GILBERTO DE CASTRO JUNIOR

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Instituto do Câncer do Estado de São Paulo, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/24 - Laboratório de Oncologia Experimental, Hospital das Clínicas, Faculdade de Medicina - Líder

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search.filters.applied.f.dateIssued: 2023 × Assunto: Durvalumab ×

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  • conferenceObject
    AVANZAR: Phase III Study of Datopotamab Deruxtecan (Dato-DXd) plus Durvalumab plus Carboplatin as 1L Treatment of Advanced/mNSCLC
    (2023) AGGARWAL, C.; CHEEMA, P.; ARRIETA, O.; BONANNO, L.; BORGHAEI, H.; HU, Y.; KIM, D. -W.; CASTRO JUNIOR, G. de; HEPNER, A.; DENG, C.; RIEGO, M. Gonzalez del; KATO, T.
  • article 0 Citação(ões) na Scopus
    NEPTUNE China cohort: First-line durvalumab plus tremelimumab in Chinese patients with metastatic non-small-cell lung cancer
    (2023) CHENG, Ying; ZHOU, Qing; HAN, Baohui; FAN, Yun; SHAN, Li; CHANG, Jianhua; SUN, Si; FANG, Jian; CHEN, Yuan; SUN, Jianguo; WU, Gang; MANN, Helen; NAICKER, Kirsha; SHIRE, Norah; MOK, Tony; JR, Gilberto de Castro
    Objectives: The phase 3 NEPTUNE study (NCT02542293) evaluated first-line durvalumab plus tremelimumab (DT) versus chemotherapy for metastatic NSCLC. Prespecified exploratory analyses were conducted in an extended cohort enrolled in China. Materials and methods: Patients were randomized (1:1) to DT or standard chemotherapy, stratified by PD-L1 tumor cell (TC) expression (>= 25 % vs < 25 %), histology, and smoking history. The primary analysis for this cohort was overall survival (OS) in patients with PD-L1 TC < 1 %. Secondary analyses included OS and progression-free survival (PFS) in the ITT population and PD-L1 subgroups, and safety. No alpha was allocated to these cohort analyses (data cut-off, 21-September-2020). Results: 78 and 82 patients were randomized to DT and chemotherapy, respectively; 26 and 29 had PD-L1 TC < 1 % (median follow-up, 31.2 and 29.7 months [censored patients]). Among patients with PD-L1 TC < 1 %, OS favored DT versus chemotherapy (HR 0.60; 95 % CI, 0.32-1.11), with medians of 15.0 months (95 % CI, 10.5-27.4) and 11.7 months (95 % CI, 8.6-20.5), respectively; 24-month rates were 36.0 % (95 % CI, 18.2-54.2) and 17.9 % (95 % CI, 6.5-33.7). In the ITT population, OS was prolonged with DT versus chemotherapy (HR 0.70; 95 % CI, 0.48-1.02); medians were 20.0 and 14.1 months and 24-month rates were 44.2 % and 30.4 %. PFS was similar in the PD-L1 TC < 1 % (HR 1.13; 95 % CI, 0.59-2.14) and ITT (HR 0.95; 95 % CI, 0.66-1.36) populations; 12-month rates were 15.6 % versus 11.3 % and 23.9 % versus 16.6 %. Grade 3/4 treatment-related adverse events (TRAEs) occurred in 31.2 % with DT and 52.6 % with chemotherapy; 3.9 % versus 10.3 % discontinued due to TRAEs. Conclusions: In exploratory analyses, first-line DT showed a trend towards improved OS versus chemotherapy among Chinese patients in the PD-L1 TC < 1 % population and ITT population, with 24-month OS and 12-month PFS rates indicating benefit in survival curve tails. DT was well tolerated with no new safety signals.
  • article 21 Citação(ões) na Scopus
    NEPTUNE: Phase 3 Study of First-Line Durvalumab Plus Tremelimumab in Patients With Metastatic NSCLC
    (2023) JR, Gilberto de Castro; RIZVI, Naiyer A.; SCHMID, Peter; SYRIGOS, Konstantinos; MARTIN, Claudio; YAMAMOTO, Nobuyuki; CHENG, Ying; MOISEYENKO, Vladimir; SUMMERS, Yvonne; VYNNYCHENKO, Ihor; LEE, Sung Yong; BRYL, Maciej; ZER, Alona; ERMAN, Mustafa; TIMCHEVA, Constanta; RAJA, Rajiv; NAICKER, Kirsha; SCHEURING, Urban; WALKER, Jill; MANN, Helen; CHAND, Vikram; MOK, Tony; NEPTUNE Investigators
    Introduction: NEPTUNE, a phase 3, open-label study, evaluated first-line durvalumab plus tremelimumab versus chemotherapy in metastatic NSCLC (mNSCLC).Methods: Eligible patients with EGFR and ALK wild-type mNSCLC were randomized (1:1) to first-line durvalumab (20 mg/kg every 4 weeks until progression) plus trem-elimumab (1 mg/kg every 4 weeks for up to four doses) or standard chemotherapy. Randomization was stratified by tumor programmed death-ligand 1 expression (>= 25% versus <25%), tumor histologic type, and smoking history. The amended primary end point was overall survival (OS) in patients with blood tumor mutational burden (bTMB) greater than or equal to 20 mutations per megabase (mut/ Mb). Secondary end points included progression-free sur-vival (PFS) in patients with bTMB greater than or equal to 20 mut/Mb and safety and tolerability in all treated patients. Results: As of June 24, 2019, 823 patients were randomized (intention-to-treat [ITT]); 512 (62%) were bTMB-evaluable, with 129 of 512 (25%) having bTMB greater than or equal to 20 mut/Mb (durvalumab plus tremelimumab [n = 69]; chemotherapy [n = 60]). Baseline characteristics were balanced in the intention-to-treat. Among patients with bTMB greater than or equal to 20 mut/Mb, OS improvement with durvalumab plus tremelimumab versus chemotherapy did not reach statistical significance (hazard ratio 0.71 [95% confidence interval: 0.49-1.05; p = 0.081]; median OS, 11.7 versus 9.1 months); the hazard ratio for PFS was 0.77 (95% confidence interval, 0.51-1.15; median PFS, 4.2 versus 5.1 months). In the overall safety population, incidence of grade 3 or 4 treatment-related adverse events was 20.7% (durva-lumab plus tremelimumab) and 33.6% (chemotherapy).Conclusions: NEPTUNE did not meet its primary end point of improved OS with durvalumab plus tremelimumab versus chemotherapy in patients with mNSCLC and bTMB greater than or equal to 20 mut/Mb. Despite the amended study design, with a resultant small primary analysis pop-ulation, therapeutic activity was aligned with expectations based on mechanistic biology and previous studies.(c) 2022 International Association for the Study of Lung Cancer.