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Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer

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The FDA has approved nivolumab (Opdivo) for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease, in patients have. CheckMate-577, a phase 3 trial evaluating Opdivo (nivolumab) as adjuvant therapy for patients with resected esophageal or gastroesophageal junction cancer, meets primary endpoint of disease-free. Adjuvant nivolumab provided clinically meaningful efficacy in a phase 3 trial of patients with esophageal cancer (EC) or gastroesophageal junction cancer (GEJC), according to a presentation.

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  1. Opdivo is the first and only treatment to demonstrate superior efficacy in patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and resection Second tumor, in addition to melanoma, where Opdivo has demonstrated a benefit in the adjuvant setting. PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3.
  2. The FDA granted approval to adjuvant nivolumab (Opdivo) for the treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT), according to a press release from Bristol Myers Squibb, developer of the agent. 1. The agent was.
  3. Kelly RJ, Ajani JA, Kuzdzal J, et al. Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy: first results of the CheckMate 577.
  4. Abstract No : Abstract: #LBA9 Indication : Esophageal Cancer, Gastroesophageal junction cancer Intervention : Nivolumab Company : Bristol-Myers Squibb Technology : PD-1/PD-L1 inhibitor Results: 794 patients were randomized (nivolumab, 532; placebo, 262). Approximately 70% of patients had adenocarcinoma and almost 60% had a pathologic lymph node status ≥ypN1 in both groups

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received. 2.Kelly RJ, Ajani JA, Kuzdzal J, et al. Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy: first results of the CheckMate 577 study. Poster presented at: 2020 European Society for Medical Oncology (ESMO) Virtual Congress. September 19-21, 2020 Kelly RJ, Ajani JA, Kuzdzal J, et al. LBA9_PR adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiation therapy (CRT): first. Adjuvant nivolumab improved disease-free survival (DFS) compared with placebo among patients with stage II or III esophageal or gastroesophageal junction (GEJ) cancers with residual pathologic.

CONCLUSIONS 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 adjuvant therapy than among those who received placebo CheckMate 577 (NCT02743494) 4 is a Phase III trial investigating the safety and efficacy of adjuvant nivolumab (NIVO), an anti-PD-1 monoclonal antibody, in resected esophageal or gastroesophageal junction cancer (EC/GEJC) in patients with residual pathologic disease post-neoadjuvant chemoradiotherapy. Early results were promising, nivolumab improved disease-free survival (DFS) by more than two.

Nivolumab (Opdivo) as adjuvant therapy following complete resection of esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who previously received neoadjuvant chemoradiotherapy was approved by the FDA, according to the company responsible for developing the drug, Bristol Myers Squibb. 1 The supplemental biologics license application for this indication. The improvement in disease-free survival (DFS) with adjuvant nivolumab was seen in both in patients with adenocarcinoma and squamous cell carcinoma. Notably, overall survival data were not included in this report. DFS was improved with nivolumab compared with placebo in patients with resected esophageal or gastroesophageal junction cancer Adjuvant nivolumab (Opdivo) prolonged disease-free survival (DFS) as treatment of patients with resected esophageal or gastroesophageal junction (GEJ) cancer compared with placebo, meeting the primary end point of the phase 3 CheckMate-577 clinical trial, according to prespecified interim analysis data announced in a press release from Bristol.

Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiation therapy (CRT): first results of the CheckMate 577 study. Ann Oncol 2020; 31: Abstract LBA9_PR The Food and Drug Administration (FDA) has approved Opdivo® (nivolumab) for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual. FDA Grants Priority Review to Adjuvant Nivolumab for Resected Esophageal/GEJ Cancer. January 20, 2021. Danielle Ternyila. Danielle Ternyila. The FDA accepted a supplemental Biologics License Application for nivolumab as adjuvant treatment of patients with resected esophageal or gastroesophageal junction cancer after neoadjuvant chemoradiation.

CheckMate -577 is a Phase 3 randomized, multi-center, double-blind study evaluating Opdivo as an adjuvant therapy in patients with resected esophageal or gastroesophageal junction (GEJ) cancer who have received neoadjuvant chemoradiotherapy (CRT) and have not achieved a pathological complete response. The primary endpoint of the trial is. Adjuvant nivolumab (NIVO) in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT): Expanded efficacy and safety analyses from CheckMate 577 In CheckMate 577 study conducted among patients with resected oesophageal or gastroesophageal junction cancer after neoadjuvant chemoradiotherapy, adjuvant therapy with nivolumab was associated with a significantly longer disease-free survival (DFS) than placebo. The safety profile of nivolumab was similar to that seen in other solid tumours Original Article Apr 01, 2021 Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer R. J. Kelly and Others Esophageal cancer causes more than half a million deaths each year Adjuvant Nivolumab Practice-Changing in Resected Gastroesophageal Cancer. A significant and clinically meaningful improvement of disease-free survival was observed in a global, randomized, placebo-controlled, Phase III trial among patients who had already had their esophageal or gastroesophageal cancers treated with surgery, radiation.

In the phase II randomized EORTC VESTIGE trial (NCT03443856), patients with high risk resected gastric or esophageal adenocarcinoma will be randomized to either adjuvant chemotherapy (as before surgery) or to immunotherapy with nivolumab and low dose ipilimumab (nivolumab 3 mg/kg IV Q2W plus Ipilimumab 1 mg/kg IV Q6W for 1 year). The primary. THURSDAY, April 1, 2021 (HealthDay News) — Among patients with resected esophageal or gastroesophageal junction cancer who have received neoadjuvant chemoradiotherapy, disease-free survival is significantly longer with nivolumab adjuvant therapy versus placebo, according to a study published in the April 1 issue of the New England Journal of Medicine 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. Adjuvant nivolumab is the first therapy to provide a statistically significant and clinically meaningful improvement in disease-free survival in patients with resected esophageal and gastroesophageal junction cancer. This news comes from research presented at the Society of Surgical Oncology 2021 International Conference on Surgical Cancer Care. FDA Approves Nivolumab for Completed Resected Esophageal, Gastroesophageal Junction Cancer. Median disease-free survival was twice as long in patients who received nivolumab compared to patients who received a placebo. Officials with the FDA have approved nivolumab (Opdivo) as the first and only immunotherapy indicated for the adjuvant.

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Kelly, Ronan J., et al. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. NEW ENGLAND JOURNAL OF MEDICINE, vol. 384, no. 13, 2021. 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 Squibb announced that Opdivo (nivolumab) has been approved by the Food and Drug Administration (FDA) for the adjuvant treatment of patients with completely resected esophageal or gastroesophageal junction cancer who still had residual disease after undergoing neoadjuvant chemoradiotherapy Fort Myers, Fla., April 29, 2021 -- Medical oncologist Syed Zafar MD, who practices at three Florida Cancer Specialists & Research Institute (FCS) locations in Lee County, is co-author of a new study entitled Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. Published online April 1, 2021 in the New England Journal of Medicine (NEJM), the study evaluates the. OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT)

Adjuvant Nivolumab in Resected Esophageal or

  1. In the phase II randomized EORTC VESTIGE trial (NCT03443856), patients with high risk resected gastric or esophageal adenocarcinoma will be randomized to either adjuvant chemotherapy (as before surgery) or to immunotherapy with nivolumab and low dose ipilimumab (nivolumab 3 mg/kg IV Q2W plus Ipilimumab 1 mg/kg IV Q6W for 1 year)
  2. 1. Adjuvant nivolumab significantly improved disease-free survival compared to placebo among patients with resected esophageal or gastroesophageal junction cancer. 2. Adverse events were more common in the nivolumab group compared to the placebo group. Evidence Rating Level: 1 (Excellent) Study Rundown: Neoadjuvant chemotherapy followed by surgery and surveillance is the current standard of.
  3. For this global, randomized, double-blind, phase III study, 794 patients with resected, stage II/III esophageal/gastroesophageal junction cancer who received neoadjuvant chemoradiation and had residual pathologic disease were randomized 2:1 to nivolumab 240 mg every 2 weeks for 16 weeks, followed by 480 mg given every 4 weeks (n = 532) or.
  4. THURSDAY, April 1, 2021 (HealthDay News) -- Among patients with resected esophageal or gastroesophageal junction cancer who have received neoadjuvant chemoradiotherapy, disease-free survival is significantly longer with nivolumab adjuvant therapy versus placebo, according to a study published in the April 1 issue of the New England Journal of Medicine
  5. Kelly RJ, Ajani JA, Kuzdzal J, et al. LBA9_PR Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiation therapy (CRT): First results of the CheckMate 577 study. Ann Oncol. 2020;31:S1193-S1194
  6. The FDA has granted priority review to a supplemental biologics license application for nivolumab (Opdivo) for use as an adjuvant treatment for patients with resected esophageal or gastroesophageal junction (GEJ) cancer following neoadjuvant chemoradiation treatment. 1 The application was based on data from the phase 3 CheckMate-577 trial (NCT02743494), which demonstrated that nivolumab.

ESMO 2020 | Adjuvant nivolumab potential new standard-of

The adjuvant use of nivolumab has been described as practice-changing in patients with resected esophageal or gastroesophageal junction cancer who have received chemoradiotherapy before surgery Source Reference: Kelly RJ, et al Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy: First results of the CheckMate 577. Esophageal or GE junction cancer (adeno or SCC) pts who received neoadjuvant chemoRT => undergone R0 resection during which pathological residual disease was found; Adjuvant nivolumab vs. placebo x 1 year or until disease progression; Efficacy: Median DFS: 22.4 vs. 11.0 mos (HR: 0.69 [0.56-0.86] It was previously reported that nivolumab is the first adjuvant therapy to provide a statistically significant and clinically meaningful improvement in disease-free survival versus a placebo in resected esophageal cancer/gastroesophageal junction cancer following neoadjuvant therapy, said Eric Van Cutsem, MD, PhD, professor of internal.

FDA approves nivolumab for resected esophageal or GEJ cance

Adjuvant nivolumab in resected esophageal or

The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur: On May 20, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy International Interdisciplinary Everything Esophageal The International Society for Diseases of the Esophagus is a 501(c)3 non-profit organization. General Inquiries: info@isde.ne Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer. N Engl J Med. 2021;384:1191-1203; Ilson DH. Adjuvant nivolumab in esophageal cancer—a new standard of care. N Engl J Med. 2021;384:1269-1271

Among patients with resected esophageal or gastroesophageal junction cancer who had received neoadjuvant chemoradiotherapy, median disease-free survival was significantly longer — more than double (22.4 months vs. 11.0 months, HR 0.69, p<0.001) — among those who received nivolumab (Opdivo ®) adjuvant therapy compared to those who received. Esophageal or GE junction cancer (adeno or SCC) pts who received neoadjuvant chemoRT => undergone R0 resection during which pathological residual disease was found; Adjuvant nivolumab vs. placebo x 1 year or until disease progression; Efficacy: Median DFS: 22.4 vs. 11.0 mos (HR: 0.69 [0.56-0.86]

Disease-free survival significantly longer in patients with resected esophageal, gastroesophageal junction cancer. THURSDAY, April 1, 2021 (HealthDay News) — Among patients with resected esophageal or gastroesophageal junction cancer who have received neoadjuvant chemoradiotherapy, disease-free survival is significantly longer with nivolumab adjuvant therapy versus placebo, according to a. Kelly RJ et al., Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy: first results of the CheckMate 577 study. ESMO 2020, LBA9 ESMO 2020, LBA

2. U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer. News release. Princeton, New Jersey. Published January 20, 2021 Results from the phase III CheckMate -577 trial demonstrated that adjuvant treatment with Opdivo (nivolumab) showed a statistically significant and clinically meaningful improvement in disease-free survival, the trial's primary endpoint, compared to placebo in patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and tumor resection. To. Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiation therapy (CRT): first results of the CheckMate 577 study Ann Oncol , 31 ( suppl 4 ) ( 2020 ) , pp. S1142 - S121

OncLive 20May2021 FDA Approves Adjuvant Nivolumab for Resected Esophageal or GEJ Cancer May 20, 2021. Kristi Rosa . The FDA has approved nivolumab for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, in patients have received neoadjuvant chemoradiotherapy. FDA 25 Jun 2021 According to a Bristol-Myers Squibb media release, based on the data from this study, Committee for Medicinal Products for Human Use (CHMP) of the EMA has recommended approval of Opdivo for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease. U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer See- Kelly RJ, Ajani JA, Kuzdzal J, et al. Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy: first results of the CheckMate 577 study . Poster presented at: 2020 European Society for Medical Oncology (ESMO) Virtual Congress. September 19-21, 2020 OPDIVO (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received.

CheckMate 577 is the first trial to demonstrate the

An Investigational Immuno-therapy Study of Nivolumab or

Kelly RJ, Ajani JA, Kuzdzal J, et al. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. New England Journal of Medicine . 2021 Apr. 01. 384:1191-1203 FDA Approves Opdivo (nivolumab) as Adjuvant Treatment of Completely Resected Esophageal or Gastroesophageal Junction Cancer in Patients who have Received Neoadjuvant Chemoradiotherapy - May 20, 2021 FDA Approves Opdivo (nivolumab) in Combination with Cabometyx (cabozantinib) as First-line Treatment for Patients with Advanced Renal Cell. Kelly RJ, Ajani JA, Kuzdzal J, et al. Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy: first results of the CheckMate 577 study. Poster presented at: 2020 European Society for Medical Oncology (ESMO) Virtual Congress. September 19-21, 2020 Recently, adjuvant nivolumab was also shown to confer benefit in patients with resected esophageal cancer following neoadjuvant chemoradiation. Now in EA2174, we look to take this a step further by evaluating the role of immunotherapy in the peri-operative setting CheckMate -577 is a Phase 3 randomized, multi-center, double-blind study evaluating Opdivo as an adjuvant therapy in patients with resected esophageal or gastroesophageal junction (GEJ) cancer who.

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo ® (nivolumab, injection for intravenous use) for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT). 1 The approval is based on. Adjuvant treatment with nivolumab in the CheckMate -577 trial doubled patients' time without disease recurrence, representing the first adjuvant treatment advancement for these patients with esophageal or gastroesophageal junction cancer Approximately 50% of patients with esophageal or gastroesophageal junction cancer who undergo neoadjuvant chemoradiation therapy followed by tumor resection will have disease recurrence within four years, and among those who do not respond completely to neoadjuvant treatment, recurrence will occur sooner, said Ronan J. Kelly M.D., MBA.

Adjuvant Nivolumab Improves DFS in Resected Esophageal

The use of adjuvant nivolumab was associated with a 31% reduction in the risk of recurrence or death. Patients with esophageal carcinoma (60%) predominated over patients with GEJ tumors (40%) and the benefit of using adjuvant nivolumab was better expressed in esophageal cancer (HR = 0.61) than in GEJ tumors (HR = 0.87 )

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