Latest news with #SERENA-6
Yahoo
4 days ago
- Business
- Yahoo
AstraZeneca Highlights Significant Gains Across Three Major Cancer Trials At ASCO
AstraZeneca Plc (NASDAQ:AZN) on Monday released results from three Phase 3 clinical trials at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting: DESTINY-Breast09, MATTERHORN, and SERENA-6. In the DESTINY-Breast09 trial, Enhertu (trastuzumab deruxtecan) combined with pertuzumab was evaluated as a first-line treatment for HER2-positive metastatic breast cancer, compared to a standard regimen of a taxane, trastuzumab, and pertuzumab (THP). Topline data were shared in indicated that the Enhertu combination reduced the risk of disease progression or death by 44%. Median progression-free survival (PFS) reached 40.7 months with the Enhertu regimen versus 26.9 months for THP, a benefit observed across patient subgroups. Investigator-assessed median PFS was 40.7 months for the Enhertu arm and 20.7 months for THP. The confirmed objective response rate was 85.1% for the Enhertu combination and 78.6% for THP, with 58 complete responses in the Enhertu group compared to 33 with THP. The median duration of response was 39.2 months for the Enhertu combination and 26.4 months for THP. Overall survival data was not yet mature, though an early trend favored the Enhertu combination. The MATTERHORN trial assessed Imfinzi (durvalumab) with standard FLOT chemotherapy as a perioperative treatment for resectable, early-stage, and locally advanced gastric and gastroesophageal junction (GEJ) cancers, compared to chemotherapy alone. Topline data were released in March. A planned interim analysis showed that the Imfinzi-based regimen led to a 29% reduction in the risk of disease progression, recurrence, or death. Median event-free survival (EFS) was not reached in the Imfinzi arm, compared to 32.8 months in the chemotherapy-alone arm. The estimated 24-month EFS rate was 67.4% for the Imfinzi regimen and 58.5% for chemotherapy alone. A trend towards improved overall survival was noted for the Imfinzi-based regimen, with formal assessment to follow. The SERENA-6 trial investigated camizestrant combined with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumors developed an ESR1 mutation during first-line treatment with an aromatase inhibitor (AI) and a CDK4/6 inhibitor. Topline data were shared in February. The trial compared switching to the camizestrant combination against continuing the AI plus CDK4/6 inhibitor. The camizestrant combination reduced the risk of disease progression or death by 56%. Median PFS was 16.0 months for patients who switched, versus 9.2 months for those continuing the AI combination. The median time to deterioration of global health status was 23.0 months for the camizestrant arm and 6.4 months for the AI combination arm. While data for time to second disease progression and overall survival were immature, a trend favored the camizestrant combination for PFS2. Price Action: AZN stock is trading lower by 0.95% at $72.14 at last checkMonday. Read Next:Photo by Piotr Swat Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? ASTRAZENECA (AZN): Free Stock Analysis Report This article AstraZeneca Highlights Significant Gains Across Three Major Cancer Trials At ASCO originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
Business Wire
4 days ago
- Business
- Business Wire
SERENA-6 Phase III Trial Demonstrates Clinical Value of Guardant360 CDx Test to Detect Emergence of Endocrine Resistance and Inform a Switch in Therapy Before Radiological Disease Progression in Advanced Breast Cancer
PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the results of the Phase III SERENA-6 trial - sponsored by AstraZeneca - demonstrate the clinical value of the Guardant360® CDx test in a circulating tumor DNA-guided approach to detect and treat emerging resistance in 1st-line therapy ahead of radiological disease progression in breast cancer. Study results were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and were published in The New England Journal of Medicine. SERENA-6 is the first global, double-blind, registrational Phase III trial to use a ctDNA-guided approach to detect the emergence of endocrine resistance and inform a switch in therapy before disease progression is detected in imaging scans. The novel trial design used ctDNA monitoring with the Guardant360 liquid biopsy test at the time of routine tumor scans to identify patients for early signs of endocrine resistance and the emergence of ESR1 mutations. 'SERENA-6 is a landmark study that is creating a new paradigm using liquid biopsy to enable a switch to a new treatment as soon as you see the cancer showing signs of resistance,' said Helmy Eltoukhy, Guardant Health chairman and co-CEO. 'This use of the Guardant360 CDx test highlights how we are pushing the boundaries of what can be done with liquid biopsy in characterizing disease and potential drug efficacy, providing insights that could potentially change clinical practice and improve outcomes in patients with advanced breast cancer.' Following detection of an ESR1 mutation without radiological disease progression, the endocrine therapy of patients was switched to AstraZeneca's camizestrant from ongoing treatment with an aromatase inhibitor (AI), while continuing combination with the same cyclin-dependent kinase (CDK) 4/6 inhibitor. The trial demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumors had an emergent ESR1 mutation as detected by Guardant360 CDx. About Guardant360 CDx The first FDA-approved blood test for complete genomic testing, Guardant360 CDx is approved as a companion diagnostic fur multiple therapies in non-small cell lung cancer. It is also the only FDA-approved companion diagnostic for targeted therapy in advanced breast cancer patients with ESR1 mutations. The test is broadly covered by Medicare and commercial insurers, representing over 300 million lives. For more information, visit the Guardant360 CDx website. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit and follow the company on LinkedIn, X (Twitter) and Facebook. Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health's liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health's financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operation' and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2024, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health's views as of any date subsequent to the date of this press release.
Business Insider
4 days ago
- Business
- Business Insider
Arvinas downgraded to Market Perform from Outperform at Leerink
Leerink analyst Andrew Berens downgraded Arvinas (ARVN) to Market Perform from Outperform with a price target of $9, down from $10, after the company presented full results from the Phase 3 VERITAC-2 trial evaluating vepdegestrant in second-line HR+/HER2- metastatic breast cancer patients. The firm says that while the full presentation demonstrates the drug is active in patients with ESR1 mutations and likely approvable, it is not convinced vepdeg is best-in-class. Further, a number of key uncertainties in the rapidly evolving treatment paradigm for ESR1m breast cancer landscape have emerged, the analyst tells investors in a research note. Leerink 'gradually tempered the ESR1m rate in second-line from 30% to 15% to reflect potential impact from the SERENA-6 data, as well as ongoing first-line oral SERD trials, lowering its assumed worldwide peak vepdeg sales to $416M from $576M.
Business Insider
4 days ago
- Health
- Business Insider
AstraZeneca announces results from SERENA-6 Phase III trial
Positive results from the SERENA-6 Phase III trial showed that AstraZeneca's (AZN) camizestrant in combination with a cyclin-dependent kinase 4/6 inhibitor demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival, PFS. The trial evaluated switching to the camizestrant combination versus continuing standard-of-care treatment with an aromatase inhibitor in combination with a CDK4/6 inhibitor in the 1st-line treatment of patients with hormone receptor-positive, HER2-negative advanced breast cancer whose tumors have an emergent ESR1 mutation. These results will be presented today during the Plenary Session at the 2025 American Society of Clinical Oncology, ASCO, Annual Meeting in Chicago, IL and simultaneously published in The New England Journal of Medicine. Results showed the camizestrant combination reduced the risk of disease progression or death by 56% compared to standard-of-care treatment as assessed by investigator. Median PFS was 16.0 months for patients who switched to the camizestrant combination versus 9.2 months for the comparator arm. Importantly, a consistent PFS benefit was observed across all CDK4/6 inhibitors and clinically relevant subgroups in the trial, including analysis by age, race, region, time of ESR1 mutation detection and type of ESR1 mutation. Confident Investing Starts Here:
Yahoo
5 days ago
- Business
- Yahoo
Camizestrant reduced the risk of disease progression or death by 56% in patients with advanced HR-positive breast cancer with an emergent ESR1 tumor mutation in SERENA-6 Phase III trial
First pivotal trial to demonstrate clinical value of monitoring circulating tumor DNA to detect and treat emerging resistance in 1st-line therapy ahead of disease progression in breast cancer First and only next-generation oral SERD and complete ER antagonist to demonstrate consistent progression-free survival benefit in combination with widely approved CDK4/6 inhibitors in 1st-line advanced breast cancer WILMINGTON, Del., June 01, 2025--(BUSINESS WIRE)--Positive results from the SERENA-6 Phase III trial showed that AstraZeneca's camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS). The trial evaluated switching to the camizestrant combination versus continuing standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumors have an emergent ESR1 mutation. These results will be presented today during the Plenary Session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL (abstract #LBA4) and simultaneously published in The New England Journal of Medicine. Results showed the camizestrant combination reduced the risk of disease progression or death by 56% compared to standard-of-care treatment (based on a hazard ratio [HR] of 0.44; 95% confidence interval [CI] 0.31–0.60; p<0.00001) as assessed by investigator. Median PFS was 16.0 months for patients who switched to the camizestrant combination versus 9.2 months for the comparator arm. Importantly, a consistent PFS benefit was observed across all CDK4/6 inhibitors and clinically relevant subgroups in the trial, including analysis by age, race, region, time of ESR1 mutation detection and type of ESR1 mutation. The camizestrant combination was also associated with a meaningful delay in time to deterioration in quality of life, where in an exploratory endpoint, the camizestrant combination reduced the risk of deterioration in global health status and quality of life by 47% compared with the AI combination (HR 0.53; 95% CI, 0.33-0.82; nominal p<0.001). The median time to deterioration of global health status was 23.0 months in patients treated with the camizestrant combination, versus 6.4 months in patients that continued treatment with the AI combination (EORTC QLQ-C30). The camizestrant combination also delayed the time to deterioration of pain compared with the AI combination. Data for the key secondary endpoints of time to second disease progression (PFS2) and overall survival (OS) were immature at the time of this interim analysis. However, a trend toward extended treatment benefit was observed with the camizestrant combination based on PFS2 (HR 0.52; 95% CI 0.33-0.81; p=0.0038 [interim analysis threshold p=0.0001]). The trial will continue to assess OS, PFS2 and other key secondary endpoints. Nicholas Turner, MD, PhD, Professor of Molecular Oncology at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, London, UK, and co-principal investigator for the trial, said: "Today's news marks a pivotal moment in breast cancer care and redefines how we think about drug resistance in this type of breast cancer. The results of the innovative SERENA-6 trial show that switching from an aromatase inhibitor to camizestrant in combination with any of the three CDK4/6 inhibitors after emergence of an ESR1 mutation more than halved the risk of disease progression or death and delayed deterioration in quality of life by nearly 18 months. This proactive approach exemplifies a new treatment strategy in oncology; by treating developing resistance before it causes disease progression and deterioration in quality of life, we can extend the benefit of 1st-line treatment to optimize patient outcomes." Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "As the first pivotal trial to demonstrate the clinical value of monitoring circulating tumor DNA to detect emerging resistance and change therapy at the earliest opportunity; SERENA-6 is redefining the clinical paradigm in breast cancer. Camizestrant is the first and only next-generation oral SERD and complete estrogen receptor antagonist to demonstrate benefit in combination with widely approved CDK4/6 inhibitors in this 1st-line setting, and these results support its potential as a new standard-of-care endocrine therapy backbone in the treatment of HR-positive breast cancer." Summary of results: SERENA-6 Camizestrant + CDK4/6 inhibitor (n=155) AI + CDK4/6 inhibitor (n=155) PFSi Median PFS (months) 16.0 (12.7-18.2) 9.2 (7.2-9.5) Hazard ratio (95% CI) 0.44 (0.31-0.60) p-value p<0.00001 Time to deterioration in global health status/quality of lifeii Mean TTD (months) 23.0 (13.8-NC) 6.4 (2.8, 14.0) Hazard ratio (95% CI) 0.53 (0.33-0.82) p-value (nominal) p<0.001 PFS2iii Events 38 47 Hazard ratio (95% CI) 0.52 (0.33-0.81) p-value P=0.0038 [interim analysis threshold P=0.0001] CI, confidence interval; HR, hazard ratio; NC, not calculable; TTD, time-to-deterioration.i PFS was defined per RECIST v1.1. HR was estimated using the Cox proportional hazard model adjusted for stratification Assessments were conducted at baseline, weeks 4, 8 and 12 and then every 8 weeks until PFS2. Analysis conducted in patients with a baseline score and at least one post-baseline assessment. TTD in global health status/quality of life, an exploratory endpoint, was defined as the time from randomization to first deterioration that was confirmed at a subsequent timepoint measured using the European Organization for Research and Treatment of Cancer 30-item quality-of-life questionnaire (EORTC QLQ-30). Deterioration was defined as a decrease from baseline ≥16.6. HR was estimated using the Cox proportional hazard model stratified by time of ESR1 mutation detection (one test vs more than one test), and time from initiation of AI + CDK4/6i to randomization (<18 months vs. ≥18 months).iii HR was estimated using the Cox proportional hazard model adjusted for stratification factors. Final PFS2 analysis will occur at 158 PFS2 events. The safety profile of camizestrant in combination with palbociclib, ribociclib or abemaciclib in SERENA-6 was consistent with the known safety profile of each medicine. Consistent with the longer duration of exposure to the combination of camizestrant and CDK4/6 inhibitors in the trial, Grade 3 or higher adverse events from all causes occurred in 60% of patients in the camizestrant arm versus 46% in the AI arm; the majority of which were hematological events typically associated with CDK4/6 inhibitor treatment and included neutropenia (45% vs. 34%), anemia (5% vs. 5%) and leukopenia (10% vs. 3%). If experienced, photopsia - reported as brief flashes of light in the peripheral vision - did not impact daily activities of patients in the trial and was reversible. There were no structural changes in the eye or changes in visual acuity. No new safety signals were identified and discontinuation rates were very low and similar in both arms, with 1% patients discontinuing camizestrant and 2% patients discontinuing an AI. Discontinuation of the CDK4/6 inhibitor occurred in 1% of patients in both arms of the trial. SERENA-6 is the first global, double-blind, registrational Phase III trial to use a circulating tumor DNA (ctDNA)-guided approach to detect the emergence of endocrine resistance and inform a switch in therapy before disease progression. The novel trial design used ctDNA monitoring at the time of routine tumor scans to identify patients for early signs of endocrine resistance and the emergence of ESR1 mutations. Following detection of an ESR1 mutation without disease progression, the endocrine therapy of patients was switched to camizestrant from ongoing treatment with an AI, while continuing combination with the same CDK4/6 inhibitor. Based on the results of the SERENA-6 Phase III trial, camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) has been granted Breakthrough Therapy Designation (BTD) in the US by the Food and Drug Administration for the treatment of adult patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer upon emergence of ESR1 mutation during first-line endocrine-based therapy. Notes HR-positive breast cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million patients were diagnosed with breast cancer in 2022, with more than 665,000 deaths globally.1 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.2 HR-positive breast cancer, characterized by the expression of estrogen or progesterone receptors, or both, is the most common subtype of breast cancer with 70% of tumors considered HR-positive and HER2-negative.2 ERs often drive the growth of HR-positive breast cancer cells.3 Globally, approximately 200,000 patients with HR-positive breast cancer are treated with a medicine in the 1st-line setting; most frequently with endocrine therapies that target estrogen receptor (ER)-driven disease, which are often paired with CDK4/6 inhibitors.4-6 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.6 Once this occurs, treatment options are limited and survival rates are low with 35% of patients anticipated to live beyond five years after diagnosis.2,6,7 Mutations in the ESR1 gene are a key driver of endocrine resistance and are widely tested for in clinical practice at time of disease progression on 1st-line therapies.8,9 These mutations emerge during treatment of the disease, becoming more prevalent as the disease progresses and are associated with poor outcomes.8,9 Approximately 30% of patients with endocrine sensitive HR-positive disease develop ESR1 mutations during 1st-line treatment without disease progression.4 The optimization of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research. SERENA-6 SERENA-6 is a Phase III, double-blind, randomized trial evaluating the efficacy and safety of camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) versus treatment with an AI (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with HR-positive, HER2-negative advanced breast cancer (patients with either locally advanced disease, or metastatic disease) whose tumors have an emergent ESR1 mutation. The global trial enrolled 315 adult patients with histologically confirmed HR-positive, HER2-negative advanced breast cancer, undergoing treatment with an AI in combination with a CDK4/6 inhibitor as 1st-line treatment. The primary endpoint of the SERENA-6 trial is PFS as assessed by investigator, with secondary endpoints including OS, and PFS2 by investigator assessment. Camizestrant Camizestrant is an investigational, potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist that is currently in Phase III trials for the treatment of HR-positive breast cancer. AstraZeneca's broad, robust and innovative clinical development program, including the SERENA-6, SERENA-4, CAMBRIA-1 and CAMBRIA-2 trials, is evaluating the safety and efficacy of camizestrant when used as a monotherapy or in combination with CDK4/6 inhibitors to address a number of areas of unmet need in HR-positive, HER2-negative breast cancer. Camizestrant has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. In the SERENA-2 Phase II trial, camizestrant demonstrated PFS benefit versus fulvestrant irrespective of ESR1 mutation status or prior treatment with CDK4/6 inhibitors in patients with ER-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy. The SERENA-1 Phase I trial demonstrated that camizestrant is well tolerated and has a promising anti-tumor profile when administered alone or in combination with palbociclib, ribociclib and abemaciclib; three widely used CDK4/6 inhibitors. AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death. AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumor environment. With fam-trastuzumab deruxtecan-nxki, a HER2-directed ADC, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer, and are exploring its potential in earlier lines of treatment and in new breast cancer settings. In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines fulvestrant and goserelin and aims to reshape the HR-positive space with first-in-class AKT inhibitor, capivasertib, the TROP-2-directed ADC, datopotamab deruxtecan-dlnk and next-generation oral SERD and potential new medicine camizestrant. PARP inhibitor olaparib is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with Merck & Co., Inc. (MSD outside the US and Canada) continue to research olaparib in these settings and to explore its potential in earlier disease. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer. To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of datopotamab deruxtecan-dlnk alone and in combination with immunotherapy durvalumab. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit and follow the Company on social media @AstraZeneca. References Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 Apr 4. doi: 10.3322/caac.21834. National Cancer Institute. Cancer Stat facts: Female breast cancer subtypes. Available at: Accessed June 2025. Scabia V, et al. Estrogen receptor positive breast cancers have patient specific hormone sensitivities and rely on progesterone receptor. Nat Commun. 2022; 10.1038/s41467-022-30898-0. Cerner CancerMPact database. Accessed June 2025. Lin M, et al. Comparative Overall Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive, HER2-negative metastatic breast cancer. J Cancer. 2020; 10.7150/jca.48944. Lloyd M R, et al. Mechanisms of Resistance to CDK4/6 Blockade in Advanced Hormone Receptor–positive, HER2-negative Breast Cancer and Emerging Therapeutic Opportunities. Clin Cancer Res. 2022; 28(5):821-30. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology (NCCN Guidelines). Available at: Accessed June 2025. Brett O, et al. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor‑positive breast cancer. Breast Cancer Res. 2021; 23:85. Zundelevich, A, et al. ESR1 mutations are frequent in newly diagnosed metastatic and loco-regional recurrence of endocrine-treated breast cancer and carry worse prognosis. Breast Cancer Res. 2020; 22:16. US-101612Last updated 06/25 View source version on Contacts Media Inquiries Fiona Cookson +1 212 814 3923Jillian Gonzales +1 302 885 2677 US Media Mailbox: usmediateam@
