Roche's Tecentriq in combination with Abraxane improves outcomes as an initial treatment for people with PD-L1-positive metastatic triple-negative breast cancer
Basel, 20 October 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the Phase III IMpassion130 study of Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [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:
Novartis investigational BYL719 (alpelisib) plus fulvestrant nearly doubles median PFS in patients with PIK3CA mutated HR+/HER2- advanced breast cancer compared to fulvestrant alone
Basel, October 20, 2018 - Novartis today announced positive results from the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) in combination with fulvestrant. The trial evaluated the efficacy and safety of alpelisib in postmenopausal women with PIK3CA mutated hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer that progressed on or after an aromatase inhibitor with or without a CDK4/6 inhibitor. These data will be presented today at the official press briefing at the European Society for Medical Oncology (ESMO) 2018 Congress and as a late-breaker during the Presidential Symposium (Abstract LBA3_PR).
SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Cronos Group Inc. of Class Action Lawsuit and Upcoming Deadline – CRON
NEW YORK, Oct. 19, 2018 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Cronos Group Inc. (“Cronos” or the “Company”) (NASDAQ: CRON) and certain of its officers. The class action, filed in United States District Court, Southern District of New York, and index under 18-cv-08406, is on behalf of a class consisting of all persons other than Defendants who purchased or otherwise acquired Cronos securities between August 21, 2018 and August 30, 2018, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
TORONTO, Oct. 19, 2018 (GLOBE NEWSWIRE) -- Mount Logan Capital Inc. (formerly Marret Resource Corp.) (NEO:MAR) (“Marret” or the “Company”) is pleased to announce that it has completed its previously announced arrangement (the “Arrangement”) under the provisions of the Business Corporations Act (Ontario), pursuant to which, among other things:
SHAREHOLDER ALERT: Rigrodsky & Long, P.A. Announces A Securities Fraud Class Action Lawsuit Has Been Filed Against Applied Optoelectronics, Inc.
WILMINGTON, Del., Oct. 19, 2018 (GLOBE NEWSWIRE) -- Rigrodsky & Long, P.A.:
SHAREHOLDER ALERT: Rigrodsky & Long, P.A. Announces A Securities Fraud Class Action Lawsuit Has Been Filed Against Chegg, Inc.
WILMINGTON, Del., Oct. 19, 2018 (GLOBE NEWSWIRE) -- Rigrodsky & Long, P.A.:
NEW YORK, Oct. 19, 2018 (GLOBE NEWSWIRE) -- Niu Technologies (Nasdaq: NIU), the world's leading provider of smart urban mobility solutions, visited the Nasdaq MarketSite in Times Square today in celebration of its initial public offering (IPO) on The Nasdaq Stock Market.
BCB Bancorp, Inc. Earnings increase 43 Percent to $4.6 Million in the Third Quarter of 2018; Declares Quarterly Cash Dividend of $0.14 Per Share
BAYONNE, N.J., Oct. 19, 2018 (GLOBE NEWSWIRE) -- BCB Bancorp, Inc. (the “Company”), Bayonne, NJ (NASDAQ: BCBP), the holding company for BCB Community Bank (the “Bank”), today reported net income increased $1.4 million, or 42.8 percent to $4.6 million, or $0.27 per diluted share, in the third quarter of 2018, compared to $3.2 million, or $0.25 per diluted share, in the third quarter of 2017. In the second quarter of 2018, net income was $2.3 million, or $0.13 per diluted share, with $2.0 million of acquisition-related expenses.
LAS VEGAS, NV, Oct. 19, 2018 (GLOBE NEWSWIRE) -- MJ Holdings Inc. (OTC: MJNE) (“MJNE” or “Company”), a fast growing Nevada cannabis company is being featured at the first ever cannabis conference in the state of Utah. MJ Holdings CEO Paris Balaouras will speak at the conference along with many other top cannabis executives.
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