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Association details:
Biomarker:No biomarker
Cancer:Esophageal Squamous Cell Carcinoma
Drug:Opdivo (nivolumab) (PD1 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Title:

U.S. Food and Drug Administration Approves Two Opdivo® (nivolumab)-Based Regimens as First-Line Treatments for Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Published date:
05/27/2022
Excerpt:
Bristol Myers Squibb...announced that the U.S. Food and Drug Administration (FDA) has approved both Opdivo (nivolumab) (injection for intravenous use) in combination with fluoropyrimidine- and platinum-containing chemotherapy and Opdivo plus Yervoy (ipilimumab) as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) regardless of PD-L1 status. The approvals are based on the Phase 3 CheckMate -648 trial, which evaluated Opdivo in combination with chemotherapy (n=321) and Opdivo plus Yervoy (n=325) each compared to chemotherapy alone (n=324), and was the largest Phase 3 trial of an immunotherapy in first-line ESCC.
Secondary therapy:
Chemotherapy
Evidence Level:
Sensitive: A1 - Approval
Published date:
11/24/2020
Excerpt:
Opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.
Evidence Level:
Sensitive: A1 - Approval
Source:
Published date:
06/10/2020
Excerpt:
OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of...patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.
Evidence Level:
Sensitive: A1 - Approval
Title:

Japan Ministry of Health, Labor and Welfare Approves Opdivo (nivolumab) for the Treatment of Patients with Unresectable Advanced or Recurrent Esophageal Cancer

Published date:
02/21/2020
Excerpt:
...Bristol-Myers Squibb Company (NYSE: BMY) today announced Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Opdivo (nivolumab) for the treatment of patients with unresectable advanced or recurrent esophageal cancer that has progressed following chemotherapy.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

Nivolumab for previously treated unresectable advanced or recurrent oesophageal cancer

Published date:
06/15/2021
Excerpt:
Nivolumab is recommended, within its marketing authorisation, for treating unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma in adults after fluoropyrimidine and platinum-based therapy.
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
Esophageal and Esophagogastric Junction Cancers: Preferred Regimens…Nivolumab for esophageal squamous cell carcinoma…
Evidence Level:
Sensitive: B - Late Trials
Title:

Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Opdivo (nivolumab) as Second-Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Published date:
10/16/2020
Excerpt:
...Bristol Myers Squibb (NYSE:BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based combination chemotherapy....The CHMP positive opinion was based on results from the Phase 3 ATTRACTION-3 trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) in patients who received Opdivo versus chemotherapy, as well as a favorable safety profile.
Evidence Level:
Sensitive: B - Late Trials
Title:

Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial

Published date:
09/30/2019
Excerpt:
At the time of data cutoff on Nov 12, 2018, median follow-up for overall survival was 10·5 months (IQR 4·5-19·0) in the nivolumab group and 8·0 months (4·6-15·2) in the chemotherapy group. At a minimum follow-up time (ie, time from random assignment of the last patient to data cutoff) of 17·6 months, overall survival was significantly improved in the nivolumab group compared with the chemotherapy group (median 10·9 months, 95% CI 9·2-13·3 vs 8·4 months, 7·2-9·9; hazard ratio for death 0·77, 95% CI 0·62-0·96; p=0·019).
DOI:
10.1016/S1470-2045(19)30626-6
Trial ID: