Search Results
Your search for ,nab matches 337 pages
Showing 201 - 250FDA Grants Accelerated Approval to Atezolizumab/ Nab-paclitaxel in Triple-Negative Breast Cancer
ON MARCH 8, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) for the treatment of adults with unresectable, locally advanced or metastatic, PD-L1–positive triple-negative breast cancer. PD-L1 status is determined by...
The Risks of Drug Approval Based on Shaky Evidence
Two recent publications in The New England Journal of Medicine (NEJM), and the resulting drug approval applications that have already been filed, lead to concern that the basis of medical practice on valid evidence may be corrupted. Each involves statistically shaky analysis leading to a striking...
FDA Pipeline: Assay Approval, Breakthrough Designations for AI Technology and CLL, and More
In the past week, the U.S. Food and Drug Administration (FDA) approved a companion diagnostic assay, granted Breakthrough Device and Breakthrough Therapy designations, and extended the review period of a proposed treatment. The agency also published four draft guidances and one final guidance...
FDA Grants Accelerated Approval to Atezolizumab/Nab-Paclitaxel; Regular Approval Contingent on Confirmatory Trials
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq) plus nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) for the treatment of adults with unresectable, locally advanced or metastatic, programmed cell death ligand 1 (PD-L1)-positive ...
Elizabeth A. Mittendorf, MD, PhD, on Breast Cancer Immunotherapy: Building on Recent Successes
Elizabeth A. Mittendorf, MD, PhD, of Dana-Farber Cancer Institute, discusses the encouraging data on atezolizumab plus nab-paclitaxel in the first-line setting for metastatic triple-negative breast cancer, and the potential benefits of combining immune checkpoint inhibitors with targeted treatment...
Pembrolizumab in Combination With Chemotherapy in First-Line Treatment of Metastatic Squamous NSCLC
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 30, 2018, pembrolizumab in combination with...
Expert Point of View: Andrew X. Zhu, MD, PhD
ANDREW X. ZHU, MD, PhD, of Massachusetts General Hospital Cancer Center and Harvard Medical School, noted that Prep-02/ JSAP-05 is the first study to show the value of neoadjuvant chemotherapy in patients with resectable pancreatic adenocarcinoma. However, the findings are applicable only to Asian ...
Emerging Role for Neoadjuvant Treatment of Resectable Pancreatic Cancer
SEVERAL STUDIES presented at the 2019 Gastrointestinal Cancers Symposium evaluated the benefits of neoadjuvant treatment in patients with pancreatic cancer—and in patients deemed fully resectable, not just “borderline” resectable.1-3 Although the standard of care for resectable pancreatic ductal...
Selected Abstracts From the San Antonio Breast Cancer Symposium
Each year, The ASCO Post asks Jame Abraham, MD, FACP, Director of the Breast Oncology Program at Taussig Cancer Institute and Professor of Medicine at the Cleveland Clinic Lerner College of Medicine, to offer his picks for the most important research presented at the 2018 San Antonio Breast Cancer ...
FDA Pipeline: Updates on Treatments in NSCLC and Lymphomas, Plus New Dosimetry Software
The U.S. Food and Drug Administration (FDA) recently granted the following application, designations, and clearance: sBLA for Atezolizumab Plus Chemotherapy for First-Line Treatment of Metastatic, Nonsquamous NSCLC On January 17, the FDA accepted a supplemental biologics license application...
IMpassion130 Trial: Changing the Treatment Landscape in Metastatic Triple-Negative Breast Cancer
THE IMPASSION130 trial—reported in The New England Journal of Medicine by Schmid et al1 and reviewed in this issue of The ASCO Post—was an eagerly awaited study in newly diagnosed metastatic triple-negative breast cancer. To briefly review, 902 patients were randomly assigned in a 1:1 fashion to...
Addition of Atezolizumab to Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer: IMpassion130 Trial
AS REPORTED in The New England Journal of Medicine by Peter Schmid, MD, PhD, of the Barts Cancer Institute, Queen Mary University of London, and colleagues, the phase III IMpassion130 trial has shown that the addition of atezolizumab to nanoparticle albumin-bound (nab)-paclitaxel significantly...
Challenge Moving Forward in Breast Cancer Treatment: To Show That New Approaches Change Outcomes
ADVANCES IN treating breast cancer over the past 20 years have brought us to the point where treatment can be confidently de-escalated for some patients, and immunotherapy and precision decision-making may change the way breast cancer is treated for others, William Gradishar MD, FASCO, told the...
Current Perspectives on the Treatment of Breast Cancer
“We are on the cusp of a new way to treat breast cancer,” Mary L. (Nora) Disis, MD, said in summarizing advances using immunology to treat breast cancer. Immune checkpoint inhibitors, adaptive T-cell therapies, and vaccines can enlist and rev up the immune system and be combined with chemotherapy...
FDA Pipeline: What’s New in Biosimilars, Drug Reviews, Designations, and More
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Approval for Pegfilgrastim Biosimilar The FDA recently approved a pegfilgrastim biosimilar, pegfilgrastim-cbqv (Udenyca). The biosimilar has been approved to decrease the incidence...
Expert Point of View: Giuseppe Curigliano, MD, PhD
“IMPASSION130 IS a positive study of immuno-oncology that brings breast cancer into the immunotherapy era,” said the invited discussant of the trial, Giuseppe Curigliano, MD, PhD, Associate Professor of Oncology at the University of Milan and Chair of Early Drug Development at the Institute of...
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 Pembrolizumab in Combination With Chemotherapy for First-Line Treatment of Metastatic Squamous NSCLC
On October 30, 2018, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with carboplatin and either paclitaxel or nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) as first-line treatment of metastatic squamous non–small cell lung...
Lisa A. Carey, MD, and Sherene Loi, MD, PhD, on TNBC: Combination Immune Checkpoint Inhibitor Therapy
Lisa A. Carey, MD, of the University of North Carolina, and Sherene Loi, MD, PhD, of the Peter MacCallum Cancer Centre, discuss the phase III IMpassion 130 trial testing the first-line combination of the PD-L1 inhibitor atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer...
ESMO 2018: IMpassion 130: Atezolizumab Plus Nab-Paclitaxel in Metastatic Triple-Negative Breast Cancer
A combination of immunotherapy and chemotherapy improves survival in some patients with metastatic triple-negative breast cancer, according to late-breaking results from the IMpassion130 trial reported by Schmid et al at the European Society for Medical Oncology (ESMO) 2018 Congress (Abstract...
Expert Point of View: Antoinette Wozniak, MD
Formal discussant Antoinette Wozniak, MD, of UPMC Hillman Cancer Center, Pittsburgh, said, “KEYNOTE-407 is a very positive trial, showing improved overall and progression-free survival with the addition of pembrolizumab (Keytruda) to standard chemotherapy.” In her opinion, evidence from this and...
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...
KEYNOTE-407: First-Line Pembrolizumab Plus Chemotherapy in Metastatic Squamous NSCLC
As reported at the recent International Association for the Study of Lung Cancer 19th World Conference on Lung Cancer and in The New England Journal of Medicine by Paz-Ares et al, the phase III KEYNOTE-407 trial has shown that the addition of pembrolizumab to platinum-based chemotherapy...
First-Line Nab-Paclitaxel and Gemcitabine in Advanced Cholangiocarcinoma
In a phase II trial reported in JAMA Oncology, Sahai et al found that the first-line combination of nab-paclitaxel and gemcitabine—though it did not meet the progression-free survival primary endpoint—may constitute a treatment option in advanced cholangiocarcinoma. Study Details In...
Erratum
In the July 10, 2018, issue of The ASCO Post, the article “KEYNOTE-407: Pembrolizumab Plus Chemotherapy Benefits Response, Survival in Squamous NSCLC” contained an error in the regimen for pembrolizumab (Keytruda). The study regimen, which has been corrected in the online version on ASCOPost.com,...
Atezolizumab Plus Chemotherapy Extends Survival in Squamous NSCLC Regardless of PD-L1 Level
Patients with advanced squamous non–small cell lung cancer (NSCLC) had a greater benefit from first-line treatment with the combination of atezolizumab (Tecentriq) plus chemotherapy vs chemotherapy alone in the randomized, phase III, IMpower131 clinical trial.1 At the landmark of 12-month...
FDA Accepts sBLA for Pembrolizumab in Combination With Chemotherapy as First-Line Treatment for Metastatic Squamous NSCLC
The U.S. Food and Drug Administration (FDA) has accepted for review a supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) in combination with carboplatin/paclitaxel or nab-paclitaxel (Abraxane) as a first-line treatment for metastatic squamous non–small cell lung...
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 ...
IMpassion130: Atezolizumab Plus Nab-Paclitaxel in Metastatic or Locally Advanced Triple-Negative Breast Cancer
The phase III IMpassion130 study has met its co-primary endpoint of progression-free survival (PFS). Results demonstrated that the combination of atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) as first-line treatment significantly reduced the risk of disease worsening or death in patients...
Addition of Panitumumab to Neoadjuvant Chemotherapy in Primary HER2-Negative Inflammatory Breast Cancer
In a single-center phase II study reported in JAMA Oncology, Matsuda et al found that adding the EGFR inhibitor panitumumab (Vectibix) to neoadjuvant chemotherapy produced high pathologic complete response (pCR) rates in patients with primary triple-negative inflammatory breast cancer. Study...
Actively Recruiting Clinical Trials Focused on Pancreatic Cancer
THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on pancreatic cancer. These studies are investigating radiotherapy; cancer vaccines; combination treatments; novel cell therapies; response prediction; and more. All of the studies ...
Expert Point of View: Charles G. Drake, MD, PhD and Hatem H. Soliman, MD
Formal discussant of the GeparNuevo presentation, Charles G. Drake, MD, PhD, of the Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, said, “It is important that neoadjuvant immunotherapy combinations are being studied. There is a lot of enthusiasm for...
Priming the Immune System: Neoadjuvant Durvalumab Plus Chemotherapy May Be Beneficial in Triple-Negative Breast Cancer
The addition of durvalumab -(Imfinzi) to anthracycline/taxane-based chemotherapy had encouraging results as neoadjuvant therapy for early triple-negative breast cancer in the randomized phase II GeparNuevo study presented at the 2018 ASCO Annual Meeting.1 The results were positive in a subgroup of...
Using Neoadjuvant Therapy to Reduce Early Recurrences, Increase Survival in Patients With Pancreatic Cancer
USE OF THE FOLFIRINOX regimen (fluorouracil, leucovorin, irinotecan, and oxaliplatin) was associated with a 4.9-month improvement in overall survival compared to gemcitabine/ nab-paclitaxel (Abraxane) in the neoadjuvant treatment of resectable and borderline-resectable pancreatic head...
2018 ASCO: Pembrolizumab Plus Chemotherapy as First-Line Treatment of Metastatic Squamous NSCLC: KEYNOTE-407 Study
Results from KEYNOTE-407, a randomized, double-blind, placebo-controlled, phase III study evaluating pembrolizumab (Keytruda) in combination with carboplatin/paclitaxel or carboplatin/nab-paclitaxel (Abraxane) as first-line treatment for metastatic squamous non–small cell lung cancer...
Robert M. Jotte, MD, PhD, on NSCLC: Results From the IMpower131 Trial
Robert M. Jotte, MD, PhD, of Rocky Mountain Cancer Centers, discusses phase III study findings on atezolizumab plus carboplatin plus paclitaxel or nab-paclitaxel vs carboplatin plus nab-paclitaxel, as first-line therapy in advanced squamous non–small cell lung cancer (Abstract LBA9000).
2018 ASCO: IMpower 131 Studies Addition of Atezolizumab to Chemotherapy in Advanced Squamous NSCLC
Initial findings from a randomized phase III clinical trial showed that patients with advanced squamous non–small cell lung cancer (NSCLC) benefit more from initial treatment with the programmed cell death ligand 1 (PD-L1)-targeted immunotherapy atezolizumab (Tecentriq) and chemotherapy than...
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,...
IMpower131 Study: Atezolizumab Plus Chemotherapy in Advanced Squamous NSCLC
On March 20, Genentech announced that the phase III IMpower131 study met its coprimary endpoint of progression-free survival (PFS) and demonstrated that the combination of atezolizumab (Tecentriq) plus chemotherapy (carboplatin and nanopartical albumin-bound [nab]-paclitaxel [Abraxane])...
Conquer Cancer Foundation Recognizes 70 Young Oncology Researchers’ Findings With Merit Awards
ASCO’s Conquer Cancer Foundation is pleased to announce the recipients of its Merit Awards in gastrointestinal cancers, clinical immuno-oncology, genitourinary cancers, and cancer survivorship. The following 70 researchers— oncology fellows and trainees honored for the quality and scientific merit...
Small Study Evaluates Novel Immunotherapeutic in Metastatic Pancreatic Cancer
IN PATIENTS WITH metastatic pancreatic adenocarcinoma, 1-year survival reached 43% following treatment with a novel immunotherapy—PEGylated human IL-10 (AM0010, pegilodecakin)—plus chemotherapy, in a small study reported at the 2018 Gastrointestinal Cancers Symposium.1 “We saw a very high disease...
FDA Grants Fast Track Designation to Pamrevlumab in Locally Advanced Unresectable Pancreatic Cancer
On March 1, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the anti–connective tissue growth factor (CTGF) antibody pamrevlumab for the treatment of patients with locally advanced unresectable pancreatic cancer. This follows review of the phase II clinical...
EXPERT POINT OF VIEW: Brian M. Wolpin, MD, MPH
Invited discussant Brian M. Wolpin, MD, MPH, of Dana-Farber Cancer Institute in Boston, said the results of the LAPACT trial will be useful as an aid to patient counseling as well as in designing and interpreting future studies. However, he added, they are not “practice-changing,” as nanoparticle...
LAPACT Trial Confirms Efficacy of Nab-Paclitaxel Plus Gemcitabine as Induction Therapy in Pancreatic Cancer
Patients newly diagnosed with locally advanced pancreatic cancer who received induction therapy with nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) and gemcitabine achieved a time to treatment failure and median progression-free survival that exceeded the protocol-specified target by more...
EXPERT POINT OF VIEW: Eric P. Winer, MD, FASCO; Heikki Joensuu, MD; and Julie Gralow, MD, FASCO
IN INTERVIEWS with The ASCO Post and in discussions held during the meeting, several breast cancer experts weighed in on the findings of GeparSepto and CALGB 40502. Eric P. Winer, MD, FASCO, Chief of the Division of Women’s Cancers and the Thompson Senior Investigator in Breast Cancer Research at ...
Updates of Key Studies Differ on Relative Benefit of Nab-Paclitaxel in Breast Cancer
TWO IMPORTANT STUDIES, both updates of earlier findings and presented at the 2017 San Antonio Breast Cancer Symposium, provided different findings as to the relative benefit of nanoparticle albumin-bound (nab)-paclitaxel (Abraxane), vs solvent-based paclitaxel in breast cancer. “The two studies...
Nab-Paclitaxel vs Paclitaxel in Neoadjuvant Treatment of HER2-Negative Breast Cancer
In a European phase III trial (ETNA) reported in JAMA Oncology, Gianni et al found no significant difference in pathologic complete response rate with nab-paclitaxel (Abraxane) vs paclitaxel followed by an anthracycline regimen in neoadjuvant treatment for HER2-negative breast cancer. Study...
2018 GI CANCERS SYMPOSIUM: Nab-Paclitaxel Plus Gemcitabine in Locally Advanced Pancreatic Cancer
Primary endpoint findings and updated results of secondary endpoints from the phase II LAPACT trial of nanoparticle albumin–bound (nab)-paclitaxel (Abraxane) plus gemcitabine in patients with locally advanced pancreatic cancer were presented by Hammel et al at the 2018 Gastrointestinal (GI)...
Novel Antibody-Drug Conjugate Active in Refractory Triple-Negative Breast Cancer
In relapsed or refractory triple-negative breast cancer, the antibody-drug conjugate sacituzumab govitecan (IMMU-132) demonstrated significant clinical activity in an open-label study presented at the 2017 San Antonio Breast Cancer Symposium.1 “Metastatic triple-negative breast cancer is an...
Addition of PEGPH20 to Nab-Paclitaxel/Gemcitabine in Pancreatic Ductal Adenocarcinoma
In a phase II study reported in the Journal of Clinical Oncology, Hingorani et al found that the addition of pegvorhyaluronidase alfa (PEGPH20) to nab-paclitaxel (Abraxane)/gemcitabine improved progression-free survival in patients with previously untreated metastatic pancreatic ductal...
