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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Title:

Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Patients with Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma with Tumor Cell PD-L1 Expression >=1%

Published date:
04/05/2022
Excerpt:
Bristol Myers Squibb...announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression ≥ 1%. The EC’s decision is based on results from the Phase 3 CheckMate -648 trial, in which treatment with Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to fluoropyrimidine- and platinum-containing chemotherapy at the pre-specified interim analysis.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
01/05/2023
Excerpt:
For patients with esophageal squamous cell carcinoma and PD-L1 tumor proportion score ≥ 1%, nivolumab plus CT, or nivolumab plus ipilimumab is recommended.
DOI:
10.1200/JCO.22.02331
Evidence Level:
Sensitive: B - Late Trials
Title:

Nivolumab (NIVO) plus chemotherapy (chemo) or ipilimumab (IPI) vs chemo as first-line (1L) treatment for advanced esophageal squamous cell carcinoma (ESCC): 29-month (mo) follow-up from CheckMate 648.

Published date:
01/17/2023
Excerpt:
Adults with previously untreated, unresectable advanced, recurrent, or metastatic ESCC were randomized to NIVO (240 mg Q2W) + chemo (fluorouracil + cisplatin Q4W), NIVO (3 mg/kg Q2W) + IPI (1 mg/kg Q6W) or chemo....Responses were more durable and a larger proportion of responders had a duration of response (DOR) ≥ 24 mo with NIVO + chemo and NIVO + IPI vs chemo in pts with tumor cell PD-L1 ≥ 1% (22%, 36%, 13%, respectively) and all randomized pts (21%, 29%, 13%)….NIVO + chemo and NIVO + IPI continued to demonstrate clinically meaningful survival benefit vs chemo, durable objective responses, and acceptable safety profiles with longer follow-up.
Secondary therapy:
cisplatin + 5-fluorouracil
DOI:
10.1200/JCO.2023.41.3_suppl.290
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) for First-Line Treatment of Patients with Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Published date:
02/25/2022
Excerpt:
Bristol Myers Squibb...announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression ≥ 1%...The positive opinion is based on results from the Phase 3 CheckMate -648 trial, which showed that treatment with Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to fluoropyrimidine- and platinum-containing chemotherapy at the pre-specified interim analysis in patients with unresectable advanced, recurrent or metastatic ESCC with tumor cell PD-L1 expression ≥1% (median, 13.7 months vs 9.1 months, HR = 0.64; 98.6% CI: 0.46 to 0.90; p-value = 0.001). The safety profile of Opdivo plus Yervoy was consistent with previously reported studies.
Secondary therapy:
cisplatin + 5-fluorouracil
Evidence Level:
Sensitive: B - Late Trials
Title:

Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma

Published date:
02/03/2022
Excerpt:
...overall survival was significantly longer with nivolumab plus chemotherapy than with chemotherapy alone, both among patients with tumor-cell PD-L1 expression of 1% or greater (median, 15.4 vs. 9.1 months; hazard ratio, 0.54; 99.5% confidence interval [CI], 0.37 to 0.80; P<0.001) and in the overall population (median, 13.2 vs. 10.7 months; hazard ratio, 0.74; 99.1% CI, 0.58 to 0.96; P=0.002). Overall survival was also significantly longer with nivolumab plus ipilimumab than with chemotherapy among patients with tumor-cell PD-L1 expression of 1% or greater (median, 13.7 vs. 9.1 months; hazard ratio, 0.64; 98.6% CI, 0.46 to 0.90; P=0.001) and in the overall population (median, 12.7 vs. 10.7 months; hazard ratio, 0.78; 98.2% CI, 0.62 to 0.98; P=0.01).
DOI:
10.1056/NEJMoa2111380
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Nivolumab (NIVO) plus ipilimumab (IPI) or NIVO plus chemotherapy (chemo) versus chemo as first-line (1L) treatment for advanced esophageal squamous cell carcinoma (ESCC): First results of the CheckMate 648 study.

Published date:
05/19/2021
Excerpt:
...NIVO + chemo and NIVO + IPI led to statistically significant improvement in OS vs chemo in pts with tumor cell PD-L1 ≥ 1%....NIVO plus chemo and NIVO plus IPI both demonstrated superior OS vs chemo, along with durable objective responses.
DOI:
10.1200/JCO.2021.39.15_suppl.LBA4001
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Bristol Myers Squibb Announces Opdivo (nivolumab) plus Chemotherapy and Opdivo plus Yervoy (ipilimumab) Demonstrate Superior Survival Benefit Compared to Chemotherapy in Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Published date:
04/08/2021
Excerpt:
Bristol Myers Squibb...today announced positive topline results from the Phase 3 CheckMate -648 trial evaluating treatment with Opdivo (nivolumab)plus chemotherapy or Opdivo plus Yervoy (ipilimumab) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC)....Opdivo plus Yervoy also met its primary and secondary endpoints by demonstrating statistically significant and clinically meaningful improvement in overall survival in patients whose tumors express PD-L1 and in the all-randomized population.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin

Excerpt:
......
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Nivolumab (NIVO) plus chemotherapy (chemo) or ipilimumab (IPI) versus chemo as first-line (1L) treatment for advanced esophageal squamous cell carcinoma (ESCC): Expanded efficacy and safety analyses from CheckMate 648.

Published date:
05/26/2022
Excerpt:
Among all pts randomized to NIVO + chemo (n = 321), NIVO + IPI (n = 325), or chemo (n = 324), PFS2 favored NIVO + chemo (HR 0.64, 95% CI 0.54–0.77) and NIVO + IPI (HR 0.74, 95% CI 0.62–0.88) vs chemo. ORR (95% CI) was 47% (42–53), 28% (23–33), and 27% (22–32), respectively. More responders with NIVO + chemo or NIVO + IPI vs chemo had prolonged DOR (≥12 mo; 39%, 48%, and 23%, respectively). Efficacy data by tumor cell PD-L1 and PD-L1 combined positive score will be presented. NIVO + chemo and NIVO + IPI demonstrated favorable PFS2 and a higher proportion of pts with prolonged DOR vs chemo, as well as acceptable safety profiles.
DOI:
10.1200/JCO.2022.40.16_suppl.4035
Trial ID: