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 factors.ii 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 astrazeneca-us.com 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: https://seer.cancer.gov/statfacts/html/breast-subtypes.html. 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: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. 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
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- Business Wire
Renesas Announces Expected Loss Resulting from Signing Restructuring Support Agreement with Wolfspeed
TOKYO--(BUSINESS WIRE)--Renesas Electronics Corporation (TSE: 6723, "Renesas"), a premier supplier of advanced semiconductor solutions, today announced that it has entered into a Restructuring Support Agreement (the "Restructuring Support Agreement") with Wolfspeed, Inc. (NYSE: WOLF, "Wolfspeed") and its principal creditors for the financial restructuring of Wolfspeed. As a result, Renesas expects to record a loss as described below. 1. Details of Loss As , Renesas entered into the silicon carbide wafer supply agreement with Wolfspeed, and through Renesas' wholly owned subsidiary in the United States, it provided a deposit (the "Deposit") of US$2 billion (approximately 292.0 billion yen) to Wolfspeed. In October 2024, Renesas and Wolfspeed amended their agreement and increased the outstanding principal amount of the Deposit to US$2.062 billion (approximately 301.1 billion yen). Subsequently, Wolfspeed has experienced financial challenges. On May 8, 2025, during its quarterly earnings call, Wolfspeed disclosed that to achieve its stated goal of strengthening its balance sheet, it may implement a transaction through an in-court solution. Due to Wolfspeed's contemplation of an in-court option, Wolfspeed included required going concern language in the footnotes to its financial statements for the quarterly period ended March 30, 2025. In response to this situation, Renesas has been engaging in discussions with Wolfspeed and today entered into the Restructuring Support Agreement among Wolfspeed and its principal creditors, pursuant to which Renesas agreed to, among other things, convert the Deposit of US$2.062 billion into convertible notes, common stock, and warrants issued by Wolfspeed as follows (the 'Restructuring'). Wolfspeed convertible notes: US$204 million (approximately 29.8 billion yen) in aggregate principal amount, convertible to Wolfspeed common stock, maturing in June 2031. These notes are convertible into 13.6% of Wolfspeed's total issued shares on a non-diluted basis at the time of the completion of the Restructuring. On a fully diluted basis, and prior to the exercise of the warrants to be granted to Renesas, this corresponds to 11.8%. Wolfspeed common stock: equivalent to 38.7% (17.9% on a fully diluted basis, prior to Renesas warrants exercise) of the total number of issued shares of Wolfspeed at the completion of the Restructuring. Wolfspeed warrants: equivalent to 5% (on a fully diluted basis) of the total number of issued shares of Wolfspeed at the completion of the Restructuring. The Restructuring is expected to be consummated through proceedings under Chapter 11 of the U.S. Bankruptcy Code. It is expected that Wolfspeed will file a petition with the court to initiate such proceedings in the near future. The Restructuring is expected to become effective by the end of September 2025, subject to court approval of the restructuring plan. If the necessary regulatory approvals have not been obtained by the time the Restructuring takes effect, Renesas will hold rights to instruments with equivalent economic value to Wolfspeed's convertible notes, common stock, and warrants until those approvals are received. In connection with the signing of the Restructuring Support Agreement, Renesas expects to record a loss on the deposited receivables related to the Deposit in its consolidated financial statements. Although the timing and amount of such loss have not been determined at this time, Renesas believes that there is a possibility of recording a loss of approximately 250 billion yen (converted at an average exchange rate of 150 yen to the dollar during the period) in the consolidated financial statements for the six months ending June 30, 2025. Please note that this amount is an estimate calculated by Renesas' internal analysis based on the currently available information and may increase or decrease due to various factors. The definitive timing and amount of the loss to be recorded will be determined in consultation with Renesas' auditor and will be announced once it is determined. 2. Future Outlook Renesas discloses revenue, gross margin, and operating margin on a "Non-GAAP" basis and does not disclose a forecast for profit attributable to owners of parent. Therefore, there is no change to the forecast for the six months ending June 30, 2025, announced on April 24, 2025. (Note1) Unless otherwise indicated, yen equivalents in this material are calculated using the exchange rate as of June 20, 2025: 146 yen to the dollar. (Note2) Non-GAAP figures are calculated by removing or adjusting non-recurring items and other adjustments from GAAP (IFRS basis) figures following a certain set of rules. Renesas believes non-GAAP measures provide useful information in understanding and evaluating its constant business results, and therefore, forecasts are provided on a non-GAAP basis. This adjustment and exclusion include the amortization of intangible assets recognized from acquisitions, other PPA (purchase price allocation) adjustments and stock-based compensation, as well as other non-recurring expenses and income Renesas believes to be applicable. Expand About Renesas Electronics Corporation Renesas Electronics Corporation (TSE: 6723) empowers a safer, smarter and more sustainable future where technology helps make our lives easier. A leading global provider of microcontrollers, Renesas combines our expertise in embedded processing, analog, power and connectivity to deliver complete semiconductor solutions. These Winning Combinations accelerate time to market for automotive, industrial, infrastructure and IoT applications, enabling billions of connected, intelligent devices that enhance the way people work and live. Learn more at Follow us on LinkedIn, Facebook, Twitter, YouTube, and Instagram. (FORWARD-LOOKING STATEMENTS) The statements in this press release with respect to the plans, strategies and financial outlook of Renesas and its consolidated subsidiaries (collectively 'we') are forward-looking statements involving risks and uncertainties. Such forward-looking statements do not represent any guarantee by management of future performance. In many cases, but not all, we use such words as 'aim,' 'anticipate,' 'believe,' 'continue,' 'endeavor,' 'estimate,' 'expect,' 'initiative,' 'intend,' 'may,' 'plan,' 'potential,' 'probability,' 'project,' 'risk,' 'seek,' 'should,' 'strive,' 'target,' 'will' and similar expressions to identify forward-looking statements. You can also identify forward-looking statements by discussions of strategy, plans or intentions. These statements discuss future expectations, identify strategies, contain projections of our results of operations or financial condition, or state other forward-looking information based on our current expectations, assumptions, estimates and projections about our business and industry, our future business strategies and the environment in which we will operate in the future. Known and unknown risks, uncertainties and other factors could cause our actual results, performance or achievements to differ materially from those contained or implied in any forward-looking statement, including, but not limited to, general economic conditions in our markets, which are primarily Japan, North America, Asia, and Europe; demand for, and competitive pricing pressure on, products and services in the marketplace; ability to continue to win acceptance of products and services in these highly competitive markets; fluctuations in currency exchange rates, particularly between the yen and the U.S. dollar; and risks and uncertainties associated with Wolfspeed's proceedings under Chapter 11 of the U.S. Bankruptcy Code, including Wolfspeed's ability to maintain relationships with suppliers, customers, employees and other third parties and regulatory authorities as a result of such proceedings, and other factors discussed in Wolfspeed's filings with the U.S. Securities and Exchange Commission. Among other factors, a downturn of the world economy; deteriorating financial conditions in world markets, or a deterioration in domestic and overseas stock markets, may cause actual results to differ from the projected results forecast. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as otherwise required by law. This press release is based on the economic, regulatory, market and other conditions as in effect on the date hereof. It should be understood that subsequent developments may affect the information contained in this presentation, which neither we nor our advisors or representatives are under an obligation to update, revise, or affirm.
