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Showing 2851 - 2900HIMALAYA Trial: First-Line Tremelimumab Plus Durvalumab Improves Overall Survival in Unresectable Hepatocellular Carcinoma
Patients with advanced, unresectable hepatocellular carcinoma may be gaining another first-line treatment option. In the global phase III HIMALAYA trial, a single priming dose of tremelimumab plus regular-interval durvalumab significantly improved overall survival, according to Ghassan K....
Expert Point of View: Nilofer Azad, MD
Nilofer Azad, MD, Professor of Oncology at Johns Hopkins University School of Medicine and Co-Director of Cancer Genetics and Epigenetics at the Sidney Kimmel Comprehensive Cancer Center, Baltimore, was invited to discuss the results of the phase III TOPAZ-1 study, which found an overall survival...
TOPAZ-1: Overall Survival Prolonged With First-Line Immunotherapy Plus Chemotherapy in Biliary Tract Cancer
For the first time, a phase III study has shown an overall survival benefit for upfront treatment using immunotherapy plus chemotherapy in advanced biliary tract cancer. In the TOPAZ-1 trial, the addition of the anti–PD-L1 agent durvalumab to gemcitabine plus cisplatin significantly improved...
Oncology Drugs With Accelerated Approval: Is It Time for a Reset?
Regulations that are developed by the U.S. Food and Drug Administration (FDA) must have some shelf-life before revisions are considered. The FDA has several mechanisms to provide patients with more rapid access to medicines. One such pathway is accelerated approval. Backward Glance at Accelerated...
PALLAS Trial in Hormone Receptor–Positive, HER2-Negative Breast Cancer: Defining the Role of Adjuvant CDK4/6 Inhibition
Over the past 7 years, the introduction of combined endocrine therapy with cyclin-dependent kinase (CDK) 4/6 inhibitors resulted in a dramatic improvement in outcomes for patients with metastatic, hormone receptor–positive, HER2-negative breast cancer. Early attempts to modulate the cell cycle with ...
PALLAS Trial: No Invasive Disease–Free Survival Benefit With Addition of Adjuvant Palbociclib to Endocrine Therapy in Early Breast Cancer
As reported in the Journal of Clinical Oncology by Michael Gnant, MD, of the Comprehensive Cancer Center, Medical University of Vienna, and colleagues, the final analysis of the phase III PALLAS trial has shown no invasive disease–free survival benefit with the addition of adjuvant palbociclib to...
In All Candor, What Does CANDOR Bring to the Table in Relapsed or Refractory Multiple Myeloma?
An updated analysis of the phase III CANDOR study—recently reported by Usmani et al and summarized in this issue of The ASCO Post—confirmed a significant progression-free survival benefit for the combination of daratumumab, carfilzomib, and dexamethasone (KdD) over carfilzomib and dexamethasone...
Continued Progression-Free Survival Benefit With Carfilzomib/Dexamethasone/Daratumumab vs Carfilzomib/Dexamethasone in Relapsed or Refractory Multiple Myeloma
In an updated analysis of the pivotal phase III CANDOR trial reported in The Lancet Oncology, Saad Z. Usmani, MD, of Levine Cancer Institute/Atrium Health, and colleagues found that the addition of daratumumab to carfilzomib and dexamethasone (KdD) continued to show a large progression-free...
Neoadjuvant Chemoradiotherapy vs Upfront Surgery in Resectable and Borderline Resectable Pancreatic Cancer
As reported in the Journal of Clinical Oncology by Versteijne et al, long-term follow-up of the Dutch phase III PREOPANC trial has shown an overall survival benefit among patients receiving neoadjuvant chemoradiotherapy vs upfront surgery for resectable and borderline resectable pancreatic cancer;...
Sugemalimab After Concurrent or Sequential Chemoradiation for Unresectable Stage III NSCLC
In an interim analysis of the Chinese phase III GEMSTONE-301 study reported in The Lancet Oncology, Zhou et al found that the PD-L1 inhibitor sugemalimab prolonged progression-free survival vs placebo in patients with locally advanced unresectable stage III non–small cell lung cancer (NSCLC)...
Predictive Model for Severe Fatigue After Breast Cancer Diagnosis
In a study reported in the Journal of Clinical Oncology, Di Meglio et al developed a predictive model for severe fatigue after a diagnosis of breast cancer. Study Details The study involved data on patients with stage I to III breast cancer included in the prospective multicenter CANcer TOxicity...
Efficacy of Trametinib in Recurrent Low-Grade Serous Ovarian Carcinoma
A study published by David Gershenson, MD, and colleagues in The Lancet reported that the MEK inhibitor trametinib reduced the risk of disease progression or death by 52% compared to standard-of-care therapies in low-grade serous ovarian carcinoma. The international, multicenter phase II/III trial...
High Response Rate Seen With Nivolumab Added to Encorafenib and Cetuximab in BRAF V600E–Mutated Metastatic Colorectal Cancer
The combination of the BRAF inhibitor encorafenib with cetuximab and nivolumab produced responses in 50% of patients and disease control in 96% of patients with microsatellite-stable BRAF V600E–mutated metastatic colorectal cancer in a phase I/II trial reported at the 2022 ASCO Gastrointestinal...
Expert Point of View: Demetris Papamichael, MB, BS
The invited discussant of the SOLSTICE trial1 was Demetris Papamichael, MB, BS, Consultant Medical Oncologist at the Bank of Cyprus Oncology Centre and Associate Professor at St. George’s Hospital and Medical School, University of London. He said that although the study concluded...
SOLSTICE Trial: Trifluridine/Tipiracil Plus Bevacizumab in Metastatic Colorectal Cancer
For the treatment of metastatic colorectal cancer in patients unfit for intensive chemotherapy, trifluridine/tipiracil plus bevacizumab as first-line therapy was no more effective than capecitabine plus bevacizumab, investigators from the phase III SOLSTICE trial reported in a European Society for...
PACIFIC Trial: 5-Year Survival Outcomes With Durvalumab After Chemoradiotherapy in Stage III NSCLC
As reported in the Journal of Clinical Oncology by Spigel et al, long-term follow-up of the phase III PACIFIC trial has shown maintained progression-free and overall survival benefits with consolidation durvalumab vs placebo after chemoradiotherapy in unresectable stage III non–small cell lung...
CheckMate 648: Nivolumab Plus Chemotherapy or Ipilimumab vs Chemotherapy in Previously Untreated Advanced Esophageal Squamous Cell Carcinoma
As reported in The New England Journal of Medicine by Doki et al, the phase III CheckMate 648 trial has shown improved overall survival with nivolumab combined with chemotherapy or ipilimumab vs chemotherapy alone in patients with previously untreated advanced esophageal squamous cell carcinoma, in ...
FDA Investigating Possible Increased Risk of Death With Lymphoma Treatment Umbralisib
The U.S. Food and Drug Administration (FDA) is investigating a possible increased risk of death associated with umbralisib (Ukoniq), a kinase inhibitor including PI3K-delta and CK1-epsilon, approved to treat marginal zone and follicular lymphomas. The FDA determined that initial findings from the...
Outcomes in a Large Cohort of Patients With Ultra-Low–Risk Breast Cancer: Analysis From the MINDACT Trial
As reported in the Journal of Clinical Oncology by Josephine M.N. Lopes Cardozo, MD, and colleagues, long-term follow-up in the phase III MINDACT trial has shown excellent outcomes among a large group of patients with ultra-low–risk breast cancer as classified by the 70-gene signature assay, with...
Addition of Sugemalimab to Platinum-Based Chemotherapy for Metastatic Squamous or Nonsquamous NSCLC
In the Chinese phase III GEMSTONE-302 trial reported in The Lancet Oncology, Caicun Zhou, MD, and colleagues found that the addition of the PD-L1 inhibitor sugemalimab to platinum-based chemotherapy improved progression-free survival in the first-line treatment of metastatic squamous or nonsquamous ...
Assessing Value in Gastrointestinal Cancer Treatments
The era of precision oncology, in which molecular biomarkers are used to help guide drug delivery, has dovetailed with the emerging issues of value-based care and cost containment. To shed light on these issues and more, The ASCO Post spoke with Hanna K. Sanoff, MD, MPH, Clinical Medical Director...
SIOG Annual Conference Explores the Past, Present, and Future of Geriatric Oncology
The 2021 Annual Conference of the International Society of Geriatric Oncology (SIOG) was held on November 4–5. Although participants could not join the conference in person, attendees could still stay informed about the latest developments in geriatric oncology through the virtual platform. The...
Anthony B. El-Khoueiry, MD, on Hepatocellular Carcinoma: Expert Perspective on Novel Additive Strategies
Anthony B. El-Khoueiry, MD, of the University of Southern California, Norris Comprehensive Cancer Center, discusses two key phase III studies of first-line treatment in hepatocellular carcinoma: the LAUNCH trial, which explored lenvatinib combined with transarterial chemoembolization for advanced...
Palbociclib Exposure and Discontinuation and Potential Impact on Outcome in the PALLAS Trial
In an analysis reported in the Journal of Clinical Oncology, Erica L. Mayer, MD, MPH, and colleagues found that early discontinuation and lower exposure intensity of oral palbociclib did not appear to account for the lack of invasive disease–free survival benefit observed with the addition of...
PET-Based De-escalation Strategy for Previously Untreated Advanced Hodgkin Lymphoma
As reported in the Journal of Clinical Oncology by Casasnovas et al, final results of the phase III AHL2011 Lymphoma Association Study showed continued similarity of progression-free and overall survival over long-term follow-up with positron-emission tomography (PET)-based de-escalation of...
Zev A. Wainberg, MD, on Gastric or Gastroesophageal Junction Adenocarcinoma: Follow-up Data on Pembrolizumab and Chemotherapy
Zev A. Wainberg, MD, of the University of California, Los Angeles, discusses an update, of 25 additional months, on phase III safety and efficacy results from the KEYNOTE-062 trial. This study compared pembrolizumab with or without chemotherapy vs chemotherapy alone for patients with PD-L1–positive ...
David Cescon, MD, PhD, Comments on the MONALEESA Analyses
David Cescon, MD, PhD, Clinician Scientist at the Princess Margaret Cancer Centre in Toronto, Canada, was the invited discussant of the two MONALEESA analyses.1,2 He noted that the most recent overall survival analysis, presented at the European Society for Medical Oncology (ESMO) Congress 2021,...
MONALEESA Analyses Show Widespread Benefit for Ribociclib in Hormone Receptor–Positive, HER2-Negative Breast Cancer
Further analyses of the MONALEESA metastatic breast cancer trials have shown that the benefit of ribociclib plus endocrine therapy in the first-line setting extends to most intrinsic molecular subtypes and is consistent across multiple subgroups. The studies were presented at the 2021 San Antonio...
Addition of Spartalizumab to Dabrafenib/Trametinib for BRAF V600–Mutant Advanced Melanoma
As reported in the Journal of Oncology by Reinhard Dummer, MD, and colleagues, the phase III COMBI-i trial has shown no significant progression-free survival benefit with the addition of the anti–PD-1 antibody spartalizumab to dabrafenib and trametinib in patients with no prior systemic treatment...
Addition of Perioperative Trastuzumab to Neoadjuvant Chemoradiation for Patients With HER2-Overexpressing Esophageal Adenocarcinoma
As reported in The Lancet Oncology by Howard P. Safran, MD, and colleagues, the phase III NRG Oncology/RTOG-101 trial has shown no significant disease-free survival benefit with the addition of perioperative trastuzumab to neoadjuvant chemoradiation in previously untreated patients with...
FDA Approves Tebentafusp-tebn for the Treatment of Unresectable or Metastatic Uveal Melanoma
On January 26, the U.S. Food and Drug Administration (FDA) granted approval to tebentafusp-tebn (Kimmtrak) for the treatment of adult patients with HLA-A*02:01–positive, unresectable or metastatic uveal melanoma. Tebentafusp’s approval establishes several firsts: as the first T-cell receptor...
Lenvatinib/Pembrolizumab vs Chemotherapy in Previously Treated Patients With Advanced Endometrial Cancer
As reported in The New England Journal of Medicine by Vicky Makker, MD, and colleagues, the phase III Study 309-KEYNOTE-775 trial has shown prolonged progression-free and overall survival with lenvatinib plus pembrolizumab vs physician’s choice of chemotherapy among previously treated patients with ...
Ghassan K. Abou-Alfa, MD, MBA, on Hepatocellular Carcinoma: Open-Label Trial of Tremelimumab and Durvalumab
Ghassan K. Abou-Alfa, MD, MBA, of Memorial Sloan Kettering Cancer Center and Weill Medical College at Cornell University, discusses phase III results of the HIMALAYA trial, which showed the combination of a single priming dose of tremelimumab added to durvalumab is superior to sorafenib for...
Nilofer Saba Azad, MD, on Novel Treatment Combinations Under Study in Biliary Tract Cancers
Nilofer Saba Azad, MD, of Johns Hopkins Sidney Kimmel Cancer Center, assesses the findings from the phase III TOPAZ-1 trial, a study of durvalumab in combination with gemcitabine plus cisplatin in patients with advanced biliary tract cancer. Dr. Azad explains why the study sets a potential new...
From the Vietnam War to the Stanford Cancer Institute: The Professional Journey of Quynh-Thu Le, MD
In this installment of the Living a Full Life series, guest editor, Jame Abraham, MD, FACP, spoke with Quynh-Thu Le, MD, Chair of the Department of Radiation Oncology and Co-Director of the Radiation Biology Program of the Stanford Cancer Institute, and one of the Group Chairs of the NRG Oncology...
Pembrolizumab for Adjuvant Treatment of Stage IIB or IIC Melanoma
On December 3, 2021, pembrolizumab was approved for adjuvant treatment of adult and pediatric (≥ 12 years of age) patients with stage IIB or IIC melanoma following complete resection.1 Supporting Efficacy Data Approval was based on findings in the phase III, double-blind KEYNOTE-716 trial...
Rituximab Plus Chemotherapy for Pediatric Mature B-Cell Non-Hodgkin Lymphoma and Mature B-Cell Acute Leukemia
On December 2, 2021, rituximab was approved for use in combination with chemotherapy for pediatric patients (≥ 6 months to 18 years) with previously untreated, advanced-stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia.1...
Adjuvant Atezolizumab in IMpower010: Moving the Needle in Early-Stage NSCLC
Adjuvant platinum-based chemotherapy for early-stage non–small cell lung cancer (NSCLC) is currently almost an afterthought and is taken for granted as a standard of care for patients with stage II to IIIA NSCLC after resection. The earliest meta-analysis, published in 1995,1 gave the first hint of ...
Adjuvant Atezolizumab Improves Disease-Free Survival Following Adjuvant Chemotherapy in PD-L1–Positive Resected Stage II–IIIA NSCLC
As reported in The Lancet by Enriqueta Felip, MD, of Vall d’Hebron University Hospital, Barcelona, and colleagues, the phase III IMpower010 trial has shown improved disease-free survival with adjuvant atezolizumab vs best supportive care in the predefined population of patients with resected stage ...
Promise and Need for More Progress in Treatment of Squamous Cell NSCLC
A greater understanding of the mutational landscape in non–small cell lung cancer (NSCLC) has identified key oncogenes, such as EGFR, ALK, ROS, RET, and BRAF, among others. These discoveries, coupled with the availability of specific targeted small-molecule inhibitors, have transformed the...
Ian E. Krop, MD, PhD, Named Chief Clinical Research Officer, Associate Cancer Center Director for Clinical Research at Yale Cancer Center
Ian E. Krop, MD, PhD, has been appointed Chief Clinical Research Officer, Associate Cancer Center Director for Clinical Research, and Director of the Yale Cancer Center Clinical Trials Office. Dr. Krop will assume his new position on March 2, 2022. “I’m pleased to announce Dr. Krop will work with ...
Pembrolizumab Plus Chemotherapy in Advanced Esophageal Cancer: Good News for Some, but More Work to Be Done
Multiple comparisons of traditional cytotoxic chemotherapy combinations that began decades ago led to the adoption of the platinum plus fluorouracil doublet as the standard of care for treatment of recurrent or metastatic esophageal cancer.1 Other combinations created by the addition and/or...
BELINDA Trial: CAR T-Cell Therapy Fails to Improve Outcomes in Aggressive Non-Hodgkin Lymphoma
The autologous chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel failed to improve event-free survival vs standard-of-care treatment strategies in patients with aggressive, relapsed or refractory non-Hodgkin lymphoma (NHL), according to results of the phase III BELINDA trial,...
Circadian Timing of Immune Checkpoint Inhibitors: Beyond Good Times and Bad Times
After almost a century of limited efficacy of cancer immunotherapy,1 the breakthrough happened in 2012 with the discovery of immune checkpoint inhibitors,2,3 leading to the 2018 Nobel Prize in Physiology or Medicine for James P. Allison and Tasuku Honjo. Yet about 40% of patients on immune...
Expert Point of View: Joseph Mikhael, MD
The ASCO Post asked Joseph Mikhael, MD, Chief Medical Officer of the International Myeloma Foundation and Professor in the Applied Cancer Research and Drug Discovery Division at the Translational Genomics Research Institute (an affiliate of City of Hope Cancer Center), to comment on the GMMG-HD7...
Isatuximab-Containing Induction Therapy for Multiple Myeloma Increases Measurable Residual Disease Negativity
For the first-line treatment of newly diagnosed multiple myeloma, the percentage of patients achieving measurable residual disease (MRD, previously called minimal residual disease) negativity was significantly greater when the anti-CD38 monoclonal antibody isatuximab was added to a standard...
Mosunetuzumab Meets Primary Endpoint of Phase II Trial in Relapsed or Refractory Follicular Lymphoma
The bispecific antibody mosunetuzumab achieved deep and durable remissions as monotherapy in patients with relapsed or refractory follicular lymphoma, according to the results of a pivotal phase II trial presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition.1 In ...
Expert Point of View: Jane N. Winter, MD and Christopher R. Flowers, MD, MS
Jane N. Winter, MD, Professor of Medicine at Northwestern University’s Feinberg School of Medicine and the 2022 President of the American Society of Hematology (ASH), and Christopher R. Flowers, MD, MS, Chair of the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer...
POLARIX: Addition of Polatuzumab Vedotin-piiq to Standard of Care Significantly Reduces Progression of Diffuse Large B-Cell Lymphoma
As a first-line treatment of inter-mediate- or high-risk diffuse large B-cell lymphoma, the addition of the antibody-drug conjugate polatuzumab vedotin-piiq to standard-of-care therapy resulted in a 27% reduction in the relative risk of disease progression, relapse, or death, with a similar safety...
Lisocabtagene Maraleucel Improves Outcomes in Relapsed or Refractory Large B-Cell Lymphoma
Chimeric antigen receptor (CAR) T-cell therapy with lisocabtagene maraleucel could prove to be the new standard-of-care treatment for patients with relapsed or refractory large B-cell lymphoma in the second-line setting, according to data presented at the 2021 American Society of Hematology (ASH)...
