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Efficacy and Safety of Sintilimab Plus Pemetrexed and Platinum as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC: a Randomized, Double-Blind, Phase 3 Study (Oncology pRogram by InnovENT anti-PD-1-11)
- Source :
- Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 15(10)
- Publication Year :
- 2020
-
Abstract
- Sintilimab, an anti-programmed death 1 antibody, plus pemetrexed and platinum had revealed promising efficacy for nonsquamous NSCLC in a phase 1b study. We conducted a randomized, double-blind, phase 3 study to compare the efficacy and safety of sintilimab with placebo, both in combination with such chemotherapy (ClinicalTrials.gov: NCT03607539).A total of 397 patients with previously untreated, locally advanced or metastatic nonsquamous NSCLC without sensitizing EGFR or anaplastic lymphoma kinase genomic aberration were randomized (2:1 ratio) to receive either sintilimab 200 mg or placebo plus pemetrexed and platinum once every 3 weeks for four cycles, followed by sintilimab or placebo plus pemetrexed therapy. Crossover or treatment beyond disease progression was allowed. The primary end point was progression-free survival (PFS) as judged by an independent radiographic review committee.As of November 15, 2019, the median follow-up was 8.9 months. The median PFS was significantly longer in the sintilimab-combination group than that in the placebo-combination group (8.9 versus 5.0 mo; hazard ratio, 0.482, 95% confidence interval [CI]: 0.362-0.643; p0.00001). The confirmed objective response rate was 51.9% (95% CI: 45.7%-58.0%) in the sintilimab-combination group and 29.8% (95% CI: 22.1%-38.4%) in placebo-combination group. The incidence of grade 3 or higher adverse events was 61.7% in sintilimab-combination group and 58.8% in placebo-combination group.In Chinese patients with previously untreated, locally advanced or metastatic nonsquamous NSCLC, the addition of sintilimab to chemotherapy with pemetrexed and platinum resulted in considerably longer PFS than with chemotherapy alone with manageable safety profiles.
- Subjects :
- 0301 basic medicine
Pulmonary and Respiratory Medicine
Oncology
medicine.medical_specialty
Lung Neoplasms
medicine.medical_treatment
Phases of clinical research
Pemetrexed
Placebo
Antibodies, Monoclonal, Humanized
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Clinical endpoint
Anaplastic lymphoma kinase
Humans
Platinum
Chemotherapy
business.industry
Hazard ratio
Confidence interval
030104 developmental biology
030220 oncology & carcinogenesis
business
medicine.drug
Subjects
Details
- ISSN :
- 15561380
- Volume :
- 15
- Issue :
- 10
- Database :
- OpenAIRE
- Journal :
- Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
- Accession number :
- edsair.doi.dedup.....b99d8e9dc5d07cd3f270abd0b55d3e84