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Showing 351 - 400Expert Point of View: Shahrokh Shariat, MD
“BACILLUS CALMETTE-GUÉRIN (BCG) failures are quite common, with a 66% recurrence rate at 5 years, and about 25% of patients will have disease progression,” explained formal discussant Shahrokh Shariat, MD, Chair of the Department of Urology at Medical University, Vienna, and Adjunct Professor at...
Immunotherapy Improves Survival in a Subset of Patients With Metastatic Triple-Negative Breast Cancer
IMMUNOTHERAPY APPEARS to be the new upfront standard of care for patients with metastatic triple-negative breast cancer, based on a late-breaking presentation at the European Society for Medical Oncology (ESMO) 2018 Congress1 and simultaneously published in The New England Journal of Medicine.2 In ...
FDA Approves Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
On November 6, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies,...
Regardless of Taxane Used, Pembrolizumab Plus Chemotherapy Improves Survival in Squamous NSCLC
The addition of pembrolizumab (Keytruda) to a standard platinum doublet as first-line therapy improved overall and progression-free survival in patients with metastatic squamous non–small cell lung cancer (NSCLC), in the primary analysis of KEYNOTE-407.1,2 Furthermore, it did not seem to matter...
Expert Point of View: Everett Vokes, MD
“PACIFIC is a positive trial, with a 32% improvement in survival, and maintenance durvalumab is a new standard of care,” stated formal discussant Everett Vokes, MD, Chair of the Department of Medicine at the University of Chicago and a pioneer in the concurrent use of chemotherapy and radiotherapy ...
Expert Point of View: Hossein Borghaei, MS, DO
Formal discussant, Hossein Borghaei, MS, DO, of Fox Chase Cancer Center, was guardedly optimistic about the IMpower132 trial results. “The study met its primary endpoint, and investigator-assessed progression-free survival was superior in the investigational arm. Overall survival was not mature,...
Inaugural Award Recipient Studies Potential of HE4 Blockade as a Novel Immune Therapy in Ovarian Cancer
In 2018, Bristol-Myers Squibb (BMS) provided funds for Conquer Cancer to establish a Young Investigator Award (YIA) supporting female researchers and underscore the importance of gender diversity in oncology practice and research. “We provided this grant as part of our commitment to empowering...
FDA Approves Nivolumab Plus Low-Dose Ipilimumab for Second-Line Treatment of MSI-H/dMMR Metastatic Colorectal Cancer
Today, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the treatment of adult and pediatric patients aged 12 years and older with microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR)...
Treatment Beyond Disease Progression in Melanoma: Challenge Centers on Knowing Who May Benefit
Dr. Weiss is Assistant Professor (Medical Oncology), Developmental Therapeutics, Melanoma Program, Yale Cancer Center. Dr. Sznol is Professor of Medicine (Medical Oncology); Co-Director, Cancer Immunology Program, Yale Cancer Center Co-Director, Yale SPORE in Skin Cancer, New Haven, Connecticut. ...
Evidence Builds for Tumor Mutational Burden as Biomarker in Lung Cancer
TUMOR MUTATIONAL burden is emerging as a predictive biomarker for the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) in non–small cell lung cancer (NSCLC), as well as other tumor types. However, experts say tumor mutational burden has hurdles to overcome. At the 2018 Annual Meeting of...
Expert Point of View: Charles Drake, MD, PhD
“THIS TRIAL is a clear winner for the treatment of squamous non–small cell lung cancer [NSCLC],” stated formal discussant Charles Drake, MD, PhD, of Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York. “The concept underlying the combination of checkpoint...
KEYNOTE-407: Pembrolizumab Plus Chemotherapy Benefits Response, Survival in Squamous NSCLC
THE COMBINATION of pembrolizumab (Keytruda) plus platinum-based chemotherapy improved overall survival, response rates, and duration of response in patients with advanced squamous cell non–small cell lung cancer (NSCLC) compared with chemotherapy alone irrespective of programmed cell death ligand 1 ...
Both Patients and Clinicians Face Challenges in Recognizing and Reporting Immune-Related Adverse Events
The publication of ASCO’s toxicity management guidelines for immune checkpoint antibodies by Brahmer and colleagues,1 reviewed in this issue of The ASCO Post, has been long awaited, considering more than 15 distinct indications have been granted by the U.S. Food and Drug Administration (FDA). The ...
ASCO Clinical Practice Guideline on Managing Immune-Related Adverse Events: Next Big Step for Immune Checkpoint Inhibitors
The publication of the ASCO clinical practice guideline for the management of immune therapy–related adverse events—reviewed in this issue of The ASCO Post—represents an important next step in the incorporation of checkpoint blocking antibodies as standard cancer treatment modalities.1 The U.S....
Adjuvant Pembrolizumab Improves Relapse-Free Survival in High-Risk Stage III Melanoma
ADJUVANT THERAPY with pembrolizumab (Keytruda) significantly prolonged recurrence-free survival compared with placebo for patients with resected high-risk stage III melanoma, according to the results of the EORTC 1325/KEYNOTE-054 trial.1 Patients who received pembrolizumab had a 43% reduction in...
Combined Immune Checkpoint and VEGF Inhibition: Exciting yet Challenging Time for Renal Cancer Therapeutics
The treatment paradigm for metastatic clear cell renal cell carcinoma continues to evolve at a rapid pace. We have recently approved agents that target the vascular endothelial growth factor receptor (VEGFR) pathway in the front-line setting—such as the tyrosine kinase inhibitor cabozantinib...
FDA Accepts sBLA, Grants Priority Review for Nivolumab in Previously Treated Patients With SCLC
On April 18, the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental biologics license application (sBLA) for nivolumab (Opdivo) to treat patients with small cell lung cancer (SCLC) whose disease has progressed after two or more prior lines of therapy. ...
Lower-Dose Radiation in HPV-Positive Head and Neck Cancers After Induction Chemotherapy
The results of a phase II clinical trial suggest that patients with head and neck cancers associated with the human papillomavirus (HPV) may receive significantly lower doses of radiation safely and effectively after response to induction chemotherapy.1 These findings from the OPTIMA study,...
FDA Accepts sBLA for Nivolumab Plus Ipilimumab in Previously Treated MSI-H or dMMR Metastatic Colorectal Cancer
On March 27, the U.S. Food and Drug Administration (FDA) accepted a supplemental biologics license application (sBLA) for nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of adults with microsatellite instability–high (MSI-H) or mismatch repair deficient...
Pembrolizumab Survival Advantage Upheld in Advanced Urothelial Carcinoma
Patients with recurrent urothelial cancer had sustained improvement in overall survival at 2 years after they received second-line treatment with pembrolizumab (Keytruda) vs chemotherapy, according to an updated survival analysis of the phase III KEYNOTE-045 trial presented at the 2018...
FDA Approves sBLA Updating Nivolumab Dosing Schedule Across Indications
On March 6, Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the nivolumab (Opdivo) dosing schedule to include 480 mg infused every 4 weeks for a majority of approved indications. This approval will ...
Use of Direct Oral Anticoagulants in Preventing VTE in Patients With Cancer
THE FIRST TWO randomized trials to directly compare direct oral anticoagulants vs low–molecular-weight heparin for management of venous thromboembolism (VTE) in patients with cancer suggest that direct oral anticoagulants may become the new standard of care.1,2 Direct oral anticoagulants appear to...
Novel Agent Appears Active in Advanced or Aggressive Systemic Mastocytosis
THE INVESTIGATIONAL agent BLU-285 (avapritinib) has shown significant activity in patients with advanced or aggressive forms of systemic mastocytosis, a rare blood disorder that originates in mast cells, according to the findings of a phase I trial reported at the 2017 American Society of...
Superior Progression-Free Survival With First-Line Nivolumab Plus Ipilimumab vs Chemotherapy in NSCLC With High Tumor Mutation Burden
The ongoing phase III CheckMate-227 study met its coprimary endpoint of progression-free survival with a combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) vs chemotherapy in patients with first-line advanced non–small cell lung cancer (NSCLC) whose tumors have a high (≥ 10...
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...
Durvalumab Therapy Improves Outcomes in Patients With Unresectable Stage III NSCLC
The PACIFIC study showed that the addition of the programmed cell death ligand 1 (PD-L1) inhibitor durvalumab (Imfinzi) following chemoradiotherapy for patients with unresectable stage III non–small cell lung cancer (NSCLC) dramatically improved progression-free survival compared with placebo....
Unraveling PD-L1 Assays in NSCLC: Are They Interchangeable?
With the availability of at least five checkpoint inhibitors to treat non–small cell lung cancer (NSCLC) and other solid tumors, appropriate patient selection for these expensive treatments remains key. The hope is that testing the level of programmed cell death ligand 1 (PD-L1) expression in tumor ...
International Trials Reveal New Findings in the Management of Breast and Ovarian Cancers
The European Society for Medical Oncology (ESMO) 2017 Congress, held in Madrid, featured important news including at least seven practice-changing or potentially practice-changing trials, which are covered in recent issues of The ASCO Post. Here we present additional highlights of studies in breast ...
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)...
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...
Expert Point of View: Manuela Schmidinger, MD
FORMAL DISCUSSANT, Manuela Schmidinger, MD, of the Medical University of Austria, Vienna, commented on the CheckMate 214 findings. “We have just seen a change in the paradigm in the treatment of metastatic renal cell cancer.” “More than a decade ago, VEGF [vascular endothelial growth factor]...
Nivolumab Approved in Japan for Unresectable Advanced or Recurrent Gastric Cancer That Has Progressed After Chemotherapy
On September 22, Bristol-Myers Squibb Company announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) approved nivolumab (Opdivo) for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy. This approval was based on the phase III ...
Adjuvant Nivolumab vs Ipilimumab in Resected Stage III or IV Melanoma
The phase III Checkmate 238 trial has shown improved recurrence-free survival with adjuvant nivolumab (Opdivo) vs ipilimumab (Yervoy) in patients with resected advanced melanoma. The findings were reported by Jeffrey Weber and colleagues in The New England Journal of Medicine. Study Details In the ...
Expert Point of View: Reinhard Dummer, MD, and Jeffrey Weber, MD, PhD
ASSUMING THE regimens evaluated in COMBI-AD and CheckMate 238 are both approved by the U.S. Food and Drug Administration for the treatment of high-risk resected melanoma, clinicians may be faced with a tough choice. ESMO experts and the study’s investigators weighed in on this issue in a lively...
Significant Improvement in Outcomes Reported With Adjuvant Therapy for Melanoma
FOR PATIENTS with malignant melanoma, the significant improvement in outcomes with targeted agents and antibodies against the programmed cell death protein 1 (PD-1) has now been observed in the adjuvant setting. Two landmark studies presented at the European Society for Medical Oncology (ESMO) 2017 ...
Updates of Key Trials in Metastatic Non–Small Cell Lung Cancer: KEYNOTE-024 and AvaALL
IMMUNOTHERAPY AND ANTIANGIOGENESIS were highlighted in a session on metastatic non–small cell lung cancer (NSCLC) at the Best of ASCO New Orleans meeting. Matthew Gubens, MD, MS, presented the selected abstracts from the ASCO Annual Meeting.1 Dr. Gubens is Associate Professor of Thoracic Medical...
CheckMate-214: Nivolumab and Ipilimumab in Intermediate- and Poor-Risk Previously Untreated Advanced or Metastatic RCC
On August 15, Bristol-Myers Squibb Company announced topline results from the CheckMate-214 trial investigating nivolumab (Opdivo) in combination with ipilimumab (Yervoy) vs sunitinib (Sutent) in intermediate- and poor-risk patients with previously untreated advanced or metastatic renal cell...
FDA Approves Nivolumab in MSI-H or dMMR Metastatic Colorectal Cancer
Today, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) injection for intravenous use for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer...
FDA Expands Approval of Ipilimumab to Include Pediatric Patients 12 Years and Older With Unresectable or Metastatic Melanoma
Today, the U.S. Food and Drug Administration (FDA) expanded the indication for ipilimumab (Yervoy) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Ipilimumab was evaluated in 2 trials of pediatric...
Combination Strategies for Jump-Starting the Immune Response
CHECKPOINT INHIBITORS have dramatically changed the landscape of the treatment of melanoma, lung, bladder, and other cancers. Researchers are focusing on exploring ways to extend the use of checkpoint inhibitors to other disease states and to combine them with novel agents and improve outcomes. At ...
Expert Point of View: Nitin Jain, MD, and Susan O'Brien, MD
Formal discussant of the GENUINE trial, Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, Houston, noted that the majority of responses to ibrutinib (Imbruvica) in high-risk patients are partial responses. “These patients [have disease progression] even in the context of...
SU2C Awards Innovative Research Grants in Immuno-oncology to 10 Early-Career Scientists
Stand Up to Cancer (SU2C) has announced the award of $7.5 million in Innovative Research Grants focused on immuno-oncology to 10 early-career scientists, in a program funded by a grant from Bristol-Myers Squibb Company (BMS), an SU2C Visionary Supporter. These awards were announced at the 2017...
Expanding Role Seen for Minimal Residual Disease in Managing Multiple Myeloma
Minimal residual disease is a promising biomarker for guiding the management of multiple myeloma that is becoming increasingly important with the advent of more efficacious therapies, according to emerging data and expert opinion. “The story of minimal residual disease in multiple myeloma is like...
Nivolumab, as Salvage, Improves Overall Survival in Gastric Cancer
Gastric cancer can apparently be added to the growing list of malignancies for which drugs targeting the programmed cell death protein 1 (PD‑1) receptor are effective, according to the results of the phase III ONO-4538 investigation conducted in Asia and presented at the 2017 Gastrointestinal...
Expert Point of View: Anas Younes, MD
Anas Younes, MD, Chief of the Lymphoma Service at Memorial Sloan Kettering Cancer Center, New York, commented on the brentuximab vedotin (Adcetris)/nivolumab (Opdivo) combination studies, noting that complete response rates of 60% are “impressive.” “It seems that in the pretransplant setting, the...
Reducing Doses and Stopping Tyrosine Kinase Inhibitors Gain Favor in Chronic Myeloid Leukemia
Tyrosine kinase inhibitors, such as imatinib, nilotinib (Tasigna), and dasatinib (Sprycel), have revolutionized the treatment of chronic myeloid leukemia (CML). A substantial percentage of patients achieve deep and meaningful remissions on these agents. More recently, partly driven by patients’ and ...
Experts Consider the New Immunotherapy Paradigm in Advanced Lung Cancer
One immune checkpoint inhibitor has now moved to the front of the line for treating advanced non–small cell lung cancer (NSCLC). Based on pivotal studies presented at the 2016 European Society for Medical Oncology (ESMO) Congress, pembrolizumab (Keytruda) became a first-line option, and it is...
Expert Point of View: Alice T. Shaw, MD, PhD
Commenting on ASCEND-5, Alice T. Shaw, MD, PhD, Director of Thoracic Oncology at the Massachusetts General Hospital Cancer Center, Boston, noted that it is the first randomized study to examine how a second-generation anaplastic lymphoma kinase (ALK) inhibitor compares to standard second-line...
Immunotherapy Is Not a Replacement Therapy
Some patients who ask about immunotherapy do so because they don’t want to get chemotherapy. Immunotherapy “is not a replacement yet, especially for chemotherapy, which has a track record of curing cancer,” Anas Younes, MD, medical oncologist and Chief of the Lymphoma Service at Memorial Sloan...
