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Found 1 Presentation For Request "1263p"

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1263P - Tislelizumab + chemotherapy vs chemotherapy alone as first-line treatment for locally advanced/metastatic nonsquamous NSCLC

Presentation Number
1263P
Speakers
  • Shun Lu (Shanghai, China)
Date
17.09.2020

Abstract

Background

Tislelizumab + chemotherapy has shown antitumor activity with a favorable tolerability profile in patients (pts) with histologically confirmed nsq-NSCLC.

Methods

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. Patients with known EGFR mutations or ALK rearrangement were ineligible. Patients were stratified by disease stage (IIIB vs IV) and tumor cell PD-L1 expression (<1% vs 1-49% vs ≥50%) assessed using the Ventana PD-L1 (SP263) Assay. Platinum was administered for 4-6 cycles at investigator’s discretion; crossover to tislelizumab was allowed. Treatment beyond progression was allowed for tislelizumab. The primary endpoint, progression-free survival per RECIST v1.1, was assessed by Independent Review Committee (PFSIRC); key secondary endpoints included overall survival (OS), objective response rate (ORRIRC), duration of response (DoRIRC), and safety/tolerability.

Results

As of 23 Jan 2020, 334 pts with nsq-NSCLC (A, n=223; B, n=111) were randomized; median study follow-up was 9.8 mo (95% CI: 9.23,10.38). PFSIRC was significantly longer with tislelizumab combination therapy than chemotherapy alone (P=0.0044; HR=0.645 [95% CI: 0.462, 0.902]; median PFSIRC, 9.7 mo vs 7.6 mo). ORRIRC was 57% (95% CI: 50.6, 64.0) and 37% (95% CI: 28.0, 46.6) in Arms A and B, respectively. Median DoR in Arm A was 8.5 mo (95% CI: 6.80, 10.58) and 6.0 mo (95% CI: 4.99, NE) in Arm B. A total of 221 pts (99.5%) had a treatment-related AE (TRAE) in Arm A; 185 pts (83%) had AEs related to tislelizumab. Of 140 pts (63%) with grade ≥3 TRAEs, 69 (31%) were considered related to tislelizumab by the investigator. In Arm B, 107 pts (97%) experienced ≥1 TRAE, of which 50 (46%) were grade ≥3. Across the entire study, four pts (1%) had fatal pneumonitis; 3 of which were considered possibly related to tislelizumab.

Conclusions

Tislelizumab plus chemotherapy was generally well tolerated and demonstrated antitumor activity in pts with nsq-NSCLC.

Clinical trial identification

NCT03663205.

Editorial acknowledgement

Writing and editorial assistance was provided by Stephan Lindsey, PhD, and Elizabeth Hermans, PhD (OPEN Health Medical Communications, Chicago. IL), and funded by the study sponsor.

Legal entity responsible for the study

This study was sponsored by BeiGene, Ltd.

Funding

BeiGene, Ltd.

Disclosure

S. Lu: Research grant/Funding (institution): AstraZeneca BMS, Hutchison, BMS, Heng Rui, and Roche; Speaker Bureau/Expert testimony: AstraZeneca, Roche, Hanseng; Advisory/Consultancy: AstraZeneca, Boehringer Ingelheim, Hutchison Medipharma, Simcere, and Roche. Y. Sun: Speaker Bureau/Expert testimony: AstraZeneca, Roche. Y. Bao, L. Liang: Full/Part-time employment: BeiGene, Ltd. All other authors have declared no conflicts of interest.

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