Efficacy and safety of brodalumab in patients with psoriasis who had inadequate responses to ustekinumab: subgroup analysis of two randomized phase III trials

2018 ◽  
Vol 180 (2) ◽  
pp. 306-314 ◽  
Author(s):  
R.G. Langley ◽  
A.W. Armstrong ◽  
M.G. Lebwohl ◽  
A. Blauvelt ◽  
S. Hsu ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Phase Iii Trials

scholarly journals Efficacy and Safety of Moxifloxacin in Hospitalized Patients with Secondary Peritonitis: Pooled Analysis of Four Randomized Phase III Trials

2014 ◽  
Vol 15 (5) ◽  
pp. 567-575 ◽  
Author(s):  
Jan J. De Waele ◽  
Jose M. Tellado ◽  
Günter Weiss ◽  
Jeffrey Alder ◽  
Frank Kruesmann ◽  
...  
Keyword(s):  
Pooled Analysis ◽  
Hospitalized Patients ◽  
Secondary Peritonitis ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Phase Iii Trials

The efficacy and safety of mirabegron in treating OAB: a systematic review and meta-analysis of phase III trials

2013 ◽  
Vol 46 (1) ◽  
pp. 275-284 ◽  
Author(s):  
Yuanshan Cui ◽  
Huantao Zong ◽  
Chenchen Yang ◽  
Huilei Yan ◽  
Yong Zhang
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Phase Iii Trials

Phase Ib study of sintilimab in combination with chemotherapy for 1L advanced or metastatic non-small cell lung cancer (NSCLC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20546-e20546 ◽  
Author(s):  
Nong Xu ◽  
Kejing Ying ◽  
Ziping Wang ◽  
Yunpeng Liu ◽  
Haiping Jiang ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Primary Objective ◽  
Phase Iii ◽  
Egfr Mutations ◽  
Efficacy And Safety ◽  
Two Phase ◽  
Phase Ib ◽  
Biomarker Analysis ◽  
Phase Iii Trials ◽  
Treatment Naïve

e20546 Background: Anti-programmed death-1 antibodies (PD-1 Abs) have shown benefits in advanced NSCLC. The efficacy and safety of sintilimab, a PD-1 Ab, in combination with chemotherapy for 1L NSCLC is evaluated in this phase Ib study (NCT02937116). Methods: The study enrolled treatment-naïve unresectable locally advanced or metastatic non-squamous (nsq-) and squamous (sq-) NSCLC patients with neither EGFR mutations nor ALK rearrangements in cohort D and E respectively. Patients received sintilimab 200mg IV q3w in combination with pemetrexed 500mg/m2 and cisplatin 75mg/m2 IV q3w (4 cycles) in cohort D, or gemcitabine 1250mg/m2 D1,8 and cisplatin 75mg/m2 D1 IV q3W (6 cycles) in cohort E until disease progression, unacceptable toxicity or death. The primary objective was to evaluate the efficacy and safety of the combination. Results: As data cutoff (15 Jan 2019), 21 and 20 patients were enrolled in cohort D and E respectively. ORR in nsq- and sq-NSCLC were 68.4% (95%CI, 43.4 to 87.4) and 64.7% (95%CI, 38.3 to 85.8) respectively based on data of 19 and 17 patients with at least one radiological assessment. Median PFS was 11.4 months (95%CI, 3.1 to NA) and 6.5 months (95%CI, 5.3 to 8.0) respectively (Table). Totally 38 (92.7%) patients experienced at least one treatment emergent adverse event (TEAE). Treatment-related AEs (TRAEs) occurred in 28 (68.3%) patients. TRAE ≥grade 3 occurred in 4 (9.8%) patients. Immune related AEs occurred in 10 patients (24.4%), the most common of which were skin rash (N = 5), pneumonitis (N = 3) and hypothyroidism (N = 2). There was no AEs leading to death. The biomarker analysis was ongoing. Conclusions: The combination of sintilimab and chemotherapy showed efficacy with an acceptable safety profile in 1L nsq- and sq-NSCLC. Two phase III trials are ongoing to evaluate the combination in 1L nsq- (NCT03607539) and sq-NSCLC (NCT03629925) respectively. Clinical trial information: NCT02937116. [Table: see text]

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