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Indications

Prescribing Information

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Potential OPDIVO® (nivolumab) user with his friend, running to the ocean to surf.
Potential OPDIVO® (nivolumab) user with his friend, running to the ocean to surf.

Clinical trial results for
advanced esophageal
squamous cell cancer

For previously untreated adults with
advanced or metastatic esophageal
squamous cell cancer (ESCC)

Actor portrayals.
OPDIVO + YERVOY is not approved for people younger
than 18 years of age.

An FDA-approved combination of two immunotherapies that helped more people live longer compared to chemotherapy

About the clinical trial

In a clinical trial of 649 people with previously untreated advanced or metastatic esophageal squamous cell cancer, 325 people were given OPDIVO + YERVOY and 324 people were given chemotherapy. The chemotherapy used in this clinical trial was fluorouracil and cisplatin.

More people given OPDIVO + YERVOY were alive at 1 year compared to chemotherapy

54% of those given OPDIVO® + YERVOY® for advanced ESCC were alive at 1 year, versus the 44% given chemotherapy.

In the clinical trial, people given OPDIVO + YERVOY had a 22% lower risk of dying than those given chemotherapy alone.

People given OPDIVO + YERVOY lived longer compared to chemotherapy

At 13 months, half the people given OPDIVO® + YERVOY® were alive.
OPDIVO + YERVOY

Half the people were alive

At 11 months, half the people given YERVOY® were alive.
Chemotherapy

Half the people were alive

More people given OPDIVO + YERVOY saw their tumors
shrink or disappear completely compared to chemotherapy

OPDIVO + YERVOY 

Chemotherapy

Tumors disappeared completely (complete response)

11% saw tumors disappear completely in response to OPDIVO® + YERVOY® compared to 6 % in response to chemotherapy.

Tumors shrank
(partial response)

17% saw tumors shrink in response to OPDIVO® + YERVOY® compared to 21% in response to chemotherapy.

Tumors shrank or disappeared completely (overall response)

28% given OPDIVO® + YERVOY® saw an overall response to treatment compared to compared to 27% given chemotherapy.

Words to know

Overall response rate is the percentage of patients who responded to treatment. These patients saw their tumors either shrink or disappear completely.

Partial response is when a tumor reacts to treatment and shrinks.

Complete response is when a tumor reacts to treatment and disappears completely. This is the disappearance of any measurable tumors in response to treatment. This does not mean the cancer has been cured.

OPDIVO + YERVOY will not work for everyone. Individual results may vary.

Hands exploring how OPDIVO® (nivolumab) works and learning how this treatment may help fight cancer.

How treatment works

See how this treatment may help your body fight cancer

OPDIVO® (nivolumab) side effects.

Side effects

View side effects of treatment and learn how to manage them

Nurse monitoring a gentleman's infusion of OPDIVO® (nivolumab) immunotherapy treatment.

Getting an infusion

See your recommended treatment plan and what to expect from an infusion

For previously untreated adults with advanced or metastatic esophageal squamous cell cancer (ESCC)

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults with cancer of the tube that connects your throat to your stomach (esophageal cancer) when your cancer is a type called squamous cell carcinoma and cannot be removed with surgery (advanced) or has spread to other parts of the body (metastatic), and you have not already had treatment for your advanced or metastatic esophageal cancer.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.

It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.



466-US-2400098   06/24