Abstract 1318P
Background
Sugemalimab (suge) plus platinum-based chemotherapy (chemo) significantly prolonged OS and PFS compared with placebo (pbo) plus chemo in patients (pts) with treatment-naïve, stage IV NSCLC in GEMSTONE-302, a randomized, double-blind, phase 3 study. We report the updated results with approximately 4 years of follow-up.
Methods
Eligible pts were randomized 2:1 to receive suge (1200 mg, IV) or pbo Q3W, plus chemo (squamous [sq] NSCLC: carboplatin+paclitaxel; non-squamous [nsq] NSCLC: carboplatin+pemetrexed) Q3W for up to 4 cycles, followed by maintenance therapy (sq-NSCLC: suge/pbo; nsq-NSCLC: suge/pbo+pemetrexed) for up to 35 cycles. Pts were allowed to continue treatment beyond 35 cycles at the discretion of investigators. Pts in the pbo group were allowed to cross over to receive suge monotherapy upon progressive disease. The primary endpoint was investigator-assessed PFS (INV-PFS), and OS was a key secondary endpoint.
Results
Among 479 pts randomized (suge+chemo, n=320; pbo+chemo, n=159), median time from randomization to data cutoff (May 15, 2023) was 43.5 and 43.0 months, respectively. In the ITT population, median OS was 25.2 months in suge+chemo group versus 16.9 months in pbo+chemo group (HR=0.68 [95% CI, 0.54-0.85]), with estimated 4-year OS rates of 32.1% vs 17.3%. Median INV-PFS was 9.0 months vs 4.9 months (HR=0.49 [95% CI, 0.39-0.60]). Sustained PFS and OS benefits were observed across all subgroups including different tumor histologies and PD-L1 expression levels (Table). Safety profile was consistent with previously reported results.
Table: 1318P
| ITT N=479 | TPS≥50% n=151 | TPS 1-49% n=140 | TPSConclusionsAfter around 4 years of follow-up, suge plus chemo continued to demonstrate prolonged OS and PFS versus pbo plus chemo, irrespective of tumor histology or PD-L1 expression level, without observing increased toxicity. These long-term data continue to support use of suge plus chemo as a standard first-line treatment for metastatic NSCLC. Clinical trial identificationNCT03789604. Editorial acknowledgementMedical writing and editorial assistance were provided by Yuanyuan Feng from CStone Pharmaceuticals. Legal entity responsible for the studyCStone Pharmaceuticals Co., Ltd. FundingCStone Pharmaceuticals. DisclosureC. Zhou: Financial Interests, Personal, Advisory role, Consulting fees: Innovent Biologics, Qilu, Hengrui, TopAlliance Biosciences Inc.; Financial Interests, Personal, Other, Payment or honoraria from: Eli Lilly China, Sanofi, Boehringer Ingelheim, Roche, Merck Sharp & Dohme, Qilu, Hengrui, Innovent Biologics, Alice, C-Stone, LUYE Pharma, TopAlliance Biosciences Inc., Amoy Diagnostics, AnHeart. J. Wang, Q. Wang, B. Wang, H. Dai: Financial Interests, Personal, Full or part-time Employment: CStone Pharmaceuticals; Financial Interests, Personal, Stocks/Shares: CStone Pharmaceuticals. J.J. Yang: Financial Interests, Personal, Full or part-time Employment: CStone Pharmacetuticals; Financial Interests, Personal, Member of Board of Directors: CStone Pharmacetuticals; Financial Interests, Personal, Officer: CStone Pharmacetuticals; Financial Interests, Personal, Stocks/Shares: CStone Pharmacetuticals. All other authors have declared no conflicts of interest. Resources from the same session1334P - PET/CT-guided immune checkpoint blocker treatment discontinuation vs treatment continuation in lung cancer long-term responders: A National Network Genomic Medicine Lung Cancer Germany (nNGM) analysisPresenter: Nikolaj Frost Session: Poster session 05 1335P - The relationship between nivolumab pharmacokinetics and cancer cachexia biomarkers in patients with metastatic non-small cell lung cancer (NSCLC)Presenter: Maaike Hofman Session: Poster session 05 1338P - TP53 truncating and missense mutations are linked to differential response to checkpoint blockade in patients with advanced non-small cell lung cancer (NSCLC)Presenter: Fabrizio Citarella Session: Poster session 05 1339P - Impact of KRAS, STK11, and KEAP1 co-mutations on survival outcome and response to chemoimmunotherapy in patients with metastatic NSCLCPresenter: Utsav Joshi Session: Poster session 05 1341P - Exploring the role of the gut microbiome on the efficacy of ipilimumab and nivolumab in advanced non-small cell lung cancer: A prospective observational studyPresenter: Yuki Katayama Session: Poster session 05 1342P - The efficacy of pembrolizumab vs nivolumab plus ipilimumab in metastatic NSCLC in relation to PD-L1 and TMB statusPresenter: Walid Shalata Session: Poster session 05 1343P - Adding histology-driven chemotherapy (ChT) to overcome primary resistance to first-line immunotherapy (ICI) in patients (pts) with advanced non-small cell lung cancer (aNSCLC) with PD-L1 ≥50%Presenter: Andrea De Giglio Session: Poster session 05 1344P - Plasma proteomics indicated predictive biomarkers for immuno-chemotherapy in stage IIIB-IV non-small cell lung cancer without EGFR/ALK alterationsPresenter: Zhihuang Hu Session: Poster session 05 This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. For more detailed information on the cookies we use, please check our Privacy Policy.
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