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Association details:
| Biomarker: | MSI-H/dMMR |
|---|---|
| Cancer: | Gastric Cancer |
| Drug: | Opdivo (nivolumab) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
08/29/2023
Excerpt:
Gastric Cancer: Preferred Regimens...MSI-H/dMMR tumors…Fluoropyrimidine (fluorouracil or capecitabine), oxaliplatin, and nivolumab…
Secondary therapy:
capecitabine + oxaliplatin; 5-fluorouracil + oxaliplatin
Title:
ONO Receives Approval of Opdivo® (Nivolumab) for Additional Indications of Unresectable Advanced or Recurrent Esophageal Cancer, and MSI-High Unresectable Advanced or Recurrent Colorectal Cancer in Japan for a Partial Change in Approved Items of Manufacturing and Marketing Approval
Excerpt:
Ono Pharmaceutical Co., Ltd....and Bristol-Myers Squibb...announced today that ONO received approval of Opdivo® (generic name: nivolumab) Intravenous Infusion (“Opdivo”), a human anti-human programmed cell death-1 (PD-1) monoclonal antibody in Japan for the following two additional indications, for a partial change in approved items of the manufacturing and marketing approval:...Microsatellite instability high (MSI-High) unresectable advanced or recurrent colorectal cancer that has progressed following chemotherapy...
Source:
Title:
A Phase Ib Trial to Evaluate the Safety and Efficacy of FMT and Nivolumab in Subjects With Metastatic or Inoperable Melanoma, MSI-H, dMMR or NSCLC
Excerpt:
...Subjects with a documented B-Raf (BRAF) mutation must have received the appropriate targeted therapy For MSI-H/dMMR patients -Histologically confirmed MSI-H/d...
Trial ID:
Source:
Title:
Phase Ib/II Study to Evaluate the Safety and Efficacy of Nivolumab in Combination With Paclitaxel in Epstein-Barr Virus(EBV)-Related, or Microsatellite Instability-High (MSI-H), or Programmed Cell Death Ligand 1 (PD-L1) Positive Advanced Gastric Cancer
Excerpt:
...Has documented EBV-related, MSI-high, or PD-L1 positive tumor in primary or metastatic tumor tissue 5....
Trial ID:
Less C2 evidence
Source:
Title:
The role of preoperative immune-chemotherapy in locally advanced resectable gastric cancer with microsatellite instability
Published date:
06/27/2023
Excerpt:
179 patients who received preoperative therapy were enrolled. Among all the patients, 17 (9.50%) were diagnosed with MSI-H tumors...but a combination of nivolumab + chemotherapy in patients with MSI-H gastric cancer shows a high rate of pathological response of any grade (100% of cases, TRG-1 to TRG-4) and pathological complete response (60% of cases, TRG-1).
Secondary therapy:
Chemotherapy
DOI:
10.1016/j.annonc.2023.04.089
Source:
Title:
Comparison of efficacy between immune checkpoint inhibitors and irinotecan-based chemotherapy as third-line treatment for patients with advanced gastric cancer: A Korean real-world multicenter study (KCSG ST22-06).
Published date:
05/25/2023
Excerpt:
We retrospectively reviewed patients with RMGC, whose third-line treatment started between July 2019 and June 2021 at 17 centers in South Korea. The ICI group included patients who received nivolumab or pembrolizumab...microsatellite instability-high (MSI-H)/mismatch repair-deficient (MMR-D) tumor was an independent prognostic factor for superior OS. The ICI group showed significantly longer OS than the irinotecan-based chemotherapy group in patients without peritoneal metastasis [HR 0.54 (95% CI 0.30-0.99); P=0.047)].
DOI:
10.1200/JCO.2023.41.16_suppl.e16047
Source:
Title:
Prognostic factors to predict the survival in patients with advanced gastric cancer who receive later-line nivolumab monotherapy-The Asahikawa Gastric Cancer Cohort Study (AGCC)
Published date:
11/29/2021
Excerpt:
The median OS was 7.5 (95% CI, 4.8-10.2) months and the response rate was 18.6%....The responders were aged and were frequently diagnosed with intestinal type gastric cancer, including patients with a HER2-positive status (27.3%) or microsatellite instability-high (27.3%) status....The regional cohort study of nivolumab monotherapy for gastric cancer patients revealed prognostic factors and a nomogram was developed that could predict the probability of survival.
DOI:
10.1002/cam4.4461
Source:
Title:
Matched therapies for advanced gastric cancer based on genotype: A real-world study in China.
Published date:
05/19/2021
Excerpt:
...6 (20%) dMMR/MSI-H/TMB-H (received sintilimab, pembrolizumab, tislelizumab or nivolumab, combined with antivascular or not, cohort C)...In cohort C, ORR was 17% (1/6), DCR was 67% (4/6), mPFS and mOS was 1.9 months and 6.8 months, respectively.
DOI:
10.1200/JCO.2021.39.15_suppl.e16098
Source:
Title:
CT159 - Open label, single-arm, multi-center phase Ib/II study to evaluate the safety and efficacy of nivolumab in combination with paclitaxel in Epstein-Barr virus (EBV)-related, or microsatellite instability-high (MSI-H), or programmed cell death ligand 1 (PD-L1) positive advanced gastric cancer (AGC)
Published date:
03/10/2021
Excerpt:
47 pts with either EBV-related, deficient mismatch repair (dMMR)/MSI-H or PD-L1 positive were enrolled….In patients with measurable lesions (n=33), ORR was 24% (CR 9%, PR 15%) and DCR was 39%....Combination of Nivo and PTX demonstrated antitumor activity with manageable toxicity profiles as second-line treatment for AGC.
Secondary therapy:
paclitaxel
Trial ID:
Source:
Title:
Multicentre biomarker cohort study on the efficacy of nivolumab treatment for gastric cancer
Published date:
07/03/2020
Excerpt:
...patients with unresectable or recurrent GC and prior or scheduled treatment with nivolumab as third-line or higher therapy between September 2017 and February 2019 were collected from 23 institutions. The tumour-positive score (TPS) and combined positive score (CPS) of PD-L1 expression and mismatch repair (MMR) were analysed by immunohistochemistry....The response rate was significantly higher in patients with performance status (PS) 0–1 (P = 0.026), non-peritoneal metastasis (P = 0.021), PD-L1 TPS ≥ 1 (P = 0.012), CPS ≥ 5 (P = 0.007) or ≥ 10 (P < 0.001) or MMR deficiency (P < 0.001).
DOI:
https://doi.org/10.1038/s41416-020-0975-7
Source:
Title:
Real-world efficacy and biomarker of nivolumab for advanced gastric cancer.
Published date:
01/23/2020
Excerpt:
PD-L1 expression of tumor specimens defined as tumor positive score (TPS) and combined positive score (CPS) and mismatch repair (MMR) were analyzed by immunohistochemistry....Patients with CPS≥10 and MMR deficiency showed significantly better progression-free (P = 0.005, P = 0.001) and overall survivals (P = 0.005, P = 0.002).
Source:
Title:
Marked improvement of oral intake with nivolumab monotherapy in a patient with microsatellite instability-high gastric cancer with insufficient oral intake
Published date:
11/19/2020
Excerpt:
A 76‐year‐old woman presented to our hospital with a stomachache...a case of marked improvement of oral intake by third‐line nivolumab monotherapy in a patient with MSI‐H gastric cancer with insufficient oral intake...she achieved a complete improvement of oral intake with nivolumab and had a complete tumor response after nivolumab monotherapy.
DOI:
https://doi.org/10.1002/ccr3.3399
Source:
Title:
Clinical case of the neoadjuvant treatment with nivolumab in a patient with microsatellite unstable (MSI-H) locally advanced gastric cancer
Published date:
09/22/2020
Excerpt:
...we considered feasible to offer preoperative nivolumab to a patient with T3N1M0 MSI-H GC. The patient experienced a reduction of the tumour size and the analysis of surgical material revealed complete elimination of tumour cells.
DOI:
10.1136/bcr-2020-236144
