Meeting
2022 ASCO Annual Meeting
Outcomes of sintilimab plus pemetrexed and platinum (SPP) according to stage of disease in patients (pts) with locally advanced or metastatic nonsquamous NSCLC (AMnsqNSCLC) in the phase 3 ORIENT-11 study.
Authors
Yunpeng Yang
Medical Oncology Department, Sun Yat-sen University Cancer Center, Guangzhou, China
Yunpeng Yang , Zhehai Wang , Jian Fang , Qitao Yu , Baohui Han , Shundong Cang , Gongyan Chen , Xiaodong Mei , Zhixiong Yang , Victoria Jennifer Stefaniak , David Raymond Ferry , Yumin Zhao , Shuyan Wang , Yan Wang , Luyao Sun , Li Zhang
Organizations
Medical Oncology Department, Sun Yat-sen University Cancer Center, Guangzhou, China, Shandong Cancer Hospital & Institute, Jinan, China, Department of Thoracic Oncology II, Peking University Cancer Hospital & Institute, Beijing, China, Department of Medical Oncology of Ｒespirotary, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, China, Department of Respiration, Shanghai Chest Hospital, Shanghai, China, Department of Oncology, The Henan Province Hospital of Zhengzhou University, Zhengzhou, China, Department of Respiration, Harbin Medical University Cancer Hospital, Harbin, China, Department of Respiration, Anhui Provincial Hospital, Hefei, China, Department of Oncology, Affiliated Hospital of Guangdong Medical University, Zhanjiang, China, Eli Lilly and Company, Indianapolis, IN, Innovent Biologics Inc., Suzhou, China, Medical Science and Strategy Oncology, Innovent Biologics, Inc., Suzhou, China
Research Funding
Pharmaceutical/Biotech Company
Background: In ORIENT-11, first-line (1L) SPP improved progression-free survival (PFS), overall survival (OS), objective response rate (ORR) and duration of response (DoR) compared with placebo plus pemetrexed-platinum (PPP) in pts with AMnsqNSCLC. We report outcomes from ORIENT-11 (NCT03607539) for pts treated with SPP with stage III (b & c) compared with stage IV disease. Methods: Pts with treatment-naïve locally AMnsqNSCLC without sensitizing EGFR/ALK alterations were randomly assigned to SPP (n = 266) or PPP (n = 131), stratified by PD-L1 expression, platinum-chemotherapy and sex. Primary endpoint was PFS (RECIST v1.1). Secondary endpoints included OS, ORR, DoR and safety. Kaplan-Meier method was used to analyze median PFS, OS and DoR. Stratified Cox model was used to analyze the hazard ratio (HR) of SPP vs. PPP. Clopper-Pearson method was used to calculate the 95% confidence intervals (CI) of ORR for each group. Miettinen-Nurminen method was used to analyze 95% CI of ORR difference between SPP and PPP. Data cutoff for OS data was September 15, 2021, providing a median follow-up of 30.8 months. Cutoff for other data was November 15, 2019, providing a median follow-up of 8.9 months. Results: 21 pts (7.9%) receiving SPP had stage III disease and 245 pts (92.1%) had stage IV disease. Baseline sex, age and PD-L1 expression ≥1% were similar between subgroups (Table). There were differences between subgroups in number of pts receiving carboplatin and ECOG performance status at baseline. PFS, OS, ORR and DoR outcomes were comparable between pts with stage III and stage IV disease based on the ad-hoc analyses. Any-grade adverse events (AEs) (100.0% vs. 99.6%) and AEs of Grade ≥3 (57.1% vs. 62.0%) were similar in pts with stage III and stage IV disease. Conclusions: In ORIENT-11, outcomes for pts receiving SPP as 1L therapy in AMnsqNSCLC with stage III and stage IV disease were comparable. Clinical trial information: NCT03607539.
| Stage III disease (N = 21) | Stage IV disease (N = 245) | |
|---|---|---|
| Sex = male, n (%) | 15 (71.4) | 189 (77.1) |
| Age (> 60 years), n (%) | 11 (52.4) | 129 (52.7) |
| ECOG performance status = 1, n (%) | 13 (61.9) | 177 (72.2) |
| Platinum-chemotherapy = carboplatin, n (%) | 13 (61.9) | 180 (73.5) |
| PD-L1 expression level ≥1%, n (%) | 15 (71.4) | 166 (67.8) |
| PFS, median, m (95% CI) [HR SPP vs. PPP – 95% CI] | NR (8.3, NR) [0.17 – 0.06, 0.48] | 8.1 (7.1, 10.9) [0.53 – 0.39, 0.72] |
| OS, median, m (95% CI) [HR SPP vs. PPP – 95% CI] | NR (NR, NR) [0.30 – 0.10, 0.89] | 22.6 (19.1, 27.4) [0.67 – 0.51, 0.88] |
| ORR, % (95% CI) [SPP-PPP group difference – 95% CI] | 81.0 (58.1, 94.6) [43.9 – 9.4, 71.3] | 49.4 (43.0, 55.8) [19.7 – 9.1, 29.6] |
| DoR, median, m (95% CI) [HR SPP vs. PPP – 95% CI] | NR (NR, NR) [0.05 – 0.01, 0.43] | 8.5 (6.7, NR) [0.77 – 0.38, 1.55] |
N = number of pts in subgroup n = number of pts in category m = months NR = not reached
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Abstract Details
Session Type
Publication Only
Session Title
Lung Cancer—Non-Small Cell Metastatic
Track
Lung Cancer
Sub Track
Metastatic Non–Small Cell Lung Cancer
Clinical Trial Registration Number
NCT03607539
Citation
J Clin Oncol 40, 2022 (suppl 16; abstr e21157)
DOI
10.1200/JCO.2022.40.16_suppl.e21157
Abstract #
e21157
Abstract Disclosures
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