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 session1301P - BRAF-mutant metastatic non-small cell lung cancer: Real-world data from the Italian biomarker ATLAS databasePresenter: Alessandro Russo Session: Poster session 05 1302P - MET×MET bispecific antibody davutamig (REGN5093) for MET-altered advanced non-small cell lung cancer (aNSCLC): Update from a first-in-human (FIH) studyPresenter: Byoung Chul Cho Session: Poster session 05 1303P - METPRO: Evaluating prognostic value of c-Met protein overexpression and concurrent biomarker presencePresenter: Xiuning Le Session: Poster session 05 1304P - Investigator-initiated study of crizotinib in patients with MET activated advanced stage non-small cell lung cancer: A Canadian experiencePresenter: Abdulrahman Alghabban Session: Poster session 05 1305P - Sotorasib long-term clinical outcomes in pretreated KRAS G12C-mutated advanced NSCLC: Pooled analysis from the CodeBreaK clinical trialsPresenter: Ferdinandos Skoulidis Session: Poster session 05 1306P - Trametinib plus anlotinib in non-G12C KRAS-mutant non-small cell lung cancer: A single-center, open-label, single-cohort studyPresenter: Baohui Han Session: Poster session 05 Resources: Abstract 1308P - Molecular and clinical characteristics of patients with non-small cell lung cancer (NSCLC) harboring KRAS Q61 mutationsPresenter: Lea Ruge Session: Poster session 05 1309P - A genomic scar based signature (HRDsig) and biallelic BRCA alterations identify a homologous recombination deficiency (HRD) phenotype of non-small cell lung cancer (NSCLC) potentially actionable to the PARP inhibitor rucaparib: Post-hoc analysis of lung-MAP substudy S1900APresenter: Jonathan Riess Session: Poster session 05 1310P - SHR-A1921: A trophoblast cell-surface antigen 2 (TROP-2) targeted antibody-drug conjugate (ADC) for the treatment of advanced NSCLCPresenter: Jie Wang 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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