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Association details:
| Biomarker: | MSI-H/dMMR |
|---|---|
| Cancer: | Colorectal Cancer |
| Drug: | Tevimbra (tislelizumab-jsgr) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
China NMPA Approves Tislelizumab for Patients with Microsatellite Instability-High or Mismatch Repair-Deficient Solid Tumors
Published date:
03/11/2022
Excerpt:
BeiGene, Ltd...announced that the China National Medical Products Administration (NMPA) has granted conditional approval to BeiGene’s anti-PD-1 antibody, tislelizumab, for the treatment of adult patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, including...Patients with advanced colorectal cancer (CRC) who had been treated with fluoropyrimidine, oxaliplatin and irinotecan...
Trial ID:
Source:
Title:
Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Patients With Colorectal Cancer
Excerpt:
...Pathologically (histologically) confirmed diagnosis of potentially resectable Stage II or Stage III Colon/Rectal Cancer (CRC) with MSI-H confirmed by sponsor designated central laboratory or known MSI-H status by local laboratory....
Trial ID:
Source:
Title:
A Phase II Study of Tislelizumab as Adjuvant Therapy for Patients With Stage Ⅱ and Stage Ⅲ Colon Cancer and dMMR/MSI.
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)....
Trial ID:
More C2 evidence
Source:
Title:
Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced Tumors
Excerpt:
...Or any other solid tumors with known microsatellite instability-high or mismatch repair deficient status, such as colorectal cancer or pancreatic cancer 2....
Trial ID:
Source:
Title:
Chemotherapy Sequential Tislelizumab After Radical Resection in Patients With dMMR/MSI-H or POLE/POLD1 Mutations
Excerpt:
...3.dMMR/MSI-H or POLE/POLD1 gene mutation was confirmed by immunohistochemical PCR or NGS 4.0-1 physical fitness score by the Eastern United States Cancer Collaboration (ECOG)。 5....
Trial ID:
Source:
Title:
Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer
Excerpt:
...The tissue specimens are confirmed as MSI-H by PCR or NGS....
Trial ID:
Less C2 evidence
Source:
Title:
Updated analysis from a phase 2 study of tislelizumab (TIS) monotherapy in patients (pts) with previously treated, locally advanced, unresectable/metastatic microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) solid tumors.
Published date:
05/26/2022
Excerpt:
ORR-IRC was 39.1% (n = 18; 95% CI 25.1, 54.6) in colorectal cancer (CRC) pts (N = 46), 55.6% (n = 5; 95% CI 21.2, 86.3) in G/GEJC pts (N = 9), and 60.0% (n = 12; 95% CI 36.1, 80.9) in other pts (N = 20)….With a longer follow up time, TIS demonstrated clinically meaningful improvement in ORR in pts with MSI-H or dMMR solid tumors. TIS was generally well tolerated, with no new safety signals. These data support TIS as a new treatment option for this patient population.
DOI:
10.1200/JCO.2022.40.16_suppl.e14556
Trial ID:
Source:
Title:
Updated analysis from a phase 2 study of tislelizumab (TIS) monotherapy in patients (pts) with previously treated, locally advanced, unresectable/metastatic microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) solid tumors.
Published date:
01/18/2022
Excerpt:
In this updated efficacy analysis set, at a median follow-up of 15.2 months, ORRIRC was 46.7% (n = 35; 95% CI 35.1, 58.6) in all tumor types (1-sided p < 0.0001), including 5 complete responses (CR) and 30 partial responses (PR). ORRIRC was 39.1% (n = 18; 95% CI 25.1, 54.6) in colorectal cancer (CRC) pts (N = 46), 55.6% (n = 5; 95% CI 21.2, 86.3) in G/GEJC pts (N = 9), and 60.0% (n = 12; 95% CI 36.1, 80.9) in other pts (N = 20)....With a longer follow up time, TIS demonstrated clinically meaningful improvement in ORR in pts with MSI-H or dMMR solid tumors.
Trial ID:
