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 session1244P - Association of tumor-draining lymph node metastatic patterns and neoadjuvant immunochemotherapy effectiveness in resectable non-small cell lung cancerPresenter: Yu-heng Zhou Session: Poster session 05 1245P - Efficacy and safety of neoadjuvant immunotherapy plus chemotherapy vs. neoadjuvant chemotherapy in lung cancer treatment: A mixed method meta-analysis based on global randomized controlled trialsPresenter: Yiyang Li Session: Poster session 05 Resources: Abstract 1246P - PIT-3: A multicenter phase II trial of erlotinib induction followed by surgery in stage IIIA (N2) EGFR mutated non-small cell lung cancerPresenter: Kazuya Takamochi Session: Poster session 05 1247P - Radiotherapy (RT) patterns and factors associated with pneumonitis in PACIFIC-R, a real-world study of patients (pts) with Stage III unresectable non-small cell lung cancer (UR-NSCLC) treated with durvalumab (D) after chemoradiotherapy (CRT)Presenter: Andrea Riccardo Filippi Session: Poster session 05 1248P - Osimertinib (osi) after definitive chemoradiotherapy (CRT) in unresectable stage III epidermal growth factor receptor-mutated (EGFRm) NSCLC: LAURA China cohort analysisPresenter: Xiaorong Dong Session: Poster session 05 1249P - Health-related quality of life (HRQoL) at diagnosis for unresectable stage III NSCLC: Results from the French nationwide prospective study OBSTINATE (GFPC 06-2019)Presenter: Charles Ricordel Session: Poster session 05 1250P - Impact of systemic treatment on cardiac events following chemoradiotherapy in stage III lung cancer patientsPresenter: Judit Sanz Beltran Session: Poster session 05 1251P - Retrospective evaluation of inflammatory biomarkers in patients affected by unresectable stage III NSCLC: Final results of NEUTRALITY trialPresenter: Emanuela Olmetto Session: Poster session 05 1252P - Stage III non-small cell lung cancer (NSCLC) in France, characteristics treatments and survival results of French real-world dataPresenter: Olivier Molinier 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.
|