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Association details:
| Biomarker: | MSI-H/dMMR |
|---|---|
| Cancer: | Colorectal Cancer |
| Drug: | Bavencio (avelumab) (PD-L1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Avelumab Plus 5-FU Based Chemotherapy as Adjuvant Treatment for Stage 3 MSI-High or POLE Mutant Colon Cancer
Excerpt:
...Locally confirmed defective mismatch repair (dMMR) tumour (as defined by the lack of staining on either the pre-operative biopsy samples or resection specimens of at least one of the following proteins: MLH1 (mutL homolog 1), MSH2 (mutS homologue 2), MSH6 (mutS homolog 6), PMS2 or centrally confirmed POLE exonuclease domain mutated tumour (in subjects -Gault formula (or local institutional standard method) 11....
Trial ID:
Source:
Title:
Standard Chemotherapy vs Immunotherapie in 2nd Line Treatment of MSI Colorectal Mestastatic Cancer
Excerpt:
...- MSI-H determined by immunohistochemistry (loss of expression of MLH1, MSH2, MSH6 and/or PMS2) or by molecular biology...
Trial ID:
More C2 evidence
Source:
Title:
Avelumab for MSI-H or POLE Mutated Metastatic Colorectal Cancer
Excerpt:
...Mismatch repair deficient or microsatellite instable (defined below), or POLE mutated tumors A....
Trial ID:
Source:
Title:
The benefit of adding drugs that stimulate the immune system to attack cancer to the standard treatment of colon cancer that has been removed surgically.
Excerpt:
...Locally confirmed defective mismatch repair (dMMR) tumour (as defined by the lack of staining on either the pre-operative biopsy samples or resection specimens of at least one of the following proteins: MLH1, MSH2, MSH6, PMS2) or centrally confirmed POLE exonuclease domain mutated tumour (in subjects <50 years old with pMMR tumours) 6. ...
Trial ID:
Less C2 evidence
Source:
Title:
Avelumab vs Standard Second-Line Chemotherapy in Patients With Metastatic Colorectal Cancer and Microsatellite Instability: A Randomized Clinical Trial
Published date:
08/03/2023
Excerpt:
Rates of PFS rates at 12 months were 31.2% (95% CI, 20.1%-42.9%) and 19.4% (95% CI, 10.6%-30.2%) in the avelumab and control groups, respectively, and 27.4% (95% CI, 16.8%-39.0%) and 9.1% (95% CI, 3.2%-18.8%) at 18 months....The SAMCO-PRODIGE 54 phase 2 randomized clinical trial showed, in patients with dMMR/MSI mCRC, better PFS and disease control duration with avelumab over standard second-line treatment, with a favorable safety profile.
DOI:
10.1001/jamaoncol.2023.2761
Trial ID:
Source:
Title:
LBA23 - Avelumab versus standard second-line treatment chemotherapy in metastatic colorectal cancer (mCRC) patients with microsatellite instability (MSI): The SAMCO-PRODIGE 54 randomised phase II trial
Published date:
09/05/2022
Excerpt:
In this national, multi-center, open-label phase 2 trial, pts with MSI/dMMR mCRC who progressed on oxaliplatin or irinotecan-based first-line therapy ± targeted agents, were randomized to receive standard second-line therapy or avelumab (10 mg/kg q2w)….avelumab was superior to chemotherapy +/- targeted agents with respect to PFS (p=0.025). 12- and 18-month PFS rates were 19% and 9% in arm A, and 31% and 27%, in arm B.
Trial ID:
Source:
Title:
A Phase II Study of Avelumab Monotherapy in Patients with Mismatch Repair-Deficient/Microsatellite Instability-High or POLE-Mutated Metastatic or Unresectable Colorectal Cancer
Published date:
04/24/2020
Excerpt:
The ORR was 24.2%, and all of the responders were dMMR/MSI-H. For 21 patients with MSI-H by PCR or NGS, the ORR was 28.6%....Avelumab displayed antitumor activity with manageable toxicity in patients with previously treated mCRC harboring dMMR/MSI-H.
DOI:
10.4143/crt.2020.218
