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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Tevimbra (tislelizumab-jsgr) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
BeiGene Receives European Commission Approval for Tislelizumab as Treatment for Non-Small Cell Lung Cancer
Published date:
04/23/2024
Excerpt:
...announced that the European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use.
Source:
Title:
China NMPA Approves Tislelizumab as Second- or Third-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Published date:
01/06/2022
Excerpt:
BeiGene...today announced that the China National Medical Products Administration (NMPA) has approved BeiGene’s anti-PD-1 antibody tislelizumab as a second- or third-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)....The approval of tislelizumab was supported by clinical results from a randomized, open-label, global Phase 3 trial RATIONALE 303 (NCT03358875) comparing tislelizumab to docetaxel in the second- or third-line setting in patients with locally advanced or metastatic NSCLC who have progressed on prior platinum-based chemotherapy.
Source:
Title:
China NMPA Approves Tislelizumab in Non-Small Cell Lung Cancer and Hepatocellular Carcinoma
Published date:
06/23/2021
Excerpt:
BeiGene, Ltd...today announced that the China National Medical Products Administration (NMPA) has granted its anti-PD-1 antibody tislelizumab approval for the first-line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC)....The approval of tislelizumab for the first-line treatment of patients with advanced non-squamous NSCLC was supported by clinical results from a Phase 3 trial (NCT03663205) of tislelizumab in combination with pemetrexed and platinum chemotherapy (either carboplatin or cisplatin) in patients with stage IIIB or stage IV non-squamous NSCLC, compared to pemetrexed and platinum alone.
Secondary therapy:
cisplatin + pemetrexed; carboplatin + pemetrexed
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:
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 vs TAX regardless of histology or PD-L1 expression.
Trial ID:
Source:
Title:
1263P - Tislelizumab + chemotherapy vs chemotherapy alone as first-line treatment for locally advanced/metastatic nonsquamous NSCLC
Published date:
09/14/2020
Excerpt:
In this open-label phase 3 study (NCT03663205), Chinese pts were randomized 2:1 to receive tislelizumab 200 mg + platinum (carboplatin AUC 5 or cisplatin 75 mg/m2) + pemetrexed 500 mg/m2, followed by maintenance tislelizumab + pemetrexed (Arm A); pts in Arm B received platinum + pemetrexed and maintenance pemetrexed. Tislelizumab plus chemotherapy was generally well tolerated and demonstrated antitumor activity in pts with nsq-NSCLC.
Secondary therapy:
cisplatin + pemetrexed; carboplatin + pemetrexed
Trial ID:
