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Association details:
Biomarker:MSI-H/dMMR
Cancer:Rectal Cancer
Drug:Opdivo (nivolumab) (PD1 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
12/20/2020
Excerpt:
Rectal cancer:.Primary treatment...Consider ([nivolumab ± ipilimumab] or pembrolizumab [preferred]) (dMMR/MSI-H only)
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Colorectal Cancer)
New
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...
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Preoperative Chemoradiotherapy Plus Nivolumab Before Surgery in Microsatellite Stable and Microsatellite Instability-High Locally Advanced Rectal Cancer Patients

Published date:
01/21/2022
Excerpt:
In phase I, we investigated the feasibility of sequentially-combined CRT, 5 cycles of nivolumab, and radical surgery. In phase II, patients with microsatellite stable (MSS) and microsatellite instability-high (MSI-H) LARC were evaluated. A pathological complete response (pCR) was centrally confirmed in 30% (11/37; 90% CI, 18 %-44%) and 60% (3/5) of the MSS and exploratory MSI-H cohorts, respectively. PD-L1 expression and an elevated CD8/eTreg ratio were positive predictors in patients with MSS LARC.
Secondary therapy:
Chemotherapy
DOI:
10.1158/1078-0432.CCR-21-3213
Evidence Level:
Sensitive: C3 – Early Trials
Title:

SO-37 Short-term results of VOLTAGE-A: Nivolumab monotherapy and subsequent radical surgery following preoperative chemoradiotherapy in patients with microsatellite stability and microsatellite instability-high, locally advanced rectal cancer (EPOC 1504)

Published date:
07/08/2020
Excerpt:
Promising pCR rates of 30% and 60%, with mild toxicities, were shown in MSS and MSI-H LARC patients treated with nivolumab plus radical surgery after CRT, suggesting that it is a candidate therapy for the future non-surgical approach.
DOI:
https://doi.org/10.1016/j.annonc.2020.04.052
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Locally advanced rectal cancer receiving total neoadjuvant therapy combined with nivolumab: a case report and literature review

Published date:
05/26/2022
Excerpt:
A case of LARC with MSI-H was treated with TNT with nivolumab, resulting in pCR and complete radical resection. This result suggests that nivolumab in addition to TNT can be an option as a preoperative strategy for LARC with MSI-H.
Secondary therapy:
CAPOX; capecitabine
DOI:
10.1186/s12957-022-02624-z