in Resistant Advanced Breast Cancer
The phase III BELLE-3 trial has shown prolonged progression-free survival but a worse safety profile with the addition of the pan-phosphoinositide 3-kinase inhibitor buparlisib to fulvestrant (Faslodex) in postmenopausal women with hormone receptor–positive, HER2-negative advanced breast...
Identification of Cystic Precursors to Pancreatic Cancer Using Targeted Mass Spectrometry
In a study reported in the Journal of Clinical Oncology, Jabbar et al found that mass spectroscopy proteomic analysis of the pancreatic cyst fluid biomarkers mucin-5AC (MUC5AC), mucin-2 (MUC2), and prostate stem cell antigen (PSCA) identified cystic pancreatic cancers and precursor lesions with...
Study Suggests Racial Differences in Lung Tumor Biology
According to research by the American Cancer Society, lung cancer is the second most common cancer in men and women in the United States and is the leading cause of cancer-related death. In addition, among all populations, African Americans tend to have the highest lung cancer incidence and...
ASH 2017: Clinical Activity Seen With Anti-BCMA CAR T-Cell Therapy in Heavily Pretreated Multiple Myeloma
A one-time infusion of an investigational chimeric antigen receptor (CAR) T-cell therapy that targets a protein found on most multiple myeloma cells elicited an 86% overall response rate in 21 patients whose disease had come back or had not responded after a median of seven prior treatments,...
ASH 2017: JULIET Trial: 6-Month Analysis of Tisagenlecleucel in Relapsed/Refractory DLBCL Shows Sustained Responses
Six months after receiving a single dose of tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy that targets CD-19, high response rates persist among adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), according to findings reported by Schuster et al at...
ASH 2017: ZUMA-1: Responses to CAR T-Cell Therapy Still Strong After 1 Year in Patients With Refractory NHL
Among 108 patients with fast-growing and refractory aggressive non-Hodgkin lymphoma (NHL), more than half were still alive at least a year after receiving a single infusion of a CAR T-cell therapy called axicabtagene ciloleucel that targets the CD-19 protein frequently found on cancerous lymphoma...
ASH 2017: Rapid Responses, Few Adverse Effects Seen With Targeted Agent in Phase I Trial in Systemic Mastocytosis
In a phase I trial, patients with an advanced or aggressive form of systemic mastocytosis, a rare blood disorder, had rapid and durable responses with few adverse effects following treatment with an investigational drug that targets the genetic mutation found in more than 90% of cases. Results were ...
ASH 2017: CLARITY Trial: Combination Treatment With Two Targeted Agents Shows Promise in Previously Treated CLL
One-third of patients with previously treated chronic lymphocytic leukemia (CLL) had no detectable disease after 6 months of combination therapy with the targeted agents ibrutinib (Imbruvica) and venetoclax (Venclexta), with no increase in the occurrence of tumor-lysis syndrome, a serious treatment ...
ASH 2017: Addition of Brentuximab Vedotin to Multidrug Regimen Reduces Risk of First-Line Treatment Failure in Advanced Hodgkin Lymphoma
Patients with advanced Hodgkin lymphoma (HL) who were treated with a multidrug regimen that included the targeted agent brentuximab vedotin (Adcetris) had a 23% reduction in the risk of disease progression, death, or the need for additional therapy, compared with patients who received the standard...
ASH 2017: Targeted Antibody Mogamulizumab Superior to Vorinostat for Previously Treated CTCL in Phase III Trial
In a large, international, randomized phase III trial presented by Kim et al at the 59th American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 817), patients with previously treated cutaneous T-cell lymphoma (CTCL) who received the investigational targeted drug...
ASH 2017: Sustained Benefit With Ibrutinib in Relapsed or Refractory Mantle Cell Lymphoma
The results of a pooled analysis of patients with relapsed or refractory mantle cell lymphoma (MCL) treated with ibrutinib (Imbruvica) were presented at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 151). The extended follow-up data demonstrated that...
ASH 2017: RESONATE-2 Trial: Patient-Reported Outcomes on Ibrutinib Treatment in Patients With CLL
At the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition, the 3-year follow-up data from the RESONATE-2 study (PCYC-1115/1116) were presented. The investigators found that patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)...
ASH 2017: Direct Oral Anticoagulant May Reduce Recurrence of VTE in Patients With Cancer
People with cancer have an increased risk of developing blood clots, with roughly one in five experiencing venous thromboembolism (VTE). International guidelines recommend treatment using low–molecular-weight heparin, an anticoagulant that is injected subcutaneously; however, new results from ...
SABCS 2017: Older Women With Hormone Receptor–Positive Breast Cancer May Receive Similar Benefit From CDK4/6 Inhibitors as Younger Women
Older women with hormone receptor–positive, HER2-negative metastatic breast cancer who were treated with cyclin-dependent kinase (CDK) 4/6 inhibitors achieved progression-free survival at a rate similar to that of younger women, according to data presented by Singh et al at the 2017 San...
SABCS 2017: Postmenopausal Women Who Lose Weight May Have Reduced Breast Cancer Risk
Postmenopausal women who lose weight may have a significantly reduced chance of developing breast cancer, according to data presented by Chlebowski et al at the 2017 San Antonio Breast Cancer Symposium (Abstract GS5-07). “Breast cancer is among the leading types of cancer and...
SABCS 2017: Circulating Tumor Cells May Predict Late Recurrence in Patients With Hormone Receptor–Positive Breast Cancer
Among patients with hormone receptor–positive HER2-negative stage II–III breast cancer without clinical evidence of recurrence, those who had circulating tumor cells (CTCs) detected in blood 5 years after diagnosis had an increased risk for late recurrence of breast cancer, according to ...
