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Association details:
| Biomarker: | PD-L1 overexpression |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Tevimbra (tislelizumab-jsgr) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
CT039 - Results from RATIONALE 303: A global phase 3 study of tislelizumab (TIS) vs docetaxel (TAX) as second- or third-line therapy for patients with locally advanced or metastatic NSCLC
Published date:
03/10/2021
Excerpt:
Overall, 805 pts were randomized (n=535, TIS; n=270, TAX)...With a 19-mo median follow-up (441 OS events), median OS ITT was significantly longer in Arm A vs B (17.2 vs 11.9 mo; HR=0.64 [95% CI: 0.53, 0.78]; P<.0001). OS benefit was also observed in the PD-L1 high analysis set (19.1 vs 11.9 mo; HR=0.52 [95% CI: 0.38, 0.71])...RATIONALE 303 demonstrated that, as 2 or 3L therapy in pts with advanced NSCLC, TIS was tolerable and prolonged OS by 5-7 mo with improved PFS and ORR...
Trial ID:
Source:
Title:
BeiGene Announces that RATIONALE 303 Trial of Tislelizumab in Non-Small Cell Lung Cancer Met the Primary Endpoint of Overall Survival at Interim Analysis
Published date:
11/17/2020
Excerpt:
BeiGene, Ltd....today announced that the RATIONALE 303 trial of its anti-PD-1 antibody tislelizumab versus docetaxel in the second- or third-line setting in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)...The primary endpoint of the trial is OS in all patients (the ITT population) and in patients with high PD-L1 expression...met its primary endpoint of overall survival (OS) in the intention-to-treat (ITT) patient population at the planned interim analysis, as recommended by the independent Data Monitoring Committee (DMC).
Trial ID:
Source:
Title:
Comparison of Efficacy and Safety of Anti-PD-1 Antibody BGB-A317 Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With NSCLC
Excerpt:
With severe underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse that may affect the explanation of drug toxicity or AEs or result in impaired compliance with study conduct.
Trial ID:
Source:
Title:
P2.04-33 Single-Agent Tislelizumab, an Anti-PD-1 Antibody: Results from a Phase 1 Expansion Cohort in NSCLC Patients
Published date:
10/01/2019
Excerpt:
A total of 49 patients with NSCLC...received tislelizumab....Median OS was 15.1 months (95% CI: 4.2, NR) for patients with PD-L1+ NSCLC and 11.2 months (95% CI: 6.1, NR) for patients with PD-L1–NSCLC....Tislelizumab was generally well tolerated and demonstrated antitumor activity in NSCLC patients.
DOI:
10.1016/j.jtho.2019.08.1538
Trial ID:
Source:
Title:
Use of PD-1 inhibitor tislelizumab in the treatment of advanced pulmonary sarcomatoid carcinoma: A case report
Published date:
12/24/2021
Excerpt:
...IHC showed that PD-L1 was strongly expressed (tumor proportion score [TPS]: 60%, combined positive score [CPS]:90) (Figure 2). The PD-1 antibody tislelizumab 200 mg q. 21 days was implemented on December 29, 2020. One cycle later, the patient's cough and breathlessness had reduced, and chest CT scan showed that the mass (4.1 x 3.9 cm) in the hilus of the right upper lobe of the lung and nodules in the subpleural region of the right lung had shrunk significantly, and the pleural effusion had disappeared. Tislelizumab monotherapy was maintained with a partial response (PR) achieved and no notable side effects occurred. Seven cycles later, the lesions had gradually shrunk to 1.6 x 1.3 cm and remained stable until now.
DOI:
https://doi.org/10.1111/1759-7714.14290
