F. Hoffmann-La Roche Ltd / Roche's Tecentriq in combination with Abraxane improves outcomes as an initial treatment for people with PD-L1-positive metastatic triple-negative breast cancer . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement. -- Tecentriq combination first immunotherapy regimen to demonstrate positive Phase III results in breast cancer -- Tecentriq and nab-paclitaxel significantly reduced the risk of disease worsening or death in both the intention-to-treat and PD-L1-positive populations -- Clinically meaningful overall survival improvement in the PD-L1-positive population at this interim analysis -- Data are being presented at the European Society for Medical Oncology (ESMO) 2018 Congress, featured in the press programme and simultaneously published in the New England Journal of Medicine on 20 October 2018 Basel, 20 October 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the Phase III IMpassion130 study of Tecentriq(R) (atezolizumab) plus chemotherapy (Abraxane(R) [albumin-bound paclitaxel; nab-paclitaxel]) for the initial (first-line) treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). The Tecentriq and chemotherapy combination significantly reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone in all randomised patients (intention-to-treat [ITT]) (median PFS=7.2 vs. 5.5 months; hazard ratio [HR]=0.80, 95% CI: 0.69-0.92, p=0.0025) and the PD-L1-positive population (median PFS=7.5 vs. 5.0 months; HR=0.62, 95% CI: 0.49-0.78, p<0.0001), a subgroup determined by PD-L1 biomarker testing. At this interim analysis, statistical significance was not met for overall survival (OS) in the ITT population (median OS=21.3 vs 17.6 months; HR=0.84, 95% CI: 0.69-1.02, p=0.0840), but showed a clinically meaningful 9.5-month OS improvement in the PD-L1-positive population (median OS=25.0 vs 15.5 months; HR=0.62, 95% CI: 0.45-0.86). Due to the hierarchical statistical design, results in the PD- L1 - positive population were not formally tested. Follow-up will continue until the next planned analysis. Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. "These important results in people with metastatic triple-negative breast cancer whose disease expresses the PD-L1 protein are highly encouraging and represent a significant step forward in the treatment of this challenging disease," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "We have shared the IMpassion130 results with global health authorities with the hope of bringing this Tecentriq combination to people with PD-L1- positive, metastatic triple-negative breast cancer as soon as possible." These data are being presented today at the European Society for Medical Oncology (ESMO) 2018 Congress Presidential Symposium at 16:30 - 16.45 pm CEST (abstract LBA1_PR) and will also be featured in the official ESMO press programme at 08:15 -09:00 am CEST. These results will simultaneously be published in the New England Journal of Medicine. Currently, Roche has seven ongoing Phase III studies investigating Tecentriq in TNBC, including early and advanced stages of the disease. About the IMpassion130 study The IMpassion130 study is a Phase III, multicentre, randomised, double-blind study evaluating the efficacy, safety, and pharmacokinetics of Tecentriq plus nab-paclitaxel compared with placebo plus nab-paclitaxel in people with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer (mBC). The study enrolled 902 people who were randomised equally (1:1). The co-primary endpoints are PFS per investigator assessment (RECIST 1.1) and OS. PFS and OS were assessed in all randomised patients (ITT) and in the PD-L1-positive population. Secondary endpoints include objective response rate (ORR), duration of response and time to deterioration in Global Health Status/Health-Related Quality of Life. A summary of the key study results is included below: PD-L1-positive population ITT population (programmed death-ligand 1 expression >=1% on IC) (intention-to-treat) Placebo + Placebo + Tecentriq + nab-paclitaxel nab-paclitaxel Tecentriq + nab-paclitaxel nab-paclitaxel n=185 n=184 n=451 n=451 Number of patients 369 (40.9%) 902 PFS (co-primary endpoint) Median (months) 7.5 5.0 7.2 5.5 (95% CI) (6.7, 9.2) (3.8, 5.6) (5.6, 7.5) (5.3, 5.6) Stratified HR (95% CI) 0.62 (0.49,0.78) 0.80 (0.69,0.92) Stratified p-value<0.0001 0.0025 OS (co-primary endpoint) Median (months) 25.0 15.5 21.3 17.6 (95% CI) (22.6, NE) (13.1, 19.4) (17.3, 23.4) (15.9, 20.0) Stratified HR (95% CI) 0.62 (0.45,0.86) 0.84 (0.69,1.02) Stratified p-value Results were not formally tested 0.0840 ORR (secondary endpoint) Responders 59% 43% 56% 46% 95% CI 51%, 66% 35%, 50% 51%, 61% 41%, 51% Stratified 0.0016 0.0021 p-value Not significant (alpha=0.001) Not significant (alpha=0.001) Adverse events The nature and incidence of severe adverse events (SAEs) and Grade 3-4 adverse events (AEs) were consistent with the known safety profile of the individual study drugs or the underlying disease. -- SAEs were reported in 23% of people receiving Tecentriq plus nab-paclitaxel compared to 18% of people receiving chemotherapy alone. SAEs occurring in 1% or more of people receiving Tecentriq plus nab-paclitaxel were pneumonia (2%), urinary tract infection (1%), difficulty breathing (dyspnea, 1%) and fever (pyrexia, 1%). -- Grade 3-4 AEs were reported in 49% of people receiving Tecentriq plus nab-paclitaxel compared to 42% of people receiving chemotherapy alone. The most common Grade 3-4 AEs in people receiving Tecentriq plus nab-paclitaxel were an abnormal low count of a certain type of white blood cell (neutropenia, 8%); decreased neutrophil count (5%); numbness, tingling or pain in the hands or feet (peripheral neuropathy, 6%); fatigue (4%); and decrease in red blood cells (anaemia, 3%). Peripheral neuropathy was the only Grade 3-4 AE reported with a 2% or higher incidence in people receiving Tecentriq plus nab-paclitaxel compared to people receiving chemotherapy alone (6% vs. 3%). Multimedia assets : https://www.roche.com/dam/jcr:83655b86-48ca-4a3c-93e4-ebcb28568307/en/breast-cancer-tnbc.pdf https://www.roche.com/dam/jcr:d42b5b04-64b1-4b26-a4a8-29d85d06c20f/en/the-unmet-need.mp4 Learn more about triple-negative breast cancer, which Professor Peter Schmid discusses the unmet need in affects 15% of all breast cancer cases: https://www.roche.com/dam/jcr:83655b86-48ca-4a3c-93e4-ebcb28568307/en/breast-cancer-tnbc.pdf triple-negative breast cancer https://www.roche.com/dam/jcr:d42b5b04-64b1-4b26-a4a8-29d85d06c20f/en/the-unmet-need.mp4 https://www.roche.com/dam/jcr:8762997f-5579-40f9-b7cc-e680cd81cec6/en/overview-IMpassion130.mp4 https://www.roche.com/dam/jcr:fae35beb-9d14-437e-8f67-3535697e59a6/en/the-IMpassion130-design.mp4 Professor Peter Schmid provides an overview of the Professor Peter Schmid describes the IMpassion130 IMpassion130 study results https://www.roche.com/dam/jcr:8762997f-5579-40f9-b7cc-e680cd81cec6/en/overview-IMpassion130.mp4 study design https://www.roche.com/dam/jcr:fae35beb-9d14-437e-8f67-3535697e59a6/en/the-IMpassion130-design.mp4 About triple-negative breast cancer Breast cancer is the most common cancer among women with more than 2 million diagnosed worldwide each year.[1] TNBC represents approximately 15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer.[2; 3] It is defined by the lack of expression and/or amplification of the targetable receptors for oestrogen, progesterone and HER2 amplification.[4;5] Patients with metastatic TNBC generally experience rapid progression and shorter OS compared to other subtypes of breast cancer.[6] About Tecentriq Tecentriq is a monoclonal antibody designed to bind with a protein
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