Latest news with #trastuzumab
Medscape
24-06-2025
- Health
- Medscape
Metastatic Breast Cancer Highlights From ASCO 2025
An exceptional range of practice-changing advancements in metastatic breast cancer across all subtypes were presented at ASCO 2025 and are discussed by Dr Ann Partridge of the Dana-Farber Cancer Institute. Beginning with HER2-positive disease, Dr Partridge reports on the DESTINY-Breast09 trial investigating whether trastuzumab deruxtecan (T-DXd) + pertuzumab (P) could improve upon results from the standard of care regimen, taxane + trastuzumab + P (THP), in the first-line setting. T-DXd + P increased progression-free survival (PFS), offering a future option for patients with very aggressive disease — although, Dr Partridge notes, several clinical questions remain. She highlights three studies in HER2-negative disease, starting with the SERENA-6 trial in which some patients treated with endocrine therapy who had ESR1 mutation, detected by circulating tumor DNA analysis, were switched to camizestrant. The camizestrant arm demonstrated meaningful PFS improvement. She also notes the first phase 3 trial of a proteolysis-targeting chimera, vepdegestrant, which demonstrated improved PFS in patients with ESR1 mutation. Continuing in the HER2-negative setting, she reports the updated overall survival results for inavolisib that continue to demonstrate positive PFS results. Switching gears to triple-negative disease, she discusses promising results from the ASCENT-04 trial, which tested the antibody-drug conjugate sacituzumab govitecan against chemotherapy.
Medscape
06-06-2025
- Health
- Medscape
Which Tx Combo Is Best for HER2+ Breast Cancer?
The combination of trastuzumab deruxtecan (Enhertu) with pertuzumab (Perjeta) as a first-line treatment for HER2-positive advanced metastatic breast cancer has been shown to reduce the risk for disease progression or death by more than the current standard-of-care treatment. Sara Tolaney, MD, MPH Sara Tolaney, MD, MPH, of the Dana-Farber Cancer Institute in Boston, presented this finding and other interim results of the phase 3 DESTINY-Breast09 study, at the American Society of Clinical Oncology (ASCO) 2025 annual meeting in Chicago. 'Trastuzumab deruxtecan, or T-DXd, in combination with pertuzumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, with a 44% reduction in the risk of disease progression or death when compared to a taxane, trastuzumab, and pertuzumab (THP),' said Tolaney, during her presentation. New First-line Standard? Similar results were observed across all patient subgroups, with no new safety signals, Tolaney said. 'These data suggest that T-DXd and pertuzumab may represent a new first-line standard of care for patients with metastatic HER2-positive breast cancer,' she said. The study randomized 1157 patients to three treatment groups: T-DXd 5.4 mg/kg every three weeks plus placebo, T-DXd-pertuzumab, or a taxane plus trastuzumab with pertuzumab (THP). The interim study readout includes only data from the T-DXd-pertuzumab and the taxane plus trastuzumab with pertuzumab groups. Pertuzumab + T-Dxd or Standard of Care? Median progression-free survival (PFS) was 40.7 months in the T-DXd-pertuzumab patients and 26.9 months in the taxane plus trastuzumab with pertuzumab patients ( P < .00001). Tolaney explained that the study was designed to have an interim analysis for PFS after approximately 399 events across the three arms with at least 277 events for comparison. At the time of the interim analysis, she said, only the TDX-pertuzumab and THP groups met the criteria for superiority, a P -value < .00043, which was not met for the comparison of T-DXd plus placebo to THP. The T-DXd-placebo arm remains blinded until the final progression-free survival analysis, Tolaney said. Twenty-one percent of the patients in the T-DXd-pertuzumab arm had discontinued T-DXd due to adverse events, Tolaney said; 9% of patients elected to continue with trastuzumab and pertuzumab after they discontinued T-DXd. Among hormone receptor-positive patients, 13.5% in the T-DXd-pertuzumab group and 38% in the THP group elected to add endocrine treatment. At the data cutoff, 46% of the T-DXd-pertuzumab patients and 33% of those in the THP group remained on study treatment. Median follow-up duration was 29 months. The treatment effect of T-DXd-pertuzumab became evident early in the study, Tolaney said. Six months after starting treatment, 7% of the T-DXd-pertuzumab group vs 12% of the THP group had progressed. The gap continued to widen over time, she said. 'With 26% of patients still on steady treatment with T-DXd and pertuzumab, it suggests that this median is likely to evolve with further follow-up,' she said. Objective response rates were also higher with T-DXd–pertuzumab, 86% vs 79% with THP, Tolaney said. 'The complete response rate for T-DXd and pertuzumab was 15%, which was almost double what was seen with THP (8.5%),' she said. Response duration was also longer with T-DXd-pertuzumab, with 73% remaining in response at 24 months vs 55% in the THP arm. 'Overall survival data are very immature at this timepoint with just 16% of survival events seen, but you can see that there is an early trend favoring T-DXd plus pertuzumab with a hazard ratio of 0.84,' she said. A similar number of patients in both groups had serious treatment-emergent adverse events: 27% for T-DXd-pertuzumab and 25.1% for THP, which Tolaney said, was consistent with the known toxicity profiles of both agents, with no new toxicities identified. The median duration of treatment in the DESTINY-Breast09 study was 21 months. 'A Pivotal Advancement?' Rebecca Dent, MD, deputy CEO at the National Cancer Center Singapore, called the DESTINY-Breast09 results 'a pivotal advancement in the treatment of HER2-positive metastatic breast cancer that is both clinically and statistically significant.' Rebecca Dent, MD HER2-positive metastatic breast cancer was once considered a 'death sentence,' Dent said at a press conference, but now patients can survive on therapy for years, which presents its own challenges. Regarding the T-DXd-plus-pertuzumab regimen, Dent said, 'Is this for all patients at the beginning of their treatment for metastatic disease?' The truth of the matter is we don't know.' Having better biomarkers would provide answers, she said, but for patients with extensive disease with central nervous system metastasis, pertuzumab in combination with other agents 'is clearly your first-line choice.' How to best sequence therapies is another challenge emerging with these evolving treatment regimens, Dent added. 'And then I think finally we do have to appreciate that there are toxicities: One in terms of quality of life but also cost toxicity,' she said. Which Therapeutic Regimen Costs More? Tolaney acknowledged the cost implications of adding pertuzumab to T-DXd, in an interview with Medscape Medical News . 'But I would also note,' Tolaney said, 'that the standard-of-care arm does involve getting continued trastuzumab and pertuzumab therapy.' In the PATINA study, which added palbociclib (Ibrance) to standard maintenance therapy in patients with HER2-positive metastatic breast cancer, the cost profile was similar to those of the treatments used in the newer trial, Tolaney said. 'You are looking at substantial continued cost because we're continuing to suppress the HER2 pathway for years in these patients,' she said. AstraZeneca and Daiichi Sankyo funded the study. Tolaney reported financial relationships with ADi, Ambrx, Artios Biopharmaceuticals, Arvinas, AstraZeneca, Bayer, BeiGene, Bicycle Therapeutics, BioNTech, Blueprint Medicines, Bristol Myers Squibb, Circle Pharma, Cullinan Oncology, Daiichi Sankyo, eFFECTOR Therapeutics, Eisai, Exelixis, Genentech, Gilead Sciences, Hengrui Pharmaceutical (USA), Immunomedics/Gilead, Incyte, Jazz Pharmaceuticals, Johnson & Johnson, Launch Therapeutics, Lilly, Menarini Group, Merck, Mersana, NanoString Technologies, Natera, Novartis, OncoPep, Pfizer, Reveal Genomics, Sanofi, Seagen, Sumitovant Biopharma, Summit Therapeutics, Systimmune, Tango Therapeutics, Zentalis, Zuellig Pharma, and Zymeworks. Dent reported having financial relationships with AstraZeneca, Daiichi Sankyo/Astra Zeneca, DKSH, Eisai, Gilead Sciences, Merck Sharpe and Dohme, Novartis, Pfizer, and Roche.
Yahoo
22-05-2025
- Business
- Yahoo
Immunotherapy Drugs (Monoclonal Antibodies, Immunomodulators, Vaccine) Market Size, Share & Trends Analysis and Growth Forecasts, 2025-2030
The Immunotherapy Drugs Market is set to grow from USD 257.60 billion in 2024 to USD 486.36 billion by 2030, with a CAGR of 11.20%, driven by increased awareness of chronic diseases and supportive government policies. Rising adoption of targeted therapies, such as AstraZeneca's Enhertu for breast cancer, is key. Monoclonal antibodies and cancer treatments dominate the market, with North America leading due to high immunotherapy adoption and supportive policies. Immunotherapy Drugs Market Dublin, May 22, 2025 (GLOBE NEWSWIRE) -- The "Immunotherapy Drugs Market Size, Share & Trends Analysis Report by Drug Type (Monoclonal Antibodies, Immunomodulators, Vaccine), Indication (Autoimmune Diseases, Infectious Diseases, Cancer), Region, with Growth Forecasts, 2025-2030" has been added to offering. The Immunotherapy Drugs Market is poised for explosive growth, escalating from USD 257.60 Billion in 2024 to an anticipated USD 486.36 Billion by 2030, reflecting a robust CAGR of 11.20% This growth trajectory is underpinned by heightened awareness of chronic conditions such as cancer, autoimmune, inflammatory, and infectious diseases, coupled with favorable government policies facilitating drug approval pathways. The increasing adoption of targeted therapies for chronic disease management is further amplifying the market demand for immunotherapy drugs. Remarkable advancements in the sector include the U.S. approval of Enhertu (trastuzumab) for HER2-positive breast cancer by AstraZeneca and Daiichi Sankyo in May 2022, and the EU's endorsement of F. Hoffmann-La Roche Ltd.'s Tecentriq for NSCLC in June 2022. Simultaneously, expanded research and development, particularly in emerging markets, aligns with industry growth strategies. Novartis AG's collaboration with BeiGene, Ltd. for ociperlimab in December 2021 exemplifies such strategic R&D initiatives to broaden their immune-oncology pipeline. Boosting market impetus is Pfizer, Inc.'s positive phase 2b/3 trial outcomes for ritlecitinib, targeting alopecia areata, shared in August 2021. The global rise in cancer incidences further propels the demand for immunotherapy solutions. According to Globocan, 19.3 million new oncology cases were recorded in 2020, with projections indicating a 21% rise in European cancer incidences by 2040, as per the European Society of Medical Oncology, thus heightening the need for effective immunotherapy drugs. Immunotherapy Drugs Market Report Highlights The monoclonal antibodies segment dominated with a massive 76.2% market share in 2024, driven by extensive R&D and favorable government initiatives. Demand for biologics treatments for chronic diseases like cardiovascular, respiratory, and autoimmune disorders is a primary growth driver. The cancer segment commanded a 91.4% market revenue share in 2024, fueled by a surge in global cancer cases and better healthcare infrastructure in developing regions. North America led the global immunotherapy market, holding a 49.9% revenue share in 2024, attributed to high immunotherapy adoption, favorable reimbursement policies, and increased healthcare investment. Why Should You Buy This Report? Comprehensive Market Analysis: Gain detailed insights into key regional and segmental dynamics. Competitive Landscape: Understand the positioning of leading players in the market. Future Trends: Uncover trends and drivers influencing market direction. Actionable Recommendations: Leverage insights to identify new revenue opportunities and inform strategic directions. Key Attributes: Report Attribute Details No. of Pages 100 Forecast Period 2024 - 2030 Estimated Market Value (USD) in 2024 $257.6 Billion Forecasted Market Value (USD) by 2030 $486.36 Billion Compound Annual Growth Rate 11.2% Regions Covered Global Companies Featured Amgen Inc. Novartis AG AbbVie Inc. Pfizer Inc. F. Hoffmann-La Roche Ltd Johnson & Johnson Services, Inc. AstraZeneca GSK plc. Sanofi Bayer AG For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment Immunotherapy Drugs Market CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
Medscape
19-05-2025
- Health
- Medscape
Adjuvant Pertuzumab Shows OS Benefit in Breast Cancer
Adding adjuvant pertuzumab to standard adjuvant chemotherapy and trastuzumab improved overall survival at 11 years of follow-up in patients with early human epidermal growth factor receptor 2 (HER2)–positive operable breast cancer, according to a new analysis of a phase 3 trial. The benefit was driven only by those with node-positive cancer, according to findings presented by Sibylle Loibl, MD, PhD, on May 15 at ESMO Breast Cancer 2025. The results, from 11.3 years of follow-up in the final analysis from the APHINITY trial, are the first analysis to show an overall survival benefit. 'The [invasive disease-free survival] benefit was maintained, remaining clinically meaningful in the node-positive subgroup, while no benefit was observed in the node-negative subgroup,' Loibl, an associate professor of obstetrics and gynecology at the Goethe University of Frankfurt, Frankfurt, Germany, said during her presentation. In the original trial of 4805 patients with HER2-positive operable breast cancer, 2400 patients received adjuvant pertuzumab (840 mg, then 420 mg), and 2405 received placebo, both in addition to standard adjuvant chemotherapy and 1 year of treatment with trastuzumab. The patient groups were similarly balanced in terms of nodal status, adjuvant chemotherapy regimen (with or without anthracyclines), and hormone receptor status. In the 2017 analysis published in The New England Journal of Medicine , patients receiving pertuzumab had improved invasive disease-free survival (IDFS), but the benefit compared with placebo was seen only in those with node-positive disease. The third analysis with 8 years of follow-up in 2022 showed similar findings without any overall survival benefit seen in those receiving pertuzumab. In this analysis, conducted 34 months after the third previously reported analysis, there were 62 additional deaths and 73 additional IDFS events, for a total of 452 deaths and 682 IDFS events since the trial's start. Total deaths in the pertuzumab arm were 205 (8.5%) compared with 247 (10.3%) in the placebo arm, for a 1.8% absolute difference in death rate (adjusted hazard ratio [aHR], 0.83; 95% CI, 0.69-1.00; P = .441). Stratification by nodal status revealed the difference in overall survival benefit for node-positive vs node-negative disease. In node-positive patients, those receiving pertuzumab had an 89.6% survival rate compared with 86.9% in the placebo group, an absolute difference of 2.7% (unadjusted HR, 0.79; 95% CI, 0.64-0.97). In node-negative patients, however, those receiving pertuzumab had a survival rate of 94.9% compared with 94.6% with placebo (unadjusted HR, 0.99; 95% CI, 0.66-1.49). An IDFS event occurred in 12.6% of patients receiving pertuzumab vs 15.8% receiving placebo. Distant recurrence was seen in 6.3% with pertuzumab and 8.8% with placebo, and locoregional recurrence in 1.5% with pertuzumab and 2.5% with placebo. In the pertuzumab group, IDFS was 87.2% vs 83.8% with placebo (aHR, 0.79; 95% CI, 0.68-0.92), an absolute difference of 3.4%. Again, the benefit only occurred in those with node-positive disease (HR, 0.74; 95% CI, 0.62-0.88), while patients with node-negative disease saw no benefit with pertuzumab vs placebo (HR, 1.01; 95% CI, 0.74-1.38). IDFS events did not differ by hormone receptor (HR) status, with both node-positive HR+ (HR, 0.68) and node-positive HR− (HR, 0.83) patients seeing benefits. In the node-negative patients, neither those with HR+ (HR, 1.03) nor HR− (0.98) saw benefit with pertuzumab. Cardiac events were similar in the pertuzumab (0.9%) and placebo (0.5%) groups, with similar rates of cardiac death in both groups (0.1% and 0.2%, respectively) and no new cardiac safety signals. An analysis of those only receiving anthracyclines similarly showed no significant differences in cardiac events or deaths. The data from 3 years ago showing an IDFS benefit without an overall survival benefit were 'good enough to consider pertuzumab for the node-positive population,' said invited discussant Javier Cortés, MD, PhD, of the International Breast Cancer Center at Pangaea Oncology in Barcelona, the Universidad Europea de Madrid and Hospital Beata Maria Ana in Madrid, and the Medica Scientia Innovation Research, Barcelona, Spain, with Oncoclínicas & Co in Jersey City, New Jersey, and São Paulo, Brazil. The overall survival benefit seen with pertuzumab is comparable to the 2.7% absolute benefit seen with aromatase inhibitors compared with tamoxifen, he noted. Cortés said he does not think it's necessary to wait to see an overall survival benefit to give the green light to a therapy with a clear IDFS benefit. 'The question we have to ask ourselves, in my opinion, is, should we wait to see overall survival improvements when we have significant, distant, disease-free survival improvements?' Cortés told attendees. 'You maybe are not going to see the overall survival, but you may prevent metastasis, and that's something, in my opinion, that we have to consider in the early breast cancer setting,' he said. 'In early breast cancer studies, the primary point, in my opinion, should not be invasive disease-free survival.' Instead, the primary endpoint should be distant disease-free survival, and 'we should not wait for overall survival data to mature before making drug approval decisions,' he said. 'Delaying approval may result in patients progressing to metastatic disease and dying as a consequence,' he emphasized. 'Many patients will die if we are unable to use a drug because we are waiting for the approval based on the overall survival data.' Cortés also addressed the cost-effectiveness of the therapy on the basis of analysis from the United States and Spain. 'If we select the patients carefully, if we go for the highest risk group of patients, maybe the addition of pertuzumab is likely to be cost-effective,' he said. The research was funded by F. Hoffmann-La Roche Ltd in collaboration with the Breast International Group. Loibl reported royalties from VMscope and grants or honoraria from AstraZeneca, AbbVie, Agendia, Amgen, BioNTech, Celgene/BMS, Celcuity, DSI, Exact Sciences, Gilead Sciences, GSK, Incyte, Eli Lilly and Company, Molecular Health, MSD, Novartis, Pierre Fabre, Pfizer, Relay, Roche, Sanofi, Seagen, Stemline Therapeutics/Menarini, Olema, Bayer, Bicycle, Jazz Pharmaceuticals, and BeiGene, plus three planned, issued, or pending patents. Co-lead author Martine Piccart, MD, PhD, reported receiving consulting fees, advisory roles, scientific board service, or research funding from AstraZeneca, Eli Lilly and Company, MSD, Novartis, Pfizer, Menarini, Seagen, Roche/Genentech, NBE Therapeutics, Frame Therapeutics, Gilead Sciences, Radius Health, Synthon, Servier, Immunomedics/Gilead Sciences, and Oncolytics. Cortés reported stock with MAJ3 Capital and a relative's stock in Leuko and disclosures with Roche, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Eli Lilly and Company, Merck Sharp & Dohme, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Ellipses, Hibercell, Biolnvent, GEMoaB, Gilead Sciences, Menarini, Zymeworks, Reveal Genomics, Scorpion Therapeutics, ExpreS2ion Biotechnologies, Jazz Pharmaceuticals, AbbVie, BridgeBio, BioNTech, Biocon, Novartis, Eisai, Pfizer, Stemline Therapeutics, ARIAD Pharmaceuticals, Baxalta GmbH/Servier Affaires, Bayer, Guardant Health, PIQUR Therapeutics, and IQVIA. He holds a patent for a pharmaceutical combination of a PI3K inhibitor and a microtubule-destabilizing agent and for an HER2 predictor of response.
