Latest news with #INAVO120
Gulf Today
a day ago
- Health
- Gulf Today
New breast cancer therapy can slow advance of disease, prolong survival
A new triple therapy for aggressive, advanced breast cancer slows the progression of the disease, delays the need for further chemotherapy and helps patients live longer, research revealed. The combination treatment is made up of two targeted drugs: inavolisib and palbociclib, and the hormone therapy fulvestrant. It improved overall survival by an average of seven months, compared with the patients in the control group, who were given palbociclib and fulvestrant. It also delayed progression of the disease by 17.2 months, on average, compared with 7.3 months in the control group, and patients taking inavolisib were able to delay subsequent chemotherapy treatment by almost two years longer than the patients in the control group. The results of the study, funded by Roche, were presented at the American Society of Clinical Oncology (Asco) annual meeting in Chicago and published in the New England Journal of Medicine. The international trial involved 325 patients from 28 countries, including the US, UK, Australia, Singapore, Brazil, France and Germany. Experts said it demonstrated the potential of the triple therapy for targeting PIK3CA-mutated HR+, HER2- breast cancer - a common form of the disease. About 70 percent of patients have HR+, HER2- breast cancer. PIK3CA mutations are found in 35 to 40 percent of HR+ breast cancers, and are linked to tumour growth, disease progression and treatment resistance. "The INAVO120 trial has identified a targeted treatment regimen that meaningfully improves survival in patients with untreated PIK3CA-mutated hormone receptor-positive metastatic breast cancer - a big step forward for these patients,' said Dr Jane Lowe Meisel, Co-Director of Breast Medical Oncology at Winship Cancer Institute of Emory University, and an Asco expert in breast cancer. The results also showed a substantial shrinking in cancer growth in about 62.7 percent of patients in the triple therapy group compared with 28 percent in the control group. Dr. Simon Vincent, Director of Research, support and influencing at Breast Cancer Now, said the findings were a "significant breakthrough'. Dr. Nisharnthi Duggan, a research information manager at Cancer Research UK, said, "The trial showed that adding inavolisib to targeted treatment plans improved survival. On top of this, it also delayed the progression of people's cancer and the need for chemotherapy, which could improve quality of life. We hope that more research like this will help to give people kinder cancer treatment options, and more time with their loved ones.' In the trial, more than half of the patients had disease that had already spread to three or more organs. The researchers used circulating tumour DNA (ctDNA) liquid biopsy blood tests to determine whether patients had a PIK3CA mutation. Participants were then allocated to receive either the inavolisib-based regimen or a combination of palbociclib, fulvestrant and a dummy pill. The new drug inavolisib works by blocking the activity of the PIK3CA protein. The inavolisib combination was generally well tolerated with only a few patients experiencing side-effects that led them to discontinue the treatment. Nick Turner, Professor of Molecular Oncology at the Institute of Cancer Research, London, and consultant medical oncologist at the Royal Marsden NHS Foundation Trust, led a UK arm of the trial. "The key findings from this study showed that the inavolisib-based therapy not only helped patients live longer but it more than doubled the time before their cancer progressed or worsened. It also gave them more time before needing subsequent chemotherapy which we know is something that patients really fear and want to delay for as long as possible," he stated. WAM
Business Insider
2 days ago
- Business
- Business Insider
Genentech announces final results from OS analysis of Phase III INAVO120 study
Genentech, a member of the Roche (RHHBY) Group, announced positive final results from the overall survival, OS, analysis of the Phase III INAVO120 study. These data showed Itovebi, in combination with palbociclib and fulvestrant, reduced the risk of death by more than 30% compared with palbociclib and fulvestrant alone. This represents a statistically significant and clinically meaningful improvement in overall survival for people with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The results are being presented in an oral session at the 2025 American Society of Clinical Oncology, ASCO, Annual Meeting and simultaneously published in the New England Journal of Medicine, NEJM. The Itovebi-based regimen demonstrated a meaningful OS benefit compared with palbociclib and fulvestrant alone. The median OS was 34.0 months for people in the Itovebi arm, compared with 27.0 months in the palbociclib and fulvestrant arm. The benefit seen in delaying cancer progression was maintained in the updated analysis, with the Itovebi-based regimen showing a consistent improvement in median progression free survival of 17.2 months versus 7.3 months in the comparator arm. Confident Investing Starts Here:
Business Upturn
3 days ago
- Business
- Business Upturn
New data show Roche's Itovebi significantly extended survival in a certain type of HR-positive advanced breast cancer
The Itovebi TM (inavolisib)-based regimen reduced the risk of death by more than 30% in people with PIK3CA -mutated HR-positive, HER2-negative advanced breast cancer, compared with palbociclib and fulvestrant alone 1 The PIK3CA mutation is found in approximately 40% of HR-positive advanced breast cancers and is associated with a poor prognosis 2,3 New data are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the New England Journal of Medicine 1 Basel, 31 May 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive final results from the overall survival (OS) analysis of the phase III INAVO120 study. These data showed ItovebiTM (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, reduced the risk of death by more than 30% compared with palbociclib and fulvestrant alone. This represents a statistically significant and clinically meaningful improvement in overall survival for people with PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-resistant, locally advanced or metastatic breast cancer.1 The results are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine (NEJM). 1 'For the first time, a PI3K pathway-targeted drug has shown it can help people with this breast cancer subtype live longer,' said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. 'Itovebi exemplifies our continued commitment to improve survival rates for people with this common PIK3CA mutation, for whom more effective treatment options are needed.' 'The landmark data for the inavolisib-based regimen showed not only a doubling in progression-free survival, but importantly that it extended lives and gave people more time without chemotherapy,' said Professor Nicholas Turner, Lead Study Author and Professor of Molecular Oncology at The Institute of Cancer Research, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, London, United Kingdom. 'These results give us confidence that this regimen could become the new standard of care in the first-line setting, having demonstrated a substantial benefit on patient outcomes and quality of life.' The Itovebi-based regimen demonstrated a meaningful OS benefit compared with palbociclib and fulvestrant alone.1 The median OS was 34.0 months (95% CI: 28.4–44.8) for people in the Itovebi arm, compared with 27.0 months (95% CI: 22.8–38.7) in the palbociclib and fulvestrant arm (stratified hazard ratio [HR]=0.67; 95% CI: 0.48–0.94, p-value=0.0190 [boundary=0.0469]).1 The benefit seen in delaying cancer progression was maintained in the updated analysis, with the Itovebi-based regimen showing a consistent improvement in median progression free survival of 17.2 months versus 7.3 months (stratified HR=0.42; 95% CI: 0.32-0.55) in the comparator arm.1 The Itovebi-based regimen also led to a statistically significant improvement in objective response rate (the percentage of patients whose signs of cancer completely disappear or their tumours shrink significantly after treatment) and ad-hoc exploratory analyses showed it substantially delayed time to chemotherapy by approximately two years (stratified HR=0.43; 95% CI: 0.30-0.60).1 No new safety signals were observed at the time of the final OS analysis, with a low discontinuation due to adverse events supporting good tolerability.1 The Itovebi-based regimen is approved in the United States, Switzerland, Canada, Australia, United Arab Emirates and China. In May, it received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), with a final decision regarding the approval expected from the European Commission in the near future. Data from the INAVO120 study are currently under review with other global health authorities. Beyond INAVO120, Itovebi is currently being investigated in three company-sponsored phase III studies (INAVO121, INAVO122, INAVO123), all in PIK3CA -mutated, locally advanced or metastatic breast cancer in various combinations.4-7 We are exploring additional studies in breast cancer and other tumour types with the hope of providing the benefit of this targeted therapy to more people with PIK3CA mutations. About Itovebi TM (inavolisib) Itovebi is an oral, targeted treatment that has been shown to provide well-tolerated and durable disease control in people with PIK3CA -mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer, who often have a poor prognosis and are in urgent need of new treatment options.2,3,8 Itovebi has been designed to help minimise the overall burden and toxicity of treatment and is differentiated from other PI3K inhibitors due to its high potency and specificity for the PI3K alpha isoform versus other isoforms, and unique mechanism of action that facilitates the degradation of mutated PI3K alpha.9,10 About the INAVO120 study The INAVO120 study [NCT04191499] is a phase III, randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.4 The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm.4 The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from randomisation in the clinical trial to the time when the disease progresses, or a patient dies from any cause.4 Secondary endpoints include overall survival, objective response rate, and clinical benefit rate.4 Beyond INAVO120, Itovebi is currently being investigated in three additional company-sponsored phase III clinical studies in PIK3CA -mutated locally advanced or metastatic breast cancer in various combinations:5-7 in combination with fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and endocrine combination therapy (INAVO121; NCT05646862). in combination with pertuzumab plus trastuzumab for subcutaneous injection (SC) versus pertuzumab plus trastuzumab for SC and optional physician's choice of endocrine therapy as a maintenance treatment in HER2-positive disease (INAVO122; NCT05894239). in combination with CDK4/6 inhibitor and letrozole versus placebo plus a CDK4/6 inhibitor and letrozole in the first-line setting in PIK3CA -mutated HR-positive/HER2-negative, endocrine-sensitive breast cancer (INAVO123; NCT06790693). About hormone receptor (HR)-positive breast cancer HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70% of cases.11,12 A defining feature of HR-positive breast cancer is that its tumour cells have receptors that attach to one or both hormones – oestrogen or progesterone – which can contribute to tumour growth. People diagnosed with HR-positive metastatic breast cancer often face the risk of disease progression and treatment side effects, creating a need for additional treatment options.12-14 The PI3K signalling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which have been identified as a potential mechanism of intrinsic resistance to standard of care endocrine therapy in combination with cyclin-dependent kinase 4/6 inhibitors.3 About Roche in breast cancer Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including oestrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers.11,12 About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit All trademarks used or mentioned in this release are protected by law. References [1] Turner NC, et al. INAVO120 Phase III trial final overall survival (OS) analysis of first-line inavolisib (INAVO)/placebo (PBO) + palbociclib (PALBO) + fulvestrant (FULV) in patients (pts) with PIK3CA -mutated, hormone receptor-positive (HR+), HER2-negative (HER2–), endocrine-resistant advanced breast cancer (aBC). Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, 2025 May 30-June 03; Chicago, USA. Abstract #1003. [2] Fillbrunn M, et al. PIK3CA mutation status, progression and survival in advanced HR+/HER2- breast cancer: a meta-analysis of published clinical trials. BMC Cancer. 2022;22(1):1002. [3] Anderson E, et al. A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2– Metastatic Breast Cancer. Int J Breast Cancer. 2020;2020:3759179. [4] A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA -Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (INAVO120) [Internet; cited 2025 May]. Available from: [5] A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (INAVO121) [Internet; cited 2025 May]. Available from: [6] A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA -Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (INAVO122) [Internet; cited 2025 May]. Available from: [7] A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA -Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123) [Internet; cited 2025 May]. Available from: [8] Turner NC, et al. Inavolisib-Based Therapy in PIK3CA -Mutated Advanced Breast Cancer. NEJM. 2024;391(17):1584-96. [9] Juric D, et al. A phase I/Ib study of inavolisib (GDC-0077) in combination with fulvestrant in patients (pts) with PIK3CA -mutated hormone receptor-positive/HER2-negative (HR+/HER2–) metastatic breast cancer. Presented at San Antonio Breast Cancer Symposium, 2020 December 7-10; San Antonio, USA. Abstract #P5-17-05. [10] Hong R, et al. GDC-0077 is a selective PI3K alpha inhibitor that demonstrates robust efficacy in PIK3CA mutant breast cancer models as a single agent and in combination with standard of care therapies. Cancer Res. 2018;78(4):4-14.[11] National Cancer Institute: Surveillance, Epidemiology and Ends Result Program. Cancer Stat Facts: Female Breast Cancer Subtypes [Internet; cited 2025 May]. Available from: [12] Lim E, et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park). 2012;26(8):688-94,696.[13] Tomas R and Barrios CH. Optimal management of hormone receptor positive metastatic breast cancer in 2016. Ther Adv Med Oncol. 2015;7(6):304-20. [14] Galipeau N, et al. Understanding key symptoms, side effects, and impacts of HR+/HER- advanced breast cancer: qualitative study findings. J Patient-Rep Outcomes. 2019;3(1):10.
ITV News
3 days ago
- Health
- ITV News
New three-drug therapy helps women with aggressive breast cancer live longer, trial shows
A new three-drug combination could help women with a common form of aggressive breast cancer live longer, research suggests. The treatment could also delay the need for gruelling chemotherapy, according to a trial. If approved by the NHS, it could help thousands of patients every year. Researchers are hopeful the combination could become the 'new go-to option' for women with PIK3CA-mutated hormone receptor-positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer. This mutation in the PIK3CA gene causes cells to divide and replicate uncontrollably. The final results from the INAVO120 study, led by experts at The Institute of Cancer Research, London, and the Royal Marsden NHS Foundation Trust, have been published in the New England Journal of Medicine and presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago. Professor Nick Turner said: "These results give us confidence that this treatment could become the new go-to option for patients who have HR+, HER2- breast cancer with a PIK3CA mutation, as it has shown significant improvements in both survival and quality of life." The trial included 325 patients from across 28 countries. More than half had metastatic breast cancer that had spread to three or more organs, and the majority had already had chemotherapy. What is the three-drug therapy? Researchers used a blood test known as a liquid biopsy, which detects tumour DNA in the blood, to test for the PIK3CA mutation. Of the total, 161 were given a three-drug combination comprising two targeted drugs – palbociclib, a type of cancer growth blocker, and a new drug called inavolisib, which blocks the activity of the PI3K protein – as well as the hormone therapy fulvestrant. The placebo group, which included 164 patients, was given a dummy pill plus palbociclib and fulvestrant. The study found the median overall survival in the inavolisib group was 34 months, compared with 27 months in the placebo group. The three-drug therapy also delayed disease progression by 17.2 months, compared with 7.3 months in the placebo group, with patients also able to delay chemotherapy treatment by almost two years longer. The latest results come after previous analysis of the study, published in October, showed the three-drug therapy delayed disease progression by an average of 15 months compared with 7.3 months in the placebo group. Lead author Nick Turner, a professor of molecular oncology at The Institute of Cancer Research, London, and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, said: 'The key findings from this study showed that the inavolisib-based therapy not only helped patients live longer but it more than doubled the time before their cancer progressed or worsened. 'It also gave them more time before needing subsequent chemotherapy, which we know is something that patients really fear and want to delay for as long as possible. 'These results give us confidence that this treatment could become the new go-to option for patients who have HR+, HER2- breast cancer with a PIK3CA mutation, as it has shown significant improvements in both survival and quality of life.' How many women could this help? It is estimated that about 55,000 women are diagnosed with breast cancer in the UK every year, some 70% of whom will have HR+, HER2- breast cancer. PIK3CA mutations are found in 35-40% of HR+ breast cancers. The three-drug therapy of inavolisib, palbociclib and fulvestrant is not approved in the UK. However, the combination of palbociclib and fulvestrant has been available as an option for patients with certain types of breast cancer on the NHS since 2022. Professor Kristian Helin, chief executive of The Institute of Cancer Research, London, said: "This research demonstrates how this triple combination approach effectively shuts down cancer's escape routes, giving people with metastatic breast cancer the opportunity to live well for longer. He added: 'If we are to continue improving cancer survival rates, we need to tackle treatment resistance head on. 'This research demonstrates how this triple combination approach effectively shuts down cancer's escape routes, giving people with metastatic breast cancer the opportunity to live well for longer. 'One of the challenges with combination therapies is ensuring the right drug dosages and understanding their individual effects. 'It is extremely encouraging that this study not only demonstrates the effectiveness of this approach but also shows that the therapy was generally well tolerated by patients.'
Powys County Times
3 days ago
- Health
- Powys County Times
Three-drug therapy helps women with aggressive breast cancer live longer
A new three-drug combination could help women with a common form of aggressive breast cancer live longer, research suggests. The treatment could also delay the need for gruelling chemotherapy, according to a trial. Researchers are hopeful the combination could become the 'new go-to option' for women with PIK3CA-mutated hormone receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer. This mutation in the PIK3CA gene causes cells to divide and replicate uncontrollably. The final results from the INAVO120 study, led by experts at The Institute of Cancer Research, London, and the Royal Marsden NHS Foundation Trust, have been published in the New England Journal of Medicine and presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago. The trial included 325 patients from across 28 countries. More than half had metastatic breast cancer that had spread to three or more organs and the majority had already had chemotherapy. Researchers used a blood test known as a liquid biopsy, which detects tumour DNA in the blood, to test for the PIK3CA mutation. Of the total, 161 were given a three-drug combination comprising two targeted drugs – palbociclib, a type of cancer growth blocker, and a new drug called inavolisib, which blocks the activity of the PI3K protein – as well as the hormone therapy fulvestrant. The placebo group, which included 164 patients, was given a dummy pill plus palbociclib and fulvestrant. The study found the median overall survival in the inavolisib group was 34 months, compared with 27 months in the placebo group. The three-drug therapy also delayed disease progression by 17.2 months, compared with 7.3 months in the placebo group, with patients also able to delay chemotherapy treatment by almost two years longer. The latest results come after previous analysis of the study, published in October, showed the three-drug therapy delayed disease progression by an average of 15 months compared with 7.3 months in the placebo group. Lead author Nick Turner, a professor of molecular oncology at The Institute of Cancer Research, London, and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, said: 'The key findings from this study showed that the inavolisib-based therapy not only helped patients live longer but it more than doubled the time before their cancer progressed or worsened. 'It also gave them more time before needing subsequent chemotherapy which we know is something that patients really fear and want to delay for as long as possible. 'These results give us confidence that this treatment could become the new go-to option for patients who have HR+, HER2- breast cancer with a PIK3CA mutation, as it has shown significant improvements in both survival and quality of life.' It is estimated that about 55,000 women are diagnosed with breast cancer in the UK every year, some 70% of whom will have HR+, HER2- breast cancer. PIK3CA mutations are found in 35-40% of HR+ breast cancers. The three-drug therapy of inavolisib, palbociclib and fulvestrant is not approved in the UK. However, the combination of palbociclib and fulvestrant has been available as an option for patients with certain types of breast cancer on the NHS since 2022. Prof Kristian Helin, chief executive of The Institute of Cancer Research, London, added: 'If we are to continue improving cancer survival rates, we need to tackle treatment resistance head on. 'This research demonstrates how this triple combination approach effectively shuts down cancer's escape routes, giving people with metastatic breast cancer the opportunity to live well for longer. 'One of the challenges with combination therapies is ensuring the right drug dosages and understanding their individual effects. 'It is extremely encouraging that this study not only demonstrates the effectiveness of this approach but also shows that the therapy was generally well tolerated by patients.' Reacting to the findings, Dr Simon Vincent, director of research, support and influencing at Breast Cancer Now, said: 'This is a significant breakthrough and we're proud that it builds on a series of discoveries that our funded scientists have been making at the Breast Cancer Now Toby Robins Research Centre at The Institute of Cancer Research, London, since it opened 25 years ago. 'We now hope to see this new combination therapy can be licensed by the MHRA (Medicines and Healthcare Products Regulatory Agency) and assessed by Nice (the National Institute for Health and Care Excellence) and the Scottish Medicine Council as soon as possible so that it can reach the NHS patients who could benefit from it.'
