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 session1291P - Real-world treatment and overall survival (OS) in patients (pts) with ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) in England between 2014 and 2023Presenter: Alastair Greystoke Session: Poster session 05 1292P - A national real-world analysis of ROS1+ metastatic non-small cell lung cancer patients management (explore ALK, cohort 2, GFPC 03-2019)Presenter: Gaelle Rousseau Bussac Session: Poster session 05 1293P - Mechanisms of resistance to selpercatinib in RET activated NSCLC and MTC from the LIBRETTO-001 trialPresenter: Ben Solomon Session: Poster session 05 1294P - Non-adenocarcinoma histology in patients with RET+ lung cancer: Response to RET-inhibitors and survival from the RET-MAP registryPresenter: Arianna Marinello Session: Poster session 05 1295P - EP0031 a next-generation selective RET inhibitor (SRI): Correlation of molecular and clinical responses in patients with RET alteration positive solid tumours naïve to or following prior SRIPresenter: Elena Garralda Session: Poster session 05 1296P - A phase II study to evaluate the efficacy and safety of BB-1701 in advanced or metastatic NSCLC patients with HER2 mutation/amplificationPresenter: Caicun Zhou Session: Poster session 05 1297P - A phase II study of pyrotinib combined with apatinib in first-line treatment of advanced non-small cell lung cancer patients with primary HER-2 mutations/amplificationPresenter: Wenxin Jiang Session: Poster session 05 1299P - First-line immunotherapy versus BRAF and MEK inhibitors for patients with BRAF V600E mutant metastatic non-small cell lung cancerPresenter: Alessandro Di Federico Session: Poster session 05 1300P - Treatment sequences in BRAF-V600-mutant non-small cell lung cancer: First-line targeted therapy versus first-line (chemo-) immunotherapyPresenter: Marcel Wiesweg 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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