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Association details:
| Biomarker: | HER-2 negative |
|---|---|
| Cancer: | Gastric Cancer |
| Drug: | Opdivo (nivolumab) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
Preferred Regimens...HER2 overexpression negative...Fluoropyrimidine (fluorouracil or capecitabine), oxaliplatin, and nivolumab (PD-L1 CPS ≥5) (category 1)
Secondary therapy:
5-fluorouracil + oxaliplatin; capecitabine + oxaliplatin
Source:
Title:
Nivolumab plus chemotherapy versus placebo plus chemotherapy in patients with HER2-negative, untreated, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer (ATTRACTION-4): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial
Published date:
02/01/2022
Excerpt:
….median progression-free survival at a prespecified interim analysis was 10·45 months (95% CI 8·44–14·75) in the nivolumab plus chemotherapy group….Nivolumab combined with oxaliplatin-based chemotherapy significantly improved progression-free survival, but not overall survival, in Asian patients with untreated, HER2-negative, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer...
Secondary therapy:
Chemotherapy
DOI:
10.1016/S1470-2045(21)00692-6
Trial ID:
Source:
Title:
LBA7_PR - Nivolumab plus chemotherapy versus chemotherapy alone in patients with previously untreated advanced or recurrent gastric/gastroesophageal junction (G/GEJ) cancer: ATTRACTION-4 (ONO-4538-37) study
Published date:
09/19/2020
Excerpt:
ATTRACTION-4 is a randomized, multicenter, phase 2/3 study to evaluate the efficacy and safety of nivolumab plus chemotherapy vs. chemotherapy as first-line treatment in patients with HER2-negative, advanced or recurrent G/GEJ cancer. Here we report the results of the double-blind phase III part....Patients were randomized 1:1 to receive nivolumab plus chemotherapy (N+C, S-1 plus oxaliplatin or capecitabine plus oxaliplatin) or placebo plus chemotherapy (C)....PFS was continuously longer in N+C than in C. ORR was higher in N+C than in C (57.5 vs. 47.8%; p=0.0088).
Secondary therapy:
oxaliplatin + gimeracil/oteracil/tegafur
Trial ID:
Source:
Title:
A Study of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Participants With Advanced or Metastatic Gastric Cancer
Excerpt:
...- Diagnosis of HER2 negative advanced or metastatic HER2-negative GC, GEJ adenocarcinoma or EAC whose tumours express PD-L1 with a CPS ≥ 5...
Trial ID:
Source:
Title:
Dose Escalation of DF6002 in Patients With Advanced Solid Tumors, and Expansion in Selected Indications
Excerpt:
...Histologically confirmed unresectable, locally advanced or metastatic triple negative breast cancer.PD-L1 status, HER2-negative, estrogen receptor-negative, and progesterone receptor-negative status must be evaluated by local institutions before enrolment per guidelines of the American Society of Clinical Oncology and the College of American Pathologists....
More C2 evidence
Source:
Title:
A clinical study on the perioperative treatment of locally advanced gastric and gastroesophageal junction adenocarcinoma with Nivolumab combined with CapeOx regimen
Excerpt:
...Patients with gastric or gastroesophageal junction adenocarcinoma diagnosed by endoscopy and pathology, HER2 negative, clinical stage cT3-4N+M0; 4. ...
Trial ID:
Source:
Title:
Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer
Excerpt:
...- HER2-negative status...
Trial ID:
Source:
Title:
mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
Excerpt:
...HER2 negative adenocarcinoma as defined by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (Bartley et al., Journal of Clinical Oncology [JCO] 2017) with known PD-L1 CPS (Any CPS is allowed, but should be known prior to registration) -...
Trial ID:
