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Results from the phase 3 CheckMate -648 trial evaluating treatment with Nivolumab ( Opdivo ) plus chemotherapy or Nivolumab plus Ipilimumab ( Yervoy ) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma ( ESCC ) were announced.

In the study, Nivolumab plus chemotherapy has demonstrated a statistically significant and clinically meaningful benefit for the primary and secondary endpoints of overall survival ( OS ) in patients whose tumors express PD-L1 and in the all-randomized patient population at the pre-specified interim analysis.
Additionally, Nivolumab plus chemotherapy has demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival ( PFS ) by blinded independent central review ( BICR ) in patients whose tumors express PD-L1.

Nivolumab plus Ipilimumab has 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.
Nivolumab plus Ipilimumab did not meet its other primary endpoint of progression-free survival by BICR in patients whose tumors express PD-L1.

The safety profiles of Nivolumab and the combination of Nivolumab and Ipilimumab were consistent with those previously reported.

CheckMate -648 is a randomized phase 3 study evaluating Nivolumab plus Ipilimumab or Nivolumab plus Fluorouracil and Cisplatin against Fluorouracil plus Cisplatin alone in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma.

The primary endpoints of the trial are overall survival ( OS ) and progression-free survival ( PFS ) by blinded independent central review ( BICR ) in patients whose tumors express PD-L1, for both Nivolumab-based combinations versus chemotherapy.
Secondary endpoints of the trial include overall survival and progression-free survival by BICR in the all-randomized population.

In the Nivolumab plus Ipilimumab arm, patients received treatment with Nivolumab 3 mg/kg every 2 weeks and Ipilimumab 1 mg/kg every 6 weeks up to 24 months or until disease progression or unacceptable toxicity.

In the Nivolumab plus chemotherapy arm, patients received treatment with Nivolumab 240 mg on day 1 and day 15, Fluorouracil 800 mg/m²/day on day 1 through day 5 ( for 5 days ), and Cisplatin 80 mg/m² on day 1 of four-week cycle.
Patients received Nivolumab for up to 24 months or until disease progression or unacceptable toxicity, and chemotherapy until disease progression or unacceptable toxicity.

Esophageal cancer is the eighth most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 604,000 new cases and over 544,000 deaths in 2020.
The two most common types of esophageal cancer are squamous cell carcinoma ( ESCC ) and adenocarcinoma, which account for approximately 90% and 10% of all esophageal cancers, respectively, though esophageal tumor histology can vary by region.
The overall burden of ESCC is concentrated in Asia, where roughly 80% of the global cases occurred in 2020.
The majority of esophageal cancer cases are diagnosed in the advanced setting and impact a patient’s daily life, including their ability to eat and drink.
ESCC occurs most often in the upper and middle portions of the esophagus, whereas adenocarcinoma begins in the cells of mucus-secreting glands in the esophagus and most often occurs in the lower portion of the esophagus. ( Xagena )

Source: BMS, 2021

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