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Showing 6201 - 6250Adjuvant Dabrafenib/Trametinib Combination Granted FDA Breakthrough Therapy Designation for Stage III Melanoma With BRAF V600 Mutation
On October 23, Novartis announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following...
Final Results of German Trial of PET-Guided Treatment in Advanced Hodgkin Lymphoma
Final results of the German Hodgkin Study Group phase III HD18 trial, reported in The Lancet by Borchmann et al, showed no benefit of adding rituximab (Rituxan) to escalated BEACOPP (eBEACOPP; bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) in...
ASCO/CCO Focused Guideline Update on Role of Bone-Modifying Agents in Metastatic Breast Cancer
As reported by Catherine Van Poznak, MD, of the University of Michigan, Ann Arbor, and colleagues in the Journal of Clinical Oncology, ASCO and Cancer Care Ontario (CCO) have collaborated in providing a focused update for the ASCO clinical practice guideline on the role of bone-modifying agents in...
AACR-NCI-EORTC: Rising Number of Seamless Clinical Trials in Oncology
The number of early-phase trials in oncology that adopted a seamless approach—as opposed to a traditional trial approach with defined phase I, II, and III plans—is rising, with data from the majority of them presented after 2014, according to a study presented by Barata et al at the...
AACR-NCI-EORTC: Tazemetostat as Treatment for Certain Pediatric Relapsed or Refractory Solid Tumors
Children with relapsed or refractory malignant rhabdoid tumors, epithelioid sarcomas, or poorly differentiated chordomas with a particular genetic defect tolerated treatment with the investigational drug tazemetostat well, and some had objective and durable responses, according to data from a phase ...
AACR-NCI-EORTC: Gene Therapy Shows Early Efficacy Against Recurrent Brain Cancer
More than a quarter of patients with recurrent high-grade glioma treated with the retroviral vector Toca 511 (vocimagene amiretrorepvec) combined with Toca FC (an extended-release formulation of fluorocytosine, a prodrug of fluorouracil [5-FU]) were alive more than 3 years after...
2-Year Survival Outcomes With Immunotherapy in Advanced NSCLC
Analysis of 2-year overall survival with nivolumab (Opdivo) vs docetaxel in the phase III CheckMate 017 and 057 trials showed a continued survival benefit with nivolumab in patients with previously treated advanced non–small cell lung cancer (NSCLC). The findings were reported by Horn et al...
Combination Therapy for Docetaxel-Pretreated Metastatic Castration-Resistant Prostate Cancer
The phase III AFFINITY trial has shown no survival benefit with the addition of the antisense oligonucleotide custirsen to cabazitaxel (Jevtana)/prednisone in patients with metastatic prostate cancer previously treated with docetaxel. These findings were reported in The Lancet Oncology by Beer et...
FDA Accepts sBLA for Nivolumab in Resected, High-Risk, Advanced Melanoma
On October 16, Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) to treat patients with melanoma who are at high risk of disease recurrence following complete...
FDA Approves Intravenous Rolapitant for Delayed Chemotherapy-Induced Nausea and Vomiting
On October 25, the U.S. Food and Drug Administration (FDA) approved intravenous (IV) rolapitant (Varubi) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including,...
CELESTIAL Trial: Cabozantinib Meets Primary Endpoint of Overall Survival in Patients With Advanced Hepatocellular Carcinoma
On October 16, Exelixis announced that its global phase III CELESTIAL trial met its primary endpoint of overall survival, with cabozantinib (Cabometyx) providing a statistically significant and clinically meaningful improvement in median overall survival compared to placebo in patients with...
Anti–T-Lymphocyte Globulin and Chronic GVHD-Free Survival in Unrelated Myeloablative HCT
A double-blind phase III trial has shown no benefit of anti–T-lymphocyte globulin (ATLG) vs placebo on chronic graft-vs-host disease (GVHD)-free survival in patients undergoing human leukocyte antigen (HLA)-matched unrelated myeloablative hematopoietic cell transplantation (HCT). The study...
Extended Aromatase Inhibitor Therapy After Sequential Endocrine Therapy
In the Dutch phase III DATA trial reported in The Lancet Oncology by Tjan-Heinjen et al, a nonsignificant disease-free survival advantage was found for 6 vs 3 years of adjuvant aromatase inhibitor therapy after 2 to 3 years of tamoxifen in hormone receptor–positive early breast cancer....
FDA Grants Priority Review for Olaparib in Metastatic Breast Cancer
On October 18, AstraZeneca and Merck & Co announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a supplemental New Drug Application (sNDA) for the use of olaparib (Lynparza) tablets in patients with germline BRCA-mutated, HER2-negative...
MAF Amplification and Outcomes With Adjuvant Zoledronic Acid in Early Breast Cancer
An analysis from the phase III AZURE trial has shown that MAF-negative status was associated with a benefit and MAF-positive status, with a detriment of adjuvant zoledronic acid in early breast cancer. The analysis was reported by Coleman et al in The Lancet Oncology. Study Details The current...
Effectiveness of Sentinel Lymph Node Biopsy in Patients With Newly Diagnosed Melanoma
Research presented at the 9th World Congress of Melanoma supports the updated guideline recommendation that sentinel lymph node biopsy be performed in more patients newly diagnosed with melanoma, as it has the potential to save lives due to the information the procedure provides. This biopsy can...
Intratumoral Plasmid IL-12 With Electroporation in Stage III/IV Melanoma
OncoSec Medical Incorporated presented new clinical data on ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid] with electroporation) at the 9th World Congress of Melanoma. “We are excited to share updated data from our phase II clinical monotherapy trial with ImmunoPulse ...
FDA Accepts sBLA for Durvalumab in Locally Advanced Unresectable NSCLC
On October 17, the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for durvalumab (Imfinzi) for the treatment of patients with locally advanced (stage III) unresectable non–small cell lung cancer (NSCLC) whose disease has not progressed ...
FDA Awards Grants for Clinical Trials to Stimulate Product Development for Rare Diseases
THE U.S. FOOD and Drug Administration (FDA) has awarded numerous new clinical trial research grants, totaling more than $22 million over the next 4 years, to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and ...
Carfilzomib May Be a Strong Candidate for Salvage Therapy in Relapsed/Refractory Multiple Myeloma—but Questions Remain
WITH THE INCLUSION of proteasome inhibitors and immunomodulatory agents first into salvage and then as components of first-line, consolidation, and maintenance regimens, response rates, depth of response, and median progression-free and overall survival have all improved for patients suffering...
Carfilzomib Improves Overall Survival vs Bortezomib in Relapsed/Refractory Multiple Myeloma
AT A PRESPECIFIED interim analysis, the phase III ENDEAVOR trial has shown a significant overall survival benefit for carfilzomib (Kyprolis) vs bortezomib (Velcade) in patients with relapsed/refractory multiple myeloma, as reported by Meletios A. Dimopoulos, MD, of the National and Kapodistrian...
Regional Radiation Therapy Reduces Risk of Regional Recurrence in Node-Positive Cutaneous Melanoma
IN A LARGE single-institution study reported in the Journal of the National Comprehensive Cancer Network, Tobin Strom, MD, and colleagues found that regional radiotherapy was associated with a reduced risk of regional recurrence in patients with node-positive cutaneous melanoma, including those...
No Progression-Free Survival Benefit With First-Line Nivolumab vs Chemotherapy in Advanced PD-L1–Positive NSCLC
AS REPORTED BY David P. Carbone, MD, PhD, of The Ohio State University Comprehensive Cancer Center, Columbus, and colleagues in The New England Journal of Medicine, the phase III CheckMate 026 trial has shown no progression-free survival benefit for first-line nivolumab (Opdivo) vs platinum-based...
Phase III Trial Shows No Survival Benefit to Adding First-Line Ipilimumab to Chemotherapy in Advanced Squamous NSCLC
IN A PHASE III trial reported by Ramaswamy Govindan, MD, of Washington University School of Medicine, and colleagues in the Journal of Clinical Oncology, the addition of first-line ipilimumab (Yervoy) to paclitaxel/carboplatin did not improve overall survival in patients with advanced squamous...
Nivolumab/Ipilimumab in Patients With Advanced Melanoma Who Did or Did Not Discontinue Induction Treatment due to Adverse Events
IN A RETROSPECTIVE pooled analysis of the CheckMate 069 and 067 studies reported in the Journal of Clinical Oncology, Dirk Schadendorf, MD, of the University Hospital Essen and the German Cancer Consortium, and colleagues found little difference in the efficacy of combined nivolumab (Opdivo) and...
Tremelimumab in Previously Treated Advanced Malignant Mesothelioma
In the randomized phase IIB DETERMINE trial, the cytotoxic T-lymphocyte–associated protein 4 (CTLA-4) inhibitor tremelimumab did not improve overall survival vs placebo as second- or third-line treatment of relapsed malignant mesothelioma. These findings were reported in The Lancet Oncology by...
Nivolumab Treatment Beyond Disease Progression in Advanced Melanoma
In a retrospective analysis reported in JAMA Oncology, Georgina V. Long, MBBS, PhD, of the Melanoma Institute Australia, North Sydney, and colleagues found that a substantial proportion of patients with advanced melanoma derived benefit from continued nivolumab (Opdivo) treatment after Response...
Expert Point of View: Markus Joerger, MD, PhD, and Domenica Lorusso, MD, PhD
PRESS CONFERENCE MODERATOR Markus Joerger, MD, PhD, of St. Gallen Cancer Center, Switzerland, indicated that prior to the current study, it was unclear whether chemotherapy followed by surgery would be superior to chemoradiotherapy. “I think we all agree that it has been confirmed as the standard...
Expert Point of View: Alexander Eggermont, MD, PhD
BASED ON THE RESULTS of COMBI-AD1 and CheckMate 238,2 invited discussant Alexander Eggermont, MD, PhD, Professor of Oncology at Gustave Roussy in Paris, commented: “It’s a good day for melanoma!” In COMBI-AD, treatment with the combination of dabrafenib (Tafinlar) and trametinib (Mekinist)...
CheckMate 238: Nivolumab Shows Benefit as Adjuvant Melanoma Treatment
IN THE TREATMENT of malignant melanoma, immune checkpoint inhibitors are no longer just for metastatic disease, and the best type may be agents targeting the programmed cell death protein 1 (PD-1), according to results of CheckMate 238, presented at the European Society for Medical Oncology (ESMO)...
Adjuvant BRAF/MEK Inhibition Improves Survival in Resectable Melanoma
FOR PATIENTS with locally advanced, resectable melanoma harboring BRAF mutations, adjuvant treatment with BRAF/ MEK inhibition significantly improves overall survival, results of the COMBI-AD trial have shown. The study was presented at the European Society for Medical Oncology (ESMO) 2017...
Expert Point of View: Luis Paz-Ares, MD
FORMAL DISCUSSANT of the ALEX and ALUR trials, Luis Paz-Ares, MD, Professor of Medicine at the Hospital Universitario 12 de Octubre, Madrid, said that the ALEX trial is “good news” for patients. “Importantly, 40% had baseline metastases. Disease progression was nicely controlled with alectinib...
Alectinib Yields Favorable Results in Phase III Trials of ALK-Positive NSCLC
RESULTS OF TWO separate phase III trials confirm the activity of alectinib (Alecensa) in the central nervous system (CNS) in patients with anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC). Results lend support for alectinib as the better first-line treatment option over...
Abiraterone or Docetaxel: Which Is Optimal for Hormone-Sensitive High-Risk Prostate Cancer?
ABIRATERONE ACETATE (Zytiga) plus prednisone and docetaxel have moved up from the castrate-resistant metastatic setting to earlier in the course of disease as treatment of high-risk hormone-sensitive prostate cancer in men who are initiating androgen-deprivation therapy, based on level 1 evidence...
Positive Early Data on Second-Line Ramucirumab/Docetaxel in Platinum-Refractory Advanced Urothelial Cancer
RAMUCIRUMAB (CYRAMZA) added to docetaxel improved progression-free survival and almost doubled the overall response rate compared with docetaxel alone in patients with advanced or metastatic urothelial cancer that has progressed on platinum-based chemotherapy. These results of the phase III RANGE...
Expert Point of View: Paul Harari, MD
COMMENTING ON THIS STUDY, ASTRO President Paul Harari, MD, was enthusiastic about the results. Dr. Harari is the Jack Fowler Professor and Chairman of the Department of Human Oncology at the University of Wisconsin School of Medicine and Public Health and Associate Director of the University of...
Cutting Radiation Exposure by 50% Appears Safe and Effective in HPV-Positive Head and Neck Cancer
AGGRESSIVE REDUCTION in radiation therapy appears to be a potential win-win situation for patients with human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma, according to the results of a phase II trial presented at the 2017 Annual Meeting of the American Society for...
Expert Point of View: Brian G. Czito, MD, and Benjamin Movsas, MD
BRIAN G. CZITO, MD, a radiation oncologist at Duke Cancer Institute in Durham, North Carolina, commented on the study presented by Iyengar et al at the 2017 American Society for Radiation Oncology Annual Meeting. “This study of focal high-dose radiation in stage IV patients with limited...
Consolidative Radiation Therapy: New Paradigm for Limited Metastatic NSCLC?
ADDING CONSOLIDATIVE RADIATION therapy to maintenance chemotherapy had a robust effect on preventing disease progression compared with maintenance chemotherapy alone in patients with limited metastatic non–small cell lung cancer (NSCLC), according to a late-breaking study presented at the 2017...
IASLC 2017: First-Line Pembrolizumab Increases Overall Survival vs Chemotherapy in Metastatic NSCLC With High Levels of PD-L1
Updated overall survival findings from the phase III KEYNOTE-024 trial evaluating pembrolizumab (Keytruda) as a first-line monotherapy in patients with non–small cell lung cancer (NSCLC) whose tumors express high levels of programmed cell death ligand 1 (PD-L1) were presented at the...
IASLC 2017: Treatment Based on BRCA1 Level Does Not Increase Survival of Stage II/III NSCLC Node-Positive Resected Patients
New research shows that treating stage II and III non–small cell lung cancer (NSCLC) node-positive resected patients with customized chemotherapy based on their specific BRCA1 expression levels, as opposed to providing the standard treatment, did not increase overall survival rates among...
IASLC 2017: REVEL Trial Subgroup Analysis Further Clarifies Outcomes With Ramucirumab Plus Docetaxel in Advanced Non–Small Cell Lung Cancer
New subgroup analysis from the phase III REVEL trial of ramucirumab (Cyramza) in advanced non–small cell lung cancer (NSCLC) was presented at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer in Yokohama, Japan. Specifically, these...
PI3K Inhibition in Relapsed or Refractory Indolent Lymphoma
As reported in the Journal of Clinical Oncology by Dreyling et al, the phase II CHRONOS-1 trial has shown a high response rate and durable responses with the phosphatidylinositol 3-kinase (PI3K) inhibitor copanlisib (Aliqopa) in adults with relapsed or refractory indolent lymphoma who had received...
Immunotherapy for Previously Treated Advanced Gastric Cancer
In an Asian phase III trial (ONO-4538-12, ATTRACTION-2) reported in The Lancet, Kang et al found that nivolumab (Opdivo) produced an improvement in overall survival vs placebo in patients with advanced gastric or gastroesophageal junction cancer who had disease refractory to or who were intolerant...
FDA Grants Priority Review for Cabozantinib in Previously Untreated Advanced Renal Cell Carcinoma
On October 16, the U.S. Food and Drug Administration (FDA) determined the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for patients with previously untreated advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review. The FDA granted...
IASLC 2017: Combination of Lurbinectedin and Doxorubicin in Relapsed Small Cell Lung Cancer
The final efficacy and safety data obtained from a phase I/II trial combining lurbinectedin (PM1183) with doxorubicin in relapsed small cell lung cancer were presented during a Research Perspectives oral session at the International Association for the Study of Lung Cancer (IASLC) 18th World...
Maintenance Therapy After ASCT in Younger Patients With Mantle Cell Lymphoma
In a French phase III trial, maintenance rituximab (Rituxan) improved event-free survival vs observation after autologous stem cell transplantation (ASCT) in younger patints with mantle cell lymphoma. These findings were reported by Le Gouill et al in The New England Journal of Medicine. Study...
Addition of EGFR Tyrosine Kinase Inhibitor to Chemotherapy in Resistant Non–Small Cell Lung Cancer
As reported by Mok et al in the Journal of Clinical Oncology, overall survival analysis of the phase III IMPRESS trial indicated a poorer outcome when adding gefitinib (Iressa) vs placebo to chemotherapy after disease progression on first-line gefitinib in epidermal growth factor receptor...
sNDA Submitted for Rucaparib as Maintenace Treatment for Patients With Platinum-Sensitive Recurrent Ovarian Cancer
On October 9, Clovis Oncology announced that the company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for rucaparib (Rubraca) as maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer...
Results From the Phase III JUNIPER Trial Evaluating Abemaciclib in KRAS-Mutated, Advanced NSCLC
On October 10, Eli Lilly and Company announced that its phase III JUNIPER study evaluating abemaciclib (Verzenio), a cyclin-dependent kinase (CDK) 4 and CDK6 inhibitor, as monotherapy in KRAS-mutated, advanced non–small lung cancer (NSCLC) did not meet its primary endpoint of overall...
