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Telegraph
3 days ago
- Business
- Telegraph
Breakthrough breast cancer treatment could help 1,000 women a year
A new triple-drug treatment for aggressive advanced breast cancer can cut deaths by a third, a major trial has found. The international research used liquid biopsies – described as the 'golden key' to unlocking precision medicines – that identified suitable patients. All were suffering from one of the most common forms of breast cancer, which accounts for seven in 10 cases, and had a common mutation which makes it more deadly and aggressive. The three-drug therapy comprises 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. Until now, treatment options for such patients have been limited. The trial involving the Institute of Cancer Research and The Royal Marsden NHS Foundation Trust enrolled 325 patients from 28 countries, including the UK. In all cases, cancer had spread or returned after hormone therapy and for those who had not yet received systemic treatment for metastatic disease. Of the total, 161 were given the three-drug combination. 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 therapy was far more likely to result in significant shrinkage of tumours. In total, 62.7 per cent of patients in the inavolisib group saw their tumours shrink by more than 30 per cent, compared with 28 per cent in the placebo group. The randomised, double blind trial also showed that the new combination delayed the progression of the disease by 17.2 months, on average, compared with 7.3 months in the control group. Women taking inavolisib were able to delay subsequent chemotherapy treatment by almost two years longer than the patients in the control group. Around 55,000 women are diagnosed with breast cancer in the UK every year, and 11,500 will die from the disease. The study involved women with one of the most common types of disease, who had a mutation which is more aggressive and deadly. Experts said around 1,000 women a year could be helped by the drug combination. The study, funded by pharmaceutical company Roche, which manufactures inavolisib, was presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago and simultaneously published in The New England Journal of Medicine. Lead author Nick Turner, professor of molecular oncology at the Institute of Cancer Research and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, said the 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 said. The oncologist said he hoped the triple therapy would become the standard of care for women who can benefit. Previous trial results led the United States Food and Drug Administration (FDA) to grant 'breakthrough therapy' designation for inavolisib in May 2024 with costs of around $23,000 (£17,000) monthly. It has yet to be licensed in the UK. 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.' Dr Nisharnthi Duggan, research information manager at Cancer Research UK, said: 'These results are really positive news for people living with a type of hard-to-treat breast cancer. 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.'
Sky News
3 days ago
- Business
- Sky News
New three-drug combination could help women with aggressive breast cancer live longer, study suggests
A new three-drug combination could help women with a common form of aggressive breast cancer live longer, a study has suggested. The trial, which included 325 patients from across 28 countries, showed the treatment more than doubled the time before the cancer "progressed or worsened", according to the lead author, and could delay the need for chemotherapy. The combination may 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, said the researchers. This mutation in the PIK3CA gene causes cells to divide and replicate uncontrollably. More than half of the patients in the trial 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 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 combined 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. 1:48 'More time before needing chemotherapy' Lead author Nick Turner, a professor of molecular oncology, 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. The final results of the trial, by experts at the Institute of Cancer Research and the Royal Marsden NHS Foundation Trust in London, have been published in the New England Journal of Medicine and presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago. 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. Prof Kristian Helin, chief executive of the Institute of Cancer Research, London, said: "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." Dr Simon Vincent, director of research, support and influencing at Breast Cancer Now, called the findings "a significant breakthrough".
Medscape
23-05-2025
- Health
- Medscape
Benefits Persist With Inavolisib in Breast Cancer
New findings from the phase 3 INAVO120 trial underscore the durable benefits of inavolisib added to standard therapy for PIK3CA -mutated hormone receptor–positive (HR+) human epidermal growth factor receptor 2–negative (HER2−) advanced breast cancer. The drug, in combination with palbociclib and fulvestrant, was approved in October 2024 by the US Food and Drug Administration based on previously published progression-free survival benefits. Now, mature overall survival (OS) results and longer follow-up strengthen evidence for the triplet combination, said lead author and oncologist, Nicholas C. Turner, MD, PhD, during a press conference for the American Society of Clinical Oncology (ASCO) 2025 annual meeting. 'Importantly, this is the first time that OS has been improved by a PI3 kinase pathway targeted drug…we delayed the time to chemotherapy by almost 2 years, and the adverse event profile was consistent with previous reports, with low inavolisib discontinuation rates due to adverse events,' said Turner. The INAVO120 trial included 325 patients with HR+ HER2− advanced breast cancer and a PIK3CA -mutation who had either failed hormone therapy or progressed within 1 year. Patients were randomized to either standard therapy consisting of palbociclib and fulvestrant (placebo, n = 164) or the triplet combination that included standard therapy plus inavolisib (n = 161). With a median follow-up now up 34.2 months, the study showed a 33% reduction in the risk of death in the inavolisib arm, translating to an OS of 34 months compared with 27 months in the placebo group (stratified hazard ratio [sHR] 0.67; P = .0190), he reported, in the press conference. 'We also looked at an endpoint that is really important for patients, which is the time until they have to consider chemotherapy-based care, and this was substantially improved…with almost a 2-year delay on average, to the time of needing to have chemotherapy,' he said. Specifically, while patients in the placebo group needed chemotherapy at a median of 12.6 months, this was delayed until 35.6 months in the inavolisib group (sHR, 0.43). Additionally, the previously published primary endpoint of median progression-free survival, which strongly favored inavolisib after a follow-up of roughly 21 months, (15.0 vs 7.3 months, sHR 0.43; P < .001) was maintained with longer follow-up (17.2 vs 7.3 months; sHR, 0.42). With the extended time on therapy, adverse events remained 'generally manageable,' said Turner, although he cautioned 'this is not a drug without side effects.' In total, 90.7% of patients in the inavolisib arm, and 84.7% in the placebo arm had grade 3/4 adverse events. Hyperglycemia (any grade) was experienced by 63.4% of the inavolisib group and 13.5% of the placebo group, and adverse events leading to discontinuation occurred in 6.8% and 0.6% or trial participants in each of the groups, respectively. Previously, attempts to combine PI3K inhibitors with CDK4/6 inhibitors were not possible because side-effects were much worse, explained Turner. But the specificity of inavolisib has decreased that risk. 'So, that maximizes your ability to hit PI3 kinase in the tumor while relatively sparing normal cells in the body and reducing side effects,' Turner said, during the press conference. Commenting on the study, ASCO chief medical officer and spokesperson Judy Gralow, MD, said she was particularly impressed with the therapy's benefit on time to next chemotherapy. 'Delaying the need, in the metastatic setting, to go on chemotherapy by almost 2 years is certainly an outcome that matters to patients,' she said. 'It is clear that, at least in a majority of breast cancers at the time of recurrence, we should be testing for PIK3CA mutations, as well as other alterations that direct therapy.' However, she cautioned that the triplet therapy is only indicated in a subset of PIK3CA -mutated HR+ HER2− advanced breast cancer: namely those who have progressed either during, or within a year of hormone therapy. 'So, this is not all comers, [such as] patients who had tumors that 5 years later, 7 years later, showed evidence of recurrence.' Calling the study results 'a big step forward' for this patient group, Jane Lowe Meisel, MD, co-director, Breast Medical Oncology, at the Winship Cancer Institute of Emory University School of Medicine, Atlanta, said the study 'illustrates the importance of genomic testing at the time of diagnosis of hormone receptor–positive metastatic breast cancer, so that patients with PIK3CA mutations who qualify for this approach can be readily identified.' Turner disclosed consulting or advisory roles with AstraZeneca, Exact Sciences, Gilead Sciences, GlaxoSmithKline, Guardant Health, Inivata, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Relay Therapeutics, Repare Therapeutics, and Roche. He also received research funding with AstraZeneca; Guardant Health; Inivata; Invitae; Merck Sharpe & Dohme; Natera; Personalis; Pfizer; and Roche. Meisel disclosed consulting or advisory roles with AstraZeneca, GE Healthcare, Genentech, Novartis, Olema Oncology, Pfizer, Seagen, Sermonix Pharmaceuticals, and Stemline. She also disclosed research funding from AstraZeneca, Olema Oncology, Pfizer, Seagen, and Sermonix Pharmaceuticals. Gralow disclosed having no conflicts of interest. The study was funded by F. Hoffmann–La Roche and a grant (P30CA008748) to the Memorial Sloan Kettering Cancer Center.
Globe and Mail
08-05-2025
- Business
- Globe and Mail
Renal Cell Carcinoma Pipeline Appears Robust With 30+ Companies Actively Working in the Therapeutics Segment
DelveInsight's, 'Renal Cell Carcinoma Pipeline Insight 2025' report provides comprehensive insights about 30+ companies and 30+ pipeline drugs in Renal Cell Carcinoma pipeline landscape. It covers the Renal Cell Carcinoma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Renal Cell Carcinoma therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Explore the comprehensive insights by DelveInsight and stay ahead in understanding the Renal Cell Carcinoma Treatment Landscape. Click here to read more @ Renal Cell Carcinoma Pipeline Outlook Key Takeaways from the Renal Cell Carcinoma Pipeline Report In May 2025, Merck Sharp & Dohme LLC announced a study is to evaluate the efficacy and safety of belzutifan monotherapy and belzutifan plus palbociclib combination therapy in participants with advanced clear-cell renal cell carcinoma (ccRCC) who experienced disease progression on or after receiving prior therapy. Part 1 will establish the safety of belzutifan plus palbociclib and determine a recommended dosage of palbociclib for the combination therapy by ascending dose escalation. Part 2 will evaluate the efficacy and safety of belzutifan plus palbociclib at the dosage level determined in Part 1. In May 2025, Karie Runcie announced a Phase 2 study will include men and women ≥ 18 with confirmed renal cell carcinoma who have progressed on adjuvant anti-PD-1/PD-L1 therapy, the current standard of care. Subjects will be randomized to Arm A or Arm B. Study treatment will be given in 28-day (4 week) cycles. Arm A treatment will consist of XL092 alone and will be taken once daily continuously (Day 1-Day 28). Arm B treatment will consist of XL092 plus nivolumab. XL092 will be taken once daily continuously (Day 1-Day 28) and nivolumab will be administered every 4 weeks (Day 1). Treatment will continue until progression by RECIST 1.1, toxicity, or other reasons as appropriate. DelveInsight's Renal Cell Carcinoma Pipeline report depicts a robust space with 30+ active players working to develop 30+ pipeline therapies for Renal Cell Carcinoma treatment. The leading Renal Cell Carcinoma Companies such as AstraZeneca, Infinity Pharmaceuticals, Ipsen, Novartis, Aveao pharmaceuticals, Merck Sharp & Dohme Corp., Pfizer, Bayer Healthcare, Incyte Corporation, GlaxoSmithKline, Bristol-Myers Squibb, Hoffman La Roche, Amgen, ColImmune, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Betta Pharmaceuticals, Regeneron Pharmaceuticals, Cemiplimab, Aravivie Inc, X4 pharmaceuticals, and others. Promising Renal Cell Carcinoma Therapies such as PRO1160, Cabozantinib, CTX131, Ipilimumab, Nivolumab, Zanzalintinib, AB521, and others. Discover groundbreaking developments in Renal Cell Carcinoma therapies! Gain in-depth knowledge of key Renal Cell Carcinoma clinical trials, emerging drugs, and market opportunities @ Renal Cell Carcinoma Clinical Trials Assessment Renal Cell Carcinoma Emerging Drugs Profile CM082: Betta Pharmaceuticals CM082 series have the similar skeletal structures to Icotinib Hydrochloride, as the multi-target RTK (receptor tyrosine kinase) inhibitor, mainly targeting at VEGFR and PDGFR. The drug is being evaluated in phase III stage of development for the treatment of Renal Cell Carcinoma. TQB 2450: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. TQB 2450 (formerly APL 502 and CBT 502) is a humanised immunoglobulin G1 (IgG1) monoclonal antibody targeting the programmed cell death-1 ligand-1. Phase III clinical trials are being evaluated by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. for TQB 2450 for the treatment of renal cell carcinoma. IPI-549: Infinity Pharmaceuticals IPI-549 is an oral immuno-oncology candidate which has been designed to preferentially inhibit PI3K-gamma. The drug is being studied in phase II stage of development for the treatment of renal cell carcinoma. CMN-001: ColImmune Dendritic cells have been used by colimmune for the treatment of renal failure. CMN001 is a dendritic cell vaccine for renal cell carcinoma. The drug is being evaluated in phase II stage of development for the treatment of renal cell carcinoma. The Renal Cell Carcinoma Pipeline report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of Renal Cell Carcinoma with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Renal Cell Carcinoma Treatment. Renal Cell Carcinoma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Renal Cell Carcinoma Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Renal Cell Carcinoma market. Stay informed about the Renal Cell Carcinoma pipeline trends! Uncover critical updates on therapeutic innovations and their potential impact on patients and the healthcare industry @ Renal Cell Carcinoma Unmet Needs Renal Cell Carcinoma Companies AstraZeneca, Infinity Pharmaceuticals, Ipsen, Novartis, Aveao pharmaceuticals, Merck Sharp & Dohme Corp., Pfizer, Bayer Healthcare, Incyte Corporation, GlaxoSmithKline, Bristol-Myers Squibb, Hoffman La Roche, Amgen, ColImmune, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Betta Pharmaceuticals, Regeneron Pharmaceuticals, Cemiplimab, Aravivie Inc, X4 pharmaceuticals, and others. Renal Cell Carcinoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration Oral Subcutaneous Intravenous Intramuscular Molecule Type Renal Cell Carcinoma Products have been categorized under various Molecule types such as Bispecific Antibody Peptides Small molecule Gene therapy Product Type Transform your understanding of the Renal Cell Carcinoma Pipeline! See the latest progress in drug development and clinical research @ Renal Cell Carcinoma Market Drivers and Barriers, and Future Perspectives Scope of the Renal Cell Carcinoma Pipeline Report Coverage- Global Renal Cell Carcinoma Companies- AstraZeneca, Infinity Pharmaceuticals, Ipsen, Novartis, Aveao pharmaceuticals, Merck Sharp & Dohme Corp., Pfizer, Bayer Healthcare, Incyte Corporation, GlaxoSmithKline, Bristol-Myers Squibb, Hoffman La Roche, Amgen, ColImmune, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Betta Pharmaceuticals, Regeneron Pharmaceuticals, Cemiplimab, Aravivie Inc, X4 pharmaceuticals, and others. Renal Cell Carcinoma Therapies- PRO1160, Cabozantinib, CTX131, Ipilimumab, Nivolumab, Zanzalintinib, AB521, and others. Renal Cell Carcinoma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Renal Cell Carcinoma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Stay Ahead in Oncology Research–Access the Full Renal Cell Carcinoma Pipeline Analysis Today! @ Renal Cell Carcinoma Drugs and Companies Table of Content Introduction Renal Cell Carcinoma Executive Summary Renal Cell Carcinoma: Overview Renal Cell Carcinoma Pipeline Therapeutics Renal Cell Carcinoma Therapeutic Assessment Renal Cell Carcinoma – DelveInsight's Analytical Perspective In-depth Commercial Assessment Renal Cell Carcinoma Collaboration Deals Late Stage Products (Phase III) TQB 2450: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Drug profiles in the detailed report….. Mid Stage Products (Phase II) IPI-549: Infinity Pharmaceuticals Drug profiles in the detailed report….. Early Stage Products (Phase I) AVB-S6-500: Aravive Inc. Drug profiles in the detailed report….. Preclinical Stage Products Drug Name: Company name Drug profiles in the detailed report….. Inactive Products Renal Cell Carcinoma Key Companies Renal Cell Carcinoma Key Products Renal Cell Carcinoma - Unmet Needs Renal Cell Carcinoma - Market Drivers and Barriers Renal Cell Carcinoma - Future Perspectives and Conclusion Renal Cell Carcinoma Analyst Views Renal Cell Carcinoma Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. 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