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]

Efficacy and safety of xaliproden in amyotrophic lateral sclerosis: results of two phase III trials

2004 ◽  
Vol 5 (2) ◽  
pp. 107-117 ◽  
Author(s):  
Vincent Meininger ◽  
Gilbert Bensimon ◽  
Walter G Bradley ◽  
Benjamin R Brooks ◽  
Patrice Douillet ◽  
...  
Keyword(s):  
Amyotrophic Lateral Sclerosis ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Two Phase ◽  
Phase Iii Trials ◽  
Lateral Sclerosis

Abstract #999926: Effect of Dosing and Titration of Osilodrostat on Efficacy and Safety in Patients With Cushing's Disease (CD): Results From Two Phase III Trials (LINC3 and LINC4)

2021 ◽  
Vol 27 (6) ◽  
pp. S112
Author(s):  
Maria Fleseriu ◽  
Richard J. Auchus ◽  
Peter J. Snyder ◽  
André Lacroix ◽  
Anthony P. Heaney ◽  
...  
Keyword(s):  
Cushing’S Disease ◽  
Phase Iii ◽  
Cushing's Disease ◽  
Efficacy And Safety ◽  
Two Phase ◽  
Phase Iii Trials

Early clearance of plasma EGFR mutations as a predictor of response to osimertinib and comparator EGFR-TKIs in the FLAURA trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9020-9020 ◽  
Author(s):  
Caicun Zhou ◽  
Fumio Imamura ◽  
Ying Cheng ◽  
Isamu Okamoto ◽  
Byoung Chul Cho ◽  
...  
Keyword(s):  
Egfr Mutation ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Digital Pcr ◽  
Phase Iii ◽  
Egfr Mutations ◽  
Treatment Naïve ◽  
To Receive ◽  
Egfr Tki ◽  
Egfr Tkis

9020 Background: In the Phase III FLAURA trial (NCT02296125), osimertinib, a third generation EGFR-TKI, showed superior efficacy to comparator EGFR-TKIs as first line treatment for EGFR mutation-positive (EGFRm) advanced NSCLC. In an exploratory analysis, we investigated clinical outcomes associated with detection of plasma EGFRm at 3 or 6 weeks (wks) after start of treatment. Methods: Treatment-naïve patients (pts) with EGFRm (ex19del or L858R) locally advanced or metastatic NSCLC were randomized 1:1 to receive osimertinib 80 mg once daily (QD) or comparator EGFR-TKIs (gefitinib 250 mg QD or erlotinib 150 mg QD). Plasma EGFR mutation analysis was conducted at baseline (BL), wks 3 and 6 by droplet digital PCR. Clearance was defined as undetectable levels of EGFRm in ctDNA at wks 3/6, where they were detectable at BL. Progression-free survival (PFS) was investigated based on early clearance of EGFRm. Results: In total 489/556 (88%) pts (osimertinib: 244/279; comparator: 245/277) had evaluable ctDNA at BL and wks 3/6. Of these, 342/489 (70%; osimertinib: 168/244; comparator: 174/245) had detectable BL EGFRm and were included in this analysis. See table. Conclusions: Clearance of plasma EGFRm after 3/6 wks of EGFR-TKI therapy was associated with a numerical improvement in PFS. The efficacy of osimertinib was superior to comparator EGFR-TKIs regardless of clearance status. Clinical trial information: NCT02296125. [Table: see text]

Efficacy and safety of sintilimab in combination with XELOX in first-line gastric or gastroesophageal junction carcinoma (GC/GEJC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4042-4042
Author(s):  
Nong Xu ◽  
Lin Shen ◽  
Haiping Jiang ◽  
Yulong Zheng ◽  
Jiong Qian ◽  
...  
Keyword(s):  
Checkpoint Inhibitors ◽  
Gastroesophageal Junction ◽  
Objective Response ◽  
Locally Advanced ◽  
Primary Objective ◽  
Efficacy And Safety ◽  
First Line ◽  
Biomarker Analysis ◽  
Phase 1B

4042 Background: Immune checkpoint inhibitors have shown clinical benefit in advanced GC/GEJC. This phase 1b study evaluates the efficacy and safety of sintilimab, an anti-programmed cell death-1 antibody (PD-1 Ab) in combination with XELOX for GC/GEJC in first-line setting. Methods: This phase 1b study enrolled treatment-naïve unresectable locally advanced or metastatic GC/GEJC patients without HER2 amplification in cohort F. Patients received sintilimab 200mg IV q3w until disease progression, unacceptable toxicity or death, in combination with XELOX regimen (oxaliplatin 130mg/m2 IV D1 and capecitabine 1000mg/m2 PO BID D1-14) for up to 6 cycles. The primary objective was to evaluate the efficacy of the combination per RECIST v1.1 and safety and tolerability. Results: Totally 20 patients were enrolled in cohort F. As data cutoff (15 Jan 2019), median follow up was 5.8 months (range, 2.4 to 12.5). The median dose of sintilimab was 6.5 (range, 4 to 12). The objective response rate (ORR) was 85.0% (95%CI, 62.1 to 96.8) and disease control rate (DCR) was 100.0% (95%CI, 83.2 to 100.0). Among 17 patient with BOR of PR, two patients achieved a complete response (CR) of the target lesion. The median duration of response (DOR) and median progression free survival (PFS) had not been met. Three patients underwent resection of primary tumor after achieving a BOR of partial response (N=2) and stable disease (N=1). The incidence of treatment emergent adverse events (TEAEs) was 85.0%. Treatment-related AEs (TRAEs) occurred in 14 (70.0%) patients. The incidence of TRAE ≥ Grade 3 was 15%. AEs of immune-related etiology, occurred in 6 patients (30.0%). There were no AEs that resulted in death. As data cutoff, 12 patients were still in treatment and 8 had discontinued treatment and were under survival follow up. The biomarker analysis including PD-L1 expression in tumor specimen was ongoing. Conclusions: Sintilimab in combination with XELOX in first-line GC/GEJC shows promising anti-tumor efficacy and a tolerable safety profile. The further randomized, phase 3 study of Sintilimab in combination with XELOX in this setting is ongoing (NCT03745170). Clinical trial information: NCT02937116.

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