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 session1324P - Durvalumab in treatment-naive, stage IV non-small cell lung cancer (NSCLC) patients (pts), with ECOG performance status (PS) 2-3 and high PD-L1 tumour expression: Results of IFCT-1802 SAVIMMUNE phase II trialPresenter: Valerie Gounant Session: Poster session 05 1325P - TRIDENT: Machine learning (ML) multimodal signatures to identify patients that would benefit most from tremelimumab (T) addition to durvalumab (D) + chemotherapy (CT) with data from the POSEIDON trialPresenter: Ferdinandos Skoulidis Session: Poster session 05 1326P - Clinical and genomic characteristics of advanced non-small cell lung cancer (aNSCLC) patients (pts) with long-term response to first-line (1L) immunotherapy: A real-world studyPresenter: Sameh Daher Session: Poster session 05 1327P - Lung immune prognostic index (LIPI) as a guide for addition of chemotherapy in immunotherapy in elderly patients (Pts) with non-small cell lung cancer (NSCLC): NEJ057Presenter: OSAMU HONJO Session: Poster session 05 1328P - Dynamic blood immune-inflammatory and radiomic profiling to decode distinct patterns of acquired resistance to immunotherapy in NSCLC patientsPresenter: Giulia Mazzaschi Session: Poster session 05 1330P - Phase II study of pembrolizumab (pemb) plus plinabulin (plin) and docetaxel (doc) for patients (pts) with metastatic NSCLC after failure on first-line immune checkpoint inhibitor alone or combination therapy: Initial efficacy and safety results on Immune Re-sensitizationPresenter: Yan Xu Session: Poster session 05 1331P - Efficacy, innovativeness, clinical trials, endpoints, and price of drugs with FDA approval for non-small cell lung cancer (NSCLC)Presenter: Christoph Michaeli Session: Poster session 05 1332P - Effects of immune checkpoint inhibitors for EGFR-wild/ALK-negative NSCLC patients with untreated brain metastasesPresenter: Toshihiko Iuchi Session: Poster session 05 1333P - Prognostic value of circulating nucleosomes during treatment with or without immunotherapy in non-small lung cancer (NSCLC): Results from the NUCLEO-lung studyPresenter: Léa Payen 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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