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Showing 101 - 150Expert Point of View: Meritxell Bellet Ezquerra, MD, PhD
TROPiCS-02 is a statistically positive trial, with the primary endpoint met and also now with an overall survival gain of 3.2 months,” said the study’s invited discussant Meritxell Bellet Ezquerra, MD, PhD, a senior researcher at the Vall d’Hebron Institute of Oncology, Barcelona. “TROPiCS-02 is...
TROPiCS-02: Sacituzumab Govitecan Improves Overall Survival in Hormone Receptor–Positive, HER2-Negative Breast Cancer
An overall survival benefit has now emerged for sacituzumab govitecan-hziy in women with previously treated, hormone receptor–positive/HER2-negative, locally recurrent, inoperable or metastatic breast cancer, according to a planned second interim analysis of the phase III TROPiCS-02 trial.1 The...
Trastuzumab Deruxtecan for Advanced HER2-Mutant NSCLC
On August 11, 2022, fam-trastuzumab deruxtecan-nxki was granted accelerated approval for unresectable or metastatic non–small cell lung cancer (NSCLC) with tumors that have activating HER2 mutations, as detected by a U.S. Food and Drug Administration (FDA)-approved test and who have received a...
T-DXd for Patients With HER2-Low Metastatic Breast Cancer: Patient-Reported Outcomes
Patients who received fam-trastuzumab deruxtecan-nxki (T-DXd) for HER2-low metastatic breast cancer reported that the treatment maintained their quality of life compared to conventional chemotherapy, according to results presented by Ueno et al at the European Society for Medical Oncology (ESMO)...
ASCO Updated Guideline of Biomarkers in Metastatic Breast Cancer Supports PIK3CA, BRCA1/2, PD-L1 Testing
ASCO has issued a new practice guideline update on the use of biomarkers in the management of metastatic breast cancer.1 The updated guideline revisits recommendations from the 2015 guideline and addresses topics that have emerged since then in the move toward personalized medicine in metastatic...
T-DXd Shows High Intracranial Response Rate in Patients With Active Brain Metastases From HER2-Positive Breast Cancer
In the investigator-initiated, prospective, open-label, single-arm phase II TUXEDO-1 study conducted among patients with newly diagnosed or progressive brain metastases from HER2-positive breast cancer, the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) yielded responses according...
FDA Grants Accelerated Approval to Trastuzumab Deruxtecan for HER2-Mutant NSCLC
On August 11, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for adult patients with unresectable or metastatic non–small cell lung cancer (NSCLC) whose tumors have activating HER2 mutations, as detected by an...
Expert Point of View: Rebecca A. Dent, MD
The invited discussant of the DS8201-A-U105 trial, Rebecca A. Dent, MD, Head of the Department of Medical Oncology, Senior Consultant, and Chief of the Breast Medical Oncology Service at the National Cancer Center Singapore, said the results were reassuring in terms of safety and may pave the way...
Nivolumab Plus T-DXd Under Study in HER2-Expressing Metastatic Breast Cancer
In the phase Ib DS8201-A-U105 trial, the addition of the PD-1 inhibitor nivolumab to the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) did not appear to improve outcomes over T-DXd alone (based on historical controls). However, it did establish the safety of the combination,...
Expert Point of View: Cathy Eng, MD, FACP, FASCO
Cathy Eng, MD, FACP, FASCO, the David H. Johnson Endowed Chair in Surgical and Medical Oncology, Co-Director of Gastrointestinal Oncology, and Co-Leader of the Gastrointestinal Cancer Research Program at Vanderbilt-Ingram Cancer Center, Nashville, told The ASCO Post she finds the data from...
FDA Approves First Targeted Therapy for HER2-Low Breast Cancer
On August 5, 2022, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu), an intravenous infusion for the treatment of patients with unresectable or metastatic HER2-low breast cancer. This is the first approved therapy targeted to patients with the...
ASCO Guideline Update Supports New Second- and Third-Line Treatments for HER2-Positive Breast Cancer
ASCO has issued a new practice guideline update on the use of systemic therapy for HER2-positive breast cancer, just 4 years after the previous practice guideline update was released in 2018.1,2 This latest update reviews results from multiple clinical trials published between 2016 and 2021 that...
Metastatic HER2-Positive Breast Cancer With Brain Metastases
This is Part 2 of Updates in HER2-Positive Breast Cancer, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable. In this video, Drs. Carey K. Anders, Erika Hamilton, and Sara A. Hurvitz discuss the management of metastatic HER2-positive breast cancer with ...
Metastatic HER2-Positive Breast Cancer
This is Part 1 of Updates in HER2-Positive Breast Cancer, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable. In this video, Drs. Carey K. Anders, Erika Hamilton, and Sara A. Hurvitz discuss the management of metastatic HER2-positive breast cancer. The ...
Expert Point of View: Debu Tripathy, MD
Debu Tripathy, MD, Professor and Chair of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center, Houston, shared his thoughts on TROPiCS-02 with The ASCO Post. He said the study is important because it addresses the needs of “a population with limited options, whose...
Expert Point of View: Patricia LoRusso, DO, PhD
Invited discussant Patricia LoRusso, DO, PhD, of Yale School of Medicine, said to the assembled audience at the 2022 ASCO Annual Meeting: “I see you are as excited about these data as I am,” after the applause ended following Dr. Modi’s presentation. “I want to thank our colleagues for helping to...
DESTINY-Breast04 Trial: T-DXd Significantly Improves Survival in Patients With HER2-Low Metastatic Breast Cancer
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) doubled progression-free survival compared with chemotherapy alone in patients with “HER2-low” metastatic breast cancer—ie, patients with low levels of HER2 expression. The agent also extended overall survival for patients with low ...
Akihiro Ohba, MD, on Biliary Tract Cancer: New Findings on Fam-Trastuzumab Deruxtecan-nxki
Akihiro Ohba, MD, of Japan’s National Cancer Center Hospital, discusses phase II data from the HERB trial on fam-trastuzumab deruxtecan-nxki, which showed activity in patients with HER2-expressing unresectable or recurrent biliary tract cancer (Abstract 4006).
Erika Hamilton, MD, on Metastatic Breast Cancer: Safety Follow-up Data on T-DXd vs T-DM1
Erika Hamilton, MD, of Sarah Cannon Research Institute at Tennessee Oncology, discusses phase III data from the DESTINY-Breast03 study, which reinforced the consistent safety profile of fam-trastuzumab deruxtecan-nxki (T-DXd) vs ado-trastuzumab emtansine (T-DM1) in patients with HER2-positive...
Lisa A. Carey, MD, and Shanu Modi, MD, on Breast Cancer: Is T-DXd a Potential New Standard of Care for HER2-Low Disease?
Lisa A. Carey, MD, of the University of North Carolina Lineberger Comprehensive Cancer Center, and Shanu Modi, MD, of Memorial Sloan Kettering Cancer Center, discuss the phase III findings from the DESTINY-Breast04 trial, which compared fam-trastuzumab deruxtecan-nxki (T-DXd) vs treatment of...
Expert Point of View: Mafalda Oliveira, MD, PhD
The invited discussant of the TUXEDO-1 trial1 was Mafalda Oliveira, MD, PhD, of Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona. Dr. Oliveira noted that 40% of the 15 patients in TUXEDO-1 had symptomatic disease, and 60% had central nervous system metastases...
T-DXd Shows Efficacy Against Active Brain Metastases in HER2-Positive Breast Cancer
In the single-center phase II TUXEDO-1 trial of patients with advanced HER2-positive breast cancer, fam-trastuzumab-deruxtecan-nxki (T-DXd) showed efficacy in patients with active brain metastases, yielding intracranial responses in 73.3% of the population and a median progression-free survival of...
Use of T-DXd in Previously Treated Patients With Advanced HER2-Positive Breast Cancer
On May 4, 2022, fam-trastuzumab deruxtecan-nxki (T-DXd) was granted regular approval for patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2–based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed...
Expert Point of View: Mafalda Oliveira, MD, PhD
The invited discussant of the BEGONIA trial,1 Mafalda Oliveira, MD, PhD, of Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona, called the activity of the combination of durvalumab and datopotamab deruxtecan (Dato-DXd) “notable,” with a 74% response rate overall,...
BEGONIA Trial Reports Activity With Datopotamab Deruxtecan Plus Durvalumab in Triple-Negative Breast Cancer
Preliminary results of the basket BEGONIA trial showed that the antibody-drug conjugate datopotamab deruxtecan (Dato-DXd), paired with the immune checkpoint inhibitor durvalumab, has strong activity in advanced or metastatic triple-negative breast cancer among patients not biomarker-selected for...
DESTINY-Breast03: Should Trastuzumab Deruxtecan Be the Preferred Second-Line Regimen in HER2-Positive Metastatic Breast Cancer?
Since the introduction of trastuzumab in the late 1990s, overall survival for patients with HER2-positive metastatic breast cancer has substantially improved. Median overall survival in the pivotal first-line trial was only 20.3 months in the chemotherapy arm, and 25.1 months in the...
T-DXd Improves Progression-Free Survival vs T-DM1 in Metastatic HER2-Positive Breast Cancer
As reported in The New England Journal of Medicine by Javier Cortés, MD, PhD, of the International Breast Cancer Center, Barcelona, and colleagues, the phase III DESTINY-Breast03 trial has shown significantly prolonged progression-free survival with fam-trastuzumab deruxtecan-nxki (T-DXd) vs...
Fam-Trastuzumab Deruxtecan-nxki Doubles Progression-Free Survival in HER2-Low Metastatic Breast Cancer
The use of fam-trastuzumab deruxtecan-nxki doubled progression-free survival compared with the standard-of-care treatment plus conventional chemotherapy. It also significantly improved overall survival for patients with metastatic breast cancers expressing low levels of the HER2 receptor,...
New FDA-Approved Oncology Drugs (2021–2022)
Over the past year (May 2021–May 2022), the U.S. Food and Drug Administration (FDA) approved and expanded indications for many drugs related to the treatment of different types of cancers and adverse events. The new approvals and accelerated approvals are listed below. FAM-TRASTUZUMAB...
NCCN Clinical Practice Guidelines in Oncology: 2022 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, subtypes, and topics. During the NCCN’s 27th Annual Conference, which was again...
Next-Generation PARP1-Selective Inhibitor Offers Significant Benefits Over Older Predecessors in Treatment of Solid Tumors
The first-in-human, first-in-class trial of the next-generation PARP (poly [ADP-ribose] polymerase) 1–selective inhibitor AZD5305 suggests this drug may be a welcome advance over its U.S. Food and Drug Administration (FDA)-approved predecessors in the treatment of solid tumors with alterations in...
Beyond Immunotherapy: New Targeted Agents for Advanced NSCLC
The advent of PD-1 and PD-L1 checkpoint inhibitors has changed the treatment landscape of advanced non–small cell lung cancer (NSCLC), but only approximately 20% of patients treated with immunotherapy will be alive at 5 years. According to Melissa L. Johnson, MD, Director, Lung Cancer Research,...
DESTINY-Lung01: Is Trastuzumab Deruxtecan the Answer for HER2-Mutant Lung Cancer?
The human epidermal growth factor (HER) family of receptors are a well-established therapeutic target. Indeed, seminal studies conducted nearly 2 decades ago identified a key association between activating mutations in the kinase domain of the epidermal growth factor receptor (EGFR, also known as...
DESTINY-Lung01: T-DXd Shows Durable Activity in Previously Treated Metastatic HER2-Mutant NSCLC
In a phase II trial (DESTINY-Lung01) reported in The New England Journal of Medicine, Bob T. Li, MD, PhD, MPH, of the Thoracic Oncology and Early Drug Development Service, Memorial Sloan Kettering Cancer Center, New York, and colleagues found that fam-trastuzumab deruxtecan-nxki (T-DXd) showed...
TUXEDO-1: Efficacy of T-DXd for Patients With HER2-Positive Breast Cancer and Active Brain Metastases
In the single-center phase II TUXEDO-1 trial of patients with advanced HER2-positive breast cancer, fam-trastuzumab-deruxtecan-nxki (T-DXd) showed efficacy in patients with active brain metastases, yielding intracranial responses in 73.3% of the population and a median progression-free survival of...
FDA 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...
