Home

Nivolumab metastatic esophageal cancer

OPDIVO® (nivolumab) - Official Websit

Nivolumab (Opdivo) in combination with chemotherapy as a frontline treatment demonstrated a significant survival benefit in patients with metastatic gastric cancer, gastroesophageal junction (GEJ).. Among patients with resected esophageal or gastroesophageal junction cancer who had received neoadjuvant chemoradiotherapy, disease-free survival was significantly longer among those who received.. Nivolumab was associated with a significant improvement in overall survivaland a favourable safety profile compared with chemotherapy in previously treated patients with advanced oesophageal squamous cell carcinoma, and might represent a new standard second-line treatment option for these patients

A 'Game Changer' for Patients With Esophageal Cancer. A drug that unleashes the immune system offers a rare glimmer of hope for those with a cancer that resists most treatments. Mindy Mordecai. Most tumors were gastric cancer (70%), followed by GEJ (18%), and esophageal adenocarcinoma (13%). Most patients had metastatic disease (96% and few patients had tumors with high microsatellite..

Nivolumab (Anti-PDCD1) - PDCD1(nivolumab

Patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) benefited from the addition of nivolumab (Opdivo) to either chemotherapy or ipilimumab (Yervoy) with better overall survival (OS) outcomes versus those receiving chemotherapy alone, according to updated findings from the CheckMate-648 trial (NCT03143153) presented at a presscast ahead of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting Nivolumab in combination with chemotherapy has shown clinical promise in other cancer types, including as a neoadjuvant treatment of resectable non-small cell lung cancer and unresectable advanced or metastatic esophageal squamous cell carcinoma The FDA approved nivolumab (Opdivo) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy, according to Bristol Meyers Squibb - the agent's manufacturer. The agency based the priority review and approval on. January 20, 2021 - The FDA has granted a priority review to a supplemental biologics license application for nivolumab in combination with a fluoropyrimidine- and platinum-containing chemotherapy.. Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, esophageal cancer, gastric cancer, and gastroesophageal junction cancer

Opdivo (nivolumab) has been approved as first-line therapy for patients with metastatic or advanced Esophageal Adenocarcinoma, Gastroesophageal Junction Cancer, and Gastric Cancer in combination with fluoropyrimidine- (5 FU) and platinum-containing chemotherapy. The FDA did not constrain use of Opdivo based on any minimum level of PD-L1 expression Esophageal adenocarcinoma, esophageal cancer, esophageal squamous cell carcinoma, immune checkpoint inhibitor, nivolumab, PD-1 antibody, pembrolizumab Article: Esophageal cancer is the seventh most common malignancy and the sixth leading cause of death from cancer worldwide. 1 The main histological subtypes are esophageal squamous cell. Nivolumab (Opdivo) in combination with chemotherapy as a frontline treatment demonstrated a significant survival benefit in patients with metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma, according to findings from the phase 3 CheckMate-649 trial (NCT02872116). 1 When compared with chemotherapy alone, the nivolumab combination met both primary end. Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery OPDIVO ® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma. OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma

FDA approves nivolumab in combination with chemotherapy

  1. OPDIVO ® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
  2. Officials with the FDA have approved nivolumab (Opdivo, Bristol Myers Squibb) in combination with chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, regardless of programmed death-ligand 1 (PD-L1). According to a press release, nivolumab is the.
  3. Recently, nivolumab received FDA approval for second-line treatment of esophageal squamous cell carcinoma based on results of the phase 3 ATTRACTION-3 trial. The study, which included 419 patients.
  4. In the largest of these, adding nivolumab (Opdivo) to chemotherapy improved overall survival (OS) by two to three months in untreated advanced/metastatic gastric, gastroesophageal junction (GEJ),..

Milestones of PD-1 inhibition in gastric and esophageal cancer Gastric cancer, gastroesophageal junction (GEJ) adenocarcinoma, and esophageal adenocarcinoma are substantial causes of cancer-related mortality worldwide and have poor 5-year overall survival (OS) when diagnosed at an advanced stage . Median OS with standard first-line chemotherapy for advanced or metastatic, HER2-negative gastri OPDIVO ® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. IMPORTANT SAFETY INFORMATION. Severe and Fatal Immune-Mediated Adverse Reaction Esophageal cancer is the eighth most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 600,000 new cases and over 540,000 deaths in 2020

Multiple metastatic lymph nodes were detected, including para-esophageal lymph nodes (3/5), pericardial lymph nodes (2/9), tracheal carinal lymph nodes (4/4) and mid-thoracic paratracheal lymph nodes (5/9). The time-line of the treatment process for this patient is shown in Figure 1(a). After the operation, he received 2 cycles of TP regimen. Adjuvant Nivolumab in Esophageal Cancer — A New Standard of Care. List of authors. David H. Ilson, M.D., Ph.D. April 1, 2021. N Engl J Med 2021; 384:1269-1271. DOI: 10.1056/NEJMe2101983. Preliminary clinical data involving single-agent PD-1/PD-L1 inhibitors in metastatic gastroesophageal cancer have reported response rates of 22%-27% for patients with PD-L1 + tumors and 10%-17% for unselected patients. The phase III ONO-4538-12 (ATTRACTION 2) trial has demonstrated an improved overall survival for nivolumab compared with.

Opdivo (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma TPS193 Background: Esophageal cancer (EC) is the sixth most common cause of cancer-related death worldwide, with a 5-y survival rate of 5%-8% in pts with metastatic disease. First-line platinum-based doublet chemotherapy (CTX) provides a modest survival benefit in pts with metastatic squamous cell EC (mESCC), with a median OS of 7.6 months. Over 40% of pts with EC have PD-L1+ tumors, which. Approximately 18,400 new cases of esophageal cancer are expected to be diagnosed and approximately 16,000 deaths are expected in 2020. The estimated 5-year survival rate for U.S. patients with esophageal cancer is approximately 20% , and the 5-year survival rate of advanced unresectable or metastatic esophageal cancer is 3.4%

Nivolumab ± ipilimumab in pts with advanced (adv)/metastatic chemotherapy-refractory (CTx-R) gastric (G), esophageal (E), or gastroesophageal junction (GEJ) cancer: CheckMate 032 study The FDA approved nivolumab for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after receiving fluoropyrimidine- and platinum-based. The FDA has granted approval to nivolumab (Opdivo) for the treatment of patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) after receiving prior fluoropyrimidine- and platinum-based chemotherapy, announced Bristol Myers Squibb. This is the first immunotherapy approved by the FDA for the. First-line (1L) nivolumab (NIVO) plus chemotherapy (chemo) versus chemo in advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): Expanded efficacy and. Meeting Coverage > ASCO Survival Boost With First-Line Immunotherapy for Esophageal Cancer — Nivolumab plus ipilimumab or chemo offers new option for advanced, metastatic diseas

Adjuvant treatment with the immune checkpoint inhibitor nivolumab significantly prolonged disease-free survival compared with placebo in patients with esophageal or gastroesophageal junction cancer, and treatment was extremely well tolerated, the phase III, CheckMate 577 study found 0. ( 0) The U.S. Food and Drug Administration (FDA) has approved Opdivo ( nivolumab) for the treatment of people with advanced, inoperable, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) previously treated with fluoropyrimidine - and platinum -based chemotherapy. The approval came after the regulatory agency granted. A randomised, open-label, phase 3 study comparing nivolumab monotherapy with docetaxel or paclitaxel in patients with unresectable advanced or recurrent oesophageal cancer is underway (NCT02569242). Analyses of biomarkers, such as PD-L1, CD8, and MHC class 1, to try to determine associations between the safety and activity of nivolumab are also. PRINCETON, N.J.--(BUSINESS WIRE)-- U.S. Food and Drug Administration Approves Opdivo ® (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma, Regardless of PD-L1 Expression Status. Bristol-Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) (injection for intravenous.

Nivolumab-Based Combinations Improve Survival in Advanced Esophageal Cancer. An x-ray of the esophagus and upper gastrointestinal tract following a barium swallow test. For some people with advanced esophageal cancer, two immunotherapy-based combination therapies are more effective than chemotherapy alone, which is the current standard. Moehler M, Shitara K, Garrido M, et al. Nivolumab plus chemotherapy versus chemotherapy as first-line treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma: first results of the CheckMate 649 study. Presentation at ESMO 2020. Presentation LBA6. 4. Data on file. NIVO 612

The FDA has granted a priority review to a supplemental biologics license application for nivolumab (Opdivo) in combination with a fluoropyrimidine- and platinum-containing chemotherapy for use in patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma. 1 The application was based on data from the phase 3 CheckMate-649 trial. And, a randomized trial of patients with advanced/metastatic esophageal or GEJ cancer revealed a three-month OS improvement with the addition of pembrolizumab (Keytruda) to chemotherapy. Nivolumab. That view echoes nivolumab's current approval in the US as a second-line treatment with chemo for patients with advanced or metastatic esophageal adenocarcinoma, gastric cancer, and gastroesophageal junction cancer, regardless of PD-L1 expression status Ilson DH, Wadleigh RG, Leichman LP, Kelsen DP. Paclitaxel given by a weekly 1-h infusion in advanced esophageal cancer. Ann Oncol 2007; 18:898. Muro K, Hamaguchi T, Ohtsu A, et al. A phase II study of single-agent docetaxel in patients with metastatic esophageal cancer. Ann Oncol 2004; 15:955

Department of Surgery - Liver Metastases

FDA approves nivolumab for esophageal squamous cell

PATIENTS AND METHODS Patients with locally advanced or metastatic chemotherapy-refractory gastric, esophageal, or gastroesophageal junction cancer from centers in the United States and Europe received nivolumab or nivolumab plus ipilimumab. The primary end point was objective response rate The introduction of immunotherapy to the treatment paradigms of esophageal and gastric cancers has been an exciting advance, said Namrata (Neena) Vijayvergia, MD, who added that although agents, such as nivolumab (Opdivo), are not yet approved by the FDA in the adjuvant or metastatic settings, they should be considered for use based on National Comprehensive Cancer Network (NCCN) recommendations OPDIVO ® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. IMPORTANT SAFETY INFORMATION Severe and Fatal Immune-Mediated Adverse Reaction The European Commission has approved nivolumab (Opdivo) for use as an adjuvant treatment in adult patients with esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic. Nivolumab (Opdivo) plus chemotherapy and nivolumab plus ipilimumab (Yervoy) were superior to standard chemotherapy in improving overall survival in patients with advanced esophageal squamous cell.

Feasibility study of nivolumab as neoadjuvant chemotherapy

File Type PDF Opdivo Nivolumab Treats Unresectable Or Metastatic Melanoma Skin Cancer And Metastatic Squamous Non Small Opdivo Nivolumab Treats Unresectable Or Metastatic Melanoma Skin Cancer And Metastatic Squamous Non Small When people should go to the books stores, search initiation by shop, shelf by shelf, it is in reality problematic In March, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda®) in conjunction with chemotherapy to treat metastatic esophageal cancer. The study that led to the approval found the treatment regimen improved overall survival, reducing the risk of death by 27%. The impressive benefit was mostly found in patients with squamous. Moving to advanced esophageal squamous cell carcinoma, data were presented at ASCO 2021 from the ongoing phase III CheckMate 648 study, in which 970 patients with unresectable, advanced, recurrent, or metastatic squamous esophageal cancer have been randomized to receive nivolumab 240 mg every 2 weeks with monthly chemotherapy (5-fluorouracil. Did adjuvant nivolumab therapy improve disease-free survival in the trial by Kelly et al.? Kelly et al. conducted CheckMate 577, a global, randomized, double-blind, placebo-controlled phase 3 trial that evaluated the use of a checkpoint inhibitor as adjuvant treatment after neoadjuvant chemoradiotherapy followed by surgery for esophageal or gastroesophageal junction cancer OPDIVO (nivolumab) injection, for intravenous use •patients with advanced or metastatic gastric cancer, gastroesophageal Initial U.S. Approval: 2014 junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy. (1.1 2

Esophageal, gastroesophageal (GEJ) and gastric cancer. 2020 was the year of advances in the treatment of locally advanced/metastatic esophageal and gastric cancer with mainly news in targeted treatment and immunotherapy. At ASCO GI this year, we had updates and new trials in the same setting The randomized phase III trial CheckMate 648 enrolled 970 patients with previously untreated, unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma. Patients were randomly assigned to receive treatment with nivolumab and chemotherapy (5-fluorouracil and cisplatin); nivolumab and ipilimumab; or chemotherapy alone

PRINCETON, N.J.--(BUSINESS WIRE)--Apr 16, 2021-- U.S. Food and Drug Administration Approves Opdivo® (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma, Regardless of PD-L1 Expression Status. Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) (injection for. Comment. These results demonstrate a remarkable signal of activity for nivolumab in chemotherapy-refractory squamous cancer of the esophagus that meets or exceeds the observed response seen for nivolumab and pembrolizumab in esophageal adenocarcinoma

Esophageal Ulcer in a Lung Cancer Patient - Gastroenterology

For Esophageal Cancer, Immunotherapy Likely to Play Larger

OPDIVO ® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Clinical Trials and Patient Population It can be used by itself in people with advanced squamous cell cancer of the esophagus, typically after chemotherapy has been tried. It can be used along with chemo in people with advanced adenocarcinoma of the esophagus or with advanced cancer of the GEJ. This drug is given as an intravenous (IV) infusion, usually once every 2, 3, or 4 weeks

Acute hemorrhagic gastritis after nivolumab treatment

FDA Fast-Tracks Review of 3 New Immunotherapy Options for

Learn About This New Treatment Option W/ Chemotherapy - See If OPDIVO May Be Right For Yo Today, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. CheckMate 64

Nivolumab Plus Chemotherapy Shows Significant Survival

On April 16, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo ®) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government

Adjuvant Nivolumab in Resected Esophageal or

Its efficacy was evaluated in a randomized, multicenter, open-label trial of 1,581 patients with previously untreated advanced or metastatic gastric cancer, gastroesophageal junction cancer and. It is recommended to administer nivolumab at a dose of 240 mg every 2 weeks or 480 mg every 4 weeks. For More Information. Clinicaltrials.gov (2020). Study of nivolumab in unresectable advanced or recurrent esophageal cancer. NLM Identifier: NCT02569242. Kato K, Cho BC, Takahashi M, et al (2019) FDA Approves Opdivo (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma Regardless of PD-L1 Expression Status. April 19, 2021 by admin 0 Comment

Nivolumab versus chemotherapy in patients with advanced

Abstract LBA6_PR 'Nivolumab (NIVO) plus chemotherapy (chemo) versus chemo as first-line (1l) treatment for advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC)/esophageal adenocarcinoma (EAC): First results of the CheckMate 649 study' will be presented by Markus Moehler during the Presidential Symposium III on Monday, 21. A committee of the European Medicines Agency has recommended the approval of Opdivo (nivolumab) for the treatment of people with advanced, inoperable, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) who previously received a chemo regimen containing fluoropyrimidine and a platinum agent.. The European Commission will review this opinion from the Committee for Medicinal. If lab tests after chemoradiation and surgery show that some cancer may have been left behind, treatment with an immunotherapy drug such as nivolumab (Opdivo) might be an option. If the cancer is in the upper part of the esophagus (in the neck), chemoradiation may be recommended as the main treatment instead of surgery The purpose of this study is to find out whether combining nivolumab, FOLFOX, and regorafenib may be a safe and effective treatment for people who have HER2-negative metastatic esophagogastric cancer. Nivolumab is an antibody, like the proteins made by the immune system to protect the body from harm

overview for _______________drugs

Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) Advanced or metastatic gastric cancer, and gastroesophageal junction cancer, and esophageal adenocarcinoma Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful • Esophageal Squamous Cell Carcinoma (ESCC) o Patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy. NCCN Compendium Supported Indications2 • Anal Cancer • T-Cell Lymphomas Coverage Determinations1, ABSTRACT. Esophageal cancer (EC) is the seventh most common cancer, and patients with advanced EC have a poor prognosis. Recently, nivolumab and pembrolizumab, two immune checkpoint inhibitors (ICIs) that inhibit programmed cell death protein 1, have begun to be used for the treatment of advanced esophageal squamous cell carcinoma (ESCC) Opdivo (nivolumab) was approved by FDA for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy. Efficacy was investigated in ATTRACTION-3 (NCT02569242), a multicenter, randomized (1:1), active-controlled, open-label trial in 419 patients with unresectable advanced, recurrent, or metastatic. OPDIVO ® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. IMPORTANT SAFETY INFORMATION Severe and Fatal Immune-Mediated Adverse Reaction

A 'Game Changer' for Patients With Esophageal Cancer - The

New Indication: Adjuvant nivolumab for esophageal / GEJ cancer. Study: Randomized, double-blind, placebo controlled phase III (CheckMate 577) Resected stage II/III esophageal or gastroesophageal junction cancer (R0) who had received neoadjuvant chemoradiotherapy and NOT achieved pathological CR. Adjuvant nivolumab (n=532) vs. placebo (n=262 Bristol Myers' (BMY) Opdivo Wins EC Nod for Esophageal Cancer. Biden leads national mourning of 400,000 Americans killed by COVID-19. Some Trump supporters think he's about to declare martial law. Based on this trial, for patients with HER2-negative gastric, esophageal or gastroesophageal junctional adenocarcinoma with tumor PD-L1 scores of 5 or more, the addition of nivolumab to chemotherapy will become the standard of care for first-line treatment, Salah-Eddin Al-Batran, MD, of the Krankenhaus Nordwest-University Cancer Centre. Esophageal cancer is a type of gastrointestinal cancer that starts in the inner layer of the esophagus (the mucosa) and grows. 10 In the United States, it is estimated there will be approximately. Metastatic esophageal cancer has a poor prognosis, with a 5-year relative survival rate of ≤ 8 % [8, 9]. In both gastric/GEJ and esophageal cancer, systemic treatment in the advanced setting includes chemotherapy in the first- and second-line settings plus anti-HER2 tumors in first line, as well as the anti-VEGFR-antibody ramucirumab in.

Esophageal Cancer Arises in a Hiatal Hernia - Esophagus

For Patients With Gastric, Gastroesophageal Junction, and Esophageal Cancers (5 of 11). OPDIVO ® (nivolumab) is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.. OPDIVO is indicated for the adjuvant treatment of completely resected esophageal or. For example, in patients with metastatic esophageal squamous cell carcinoma, the checkpoint inhibitor pembrolizumab was approved in combination with chemotherapy. Similarly, the U.S. FDA approved the combination of chemotherapy with another checkpoint inhibitor, nivolumab, in metastatic gastric adenocarcinoma

Esophageal cancer is the seventh most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 600,000 new cases and over 540,000 deaths in 2020 Nivolumab Treatment for Esophageal Squamous Cell Carcinoma The Lancet Oncology . Save Recommend Share . Facebook Twitter Print Email ×. You must be a member to content. Already Have An Account? Log in Now. Join PracticeUpdate Now. The Food and Drug Administration (FDA) has approved Opdivo® (nivolumab; Bristol Myers Squibb) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous.

Esophageal cancer, stomach cancer - презентация онлайн

Esophageal cancer remains a challenging disease due to limited treatment options and poor prognosis. In recent years, immune checkpoint inhibitors (ICI) have been proven to be safe and effective in the treatment of highly lethal malignancies, such as non-small cell lung cancer and melanoma. Recent clinical trials also showed promising activity in immune checkpoint inhibitors in pretreated. Esophageal cancer is the seventh most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 572,000 new cases and over 508,000 deaths in 2018. OPDIVO ® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma. OPDIVO ® (nivolumab),.

The benefit of nivolumab compared with placebo in patients with esophageal cancer or GEJ cancer was seen across all subgroups, including patients with squamous-cell carcinoma (HR, 0.61), adenocarcinoma (HR, 0.75), node-negative disease (HR, 0.74), and node-positive disease (HR, 0.67) For the global, randomized, open-label, phase III CheckMate 648 trial, 970 patients with unresectable, advanced, recurrent or metastatic esophageal squamous cell cancer were randomized 1:1:1 to nivolumab 240 mg every 2 weeks plus chemotherapy (fluorouracil and cisplatin) every 4 weeks (n = 321), nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1. In the randomized, double-blind, phase 3 trial, patients with resected stage II or III esophageal or gastroesophageal junction cancer were randomly assigned in a 2:1 ratio to receive nivolumab (at. The European Commission approved nivolumab for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination therapy. According to a release from the manufacturer, the approval is based on the Phase 3 ATTRACTION-3 trial, which showed the drug resulted in a statistically significant. OPDIVO ® (nivolumab) is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and.