Roche’s Kadcyla Demonstrates Long-Term Survival Benefit in HER2-Positive Early Breast Cancer
(IN BRIEF) Roche has released positive long-term follow-up data from the Phase III KATHERINE study, evaluating Kadcyla® (trastuzumab emtansine) as adjuvant therapy for people with HER2-positive early-stage breast cancer (eBC) who have residual invasive disease following neoadjuvant treatment. The study revealed a statistically significant and clinically meaningful improvement in overall survival (OS) with Kadcyla compared to Herceptin®. At the 7-year landmark, OS rates were 89.07% with Kadcyla and 84.37% with Herceptin. Kadcyla also maintained its benefit in invasive disease-free survival and reduced the risk of disease recurrence or death by 46%. The safety profile of Kadcyla remained consistent with previous findings. These results signify a significant advancement in treating HER2-positive early breast cancer, offering a chance for better outcomes for patients.
(PRESS RELEASE) BASEL, 9-Dec-2023 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced positive long-term follow-up data from the pivotal, phase III KATHERINE study in people with HER2-positive early-stage breast cancer (eBC) who have residual invasive disease following neoadjuvant (before surgery) treatment. A statistically significant and clinically meaningful improvement in overall survival (OS), a secondary endpoint, was observed with adjuvant (post-surgery) Kadcyla® (trastuzumab emtansine) compared to Herceptin® (trastuzumab): at the 7-year landmark OS rates were 89.07% and 84.37% with Kadcyla and Herceptin, respectively (hazard ratio [HR]=0.66, 95% CI: (0.51, 0.87), p-value =0.0027).2 Data also show that the previously reported invasive disease-free survival (primary endpoint) benefit is maintained.2 Kadcyla reduced the risk of disease recurrence or death from any cause by 46% compared to Herceptin (HR=0.54, 95% CI: (0.44, 0.66), p-value <0.0001), strengthening the results of the primary analysis of KATHERINE.2,3 The safety profile of Kadcyla was consistent with previous findings and no new safety signals were identified.2
“We are pleased that Kadcyla could offer people with HER2-positive early breast cancer with a particularly poor prognosis a chance to live longer and without recurrence of their disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The ultimate goal of treating early breast cancer is to maximise the chance of cure, and these results signify an important step forward for these patients.”
“Thanks to remarkable advances in diagnostics and treatment, more women are surviving an initial diagnosis of HER2-positive early-stage breast cancer than ever before. However, in those with higher risk disease, recurrence and long-term survival have remained a challenge,” said Prof. Dr. Sibylle Loibl, Chair of the German Breast Group (GBG), Principal Investigator of KATHERINE. “With these new data, Kadcyla is the first targeted therapy to demonstrate a significant survival benefit in people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment.”
The KATHERINE study has been conducted in collaboration with the GBG and NSABP Foundation, Inc. Full data are being presented as an oral presentation at the 2023 San Antonio Breast Cancer Symposium on Friday 08 December.
Kadcyla is approved in 113 countries and is the standard of care for people with HER2-positive eBC with residual invasive disease following neoadjuvant treatment, based on previous positive results from KATHERINE that showed Kadcyla cut the risk of disease recurrence or death by half versus Herceptin.1,3 Additionally, at three years, 88.3% of people treated with Kadcyla did not have their breast cancer return compared to 77.0% treated with Herceptin, an absolute improvement of 11.3%.3
Breast cancer is the most frequently diagnosed type of cancer, with major societal impact.4 Approximately one in five people with breast cancer will be HER2-positive, a particularly aggressive form of the disease.5 The goal in treating eBC is to provide people with the best chance for a cure.6 While we come closer to this goal with each advance, many people still have disease recurrence in the long-term and more personalised treatment options are needed to reduce this risk and help people live longer.7,8
Kadcyla is also approved for the treatment of people with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane.
About the KATHERINE study
KATHERINE is an international, multi-centre, two-arm, randomised, open-label, phase III study evaluating the efficacy and safety of Kadcyla versus Herceptin as an adjuvant therapy in people with HER2-positive early-stage breast cancer who have residual invasive disease following neoadjuvant therapy that included Herceptin and taxane-based chemotherapy.9 In KATHERINE, residual invasive disease was defined as the presence of invasive residual disease in tissue samples from breast and/or axillary nodes following neoadjuvant treatment.9 People who have residual invasive disease after neoadjuvant treatment generally have a worse prognosis than those without detectable disease at surgery.10
The primary endpoint of the study is invasive disease-free survival (iDFS) which, in this study, is defined as the time from randomisation free from invasive breast cancer recurrence or death from any cause.9 Secondary endpoints include DFS and overall survival.9
About Kadcyla
Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent chemotherapy directly to HER2-positive cancer cells, potentially limiting damage to healthy tissues. It combines two anti-cancer properties joined together by a stable linker: the HER2-targeting properties of trastuzumab (the active ingredient in Herceptin) and the chemotherapy agent DM1.11 Kadcyla is approved for the treatment of people with HER2-positive metastatic breast cancer (as of 2013) and HER2-positive early-stage breast cancer (as of 2019). Roche licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.
About Roche’s medicines for HER2-positive breast cancer
Roche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival of people with both early-stage and advanced HER2-positive disease. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 15-20% of patients.5
Roche has developed innovative medicines, including in patient-centric formulations, which have helped transform the treatment of HER2-positive breast cancer: Herceptin® (trastuzumab) in both intravenous and subcutaneous formulations, Perjeta® (pertuzumab), Kadcyla® (trastuzumab emtansine) and PHESGO® (pertuzumab, trastuzumab, and hyaluronidase-zzxf).12,13,14 Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test, which identifies people who will likely benefit from these medicines at the onset of their disease.
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 innovations in HER2-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 all forms of early-stage and advanced breast cancer, including triple-negative and hormone receptor-positive.
Our targeted medicines Herceptin® (trastuzumab), Perjeta® (pertuzumab), PHESGO® (pertuzumab, trastuzumab, and hyaluronidase-zzxf), Kadcyla® (trastuzumab emtansine) and Tecentriq® (atezolizumab) are continuing to transform the treatment of early-stage and advanced HER2-positive and triple-negative breast cancers and, through our clinical programmes, we hope to bring new treatment combinations to people with breast cancer, ultimately improving outcomes.12,13,14,15
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.
In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.
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 www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Roche data on file.
[2] Loibl S, et al. Phase III study of adjuvant ado-trastuzumab emtansine vs trastuzumab for residual invasive HER2-positive early breast cancer after neoadjuvant chemotherapy and HER2-targeted therapy: KATHERINE final IDFS and updated OS analysis. Presented at: San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, Texas, USA. Abstract #GS03-12.
[3] von Minckwitz G, et al. Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. N Engl J Med. 2019;380:617-28.
[4] Arnold M, et al. Current and future burden of breast cancer: Global statistics for 2020 and 2040. Breast. 2022;66:15-23.
[5] American Cancer Society. Breast cancer HER2 status [Internet; cited December 2023]. Available from: https://www.cancer.org/cancer/types/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-her2-status.html.
[6] Scharl A, et al. The Right Treatment for the Right Patient – Personalised Treatment of Breast Cancer. Geburtshilfe Frauenheilkd. 2015;75(7):683–91.
[7] Jorge Dino Cossetti R, et al. Comparison of breast cancer recurrence and outcome patterns between patients treated in 1986-1992 and 2004-2008. Journal of Clinical Oncology. 2014;32(15):521.
[8] Dieci MV, et al. Biomarkers for HER2-positive metastatic breast cancer: Beyond hormone receptors. Cancer Treat Rev. 2020;88:102064.
[9] Clinical trials.gov. A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) [Internet; cited December 2023]. Available from: https://clinicaltrials.gov/study/NCT01772472.
[10] Cortazar P, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014;384(9938):164-72.
[11] Verma S, et al. Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer. N Engl J Med. 2012;367(19):1783-91.
[12] National Comprehensive Cancer Network (NCCN) Breast Cancer Guidelines – Version 4.2023 [Internet; cited December 2023]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.
[13] Denduluri N, et al. Selection of optimal adjuvant chemotherapy and targeted therapy for early breast cancer: ASCO Guideline Update. J Clin Oncol. 2021;39(6):685-93.
[14] Swain S, et al. Targeting HER2-positive breast cancer: advances and future directions. Nat Rev Drug Discov. 2023;22:101-26.
[15] Schmid P, et al. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2018;379:2108-21.
Media Contacts:
Media Relations:
Phone: +41 61 688 8888
e-mail: media.relations@roche.com
SOURCE: ROCHE
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- EIC, the World’s Largest Multinational Innovation Program, to Invest €13.4M in Wi-Charge, a Game Changing Wireless Power Company
- European Weightlifting Federation on its way for Electoral Congress
- “Without women, We are unable to solve the world’s greatest challenges” — She Loves Tech 12 Hot Finalists ready to get their chance at the Local Pitch in South Europe!
- Significant improvement in increasing Time In Range and reducing hypoglycemia among people equipped with Diabeloop DBLG1
- Digi Communications N.V. Announces the Convocation of the Company’s Extraordinary General Meeting of Shareholders on 4 November 2021 in order to appoint KPMG N.V. as the Company’s new statutory auditor for the financial year 2021
- Unit of Measure enters partnership with Stibo Systems
- Haizol, metal manufacturing giant, launch a brand new website which is both user friendly and interactive
- Groundbreaking Immersive Experience from Samsung and Artist Michael Murphy Reveals a New Perspective for Visual Entertainment Through the Stunningly Slim Neo QLED TV
- Collaboration between Airbus and Neural Concept
- Archpriest Nikolay Balashov on Patriarch Bartholomew’s speeches in Kiev
- ABB's Peter Voser joins Xynteo's Europe Delivers partnership as it new Chairman
- Digi Communications NV announces that a new stock option programme was approved
- Leverage the benefits of digital manufacturing with Haizol
- Digi Communications NV announces the release of the H1 2021 Financial Results
- Digi Communications NV announces Investors Call on the Financial Results for H1 2021
- Rockegitarist-Sensasjon Rocky Kramer Har Fått Hovedrollen I Mutt Productions Filmen Rockin’ In Time
- Dispatch.d Offers Unique US Market Entry Services for European Impact Brands
- CSA Research’s New Localization Intelligence Analyzer, powered by LocHub, Helps Organizations Improve their Website’s Effectiveness for Global Customers
- Customer Data Platform Industry Accelerated During Pandemic: CDP Institute Report
- Digi Communications N.V. announces that two of its subsidiaries entered into two facility agreements
- Introducing Cap Expand Partners, Helping Business Leaders Break International Barriers
- Hong Kong’s Innovation and Technology Venture Fund Becomes Strategic Financial Investor of Ignatica
- Cure for prostate cancer on the horizon
- Fanpictor signs multi-year partnership with Royal Belgian Football Association
- Fanpictor unterzeichnet mehrjährige Partnerschaft mit dem Königlich Belgischen Fussballverband
- Fanpictor signe un partenariat pluriannuel avec la Royal Belgian Football Association
- Fanpictor firma una colaboración de varios años con la Real Federación Belga de Fútbol
- Fanpictor firma una partnership pluriennale con la Royal Belgian Football Association
- Fanpictor tekent meerjarige partnership met Koninklijke Belgische Voetbalbond
- Launch of the New Akenza Platform
- De zelflerende algoritme DBLG1®: eenvoudig te gebruiken voor een optimale en gepersonaliseerde behandeling van diabetes type 1
- Launch of the Anna Lindh Foundation Virtual Marathon for Dialogue!
- Digi Communications N.V. announces the exercise of stock options by the Executive Director of the Company pursuant to the decision of the Company’s general meeting of shareholders dated 30 April 2020 and in accordance with the stock option plan approved at the level of the Company in 2017
- New research unlocks long tail growth opportunity for the tech industry
- Digi Communications NV announces the availability of the instructions on the 2020 share dividend payment
- Digi Communications NV announces that conditional stock options were granted to several Directors of the Company based on the approval of the general meeting of shareholders from 18 May 2021
- Digi Communications N.V. Announces the Company’s General Shareholders Meeting resolutions adopted on 18 May 2021 approving, amongst others, the 2020 Annual Accounts
- Digi Communications N.V. (“Digi”) announces the Q1 2021 Financial results
- Digi Communications NV announces Investors Call for the Q1 2021 Financial Results
- Digi Communications N.V. announces an Amendment to the 2021 Financial Calendar
- Fastpayhotels Hits an Industry Milestone by Connecting 500 Hotels Per Day Through DerbySoft Technology
- 4 ways to build a more flexible supply chain
- Join the world's leading virtual CBD event for FREE
- DEEPENING STRATEGIC RELATIONSHIP BETWEEN UBC AND PIONEERING DECENTRALISED PLATFORM, MANYONE
- Mono Solutions recognizes Norwegian small business agency with best website 2021 award
- Mono Solutions and Xrysos Odigos unlock new opportunities for small businesses
- Behind the scenes of a 10,000-people online conference: creating a live-event atmosphere and leveraging cybersecurity software
- Largest Supply Chain for Face masks, FFP2, FFP3 and cloth masks
- TRANSMAR AND TRANSMETRICS SIGN DEAL FOR STATE-OF-THE-ART LOGISTICS COLLABORATION
- Amendment of Digi Communications N.V. Financial Calendar for 2021
- 4iG and Digi Communications NV’s Romanian subsidiary have entered into a term sheet with regards to a potential acquisition by 4iG of DIGI Group’s Hungarian operations
- “Building Healthy Relationships and Enhancing Gender Equality”: Young women from Cyprus, Egypt, Lebanon and Jordan come together
- Bring Ventures investit dans Crossborderit (CBIT), DDP et une solution de commerce électronique
- Bring Ventures investiert in Crossborderit (CBIT), eine DDP (geliefert verzollt) und E-Commerce Lösung
- Bring Ventures invests in Crossborderit (CBIT), DDP and ecommerce solution
- Lionspeed GP with Patrick Kolb and Lorenzo Rocco joins forces with CarCollection Motorsport in 2021
- Eurekos, ein klassenbester LMS-Anbieter, hat seine Position im renommierten Fosway 9-Grid™ für Lernsysteme verbessert
- Eurekos, en førsteklasses LMS-udbyder, har forstærket sin position på den prestigefyldte Fosway 9-Grid™ for læringssystemer
- Eurekos, ein erstklassiger LMS-Anbieter, hat seine Position auf dem renommierten Fosway 9-Grid™ für Lernsysteme weiter ausgebaut
- Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
GreenMantra Technologies Announces Exclusive Distribution Relationship with HARKE GROUP
- Digi Communications N.V.: Announces an Amendment to the Financial Calendar for 2021
- Ideanomics Invests $13M in Italian EV Motorcycle Company, Energica
- DigiSky and Asman Technology Announce Global Reseller Agreement
- Neowintech - O Marketplace Da Sua Próxima Solução Financeira
- Neowintech - Il Marketplace per la tua prossima soluzione finanziaria
- PIONEERING DECENTRALISED SECURE MESSAGING PLATFORM MANYONE ANNOUNCES STRATEGIC RELATIONSHIP WITH UNIVERSITY COLLEGE LONDON CENTRE BLOCKCHAIN TECHNOLOGY
- Digi Communications NV announces the release of the 2020 Preliminary Financial Results
- Fraunhofer IGD develops automated robotic arm to scan cultural objects in 3D, now cooperating with Phase One
- Adapt Fast or Disappear – Choosing the Right Supplier
- Digi Communications NV announces Investors Call for the 2020 Preliminary Financial Results
- A URSAPHARM Arzneimittel e a CEBINA anunciam uma parceria com vista a reaproveitar o anti-histamínico azelastina para combater a COVID-19
- URSAPHARM Arzneimittel et CEBINA annoncent un partenariat pour reconvertir l'antihistaminique azélastine afin de lutter contre la COVID-19
- URSAPHARM Arzneimittel y CEBINA anuncian una colaboración para readaptar el antihistamínico azelastine para combatir la COVID-19
- URSAPHARM Arzneimittel and CEBINA announce partnership to repurpose the antihistamine azelastine to combat COVID-19
- ANIL UZUN Will Launch Bass Guitar Lessons Series on Youtube
- Henrik Stampe Appointed CEO for Mono Solutions
- Anna Mossberg leder Nordens största privata AI-lab i Sverige: "Utan AI riskerar svenska företag att förlora sin konkurrensfördel."
- What COVID-19 has taught us about manufacturing & the importance of a digital online marketplace
- Digi Communications N.V. announces: the Supreme Court of Hungary dismissed the Company’s appeal related to the 5G Tender procedure
- Customer Data Platform Industry to Reach $1.5 Billion in 2021: CDP Institute Report
- Editor's pick archive....