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Association details:
| Biomarker: | EGFR negative |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Tyvyt (sintilimab) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
To evaluate sindillizumab first-line in a single-arm Phase II study of PD-L1≥50% advanced non-small cell lung cancer
Excerpt:
...Patients with negative EGFR-sensitive mutation and ALK fusion gene test results by genetic testing; 5. ...
Trial ID:
Source:
Title:
WS08.09 - Sintilimab versus Pembrolizumab as Monotherapy or in Combination with Chemotherapy for Treatment Naïve Metastatic Non-small Cell Lung Cancer
Published date:
07/12/2022
Excerpt:
Until Dec. 31st 2021, the median follow-up was 5.6 months. ORR was 57.6% in sintilimab arms vs. 42.9% in pembrolizumab arms, and the confirmed ORR was 45.5% (15/33) vs. 28.6% (10/35), separately. (Figure 1). The disease control rate was 87.9% vs. 91.4% in sintilimab and pembrolizumab arms, respectively. The primary endpoint was reached, with 15 confirmed PRs achieved in sintilimab arms. Survival data was still immature. Treatment-related adverse events were comparable between sintilimab and pembrolizumab arms.This head-to-head study of PD-1 inhibitors suggested comparable tumor response and similar safety profile between sintilimab and pembrolizumab.
Source:
Title:
Sintilimab, SBRT and GM-CSF for Advanced NSCLC: Safety Run-in Results of a Prospective, Multicenter, Phase II Trial
Published date:
08/18/2021
Excerpt:
This is a prospective, multi-center, phase II study (NCT04106180). Eligible patients (pts) were advanced EGFR/ALK negative NSCLC pts who had failed first-line standard chemotherapy….Partial response occurred in 7 and stable disease in 5 pts, the confirmed ORR was 35%. Median PFS was 6.9 (95% CI, 2.76-NA) months with 12 events and 1-year OS rate was 75.0% (95% CI, 58.2%-96.6%)....Triple combination of Sintilimab, SBRT and GM-CSF is safe and shows promising efficacy as a novel second-line treatment for advanced EGFR/ALK negative NSCLC.
Trial ID:
