Latest news with #camizestrant
The Independent
2 days ago
- Business
- The Independent
‘Transformational' new breast cancer drug could halt the growth of tumours
A new drug has been shown to halt the growth of certain breast cancer tumours, potentially delaying the need for chemotherapy, according to a new study. The Serena-6 trial found that camizestrant is effective in stopping cancer cells from using hormones to grow. One professor described the drug as representing "a pivotal moment in breast cancer care". Scientists said the trial marked the first global study demonstrating that early detection of cancer resistance through blood tests can significantly benefit patients. The study focused on patients with hormone-positive, HER2-negative breast cancer, which accounts for approximately 70 per cent of all cases. The results indicated that patients treated with camizestrant experienced a 56 per cent reduction in cancer progression compared to those receiving standard therapies. Doctors used a blood test to identify changes in the cancer's DNA, which signal the potential failure of current treatments. Upon detecting these signs, some patients were administered camizestrant, while others continued with their standard treatment. Those on camizestrant had their cancer stay the same and not get worse for much longer, 16 months on average, compared with about nine months for the others. The drug was safe for most patients but 1 per cent stopped taking it because of side effects. More than 3,000 patients from 23 countries took part in the study, which was funded by AstraZeneca and co-led by researchers at The Institute of Cancer Research in London. Co-principal investigator Professor Nick Turner, group leader in molecular oncology at The Institute of Cancer Research, London, said the drug is 'a pivotal moment in breast cancer care'. Professor Kristian Helin, chief executive of The Institute of Cancer Research said: 'The results of the Serena-6 trial represent more than a clinical milestone, they represent a transformational shift in how we approach precision medicine.' About 55,000 women are diagnosed with breast cancer in the UK every year and 11,500 will die from the disease, The Institute of Cancer Research said. The Serena-6 trial results were to be presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago on Sunday. Dr Catherine Elliott, director of research at Cancer Research UK, said: 'This study is a clear example of how blood tests are starting to transform cancer treatment. 'By tracking tiny traces of tumour DNA in the blood, researchers were able to spot early signs of treatment resistance and switch therapies before cancer had a chance to grow. 'It shows how circulating tumour DNA, or ctDNA, could help doctors make smarter, more timely treatment decisions. 'This approach could become an important part of how we personalise care for people with advanced breast cancer.'
Sky News
3 days ago
- Business
- Sky News
'Transformational' new drug could stop breast cancer tumours before they grow, trial finds
A new drug could stop some breast cancer tumours from using hormones to grow, a trial has found. Results from the Serena-6 trial, carried out with the Institute of Cancer Research in London, suggest that using camizestrant could help patients stay well longer and delay the need for chemotherapy. According to Cancer Research UK, the drug works by blocking oestrogen from getting into the breast cancer cell, which researchers hope can then stop or slow the growth of cancer. Breast cancer patients given the drug in the trial reduced their chances of the disease progressing by 52% compared to standard therapies. Professor Kristian Helin, chief executive of the Institute of Cancer Research, said the results "represent more than a clinical milestone, they represent a transformational shift in how we approach precision medicine". Co-principal investigator Professor Nick Turner also called the development of the drug "a pivotal moment in breast cancer care". 1:48 The study, funded by AstraZeneca, looked at patients with hormone-positive, HER2-negative breast cancer - about 70% of cases. More than 3,000 patients from 23 countries took part in phase three of the trial, which saw doctors use blood tests to detect changes in the cancer's DNA to see which treatments were ineffective. For those taking camizestrant, their cancer stabilised for around 16 months on average, compared with about nine months for other treatments. However, 1% of patients taking the new drug stopped taking it because of side effects. Further results from the Serena-6 trial will be presented at the American Society of Clinical Oncology annual meeting in Chicago on Sunday. Cancer Research UK reports that breast cancer is the most common type of the disease, with around 56,400 women and around 390 men diagnosed in the UK each year. The trial was also the first worldwide study to show that using blood tests to find early signs of cancer resistance to treatment helps patients. Dr Catherine Elliott, director of research at Cancer Research UK, praised the breakthrough as a "clear example of how blood tests are starting to transform cancer treatment". "By tracking tiny traces of tumour DNA in the blood, researchers were able to spot early signs of treatment resistance and switch therapies before cancer had a chance to grow," she added. "It shows how circulating tumour DNA, or ctDNA, could help doctors make smarter, more timely treatment decisions. "This approach could become an important part of how we personalise care for people with advanced breast cancer."
Daily Mail
3 days ago
- Business
- Daily Mail
Major discovery about 'invisible' breast tumours that are too small to show up on scans
Thousands of women have been thrown a lifeline thanks to a 'next generation' drug that can destroy breast cancer tumours, months before they even grow. The daily pill, known as camizestrant, stops cancer cells from developing, slowing the spread of the disease and delaying the need for gruelling chemotherapy. Around seven in ten breast cancer patients in the UK have a type of the disease known as HR positive HER-2 negative breast cancer—the most common form. Of these, around 40 per cent can develop an aggressive genetic mutation that makes their outlook incredibly bleak. But the 'transformational' trial found patients given the drug camizestrant saw their risk of the cancer progressing slashed by more than half. It was also the first worldwide study that showed blood tests, rather than scans, can pick up early signs of cancer returning. Doctors first used the test, known as a liquid biopsy, to spot changes in the cancer's DNA—when they found signs of an ESR1 mutation, some patients were given camizestrant, while others stayed on their usual treatment. Experts presenting the findings today at the American Society for Clinical Oncology conference (ASCO) in Chicago, hailed it a 'pivotal moment in breast cancer care' and 'truly fundamental shift in how we approach cancer'. The drug is already being fast-tracked for use in the US and has been sent for approval in the UK. Professor Nicholas Turner, an expert in molecular oncology at The Institute of Cancer Research, London and the Royal Marsden NHS Foundation Trust, who co-led the major trial, said: 'This is a pivotal moment in breast cancer care. 'This proactive approach also redefines how we think about drug resistance in this type of breast cancer. 'This is a potential new treatment strategy in oncology to treat developing resistance before it causes disease progression.' Professor Kristian Helin, chief executive of The Institute of Cancer Research, London, added: 'The results represent more than a clinical milestone—they represent a transformational shift in how we approach precision medicine. 'It is very exciting to see this technology being used to delay disease progression in patients and extend the benefits of treatment in patients with this type of advanced breast cancer and delay the need for chemotherapy for as long as possible. 'These breakthroughs are helping shape personalised breast cancer treatment, allowing doctors to adjust therapies earlier and improve patient outcomes.' In the trial, 3,325 patients HR positive HER-2 negative advanced breast cancer from 23 countries were screened for ESR1 mutations using a liquid biopsy every eight to 12 weeks. Of these, 315 women who tested positive for an ESR1 mutation were given either AstraZeneca's camizestrant and a medicine known as a CDK4/6 inhibitor or another hormone therapy as well as a CDK4/6 inhibitor. Researchers found those on the camizestrant combination slashed their risk of death or the cancer progressing by 56 per cent. The drug also kept the cancer at bay for 16 months on average compared to 9.2 months on standard treatment. Just one per cent of patients stopped taking the drug over side effects. Presenting the findings at ASCO, Susan Galbraith, executive vice president of oncology at AstraZeneca said the drug had now been given 'breakthrough therapy designation' by the Food and Drugs Administration in the US, helping to speed up regulatory review. 'We are having ongoing discussions with regulatory authorities including the UK', added. Dave Fredickson, AstraZeneca's executive vice president of oncology business unit, also said the drug demonstrated a 'truly fundamental shift in how we approach cancer care. 'We're moving away from a one size fits all era and targeting cancer early.' Meanwhile, Dr Catherine Elliott, director of research at Cancer Research UK, said: 'This study is a clear example of how blood tests are starting to transform cancer treatment. 'By tracking tiny traces of tumour DNA in the blood, researchers were able to spot early signs of treatment resistance and switch therapies before cancer had a chance to grow. 'It shows how circulating tumour DNA—or ctDNA—could help doctors make smarter, more timely treatment decisions. 'This approach could become an important part of how we personalise care for people with advanced breast cancer.'
Reuters
3 days ago
- Business
- Reuters
Blood test-guided treatment with AstraZeneca pill cut risk of breast cancer progression, study finds
CHICAGO, June 1 (Reuters) - Treating breast cancer patients with AstraZeneca's (AZN.L), opens new tab experimental pill camizestrant at the first sign of resistance to standard treatments cut the risk of disease progression or death by half, a finding that could change the way such cancers are treated, cancer experts said on Sunday. The results, presented at the American Society of Clinical Oncology meeting in Chicago, mark the first use of a blood test called a liquid biopsy to indicate the need for a change in treatment in women with a common form of breast cancer, even before tumor growth can be detected on imaging. The early switch approach in women with hormone receptor-positive, HER2-negative breast cancer resulted in a 56% reduction in the risk of disease progression or death, said Dr. Eleonora Teplinsky, an oncologist at Valley-Mount Sinai Comprehensive Cancer Care and an ASCO breast cancer expert. "When patients progress on scans, we're already behind," Teplinsky said at a media briefing. She said an early switch approach, before disease progression, allows doctors "to essentially stay ahead of the curve." Camizestrant is not yet FDA-approved, but Teplinsky believes the data will likely result in a new treatment paradigm. The trial involved 3,256 patients with advanced hormone receptor-positive, HER2-negative breast cancer, the most common type in which hormones such as estrogen fuel cancer growth. These cancers lack high levels of HER2, another cancer driver. Women in the trial had at least six months of treatment with aromatase inhibitors that block hormones fueling the cancer, as well as targeted drugs called CDK4/6 inhibitors such as Novartis' (NOVN.S), opens new tab Kisqali, Pfizer's (PFE.N), opens new tab Ibrance or Lilly's (LLY.N), opens new tab Verzenio, which block an enzyme that fuels cancer growth. About 40% of patients treated with aromatase inhibitors develop mutations in the estrogen receptor 1 gene called ESR1 mutations, a sign of early drug resistance. Camizestrant and similar drugs called Selective Estrogen Receptor Degraders (SERDS) block estrogen receptor signaling in cancer cells. In the trial, researchers used blood tests to look for ESR1 mutations until 315 patients were identified. They were randomly assigned to either switch to camizestrant plus the CDK4/6 inhibitor (157 patients) or continue with standard treatment plus a placebo (158 patients). The researchers found that it took 16 months for the disease to progress in women who got camizestrant, compared with 9.2 months in those who continued on standard therapy, a statistically significant difference in progression-free survival. No new side effects were reported and few patients from either group dropped out due to side effects. "This is going to be very impactful for our patients," said Dr. Hope Rugo, head of breast medical oncology at City of Hope in Duarte, California. The question, she said, is how do doctors incorporate the testing into clinical practice. Separately, adding AstraZeneca's immunotherapy durvalumab to standard treatment before and after surgery in patients with early-stage stomach and esophageal cancers helped extend the time patients had without cancer progression or recurrence compared to chemotherapy alone. The global study of nearly 950 patients tested durvalumab, sold under the brand Imfinzi, in combination with a chemotherapy regimen called FLOT given around the time of initial cancer surgery. Patients in the durvalumab plus FLOT arm experienced a 29% better event-free survival than those who received the chemotherapy regimen. "We demonstrate that immunotherapy works in early-stage disease, which is great," lead study author Dr. Yelena Jarnigan of Memorial Sloan Kettering Cancer Center in New York told reporters at the meeting. "We did not see any new safety signals, so this will change practice for our patients, which is exciting to see." Both studies were published on Sunday in the New England Journal of Medicine.
Associated Press
3 days ago
- Business
- Associated Press
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
WILMINGTON, Del.--(BUSINESS WIRE)--Jun 1, 2025-- 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 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 US-101612 Last updated 06/25 View source version on CONTACT: Media InquiriesFiona Cookson +1 212 814 3923 Jillian Gonzales +1 302 885 2677US Media Mailbox:[email protected] KEYWORD: DELAWARE UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: ONCOLOGY HEALTH CLINICAL TRIALS RESEARCH SCIENCE PHARMACEUTICAL BIOTECHNOLOGY SOURCE: AstraZeneca Copyright Business Wire 2025. PUB: 06/01/2025 08:00 AM/DISC: 06/01/2025 08:01 AM
