F. Hoffmann-La Roche Ltd - Roche's Kadcyla cut the risk of disease recurring by half compared to Herceptin in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment

F. Hoffmann-La Roche Ltd / Roche's Kadcyla cut the risk of disease recurring by half compared to Herceptin in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

At three years, 88.3% of people treated with Kadcyla in the adjuvant HER2-positive early breast cancer setting did not have their breast cancer return compared to 77.0% treated with Herceptin, an 11.3% improvement People who have residual disease after neoadjuvant treatment have a worse prognosis than those with no detectable disease Data from the phase III KATHERINE study will be submitted to health authorities globally, including the US Food and Drug Administration and European Medicines Agency Results are being presented at the 2018 San Antonio Breast Cancer Symposium, featured in the press programme and simultaneously published in the New England Journal of Medicine on Wednesday, 5 December 2018 Basel, 5 December 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III KATHERINE study met its primary endpoint, showing Kadcyla® (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival; iDFS) by 50% (HR=0.50, 95% CI 0.39-0.64, p=3 AEs Thrombocytopenia (decreased platelet count) 5.7% 0.3% Hypertension (high blood pressure) 2.0% 1.2% Radiation-induced skin injury 1.4% 1.0% Peripheral neuropathy (numbness, tingling or pain in the hands or feet) 1.4% 0.0% Neutropenia (decreased neutrophil count) 1.2% 0.7% Hypokalaemia (low blood potassium level) 1.2% 0.1% Fatigue 1.1% 0.1% Anaemia (decrease in red blood cells) 1.1% 0.1% 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. [2;3] 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. [10] Kadcyla is the only ADC approved as a single agent in 104 countries including the US and EU for the treatment of people with HER2-positive metastatic breast cancer who have previously received Herceptin and taxane chemotherapy, separately or in combination. 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 and advanced HER2-positive disease. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 15-20% of patients. [11] Roche has developed three innovative medicines that have helped transform the treatment of HER2-positive breast cancer: Herceptin (trastuzumab), Perjeta (pertuzumab) and Kadcyla (trastuzumab emtansine). 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 Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare - a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the tenth consecutive year, Roche has been recognised as the most sustainable company in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. 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] Geyer, et al. KATHERINE trial. Presented at SABCS; 2018 Dec 4-8; San Antonio, TX, USA. Abstract #GS1-10. [2] Hurvitz SA, et al. J Clin Oncol. 2013;31(9):1157-63. [3] Verma S, et al. N Engl J Med. 2012;367(19):1783-91. [4] Scharl A, et al. Geburtshilfe Frauenheilkd. 2015;75(7):683-91. [5] Johns Hopkins. Neoadjuvant and Adjuvant Chemotherapy. [Internet; cited 2018 November 29]. Available from: http://www.hopkinsmedicine.org/breast_center/ treatments_services/medical_oncology/ neoadjuvant_adjuvant_chemotherapy.html. [6] Slamon D, et al. BCIRG 006 trial. Presented at: SABCS; 2015 Dec 6-10; San Antonio, TX, USA. Abstract #S5-04. [7] Abt NB, et al. JAMA Surg. 2014;149(10):1068-76. [8] Kaufmann M, et al. Ann Surg Oncol. 2012;19(5):1508-16. [9] ClinicalTrials.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 2018 November 29]. Available from: https://clinicaltrials.gov/ct2/show/NCT01772472. [10] Junttila TT, et al. Breast Cancer Res Treat. 2011;128:347-56. [11] Wolff AC, et al. J Clin Oncol. 2013;31(31):3997-4013. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com - Nicolas Dunant (Head) - Patrick Barth - Ulrike Engels-Lange - Simone Oeschger - Anja von Treskow

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