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Jame Abraham, MD, FACP, on HER2-Positive Metastatic Breast Cancer: Choosing a Regimen in Clinical Practice
Jame Abraham, MD, FACP, puts findings from several trials in HER2-positive breast cancer into context, including HER2CLIMB, which investigated tucatinib, trastuzumab, and capecitabine in pretreated patients with metastatic disease; DESTINY Breast-09, which evaluated fam-trastuzumab deruxtecan-nki...
Jame Abraham, MD, FACP, on T-DXd in HER2-Positive Early Breast Cancer: Follow-up Data
Jame Abraham, MD, FACP, discusses follow-up data from the DESTINY Breast-05 and DESTINY Breast-11 trials of fam-trastuzumab deruxtecan-nki (T-DXd) for HER2-positive early breast cancer. DESTINY Breast-05 examined the agent given postneoadjuvantly, while DESTINY Breast-11 evaluated the agent in a...
HER2-Positive Breast Cancer: FDA Approves T-DXd Plus Pertuzumab
On December 15, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved...
Sacituzumab Govitecan vs Standard of Care for Certain Endocrine Therapy–Refractory Advanced Breast Cancers
Patients with hormone receptor–positive, HER2-negative advanced breast cancers had similar progression-free survival whether they were treated with sacituzumab govitecan-hziy or standard-of-care chemotherapy as the first treatment after endocrine therapy, according to results from the phase III...
New FDA-Approved Oncology Drugs and Label Updates Between December 1, 2024, and November 19, 2025
Over the past year (December 2024–November 19, 2025), the U.S. Food and Drug Administration (FDA) approved and expanded indications for many drugs related to the treatment of different types of cancers. The new approvals and accelerated approvals are listed below according to the most recent new...
ADCs vs Standard Chemotherapy: Cardiotoxicity in HER2-Positive Advanced Breast Cancer
A systematic review and meta-analysis published in JAMA Network Open compared the cardiotoxicity of novel antibody-drug conjugates (ADCs) with that of standard trastuzumab-containing chemotherapy in patients with HER2-positive locally advanced or metastatic breast cancer, finding that treatment...
European Society for Medical Oncology Congress 2025 Meeting Highlights
The European Society for Medical Oncology (ESMO) Congress 2025 in Berlin featured many important trials with the potential to significantly influence clinical practice and improve outcomes for patients with multiple tumor types. These studies highlighted the benefits of novel treatment combination...
HER2-Positive Early Breast Cancer: Trastuzumab Deruxtecan Moves Into Earlier Clinical Settings
Two pivotal studies of fam-trastuzumab deruxtecan-nxki (T-DXd) in early HER2-positive breast cancer suggest this antibody-drug conjugate (targeting the HER2 protein) may be moving into the curative setting after having shown benefit in metastatic disease in multiple previous trials. The new...
T-DXd Plus Pertuzumab in HER2-Positive Advanced or Metastatic Breast Cancer
As reported in The New England Journal of Medicine by Tolaney et al, interim analysis of the phase III DESTINY-Breast09 trial has shown significantly improved progression-free survival with fam-trastuzumab deruxtecan-nxki (T-DXd) plus pertuzumab vs a taxane (paclitaxel or docetaxel), trastuzumab,...
HER2-Positive Early Breast Cancer: Trastuzumab Deruxtecan Moves Into Earlier Clinical Settings
Two pivotal studies of fam-trastuzumab deruxtecan-nxki (T-DXd) in early HER2-positive breast cancer suggest this antibody-drug conjugate (targeting the HER2 protein) may be moving into the curative setting after having shown benefit in metastatic disease in multiple previous trials. The new...
Reversible TKI in HER2-Mutant NSCLC
The oral targeted therapy sevabertinib led to tumor reduction and manageable side effects in patients with HER2-mutant non–small cell lung cancer (NSCLC), according to data from the phase I/II SOHO-01 clinical trial. Over 70% of the patients studied saw their tumors shrink or disappear. The results ...
Treatment Rechallenge After Interstitial Lung Disease Related to T-DXd: Is It Safe?
Rechallenge with the HER2-directed antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) after grade 1 interstitial lung disease (ILD) appeared to be safe in a diverse real-world population, including many patients with breast cancer, as presented during the 2025 ASCO Annual Meeting.1 The ...
Best of ASCO 20th Anniversary: Advancing Medicine and Patient Care, ASCO Style!
For the 20th year in a row, major advances in cancer research and practice-changing clinical trials from the 2025 ASCO Annual Meeting (ASCO25) were presented at the ASCO-licensed Best of ASCO meeting, held on July 18–19, 2025, in Beirut, Lebanon. It was indeed a great celebration and commitment to...
In Second-Line Setting, T-DXd Improves Survival Outcomes in HER2-Positive Gastric or Gastroesophageal Junction Cancer
In the phase III DESTINY-Gastric04 trial, use of the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) was compared head to head with the monoclonal antibody ramucirumab and paclitaxel in patients with previously treated, HER2-positive metastatic gastric or gastroesophageal junction...
Phase III Trial Results Suggest a New Standard of Care in Metastatic HER2-Positive Breast Cancer
In the phase III DESTINY-Breast09 trial, first-line treatment with the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) plus the monoclonal antibody pertuzumab significantly delayed disease progression by more than 1 year—nearly doubling the time of disease control—over standard...
Study Shows Potential Benefits of AI-Assisted Classification in HER2-Low and HER2-Ultralow Breast Cancer
With the approval of HER2-targeted antibody-drug conjugate options for treating patients with breast cancer across different HER2 expression levels, accurate assessment of HER2 expression has become more important than ever. And a recent study may provide a solution to the challenge of accurate...
Trastuzumab Deruxtecan/Pertuzumab Leads to Improved PFS for HER2-Positive Breast Cancer
Results from the phase III DESTINY-Breast09 clinical trial found that the combination of fam-trastuzumab deruxtecan-nxki (T-DXd) with pertuzumab may delay cancer growth for longer than the current standard of care in people with HER2-positive locally advanced or metastatic breast cancer. The...
Trastuzumab Deruxtecan Improves Survival Outcomes in Patients With HER2-Positive Gastric/GEJ Cancer in Second-Line Setting
The international phase III DESTINY-Gastric04 clinical trial found that second-line treatment with fam-trastuzumab deruxtecan-nxki can help people with advanced HER2-positive gastric cancers that have grown during first-line treatment live about 3 months longer. These findings further support the...
ASCO Congratulates 2025 Special Awards Recipients
ASCO and Conquer Cancer, the ASCO Foundation, will recognize researchers, patient advocates, philanthropists, teachers, and global oncology leaders who have reshaped cancer care around the world with the Society’s highest honors at the 2025 ASCO Annual Meeting. “The recipients of this year’s...
Early-Phase Trial Shows Activity and Safety of Zongertinib in Previously Treated HER2-Mutant NSCLC
Zongertinib, an investigational oral, HER2-selective, EGFR-sparing tyrosine kinase inhibitor, elicited durable responses and demonstrated clinical benefit in patients with advanced, previously treated, HER2-mutant non–small cell lung cancer (NSCLC), according to data presented by John V. Heymach,...
NCCN Clinical Practice Guidelines in Oncology: 2025 Updates
The National Comprehensive Cancer Network (NCCN) released its first set of Clinical Practice Guidelines in Oncology (NCCN Guidelines®) in 1996, covering eight tumor types. Today, guidelines are available for more than 60 tumor types, subtypes, and related topics. During the NCCN’s 30th Annual...
AACR 2025: Oral HER2-Targeted Therapy for Advanced HER2-Mutated Lung Cancer
The novel HER2-targeted tyrosine kinase inhibitor zongertinib elicited durable responses in patients with advanced, previously treated non–small cell lung cancer (NSCLC) that harbored a HER2 mutation, according to the preliminary results of the early-phase Beamion LUNG-1 trial. These findings were...
Top Picks From SABCS 2024
Among the high-quality abstract presentations at the 2024 San Antonio Breast Cancer Symposium (SABCS), a few always stand out as particularly meritorious. Each year, The ASCO Post asks our Deputy Editor, breast cancer specialist Jame Abraham, MD, FACP, to give us his picks. Dr. Abraham is Chairman...
FDA Approves First Companion Diagnostic to Identify Patients With Metastatic Breast Cancer Eligible for T-DXd
The U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify patients with hormone receptor (HR)-positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with fam-trastuzumab...
T-DXd Approved by the FDA for Pretreated Patients With HER2-Low or -Ultralow Metastatic Breast Cancer
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in situ...
Adjuvant T-DM1 in Patients With HER2-Positive Breast Cancer: Long-Term Results of the KATHERINE Trial
Adjuvant treatment with the antibody-drug conjugate ado-trastuzumab emtansine (T-DM1) may improve survival in patients with high-risk HER2-positive breast cancer and residual invasive disease, according to long-term findings from the phase III KATHERINE trial published by Geyer et al in The New...
Trastuzumab Deruxtecan vs Chemotherapy in Advanced Breast Cancer
Researchers have examined whether the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) may improve progression-free survival in patients with advanced breast cancer who have undergone prior hormone-based therapies, according to recent findings presented by Bardia et al at the 2024...
T-DXd of Benefit in Patients With Breast Cancer and Brain Metastases
Late-breaking findings from the phase IIIb/IV, open-label DESTINY-Breast12 trial support the use of the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) in patients with HER2-positive metastatic breast cancer and brain metastases who have experienced disease progression on at least...
In Case You Missed It: Roundup From ESMO Congress 2024
In addition to our in-depth analysis of important clinical trials presented at the European Society for Medical Oncology (ESMO) Congress 2024, there is always room for more coverage from The ASCO Post, including these brief summaries of other presentations of interest. They focus on a potential...
New Hope for Patients With HER2-Mutant NSCLC: Durable Responses to Two Novel Targeted Therapies
Two novel oral HER2 tyrosine kinase inhibitors have demonstrated promising efficacy in patients with HER2-mutant non–small cell lung cancer (NSCLC), potentially transforming the treatment landscape for this challenging subset of lung cancer cases. According to data presented at the International...
Case Study Shows Striking Improvements in Patient Treated for Metastatic Prostate Cancer With Antibody-Drug Conjugate
A landmark case report suggested a potential breakthrough in the treatment of an aggressive type of prostate cancer, according to a recent study published by Lap et al in the Annals of Internal Medicine. The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) was approved by the U.S....
Whole-Person Cancer Care: A Transformative Vision for Oncology
Guest Editor’s Note: Advances in cancer treatments have led to an increase in survival rates, but the quality of life is often diminished during survivorship. Because modifiable personal behavior contributes to health-care outcomes, interventions that support healthy behaviors may improve health...
New Hope for Patients With HER2-Mutant NSCLC: Durable Responses to Two Novel Targeted Therapies
Two novel oral HER2 tyrosine kinase inhibitors have demonstrated promising efficacy in patients with HER2-mutant non–small cell lung cancer (NSCLC), potentially transforming the treatment landscape for this rare but challenging subset of lung cancer cases. According to data presented at the...
DESTINY-Breast12: T-DXd of Benefit in Patients With Breast Cancer and Brain Metastases
Late-breaking findings from the phase IIIb/IV, open-label DESTINY-Breast12 trial support the use of the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) in patients with HER2-positive metastatic breast cancer and brain metastases who have experienced disease progression on at least...
Fam-Trastuzumab Deruxtecan-nxki in Unresectable or Metastatic HER2-Positive Solid Tumors
On April 5, 2024, fam-trastuzumab deruxtecan-nxki (T-DXd) was granted accelerated approval for adults with unresectable or metastatic HER2-positive (immunohistochemistry 3+) solid tumors who received prior systemic treatment and have no satisfactory alternative treatment options.1 Supporting...
T-DXd Effective for Breast Tumors With HER2-Low and HER2-Ultralow Expression in Earlier Line of Therapy
In patients with hormone receptor–positive metastatic breast cancers with HER2-low or HER2-ultralow expression, treatment with the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) was found to be superior to chemotherapy after one or more lines of endocrine therapy. In...
T-DXd in HER2-Positive Advanced Colorectal Cancer
As reported in The Lancet Oncology by Kanwal Raghav, MD, and colleagues, the phase II DESTINY-CRC02 trial has identified the preferred dosage of single-agent fam-trastuzumab deruxtecan-nxki (T-DXd) in patients with HER2-positive advanced colorectal cancer. Study Details In the international study, ...
Study Identifies Subset of Patients With Lung Adenocarcinoma Who Have HER2 Alterations
Researchers have found that about 6% of patients with non–small cell lung cancer (NSCLC) and KRAS, EGFR, or ALK gene mutations may also have HER2 alterations, according to recent findings presented by Dahake et al at the 2024 ASCO Annual Meeting (Abstract 8534). Background Lung adenocarcinoma is...
Thomas Powles, MD, PhD, and Jonathan E. Rosenberg, MD, on Urothelial Carcinoma: The DESTINY-Pan Tumor02 Study and New Findings on Sacituzumab Govitecan
Thomas Powles, MD, PhD, of Barts Cancer Institute and the University of London, and Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discuss clinical outcomes of sacituzumab govitecan-hziy after prior exposure to enfortumab vedotin-ejfv in patients with metastatic urothelial...
T-DXd Improves Progression-Free Survival in Patients With Breast Cancer Previously Treated With Endocrine Therapy
Fam-trastuzumab deruxtecan-nxki (T-DXd) delayed cancer growth in patients with hormone receptor (HR)-positive, HER2-low or -ultralow metastatic breast cancer that progressed following endocrine therapy, according to findings from the phase III DESTINY-Breast06 trial. The research was presented by...
NCCN Clinical Practice Guidelines in Oncology: 2024 Updates
The National Comprehensive Cancer Network® published its first set of Clinical Practice Guidelines in Oncology (NCCN Guidelines®) in 1996, covering eight tumor types. Currently, guidelines are available for more than 60 tumor types, subtypes, and related topics. The NCCN’s 29th Annual Conference...
T-DXd for Advanced Solid Tumors With Activating HER2 Mutations
As reported in The Lancet Oncology by Bob T. Li, MD, PhD, MPH, and colleagues, the phase II DESTINY-PanTumor01 trial showed activity of fam-trastuzumab deruxtecan-nxki (T-DXd) in patients with unresectable or metastatic solid tumors that have specific activating HER2 mutations. The antibody-drug...
AI in Cancer Care: Embrace the Change
According to Google Chief Executive Officer Sunder Pichai, artificial intelligence (AI) is “the most profound technology humanity is working on—more profound than fire or electricity or anything that we’ve done in the past.” The impact of AI on health care and especially cancer care will not be...
T-DXd vs Physician’s Choice of Therapy in HER2-Positive Metastatic Breast Cancer: PROs in DESTINY-Breast02
In an analysis of patient-reported outcomes (PROs) in the DESTINY-Breast02 trial published in The Lancet Oncology, Tanja Fehm, MD, and colleagues found that general health status/quality of life was maintained over time with fam-trastuzumab deruxtecan-nxki (T-DXd) vs physician’s choice of therapy...
Activity Shown for Antibody-Drug Conjugates in Gynecologic Cancers
The recent approval of mirvetuximab soravtansine-gynx is a testament to the emerging benefit of antibody-drug conjugates in recurrent ovarian cancer. Other agents of this class are now eliciting excitement as they demonstrate high response rates in a population with unmet clinical needs, according...
FDA Grants Accelerated Approval to Fam-Trastuzumab Deruxtecan-nxki for Unresectable or Metastatic HER2-Positive Solid Tumors
On April 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior systemic treatment and have no...
T-DXd in HER2-Overexpressing Unresectable or Metastatic NSCLC
As reported in The Lancet Oncology by Egbert F. Smit, MD, and colleagues, primary analysis in the HER2-overexpressing unresectable or metastatic non–small cell cancer (NSCLC) cohorts of the phase II DESTINY-Lung01 trial show activity of fam-trastuzumab deruxtecan-nxki (T-DXd) in this setting. Prior ...
Highlights From the 2023 San Antonio Breast Cancer Symposium
Studies presented at the 2023 San Antonio Breast Cancer Symposium (SABCS) significantly moved the needle forward in our treatment of breast cancer. We are increasingly learning how to stratify risk, so we can optimize therapy and minimize our patients’ exposure to treatments that will not be...
Long-Term Follow-up Supports Postneoadjuvant T-DM1 Over Trastuzumab in Early, High-Risk, HER2-Positive Breast Cancer
At a median follow-up of 8.4 years, adjuvant use of ado-trastuzumab emtansine (T-DM1) continued to improve invasive disease–free survival and overall survival compared with trastuzumab in patients with HER2-positive early breast cancer with residual invasive disease after neoadjuvant therapy. These ...
Expert Point of View: Valentina Guarneri, MD
Invited discussant of the HER2CLIMB-02 trial, Valentina Guarneri, MD, of Padeva Istituto Oncologica Veneto, Italy, hailed these results as important, especially for patients with HER2-positive breast cancer and brain metastases. However, she noted, “HER2CLIMB-02 is not likely to challenge the...
