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Showing 151 - 200FDA Approves Fam-Trastuzumab Deruxtecan-nxki for Adult Patients With Unresectable or Metastatic HER2-Positive Breast Cancer
On May 4, the FDA approved fam-trastuzumab deruxtecan-nxki for pretreated adult patients with unresectable or metastatic HER2-positive breast cancer. We highlight findings from the DESTINY-Breast03 trial that led to the regular approval, and also hear from Dr. Sara Hurvitz, of the University of...
FDA Grants Regular Approval to Fam-Trastuzumab Deruxtecan-nxki for Unresectable or Metastatic HER2-Positive Breast Cancer
On May 4, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu) for pretreated adult patients with unresectable or metastatic HER2-positive breast cancer. According to the approval, patients had to have received a prior anti-HER2–based regimen either in the...
Therapies Targeting DNA Damage Response Show Antitumor Activity
Results from two early-stage clinical trials show two drugs that target the DNA damage response (DDR) pathway in cancers—the ATR inhibitor elimusertib and the PARP inhibitor AZD5305—are safe and clinically beneficial in treating patients with advanced solid tumors. Principal investigator Timothy...
DESTINY-Breast03 Trial: T-DXd vs T-DM1 in Previously Treated Patients With Metastatic HER2-Positive Breast Cancer
As reported in The New England Journal of Medicine by Javier Cortés, MD, PhD, and colleagues, the phase III DESTINY-Breast03 trial has shown significantly prolonged progression-free survival with fam-trastuzumab deruxtecan-nxki (T-DXd) vs ado-trastuzumab emtansine (T-DM1) in patients with...
Gastrointestinal Oncology 2021–2022 Almanac
The past year has seen unprecedented progress across the spectrum of gastrointestinal malignances, including the advancement of immunotherapy and targeted molecular agents and the refinement of adjuvant therapy using novel as well as existing therapies. Three themes emerging from these reports are: ...
Expert Point of View: Priyanka Sharma, MD
Priyanka Sharma, MD, of the University of Kansas Medical Center in Westwood, the invited discussant of the poster, noted that the DAISY study asked whether HER2-targeted antibody-drug conjugates—in this case, fam-trastuzumab deruxtecan-nxki (T-DXd)—have activity beyond the conventional...
T-DXd Shows Activity in HER2-Low, HER2-Undetectable Breast Cancer
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) has led to practice changes in previously treated HER2-positive metastatic breast cancer. Most notably, in the DESTINY-Breast03 trial, treatment with T-DXd produced a doubling in 12-month progression-free survival vs...
Clinical Trials Underway for T-DXd in Breast Cancer
The current standard of care for the neoadjuvant treatment of HER2-positive early-stage breast cancer consists of trastuzumab plus pertuzumab and polychemotherapy. But some patients, particularly those with locally advanced or inflammatory disease, still relapse and die. Furthermore, multiagent...
ABC Sixth International Consensus Conference Updates Guidelines for Advanced Breast Cancer
New recommendations for treating advanced breast cancer, coming from a panel of experts at the Advanced Breast Cancer (ABC) Sixth International Consensus Conference (ABC6), were recently published.1 The report highlights advances that have resulted in robust improvements in overall survival for...
Updated Findings on T-DXd in Gastrointestinal Malignancies
Updates of phase II studies evaluating fam-trastuzumab deruxtecan-nxki (T-DXd) in gastrointestinal cancers were presented at the 2022 ASCO Gastrointestinal Cancers Symposium, continuing to offer support for the antibody-drug conjugate in these malignancies. In HER2-expressing gastric cancer, T-DXd...
Clinical Trials Underway for T-DXd in Breast Cancer
The current standard of care for the neoadjuvant treatment of HER2-positive early-stage breast cancer consists of trastuzumab plus pertuzumab and polychemotherapy. But some patients, particularly those with locally advanced or inflammatory disease, still relapse and die. Furthermore, multiagent...
Expert Point of View: Priyanka Sharma, MD
Priyanka Sharma, MD, of the University of Kansas Medical Center in Westwood, the invited discussant of the poster, noted that the DAISY study asked whether HER2-targeted antibody-drug conjugates—in this case, fam-trastuzumab deruxtecan-nxki (T-DXd)—have activity beyond the conventional...
T-DXd Shows Activity in HER2-Low, HER2-Undetectable Breast Cancer
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) has led to practice changes in previously treated HER2-positive metastatic breast cancer. Most notably, in the DESTINY-Breast03 trial, treatment with T-DXd produced a doubling in 12-month progression-free survival vs...
Expert Point of View: Ciara O’Sullivan, MB, BCh, BAO
Invited discussant Ciara O’Sullivan, MB, BCh, BAO, of Mayo Clinic, Rochester, Minnesota, commented on the DESTINY-Breast03 trial at the 2021 San Antonio Breast Cancer Symposium. “The treatment of HER2-positive disease is an evolving landscape, with eight approved agents. Despite this rapid...
Second-Line T-DXd Improves Progression-Free Survival Across HER2-Positive Metastatic Breast Cancer Subgroups
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) lengthened progression-free survival and improved the objective response rate compared with the antibody-drug conjugate ado-trastuzumab emtansine (T-DM1) after trastuzumab and taxane therapy in women with HER2-positive metastatic...
Highlights From the 2021 San Antonio Breast Cancer Symposium
In its first return to a hybrid model since the COVID-19 pandemic began, the 2021 San Antonio Breast Cancer Symposium (SABCS) brought together researchers, clinicians, industry experts, patients, and advocates from across the globe to present and grapple with new data and important topics in breast ...
Expert Point of View: Philip L. McCarthy, MD
The ASCO Post invited myeloma expert Philip L. McCarthy, MD, Director of the Transplant and Cellular Therapy Program at Roswell Park Comprehensive Cancer Center, Buffalo, New York, to comment on the trials evaluating early detection of myeloma at the 2021 American Society of Hematology (ASH) Annual ...
Concordance for Low HER2 Protein Expression in Breast Cancer Tissue Using Standard Immunohistochemistry Assays
In a study reported in JAMA Oncology, Fernandez et al found that scoring accuracy for low HER2 protein expression (0 or 1+) in breast cancer tissue on standard immunohistochemistry (IHC) assays was poor. As observed by the investigators, the findings pose issues for investigation of fam-trastuzumab ...
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...
Philip L. McCarthy, MD, Comments on Trials Evaluating the Early Detection of Myeloma
The ASCO Post invited myeloma expert Philip L. McCarthy, MD, Director of the Transplant and Cellular Therapy Program at Roswell Park Comprehensive Cancer Center, Buffalo, New York, to comment on the trials evaluating early detection of myeloma at the 2021 American Society of Hematology (ASH) Annual ...
T-DXd for Previously Treated Patients With Metastatic HER2-Mutant NSCLC
In the phase II DESTINY-Lung01 trial reported in The New England Journal of Medicine, Bob T. Li, MD, PhD, MPH, and colleagues found that fam-trastuzumab deruxtecan-nxki (T-DXd) showed durable activity in patients with metastatic HER2-mutant non–small cell lung cancer (NSCLC) refractory to standard...
Expert Point of View: Ciara O’Sullivan, MB, BCh, BAO
Invited discussant Ciara O’Sullivan, MB, BCh, BAO, of Mayo Clinic, Rochester, Minnesota, commented on the DESTINY-Breast03 trial at the 2021 San Antonio Breast Cancer Symposium. “The treatment of HER2-positive disease is an evolving landscape, with eight approved agents. Despite this rapid...
Second-Line T-DXd Improves Progression-Free Survival Across HER2-Positive Metastatic Breast Cancer Subgroups
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) lengthened progression-free survival and improved objective response rate compared to the antibody-drug conjugate ado-trastuzumab emtansine (T-DM1) after trastuzumab and taxane therapy in women with HER2-positive metastatic breast...
Expert Point of View: Daniel Shao Weng Tan, BSc, MD, PhD
Invited study discussant of the DESTINY-Lung01 trial, Daniel Shao Weng Tan, BSc, MD, PhD, of the National Cancer Center, Singapore, commented: “The trial clearly showed that T-DXd [fam-trastuzumab deruxtecan--nxki] is active in HER2-mutated non–small cell lung cancer (NSCLC). The median...
T-DXd Makes Inroads in the Treatment of HER2-Mutant NSCLC
Previously treated patients with HER2-positive non–small cell lung cancer (NSCLC) achieved encouraging response rates and duration of response to the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) in the phase II DESTINY-Lung01 trial. These results were reported at the European...
Showcasing 50 Years of Advances in Cancer Research and Treatment
The AACR Cancer Progress Report 2021, published on October 13, celebrates the gains made in cancer research since President Richard Nixon signed the National Cancer Act into law on December 23, 1971, especially against such life-threatening cancers as metastatic melanoma and lung cancer.1 The...
Expert Point of View: Barbara Pistilli, MD
Barbara Pistilli, MD, of the Breast Cancer Group at Gustave Roussy Cancer Center, Villejuif, France, said the results of the TULIP trial, showing the progression-free survival benefit for vic-trastuzumab duocarmazine (SYD985), help to establish antibody-drug conjugates as key components of the...
AACR Cancer Progress Report 2021 Showcases 50 Years of Advances in Cancer Research and Treatment
The AACR Cancer Progress Report 2021 celebrates the gains made in cancer research since the National Cancer Act was signed into law on December 23, 1971. The report also recognizes the negative impact the COVID-19 pandemic has had on cancer research and patient care, the disproportionate toll both...
Novel HER2-Targeted Therapies Pose Sequencing Challenges
With three new HER2-targeted therapies approved over the past year or two alone, the treatment landscape for patients with metastatic breast cancer has become increasingly crowded. In the third-line setting and beyond, there are now at least eight HER2-targeted agents approved by the U.S. Food and...
Breast Cancer 2020–2021 Almanac
The past decade has seen an explosion of novel agents for breast cancer across subtypes. Although each new advance improves therapeutic options for patients, it also brings forth a challenging question: Who needs what treatment? Not all cancers are created equally, and similarly not all patients...
Expert Point of View: Shanu Modi, MD
Shanu Modi, MD, of the Breast Medicine Service at Memorial Sloan Kettering Cancer Center, New York, called the DESTINY-Breast03 results,1 which showed a highly significant benefit for fam-trastuzumab deruxtecan-nxki (T-DXd) over trastuzumab emtansine (T-DM1), “unprecedented.” She suggested they...
DESTINY Breast03 Trial Supports Second-Line Use of T-DXd in Metastatic HER2-Positive Breast Cancer
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) may become a new option as a second-line treatment of patients with HER2-positive unresectable or metastatic breast cancer, based on results from the global phase III DESTINY-Breast03 trial. These findings were presented by Javier...
FDA Pipeline: Recent Reviews, Designations, Applications, and Authorizations in the Oncology Space
Over the past month, the U.S. Food and Drug Administration (FDA) issued several regulatory decisions for novel treatments for patients with cancer. Priority Review for Relatlimab and Nivolumab Fixed-Dose Combination in Unresectable or Metastatic Melanoma The FDA accepted for Priority Review the...
DESTINY-Lung01: Fam-trastuzumab Deruxtecan-nxki in Previously Treated HER2-Mutant NSCLC
In the phase II DESTINY-Lung01 trial, presented at the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract LBA45) and concurrently reported in The New England Journal of Medicine, Bob T. Li, MD, PhD, MPH, and colleagues found that fam-trastuzumab deruxtecan-nxki produced durable...
DESTINY Breast03: Second-Line Fam-Trastuzumab Deruxtecan-nxki for Metastatic HER2-Positive Breast Cancer
Fam-trastuzumab deruxtecan-nxki (T-DXd) showed statistically significant improvement in progression-free survival vs trastuzumab emtansine (T-DM1) in second-line treatment for HER2-positive unresectable or metastatic breast cancer, according to results from the global phase III DESTINY-Breast03...
DESTINY-Gastric02: Fam-Trastuzumab Deruxtecan-nxki Produces Responses in Patients With HER2-Positive Gastric Cancers
In the primary analysis of the phase II DESTINY-Gastric02 trial, fam-trastuzumab deruxtecan-nxki (T-DXd) produced clinically meaningful and durable responses in Western patients with advanced HER2-positive gastric or gastroesophageal junction cancers whose disease had progressed after a...
Cancer Is Trying to Steal My Body, but I Will Not Allow It to Steal My Joy
Until I was diagnosed with HER2-positive, estrogen receptor–positive/progesterone receptor–positive de novo metastatic breast cancer in 2009, I didn’t realize that Black women could get the disease. Although my mother died of metastatic breast cancer 5 years earlier when she was 65, she was the...
Breast Cancer in 2030: Predictions From a Breast Cancer Luminary
According to George W. Sledge, Jr, MD, FASCO, Professor of Medicine in the Division of Oncology at Stanford University Medical Center, by the beginning of the next decade, clinicians will be aided by the use of artificial intelligence (AI) in many facets of care and by the approval of a wave of new ...
Fam-trastuzumab Deruxtecan-nxki for Trastuzumab-Pretreated Advanced HER2-Positive Gastric Adenocarcinoma
On January 15, 2021, the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki was approved for treatment of adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen.1,2 Supporting Efficacy Data...
NCCN Clinical Practice Guidelines in Oncology: 2021 Updates
In 1996, the National Comprehensive Cancer Network® (NCCN®) published its first set of Clinical Practice Guidelines in Oncology®, covering eight tumor types. Guidelines are now published for more than 60 tumor types and topics. During the NCCN’s 26th Annual Conference, which was held virtually...
Margetuximab-cmkb: A Novel Agent Overshadowed by an Abundance of Options in HER2-Positive Breast Cancer
It is incredible to reflect upon the scientific advances in the treatment of HER2-positive breast cancer over the past 23 years. Once considered the worst subtype of breast cancer, HER2-positive disease is now associated with the best long-term outcomes in this age of targeted treatments. With a...
Cannabis
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. In this article, Nirupa Raghunathan, MD, and Jyothirmai Gubili, MS, focus on the increasing use...
Role of Antibody-Drug Conjugates Across Breast Cancer Subtypes
For the treatment of breast cancer, antibody-drug conjugates are emerging as effective players that could impact all subtypes of this disease, according to Kevin Kalinsky, MD, MS, Director of the Glenn Family Breast Cancer at the Winship Cancer Institute of Emory University, Atlanta. In the...
Mary F. Mulcahy, MD, and Crystal S. Denlinger, MD, on NCCN Guidelines Updates: Gastric and Esophageal Cancers
Crystal S. Denlinger, MD, of Fox Chase Cancer Center, and Mary F. Mulcahy, MD, of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, discuss biomarkers for determining treatment; immune checkpoint inhibitors; when to employ such treatments as platinum/fluoropyrimidine and...
Novel Therapies and New Indications for Use in the Treatment of Gastrointestinal Cancers
The past year has witnessed the U.S. Food and Drug Administration (FDA) approval of a number of novel drugs and new indications for treating patients with gastrointestinal malignancies. A summary of these approvals is provided herein. Nivolumab plus ipilimumab: On March 10, 2020, the FDA granted...
Expert Point of View: Autumn McRee, MD
DESTINY-CRC01 study discussant, Michael S. Lee, MD, Assistant Professor of Medicine, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, called the findings “most promising” for the subsequent anti-HER2 treatment of HER2-positive metastatic colorectal cancer. The...
Fam-Trastuzumab Deruxtecan-nxki Shows Benefit in Refractory Colorectal Cancer
Having recently gained approval in metastatic breast cancer, fam-trastuzumab deruxtecan-nxki (T-DXd) is now proving its worth in metastatic colorectal cancer, according to results of the phase II DESTINY-CRC01 study in patients with HER2-positive disease.1 T-DXd is an antibody-drug conjugate...
FDA Approves Fam-Trastuzumab Deruxtecan-nxki for Previously Treated Patients With HER2-Positive Gastric Cancers
On January 15, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen....
FDA Pipeline: Priority Reviews in NSCLC, Gastric Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to a PD-1 inhibitor for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC), and also granted Priority Review to a HER2-directed antibody-drug conjugate for patients with...
Clinical Challenges of Managing Breast Cancer Brain Metastases
“Breast cancer brain metastases are a clinical challenge that are only increasing in incidence and are a consequence of advanced breast cancers, largely HER2-positive and triple-negative,” according to Carey K. Anders, MD, Professor of Medicine and Medical Director of the Duke Brain and Spine...
