A Phase 2 Study of Tislelizumab in Combination With Platinum-Based Chemotherapy as First-line Treatment for Advanced Lung Cancer in Chinese Patients

Wang, Zhijie; Zhao, Jun; Ma, Zhiyong; Cui, Jiuwei; Shu, Yongqian; Liu, Zhe; Cheng, Ying; Leaw, Shiangjiin; Wu, Yue; Ma, Yan; Tan, Wei; Ma, Xiaopeng; Zhang, Yun; Wang, Jie

doi:10.1016/j.lungcan.2020.06.007

Cited by 35 publications

(39 citation statements)

References 37 publications

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“…The ORR was 77% (95% CI: 50.1-93.2). The median PFS and median OS in the SCLC cohort was 6.9 months and 15.6 months.IrAEs in the SCLC cohort included thyroid disorders (29.4%), pneumonitis (5.9%), and type 1 diabetes mellitus (5.9%) (52).…”

Section: Pd-1 Inhibitors and Iraes In Sclcmentioning

confidence: 99%

Immune Check Point Inhibitors and Immune-Related Adverse Events in Small Cell Lung Cancer

Hou

Zhou

et al. 2021

Front. Oncol.

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Small cell lung cancer (SCLC) is a malignant solid tumor. In recent years, although immune check point inhibitors (ICIs) have achieved important advances in the treatment of SCLC, immune-related adverse events (irAEs) have occurred at the same time during the therapeutic period. Some irAEs lead to dose reduction or treatment rejection. The immune microenvironment of SCLC is complicated, therefore, understanding irAEs associated with ICIs is of great importance and necessity for the clinical management of SCLC. However, the lack of comprehensive understanding of irAEs in patients with SCLC remains remarkable. This review aims to provide an up-to-date overview of ICIs and their associated irAEs in patients with SCLC based on present clinical data.

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Section: Pd-1 Inhibitors and Iraes In Sclcmentioning

confidence: 99%

Immune Check Point Inhibitors and Immune-Related Adverse Events in Small Cell Lung Cancer

Hou

Zhou

et al. 2021

Front. Oncol.

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“…8,9 Tislelizumab in combination with platinum-based chemotherapy as first-line treatment for advanced SCLC and NSCLC, including nsq-NSCLC, resulted in robust responses in a phase 2 study (BGB-A317-206 [NCT03432598]). 10 In a phase 3 study, addition of tislelizumab to chemotherapy resulted in significantly improved progression-free survival (PFS) compared with chemotherapy alone in patients with stage IIIB or IV squamous NSCLC (RATIONALE 307; BGB-A317-307 [NCT03594747]). 11 Here, we present the efficacy and safety data from a multicenter phase 3 study (RATIONALE 304; BGB-A317-304 [NCT03663205]) comparing tislelizumab plus platinum-based chemotherapy versus platinumbased chemotherapy alone in patients with advanced nsq-NSCLC.…”

Section: Introductionmentioning

confidence: 99%

Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial

Lü

Wang

et al. 2021

Journal of Thoracic Oncology

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Introduction: Tislelizumab, an anti-programmed cell death protein-1 antibody, was specifically engineered to minimize FcɣR macrophage binding to abrogate antibody-dependent phagocytosis. Compared with chemotherapy alone, tislelizumab plus chemotherapy may improve clinical outcomes in patients with advanced nonsquamous NSCLC (nsq-NSCLC). Methods:In this open-label phase 3 trial (RATIONALE 304; NCT03663205), patients with histologically confirmed stage IIIB or IV nsq-NSCLC were randomized (2:1) to receive either arm A: tislelizumab plus platinum (carboplatin or cisplatin) and pemetrexed every 3 weeks (Q3Ws) or arm B: platinum and pemetrexed alone Q3W during induction treatment, followed by intravenous maintenance

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“…13,14 In a phase 2 trial (NCT03432598), patients with advanced lung cancer had robust responses to first-line tislelizumab plus platinum-based chemotherapy. 15 Objective response rates were 44% (non-sq-NSCLC), 77% (SCLC), and either 80% or 67% (sq-NSCLC) depending on the chemotherapy backbone administered. In this article, we present the efficacy and safety results from the pivotal phase 3 trial of tislelizumab plus chemotherapy (RATIONALE 307) in patients with treatmentnaive advanced sq-NSCLC.…”

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confidence: 97%

Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non–Small-Cell Lung Cancer

et al. 2021

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IMPORTANCE This study demonstrates that tislelizumab in combination with chemotherapy is associated with improved progression-free survival (PFS) in patients with advanced squamous non-small-cell lung cancer (sq-NSCLC).OBJECTIVE To assess the efficacy and safety/tolerability of tislelizumab plus chemotherapy vs chemotherapy alone as first-line treatment for patients with advanced sq-NSCLC. DESIGN, SETTING, AND PARTICIPANTSThis open-label, randomized phase 3 clinical trial was conducted at 46 sites in China between July 2018 and June 2019 and included patients with treatment-naive, histologically confirmed stage IIIB/IV sq-NSCLC. The data cutoff for these analyses was December 6, 2019; data extraction occurred on January 7, 2020.INTERVENTIONS Patients were randomized (1:1:1) to receive 1 of the following regimens intravenously on a 21-day cycle: tislelizumab (200 mg, day 1) plus paclitaxel (175 mg/m 2 , day 1) and carboplatin (area under the concentration of 5, day 1) (arm A); tislelizumab plus nab-paclitaxel (100 mg/m 2 , days 1, 8, and 15) and carboplatin (arm B); and paclitaxel and carboplatin (arm C). Patients were stratified by disease stage and tumor programmed cell death 1 ligand 1 (PD-L1) expression (<1% vs 1%-49% vs Ն50%). MAIN OUTCOMES AND MEASURESThe primary end point was progression-free survival (PFS) assessed by an independent review committee (IRC). Secondary end points included overall survival, investigator-assessed (INV) PFS, IRC-assessed objective response rate (ORR), and IRC-assessed duration of response, as well as the incidence and severity of adverse events (AEs). RESULTSOverall, 355 patients (median [range] age, 62 [34-74] years; 330 men [91.7%]) with sq-NSCLC received treatment. After a median study follow-up of 8.6 months (95% CI, 8.1-9.0 months), IRC-assessed PFS was significantly improved with tislelizumab plus chemotherapy (arm A, 7.6 months; arm B, 7.6 months) vs chemotherapy alone (arm C, 5.5 months; hazard ratios were 0.524 (95% CI, 0.370-0.742; P < .001 [A vs C]) and 0.478 (95% CI, 0.336-0.679; P < .001 [B vs C]). Higher IRC-assessed ORR and longer IRC-assessed duration of response were observed in arms A (72.5%; 8.2 months) and B (74.8%; 8.6 months) vs C (49.6%; 4.2 months). No association was observed between PD-L1 expression and IRC-assessed PFS or ORR. Discontinuation of any treatment because of AEs was reported in 15 (12.5%; arm A), 35 (29.7%; arm B), and 18 (15.4%; arm C) patients. In each arm, the most common grade of 3 or greater AE was decreased neutrophil levels, which aligned with known chemotherapy toxic effects. Six treatment-related AEs leading to death occurred; however, no deaths were solely attributed to tislelizumab. CONCLUSIONS AND RELEVANCEIn this phase 3 randomized clinical trial, adding tislelizumab to chemotherapy was associated with significantly prolonged IRC-assessed PFS, higher IRC-assessed ORRs, and a manageable safety/tolerability profile in patients with advanced sq-NSCLC, regardless of PD-L1 expression.TRIAL REGISTRATION ClinicalTrials.gov Identifier:...

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A Phase 2 Study of Tislelizumab in Combination With Platinum-Based Chemotherapy as First-line Treatment for Advanced Lung Cancer in Chinese Patients

Cited by 35 publications

References 37 publications

Immune Check Point Inhibitors and Immune-Related Adverse Events in Small Cell Lung Cancer

Immune Check Point Inhibitors and Immune-Related Adverse Events in Small Cell Lung Cancer

Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial

Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non–Small-Cell Lung Cancer

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