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Association details:
| Biomarker: | MSI-H/dMMR |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | Tevimbra (tislelizumab) (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...
Trial ID:
Source:
Title:
Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors
Excerpt:
Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR.
Trial ID:
Source:
Title:
1057P - Long-term follow-up of a phase II study of tislelizumab (TIS) monotherapy in patients (pts) with previously treated, locally advanced, unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors
Published date:
10/16/2023
Excerpt:
Eligible adult participants had previously treated, locally advanced, unresectable/metastatic solid tumors with centrally confirmed MSI-H/dMMR...ORR was 49.3%...With a minimum of 28.1 months’ follow-up, TIS-treated pts with previously treated MSI-H/dMMR solid tumors demonstrated a higher ORR compared with previous analysis, and durable improvements in DoR, PFS, and OS, with no new safety signals.
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:
05/26/2022
Excerpt:
Eligible adult pts with previously treated, locally advanced, unresectable/metastatic histologically confirmed MSI-H/dMMR solid tumors...were enrolled…. 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)....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:
A phase 2 study of tislelizumab monotherapy in patients with previously treated, locally advanced unresectable ormetastatic microsatellite instability-high/mismatch repair deficient solid tumors.
Published date:
05/19/2021
Excerpt:
Tislelizumab achieved statistical significance and demonstrated clinically meaningful improvement in ORR in pts with previously treated locally advanced unresectable or metastatic MSI-H or dMMR solid tumors.
DOI:
10.1200/JCO.2021.39.15_suppl.2569
Trial ID:
