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Advanced ER+ HER2+ Breast Cancer Combo Therapy Fails to Improve Outcomes

European Commission Approves Trastuzumab Deruxtecan for Second-Line HER2+ Breast Cancer

The European Commission announced an approval of trastuzumab deruxtecan as monotherapy for patients with unresectable or metastatic HER2-positive breast cancer who have already received one prior line of therapy.

This approval follows the positive opinion released by the Committee for Medicinal Products for Human Use and is based on positive results from the phase 3 DESTINY-Breast03 trial. For patients in the EU, trastuzumab deruxtecan is now available as a second-line treatment option.

In DESTINY-Breast03, trastuzumab deruxtecan reduced disease progression or death by 72% when compared to trastuzumab emtansine (HR = 0.28; 95% CI, 0.22-0.37; P < .000001).

Overall survival was significantly better in patients treated with trastuzumab deruxtecan vs trastuzumab emtansine. The objective response rate was more than doubled with trastuzumab deruxtecan compared to trastuzumab emtansine, 79.7% vs 34.2%, respectively.

The most common adverse events were nausea, vomiting, fatigue, alopecia, and neutropenia. Twelve percent of patients developed interstitial lung disease or pneumonitis, but most cases were grade 1-2.

“In the DESTINY-Breast03 trial, the time to progression was extended well beyond a year for patients receiving [trastuzumab deruxtecan], illustrating the potential for this medicine to set a new benchmark in the treatment of HER2-positive metastatic breast cancer,” Javier Cortés, MD, PhD, head of the International Breast Cancer Center in Barcelona.

This approval further supports the findings of DESTINY-Breast03 and the European Society for Medical Oncology Clinical Practice Guidelines that now recommend trastuzumab deruxtecan as the preferred second-line therapy for patients with HER2-positive metastatic breast cancer.

References:

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/enhertu-approved-in-eu-for-her2-positive-mbc.html

https://www.nejm.org/doi/full/10.1056/NEJMoa2115022

Disclosures: The study was supported by AstraZeneca.

Photo Credit: Getty Images.

By MD /alert Staff

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Metastatic Breast Cancer Therapy Gains Fast Track Designation

Nitric Oxide Synthase Inhibitor Plus Taxane Show Promise in Chemoresistant TNBC

Nitric Oxide Synthase Inhibitor Plus Taxane Show Promise in Chemoresistant TNBC

FDA Accepts Biologics License Application for New Metastatic HER2+ Breast Cancer Treatment

FDA Accepts Biologics License Application for New Metastatic HER2+ Breast Cancer Treatment

FDA Grants Fast Track Designation in HR+/HER2- Metastatic Breast Cancer

FDA Grants Fast Track Designation in HR+/HER2- Metastatic Breast Cancer

New Vaccine to Prevent Breast Cancer in Early Clinical Trials

New Vaccine to Prevent Breast Cancer in Early Clinical Trials

Therapy Targeting Inducible Nitric Oxide Signaling Shows Promise in TNBC

Therapy Targeting Inducible Nitric Oxide Signaling Shows Promise in TNBC

Trastuzumab Deruxtecan Improves Survival in HER2-Positive Breast Cancer

Trastuzumab Deruxtecan Improves Survival in HER2-Positive Breast Cancer

FDA Approves Combo of Abemaciclib, Endocrine Therapy for Early Breast Cancer

FDA Approves Combo of Abemaciclib, Endocrine Therapy for Early Breast Cancer

Atezolizumab Withdrawn from FDA Accelerated Approval for TNBC

Atezolizumab Withdrawn from FDA Accelerated Approval for TNBC

Celecoxib Shows No Benefit for Patients with Early Breast Cancer

Celecoxib Shows No Benefit for Patients with Early Breast Cancer

Research Shows Benefits of Pembrolizumab as Single Agent TNBC Treatment

Research Shows Benefits of Pembrolizumab as Single Agent TNBC Treatment

Chemotherapy Plus Treatment Combination for ERBB2-positive MBC Inferior in Clinical Practice

Chemotherapy Plus Treatment Combination for ERBB2-positive MBC Inferior in Clinical Practice

ASCO Guideline on Adjuvant Olaparib in Patients with HER2-negative Breast Cancer

ASCO Guideline on Adjuvant Olaparib in Patients with HER2-negative Breast Cancer

Durvalumab Provokes Robust Long-Term Outcomes in Patients with TNBC

Durvalumab Provokes Robust Long-Term Outcomes in Patients with TNBC

Endocrine Therapy Noninferior to Chemotherapy as First-Line Treatment for Patients with MBC

Endocrine Therapy Noninferior to Chemotherapy as First-Line Treatment for Patients with MBC

Adjuvant Olaparib Significantly Improves Invasive DFS in Patients with High-Risk EBC, BRCA Mutations

Adjuvant Olaparib Significantly Improves Invasive DFS in Patients with High-Risk EBC, BRCA Mutations

FDA Approves Sacituzumab Govitecan-hziy for Metastatic TNBC

FDA Approves Sacituzumab Govitecan-hziy for Metastatic TNBC

European Regulators Validate TNBC Biologic Treatment Application

European Regulators Validate TNBC Biologic Treatment Application

FDA Rejects Breast Cancer Therapy Due to Safety Concerns

FDA Rejects Breast Cancer Therapy Due to Safety Concerns

Large Epidemiology Study Updates Breast Cancer Risk for Women Lacking Family History

Large Epidemiology Study Updates Breast Cancer Risk for Women Lacking Family History

FDA Committee Delays Approval of Pembrolizumab for Early TNBC

FDA Committee Delays Approval of Pembrolizumab for Early TNBC

1:25 MD /Alert Exclusive

FDA Clears First Clinical Trial for Breast Cancer Vaccine

Helping Breast Cancer Oncologists Work ‘In the Trenches’

Helping Breast Cancer Oncologists Work ‘In the Trenches’

New ASCO, ASTRO, SSO Joint Clinical Guidelines for Hereditary Breast Cancer

New ASCO, ASTRO, SSO Joint Clinical Guidelines for Hereditary Breast Cancer

EU approves HER2+ Metastatic Breast Cancer Treatment

EU approves HER2+ Metastatic Breast Cancer Treatment

Studies Emphasizes Need for Universal Testing in Breast Cancer Treatment

Studies Emphasizes Need for Universal Testing in Breast Cancer Treatment

Impassion031 Outcomes Show Importance of Looking Beyond Initial Trial Data

Impassion031 Outcomes Show Importance of Looking Beyond Initial Trial Data

Combination Therapy Fails to Meet Primary Endpoints in HR+ HER2- Breast Cancer Treatment

Combination Therapy Fails to Meet Primary Endpoints in HR+ HER2- Breast Cancer Treatment

Mindfulness Shows Benefits for Young Breast Cancer

Mindfulness Shows Benefits for Young Breast Cancer

Time to Treatment Completion Associated with Poor Breast Cancer Survival

Time to Treatment Completion Associated with Poor Breast Cancer Survival

Neratinib + Capecitabine Improves QoL for HER2+ Metastatic Breast Cancer

Neratinib + Capecitabine Improves QoL for HER2+ Metastatic Breast Cancer

Study Shows Breastfeeding Can be Safe for Breast Cancer Survivors

Study Shows Breastfeeding Can be Safe for Breast Cancer Survivors

Abemaciclib Represents ‘New Standard of Care’ for Patients With High-Risk Early Breast Cancer

Abemaciclib Represents ‘New Standard of Care’ for Patients With High-Risk Early Breast Cancer

Sacituzumab Govitecan Extends Survival in Metastatic Triple-Negative Breast Cancer

Sacituzumab Govitecan Extends Survival in Metastatic Triple-Negative Breast Cancer

FDA Issues Warning Alert for Atezolizumab/Paclitaxel Combo in TNBC

FDA Issues Warning Alert for Atezolizumab/Paclitaxel Combo in TNBC

Nobel Prize Winner Links Cancer Immunotherapy to Programmed Cell Death Gene

Nobel Prize Winner Links Cancer Immunotherapy to Programmed Cell Death Gene

Neratinib and Capecitabine Improves PFS in HER2+ Metastatic Breast Cancer

Neratinib and Capecitabine Improves PFS in HER2+ Metastatic Breast Cancer

MINDACT Study Shows Continued Success in Determining Chemotherapy Usage

MINDACT Study Shows Continued Success in Determining Chemotherapy Usage

Pembrolizumab + Chemotherapy Beneficial in Triple-Negative Breast Cancer

Pembrolizumab + Chemotherapy Beneficial in Triple-Negative Breast Cancer

Advanced ER+ HER2+ Breast Cancer Combo Therapy Fails to Improve Outcomes

Advanced ER+ HER2+ Breast Cancer Combo Therapy Fails to Improve Outcomes

HER2CLIMB Study Shows Benefits of Triple Therapy for HER2+ Metastatic Breast Cancer with Brain Metastases

HER2CLIMB Study Shows Benefits of Triple Therapy for HER2+ Metastatic Breast Cancer with Brain Metastases

Featured Breast Cancer Videos

Neoadjuvant Opportunities in Early, High-Risk Breast Cancer

Neoadjuvant Opportunities in Early, High-Risk Breast Cancer

Integrating Tailored Therapy in Early, High-Risk Breast Cancer

Integrating Tailored Therapy in Early, High-Risk Breast Cancer

Providing Equitable Care in Early Breast Cancer

Providing Equitable Care in Early Breast Cancer

Going the Distance With Metastatic Breast Cancer: 'Personal Best'

Going the Distance With Metastatic Breast Cancer: "Personal Best"

Metastatic Breast Cancer: 'The Journey Begins'

Metastatic Breast Cancer: "The Journey Begins"

Breaking Research

Personalized Assay Surpasses Limits for Detecting Tumor DNA in Breast Cancer Patients

Personalized Assay Surpasses Limits for Detecting Tumor DNA in Breast Cancer Patients

Overcoming Treatment Resistance in Breast Cancer

Overcoming Treatment Resistance in Breast Cancer

Oncologist Explains How Gammapod Works for Breast Cancer

Oncologist Explains How Gammapod Works for Breast Cancer

Advancing Breast Cancer Care With Gammapod Radiation

Advancing Breast Cancer Care With Gammapod Radiation

RNA TROJAN Promotes Triple-Negative Breast Cancer Progression

RNA TROJAN Promotes Triple-Negative Breast Cancer Progression

Preventing Breast Cancer in Women Carrying BRCA1 Gene

Preventing Breast Cancer in Women Carrying BRCA1 Gene

ASCO 2023 Annual Meeting

Donepezil Does Not Improve Cancer-Related Cognitive Impairment in Breast Cancer Survivors

Donepezil Does Not Improve Cancer-Related Cognitive Impairment in Breast Cancer Survivors

Breast Cancer Index Risk Scores a Prognostic Indicator of Overall, Late Distant Recurrence

Breast Cancer Index Risk Scores a Prognostic Indicator of Overall, Late Distant Recurrence

HER3-DXd Promotes Clinical Activity in MBC at Varying HER3 Expression Levels

HER3-DXd Promotes Clinical Activity in MBC at Varying HER3 Expression Levels

Capecitabine Has Less Toxicity, Similar Survival in Metastatic Breast Cancer with Fixed Dose

Capecitabine Has Less Toxicity, Similar Survival in Metastatic Breast Cancer with Fixed Dose

Greater Weight Loss Among Women with Breast Cancer After Phone-Based Coaching

Greater Weight Loss Among Women with Breast Cancer After Phone-Based Coaching

Curated For You

Genomic Profiling Improves Metastatic Breast Cancer Research

Genomic Profiling Improves Metastatic Breast Cancer Research

New Uses for Existing Therapies in Breast Cancer Research

New Uses for Existing Therapies in Breast Cancer Research

Various Breast Cancer Research Challenges in Recurrence, Triple Negative BC

Various Breast Cancer Research Challenges in Recurrence, Triple Negative BC

Understanding Recent Breast Cancer Vaccine Breakthroughs

Understanding Recent Breast Cancer Vaccine Breakthroughs

Study of Immunotherapy Combinations for Patients with Metastatic Breast Cancer

Study of Immunotherapy Combinations for Patients with Metastatic Breast Cancer

Why Dual Light Therapy Hits Triple Negative Breast Cancer Harder

Why Dual Light Therapy Hits Triple Negative Breast Cancer Harder

Improving Outcomes for Early Onset Breast Cancer

Improving Outcomes for Early Onset Breast Cancer

SABCS 2022 Annual Meeting

Capivasertib, Fulvestrant Improves PFS in Patients with HR+/HER2– Breast Cancer

Capivasertib, Fulvestrant Improves PFS in Patients with HR+/HER2– Breast Cancer

Camizestrant Improves PFS in Patients with HR+/HER2– Breast Cancer

Camizestrant Improves PFS in Patients with HR+/HER2– Breast Cancer

Trastuzumab Deruxtecan Significantly Improves OS, PFS in Patients with MBC

Trastuzumab Deruxtecan Significantly Improves OS, PFS in Patients with MBC

Ribociclib, Endocrine Therapy Combination Improves PFS in Aggressive Breast Cancer

Ribociclib, Endocrine Therapy Combination Improves PFS in Aggressive Breast Cancer

ASCO 2022 Annual Meeting

FDA Approves Trastuzumab Deruxtecan for HER2-Low Breast Cancer

FDA Approves Trastuzumab Deruxtecan for HER2-Low Breast Cancer

European Commission Approves Trastuzumab Deruxtecan for Second-Line HER2+ Breast Cancer

European Commission Approves Trastuzumab Deruxtecan for Second-Line HER2+ Breast Cancer

Treatment Combination Shows Promise in HR+, HER2–, HER2-mutant Metastatic Breast Cancer

Treatment Combination Shows Promise in HR+, HER2–, HER2-mutant Metastatic Breast Cancer

Zanidatamab-Docetaxel Effective as First-Line Therapy in Advanced HER2+ Breast Cancer

Zanidatamab-Docetaxel Effective as First-Line Therapy in Advanced HER2+ Breast Cancer

Sacituzumab Govitecan Safe and Effective in Patients 65 and Older with TNBC

Sacituzumab Govitecan Safe and Effective in Patients 65 and Older with TNBC

Palbociclib Combination Fails to Extend Overall Survival for Advanced Breast Cancer

Palbociclib Combination Fails to Extend Overall Survival for Advanced Breast Cancer

Trastuzumab Deruxtecan Highly Effective in Patients with HER2-Low Metastatic Breast Cancer

Trastuzumab Deruxtecan Highly Effective in Patients with HER2-Low Metastatic Breast Cancer

Clinical Trials Need Better Representation Among Black Patients

Clinical Trials Need Better Representation Among Black Patients

SABCS 2020 Annual Meeting

FDA Committee Delays Approval of Pembrolizumab for Early TNBC

FDA Committee Delays Approval of Pembrolizumab for Early TNBC

1:25 MD /Alert Exclusive

FDA Clears First Clinical Trial for Breast Cancer Vaccine

Helping Breast Cancer Oncologists Work ‘In the Trenches’

Helping Breast Cancer Oncologists Work ‘In the Trenches’

EU approves HER2+ Metastatic Breast Cancer Treatment

EU approves HER2+ Metastatic Breast Cancer Treatment

Studies Emphasizes Need for Universal Testing in Breast Cancer Treatment

Studies Emphasizes Need for Universal Testing in Breast Cancer Treatment

Impassion031 Outcomes Show Importance of Looking Beyond Initial Trial Data

Impassion031 Outcomes Show Importance of Looking Beyond Initial Trial Data

Combination Therapy Fails to Meet Primary Endpoints in HR+ HER2- Breast Cancer Treatment

Combination Therapy Fails to Meet Primary Endpoints in HR+ HER2- Breast Cancer Treatment

Mindfulness Shows Benefits for Young Breast Cancer

Mindfulness Shows Benefits for Young Breast Cancer

Time to Treatment Completion Associated with Poor Breast Cancer Survival

Time to Treatment Completion Associated with Poor Breast Cancer Survival

Neratinib + Capecitabine Improves QoL for HER2+ Metastatic Breast Cancer

Neratinib + Capecitabine Improves QoL for HER2+ Metastatic Breast Cancer

ASCO 2020 Annual Meeting

MINDACT Study Shows Continued Success in Determining Chemotherapy Usage

MINDACT Study Shows Continued Success in Determining Chemotherapy Usage

Pembrolizumab + Chemotherapy Beneficial in Triple-Negative Breast Cancer

Pembrolizumab + Chemotherapy Beneficial in Triple-Negative Breast Cancer

Advanced ER+ HER2+ Breast Cancer Combo Therapy Fails to Improve Outcomes

Advanced ER+ HER2+ Breast Cancer Combo Therapy Fails to Improve Outcomes

HER2CLIMB Study Shows Benefits of Triple Therapy for HER2+ Metastatic Breast Cancer with Brain Metastases

HER2CLIMB Study Shows Benefits of Triple Therapy for HER2+ Metastatic Breast Cancer with Brain Metastases

Study Shows Tolerable Safety of Abemaciclib Plus Pembrolizumab in HER2-, Metastatic Breast Cancer

Study Shows Tolerable Safety of Abemaciclib Plus Pembrolizumab in HER2-, Metastatic Breast Cancer

Combining Eribulin and Pembrolizumab in Metastatic Triple-Negative Breast Cancer

Combining Eribulin and Pembrolizumab in Metastatic Triple-Negative Breast Cancer