Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial
This study is registered at ClinicalTrials.gov, NCT04003636.FINDINGS: Between Oct 4, 2019, and June 8, 2021, 1564 patients were screened for eligibility, 1069 of whom were randomly assigned to pembrolizumab plus gemcitabine and cisplatin (pembrolizumab group; n=533) or placebo plus gemcitabine and cisplatin (placebo group; n=536). Median study follow-up at final analysis was 25·6 months (IQR 21·7-30·4). Median overall survival was 12·7 months (95% CI 11·5-13·6) in the pembrolizumab group versus 10·9 months (9·9-11·6) in the placebo group (hazard ratio 0·83 [95% CI 0·72-0·95]; one-sided p=0·0034 [significance t...
Source: JOP - April 14, 2023 Category: Gastroenterology Authors: Robin Kate Kelley Makoto Ueno Changhoon Yoo Richard S Finn Junji Furuse Zhenggang Ren Thomas Yau Heinz-Josef Kl ümpen Stephen L Chan Masato Ozaka Chris Verslype Mohamed Bouattour Joon Oh Park Olga Barajas Uwe Pelzer Juan W Valle Li Yu Usha Malhotra Abby Source Type: research
Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial
This study is registered at ClinicalTrials.gov, NCT04003636.FINDINGS: Between Oct 4, 2019, and June 8, 2021, 1564 patients were screened for eligibility, 1069 of whom were randomly assigned to pembrolizumab plus gemcitabine and cisplatin (pembrolizumab group; n=533) or placebo plus gemcitabine and cisplatin (placebo group; n=536). Median study follow-up at final analysis was 25·6 months (IQR 21·7-30·4). Median overall survival was 12·7 months (95% CI 11·5-13·6) in the pembrolizumab group versus 10·9 months (9·9-11·6) in the placebo group (hazard ratio 0·83 [95% CI 0·72-0·95]; one-sided p=0·0034 [significance t...
Source: JOP - April 14, 2023 Category: Gastroenterology Authors: Robin Kate Kelley Makoto Ueno Changhoon Yoo Richard S Finn Junji Furuse Zhenggang Ren Thomas Yau Heinz-Josef Kl ümpen Stephen L Chan Masato Ozaka Chris Verslype Mohamed Bouattour Joon Oh Park Olga Barajas Uwe Pelzer Juan W Valle Li Yu Usha Malhotra Abby Source Type: research
Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension
CONCLUSIONS: In patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo. (Funded by Acceleron Pharma, a subsidiary of MSD; STELLAR ClinicalTrials.gov number, NCT04576988.).PMID:36877098 | DOI:10.1056/NEJMoa2213558 (Source: JOP)
Source: JOP - March 6, 2023 Category: Gastroenterology Authors: Marius M Hoeper David B Badesch H Ardeschir Ghofrani J Simon R Gibbs Mardi Gomberg-Maitland Vallerie V McLaughlin Ioana R Preston Rogerio Souza Aaron B Waxman Ekkehard Gr ünig Grzegorz Kope ć Gisela Meyer Karen M Olsson Stephan Rosenkranz Yayun Xu Barry Source Type: research
Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension
CONCLUSIONS: In patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo. (Funded by Acceleron Pharma, a subsidiary of MSD; STELLAR ClinicalTrials.gov number, NCT04576988.).PMID:36877098 | DOI:10.1056/NEJMoa2213558 (Source: JOP)
Source: JOP - March 6, 2023 Category: Gastroenterology Authors: Marius M Hoeper David B Badesch H Ardeschir Ghofrani J Simon R Gibbs Mardi Gomberg-Maitland Vallerie V McLaughlin Ioana R Preston Rogerio Souza Aaron B Waxman Ekkehard Gr ünig Grzegorz Kope ć Gisela Meyer Karen M Olsson Stephan Rosenkranz Yayun Xu Barry Source Type: research
Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension
CONCLUSIONS: In patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo. (Funded by Acceleron Pharma, a subsidiary of MSD; STELLAR ClinicalTrials.gov number, NCT04576988.).PMID:36877098 | DOI:10.1056/NEJMoa2213558 (Source: JOP)
Source: JOP - March 6, 2023 Category: Gastroenterology Authors: Marius M Hoeper David B Badesch H Ardeschir Ghofrani J Simon R Gibbs Mardi Gomberg-Maitland Vallerie V McLaughlin Ioana R Preston Rogerio Souza Aaron B Waxman Ekkehard Gr ünig Grzegorz Kope ć Gisela Meyer Karen M Olsson Stephan Rosenkranz Yayun Xu Barry Source Type: research
Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension
CONCLUSIONS: In patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo. (Funded by Acceleron Pharma, a subsidiary of MSD; STELLAR ClinicalTrials.gov number, NCT04576988.).PMID:36877098 | DOI:10.1056/NEJMoa2213558 (Source: JOP)
Source: JOP - March 6, 2023 Category: Gastroenterology Authors: Marius M Hoeper David B Badesch H Ardeschir Ghofrani J Simon R Gibbs Mardi Gomberg-Maitland Vallerie V McLaughlin Ioana R Preston Rogerio Souza Aaron B Waxman Ekkehard Gr ünig Grzegorz Kope ć Gisela Meyer Karen M Olsson Stephan Rosenkranz Yayun Xu Barry Source Type: research
Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension
CONCLUSIONS: In patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo. (Funded by Acceleron Pharma, a subsidiary of MSD; STELLAR ClinicalTrials.gov number, NCT04576988.).PMID:36877098 | DOI:10.1056/NEJMoa2213558 (Source: JOP)
Source: JOP - March 6, 2023 Category: Gastroenterology Authors: Marius M Hoeper David B Badesch H Ardeschir Ghofrani J Simon R Gibbs Mardi Gomberg-Maitland Vallerie V McLaughlin Ioana R Preston Rogerio Souza Aaron B Waxman Ekkehard Gr ünig Grzegorz Kope ć Gisela Meyer Karen M Olsson Stephan Rosenkranz Yayun Xu Barry Source Type: research
Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension
CONCLUSIONS: In patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo. (Funded by Acceleron Pharma, a subsidiary of MSD; STELLAR ClinicalTrials.gov number, NCT04576988.).PMID:36877098 | DOI:10.1056/NEJMoa2213558 (Source: JOP)
Source: JOP - March 6, 2023 Category: Gastroenterology Authors: Marius M Hoeper David B Badesch H Ardeschir Ghofrani J Simon R Gibbs Mardi Gomberg-Maitland Vallerie V McLaughlin Ioana R Preston Rogerio Souza Aaron B Waxman Ekkehard Gr ünig Grzegorz Kope ć Gisela Meyer Karen M Olsson Stephan Rosenkranz Yayun Xu Barry Source Type: research
Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension
CONCLUSIONS: In patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo. (Funded by Acceleron Pharma, a subsidiary of MSD; STELLAR ClinicalTrials.gov number, NCT04576988.).PMID:36877098 | DOI:10.1056/NEJMoa2213558 (Source: JOP)
Source: JOP - March 6, 2023 Category: Gastroenterology Authors: Marius M Hoeper David B Badesch H Ardeschir Ghofrani J Simon R Gibbs Mardi Gomberg-Maitland Vallerie V McLaughlin Ioana R Preston Rogerio Souza Aaron B Waxman Ekkehard Gr ünig Grzegorz Kope ć Gisela Meyer Karen M Olsson Stephan Rosenkranz Yayun Xu Barry Source Type: research
Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension
CONCLUSIONS: In patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo. (Funded by Acceleron Pharma, a subsidiary of MSD; STELLAR ClinicalTrials.gov number, NCT04576988.).PMID:36877098 | DOI:10.1056/NEJMoa2213558 (Source: JOP)
Source: JOP - March 6, 2023 Category: Gastroenterology Authors: Marius M Hoeper David B Badesch H Ardeschir Ghofrani J Simon R Gibbs Mardi Gomberg-Maitland Vallerie V McLaughlin Ioana R Preston Rogerio Souza Aaron B Waxman Ekkehard Gr ünig Grzegorz Kope ć Gisela Meyer Karen M Olsson Stephan Rosenkranz Yayun Xu Barry Source Type: research
Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension
CONCLUSIONS: In patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo. (Funded by Acceleron Pharma, a subsidiary of MSD; STELLAR ClinicalTrials.gov number, NCT04576988.).PMID:36877098 | DOI:10.1056/NEJMoa2213558 (Source: JOP)
Source: JOP - March 6, 2023 Category: Gastroenterology Authors: Marius M Hoeper David B Badesch H Ardeschir Ghofrani J Simon R Gibbs Mardi Gomberg-Maitland Vallerie V McLaughlin Ioana R Preston Rogerio Souza Aaron B Waxman Ekkehard Gr ünig Grzegorz Kope ć Gisela Meyer Karen M Olsson Stephan Rosenkranz Yayun Xu Barry Source Type: research
Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension
CONCLUSIONS: In patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo. (Funded by Acceleron Pharma, a subsidiary of MSD; STELLAR ClinicalTrials.gov number, NCT04576988.).PMID:36877098 | DOI:10.1056/NEJMoa2213558 (Source: JOP)
Source: JOP - March 6, 2023 Category: Gastroenterology Authors: Marius M Hoeper David B Badesch H Ardeschir Ghofrani J Simon R Gibbs Mardi Gomberg-Maitland Vallerie V McLaughlin Ioana R Preston Rogerio Souza Aaron B Waxman Ekkehard Gr ünig Grzegorz Kope ć Gisela Meyer Karen M Olsson Stephan Rosenkranz Yayun Xu Barry Source Type: research
Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension
CONCLUSIONS: In patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo. (Funded by Acceleron Pharma, a subsidiary of MSD; STELLAR ClinicalTrials.gov number, NCT04576988.).PMID:36877098 | DOI:10.1056/NEJMoa2213558 (Source: JOP)
Source: JOP - March 6, 2023 Category: Gastroenterology Authors: Marius M Hoeper David B Badesch H Ardeschir Ghofrani J Simon R Gibbs Mardi Gomberg-Maitland Vallerie V McLaughlin Ioana R Preston Rogerio Souza Aaron B Waxman Ekkehard Gr ünig Grzegorz Kope ć Gisela Meyer Karen M Olsson Stephan Rosenkranz Yayun Xu Barry Source Type: research
Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension
CONCLUSIONS: In patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo. (Funded by Acceleron Pharma, a subsidiary of MSD; STELLAR ClinicalTrials.gov number, NCT04576988.).PMID:36877098 | DOI:10.1056/NEJMoa2213558 (Source: JOP)
Source: JOP - March 6, 2023 Category: Gastroenterology Authors: Marius M Hoeper David B Badesch H Ardeschir Ghofrani J Simon R Gibbs Mardi Gomberg-Maitland Vallerie V McLaughlin Ioana R Preston Rogerio Souza Aaron B Waxman Ekkehard Gr ünig Grzegorz Kope ć Gisela Meyer Karen M Olsson Stephan Rosenkranz Yayun Xu Barry Source Type: research
Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension
CONCLUSIONS: In patients with pulmonary arterial hypertension who were receiving stable background therapy, sotatercept resulted in a greater improvement in exercise capacity (as assessed by the 6-minute walk test) than placebo. (Funded by Acceleron Pharma, a subsidiary of MSD; STELLAR ClinicalTrials.gov number, NCT04576988.).PMID:36877098 | DOI:10.1056/NEJMoa2213558 (Source: JOP)
Source: JOP - March 6, 2023 Category: Gastroenterology Authors: Marius M Hoeper David B Badesch H Ardeschir Ghofrani J Simon R Gibbs Mardi Gomberg-Maitland Vallerie V McLaughlin Ioana R Preston Rogerio Souza Aaron B Waxman Ekkehard Gr ünig Grzegorz Kope ć Gisela Meyer Karen M Olsson Stephan Rosenkranz Yayun Xu Barry Source Type: research
