Latest news with #SERENA-6
India Today
24-06-2025
- Health
- India Today
New drug could transform treatment for advanced breast cancer in India
A new drug, camizestrant, is showing promise in helping women with advanced hormone-sensitive breast cancer stay ahead of disease from a major global study, SERENA-6, suggest that this next-generation treatment could become a game-changer, especially when patients feel their body is beginning to grow resistant to standard belongs to a new class of drugs called selective estrogen receptor degraders (SERDs).advertisement These drugs work by directly blocking and destroying estrogen receptors, which fuel the growth of many breast cancers. Unlike older treatments that simply reduce estrogen levels, camizestrant acts more the SERENA-6 study, researchers tested whether switching to camizestrant early, at the first signs of drug resistance, could delay the cancer's in the trial had a common type of breast cancer called HR-positive, HER2-negative, and were already taking hormone-blocking drugs (aromatase inhibitors) along with CDK4/6 inhibitors, a combination that's considered the gold standard for first-line over time, many women stop responding to this is often due to the appearance of a mutation called ESR1, which makes the cancer resistant to hormone-blocking used a simple blood test every few months to detect this mutation before the cancer visibly the mutation appeared, half the women in the study were switched to camizestrant while continuing their CDK4/6 inhibitor. The others stayed on their original results were impressive: women who switched to camizestrant had a median progression-free survival of 16 months, compared to just 9.2 months for those who did not means the new drug helped them live comparatively longer without their cancer getting worse. One year into treatment, 61% of patients on camizestrant were still progression-free, compared to only 33% on the older was also well tolerated, with very few patients stopping treatment due to side effects. This is important, as many women need long-term therapy and quality of life findings mark a big step forward in breast cancer treatment. Camizestrant not only offers a new way to outsmart drug resistance, but also shows the value of using blood tests to guide treatment decisions in real more data becomes available, camizestrant could soon become a standard option for women with this common and challenging form of breast cancer.- Ends
Yahoo
02-06-2025
- 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
02-06-2025
- 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
02-06-2025
- 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
02-06-2025
- 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:
