國家衛生研究院 NHRI:Item 3990099045/15580
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    题名: ILLUMINATE: Efficacy and safety of durvalumab-tremelimumab and chemotherapy in EGFR mutant NSCLC following progression on EGFR inhibitors
    作者: Lee, C;Liao, BC;Subramaniam, S;Chiu, CH;Mersiades, A;Ho, CC;Brown, C;Lai, CL;Hughes, BGM;Yang, TY;O'Byrne, K;Luo, YH;Yip, S;Ho, CL;Bray, V;Su, WC;Moore, M;Feng, WL;Bai, YY;Stockler, M;Solomon, B;John, T;Yang, JCH
    贡献者: National Institute of Cancer Research
    摘要: Introduction: In advanced epidermal growth factor receptor (EGFR) mutant lung cancer, the role of immune checkpoint inhibitors (ICI), following disease progression with tyrosine kinase inhibitors (TKIs), remain uncertain. Although treatment outcomes with ICI monotherapy have been poor, ICIs and chemotherapy combination have been shown to improve survival over chemotherapy alone in this population. We conducted a phase II study aimed to determine the efficacy and tolerability of dual ICI therapy, durvalumab and tremelimumab, with platinum-pemetrexed chemotherapy, in metastatic EGFR mutant lung cancer following progression with EGFR TKIs. Methods: This international, non-comparative, two-cohort study enrolled adults from 10 Australian and 6 Taiwanese sites. Eligible participants were assigned to study cohort 1 (EGFR exon 20 T790M negative on tissue and plasma; progression on first-line osimertinib or following single line of 1st/2nd generation TKI) or cohort 2 (T790M positive on tissue and/or plasma; progression on 1 lines of TKI including osimertinib). Participants received 4 cycles of durvalumab 1500mg and tremelimumab 75mg in combination with platinum-pemetrexed chemotherapy every 3 weeks, followed by durvalumab 1500mg and pemetrexed 500mg/m2 maintenance every 4 weeks until disease progression or intolerance to treatment. The primary endpoint was objective response rate (ORR). Secondary endpoints included disease control rate (DCR), progressionfree survival (PFS), PFS rate at 12 months (PFS12), and adverse events (AEs). Results: Between April 2019 to November 2022, 100 participants were enrolled with 50 in each study cohort respectively. Study treatment was received by all eligible participants. One ineligible participant was excluded from analysis. Majority were female (n¼64, 64%), performance status 1 (51%) and median age of 60 years (range, 32-77 years). Most were also Asian ethnicity (77%) and never-smokers (73%). EGFR exon 19 deletion was detected in 57% and exon 21 L858R in 42% of tumors respectively. After a median follow-up of 22 months (interquartile range, 15-31 months), ORR for cohort 1 and cohort 2 were 15/48 (31%, 95%CI 20-45) and 10/48 (21%, 95%CI 12-34) respectively. DCR for cohort 1 and cohort 2 were 42/48 (88%, 95%CI 75-94) and 36/48 (75%, 95%CI 61-85) respectively. For cohort 1, median PFS (mPFS) was 7.0 months (IQR, 4.6-17 months) and PFS12 was 35% (95% CI 23%-53%). For cohort 2, mPFS was 4.9 months (IQR, 2.9-8.4 months) and PFS12 was 13% (95% CI 6.4%-28%). Amongst cohort 1 with evaluable PD-L1, tumor with PD-L1<50% (N¼9) had superior PFS than those with PD-L1 50% (N¼20) (mPFS 9.8 vs 4.6 months). There was no significant difference in PFS between exon 19 deletion vs exon 21 L858R In each study cohort. There was no grade 5 irAE. Grade 3-4 immune-related AEs (irAE) were reported in 17 (17%), including colitis (8%), hepatitis (4%), adrenal insufficiency (2%), and pneumonitis (1%). Study treatment was discontinued for irAEs in 6 (6%). There was no significant difference in grade 3-4 irAE rates between the two cohorts (10% vs 18%, p¼0.40). Conclusions: Durvalumab and tremelimumab with chemotherapy demonstrated promising anti-tumor activity, particularly in EGFR T790M negative tumors. The safety profile was consistent with known AEs with chemoimmunotherapy in advanced lung cancer.
    日期: 2023-11
    關聯: Journal of Thoracic Oncology. 2023 Nov;18(11, Suppl.):S63.
    Link to: http://dx.doi.org/10.1016/j.jtho.2023.09.057
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1556-0864&DestApp=IC2JCR
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