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 session1281P - Impact of common germline variants on the toxicity profile and pharmacokinetics of alectinibPresenter: Niels Heersche Session: Poster session 05 1282P - Activity of brigatinib based on genomic alterations detected on ctDNA at baseline and at progression in ALK inhibitor-naïve advanced ALK+ NSCLC from the ALTA-1L trialPresenter: Laura Mezquita Session: Poster session 05 1283P - Advanced ALK-positive non-small cell lung cancer (NSCLC) patients: Real-world treatment patterns and outcomes from the Italian biomarker ATLAS databasePresenter: Maria Lucia Reale Session: Poster session 05 1284P - Clinical utility of liquid biopsy for non-small cell lung cancer patients with ALK fusion variants treated with brigatinibPresenter: Lucía Robado de Lope Session: Poster session 05 1285P - Deep learning prediction of response to advanced-generation ALK inhibitors (aALKi) in ALK-rearranged advanced NSCLC (aNSCLC) patients using digital pathologyPresenter: Amos Stemmer Session: Poster session 05 1286P - Explore-ALK (GFPC 03-2019): A real-world prospective, multicenter study of advanced ALK rearranged non-small cell lung cancer patientsPresenter: Chantal Decroisette Session: Poster session 05 1287P - Predictive value of weight and BSA in assessing toxicity during ALK-TKIs in non-small cell lung cancerPresenter: Beatriz Jimenez Munarriz Session: Poster session 05 1288P - Clinical impact and landscape of heterogeneous ALK resistance mutations (muts) after comprehensive genomic profiling (CGP)Presenter: Paul Hofman Session: Poster session 05 1289P - Pooled efficacy and safety from 2 pivotal phase II trials of taletrectinib in patients (Pts) with advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC)Presenter: Maurice Pérol Session: Poster session 05 1290P - Updated efficacy and safety of entrectinib in patients (pts) with locally advanced/metastatic ROS1 fusion-positive (fp) NSCLCPresenter: Matthew Krebs 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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