PPT-Overall survival and safety experience from an expanded access program (EAP) of nivolumab

Milton Barros e Silva 1 Rafael Schmerling 2 Andreia Cristina de Melo 3 Sergio Azevedo 4 Bernardo Garicochea 5 Elaine McWhirter 6 Michael Smylie 7 Markus Gifoni 8 Carlos Henrique dos Anjos. the Spectrum of Lung Cancer. Karen Kelly, MD. Professor of Medicine. Associate Director for Clinical Research. Jennifer Rene Harmon Tegley and Elizabeth Erica Harmon. Endowed Chair in Cancer Clinical Research. HRACC. November 2014. Orlene Allen Weyland, M.A.,CEAP. Principal, Gallops Consulting. Gallops Consulting . 1. Objectives. 2. Trends and Facts. History and Evolution of EAP. . Selecting and Evaluation your EAP. draft-wu-hokey-rfc5296bis-01. . Yang Shi (young@h3c.com). Qin Wu (sunseawq@huawei.com). Zhen Cao (. zehn.cao@gmail.com. ). Baohong He (hebaohong@catr.cn). Status. Presented in IETF 78, Masstricht, adopted as work item after IETF 78. •low-pro�le •windowboxfor •saddle • Trunnion Accessories ROTARY COMPATIBILITY PLATE PTA25 PLATE CTA25 PLATE NO NO Overall NO NO Overall Overall NO Overall NO eventsof. . nivolumab. and . docetaxel. in the . CheckMate. 017 and . CheckMate. 057 phase III NSCLC trials. . Kartik. . Venkatachalam. Intervista a Cesare . Gridelli. Background: Nivo, a PD-1 antibody, received FDA approval based on superior overall survival in metastatic squamous (SQ) and non-squamous (NSQ) NSCLC patients who have progressed on or after platinum-based doublet chemotherapy. The purpose of this study was to assess the frequency and associated costs of grade 2–4 AEs in the CheckMate 017 (SQ) and CheckMate 057 (NSQ) phase III pivotal trials of nivo vs doc in stage IIIB/IV NSCLC. Methods: Patient-level data from these two trials were utilized to estimate the frequency of TRAEs requiring management in the nivo and doc arms, including serious and non-serious TRAEs. Minimum follow-up for AE reporting at database lock was 12 months. Grade 3–4 AE costs by event were identified from Healthcare Cost and Utilization Project (HCUP) data in 2010, which were adjusted to reflect 2012-equivalent US costs. Healthcare utilization associated with grade 2 AEs was based on clinical opinion and costs were based on HCUP or other sources as appropriate. Results: In both trials, more TRAEs were observed with doc than with nivo (Table), and the cost of managing TRAEs was 15.8 and 10.7 times higher in the doc arm vs the nivo arm for the CheckMate 017 and CheckMate 057 trials, respectively. Patients in the doc arm incurred an additional $6,585 and $5,422 per patient in managing AEs compared with patients in the nivo arm in the above two trials, respectively. The total estimated costs of managing TRAEs during these trials are presented in the Table. Conclusions: Large estimated differences in costs were observed in managing TRAEs, favoring nivo in the CheckMate 017 and CheckMate 057 pivotal trials. The reduction in costs for managing AEs with the use of nivo should be considered when assessing the value of nivo in this patient population.. CenCal PDS. Fall 2014 . Carolina Cardenas. Director, Academic Outreach & Early Assessment. ccardenas@calstate.edu. (562) 951-4724. Smarter Balanced & CAASPP. Smarter Balanced Assessment Consortia developed the assessments to be used by member states.. Critical Thinking. Jones, A. (2009) ‘. Redisciplining. generic attributes: the disciplinary context in focus’, . Studies in Higher Education. , 34(1), pp. 85-100. .. Davies, M. (2015) ‘A model of critical thinking in Higher Education’, . F.A.C.P. .. Head, Immunotherapy Section. Chief, Genitourinary Malignancies Branch . & Director, Medical Oncology Service. Center. for Cancer Research. National Cancer Institute, NIH . NIH Building 10: Immunotherapy & Prostate Cancer. Program Goals. Incidence of RCC in the United States. Survival. Current Treatment. Toxicities to Treatment. IL-2: Function. Challenges in Clinical Outcome With Targeted Drugs. Nivolumab. Mechanism of Action. in COFUND . ERANETs & JPIs . Yannis Kechagiaras. Project Manager, CeRISS . The projects BLACK SEA HORIZON & IncoNet EaP have received funding from Horizon 2020 & FP7, the EU Framework . Programmes. binnen en . tusken. teksten. Reitze Jonkman. Lektoraat . Frysk. & . Meartaligens. . Kolleezje. 13 . juny. 2017. Twa. . leardoelen. fan . dit. . kolleezje. :. Oan. . de . ein. . kensto. Associate Professor Philip Beale. Chair ANZGOG Clinical Trials Group. Medical Oncologist Sydney. Concord Hospital. Chris O’Brien Lifehouse. Royal Prince Alfred Hospital. Outline. Background to immunotherapy. in patients with Advanced . Squamous. (SQ) or Non-. Squamous. (NSQ) Non-Small Cell Lung Cancer (NSCLC). Intervista a Lucio . Crinò. Background:. . Programmed death 1 (PD-1) is an immune checkpoint that suppresses antitumor immunity. Nivolumab (ONO-4538, BMS-936558), a fully human IgG4, anti-PD-1 antibody, has shown durable clinical activity in previous phase I and II trials in several tumor types. In March 2015, U.S. Food and Drug Administration (FDA) has approved Nivolumab injection for the treatment of patients with metastatic squamous (SQ) non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Here, we report the results of two phase II studies to evaluate the efficacy and safety of nivolumab in previously treated advanced SQ (JapicCTI-No.132072) and NSQ (JapicCTI-No.132073) NSCLC pts in Japan. . Community College District . . Claremont EAP. Laurie Slez, VP Account Services. 800-834-3773. www.claremonteap.com. 2. Claremont EAP Background. Has been dedicated to providing EAP services for Bay Area employers for 20 years.