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durvalumab plus tremelimumab (n=372) vs. Standard of Care (SoC) (n=372)
randomized controlled trial
durvalumab and tremelimumab
durvalumab (20 mg/kg every 4 weeks) until disease progression plus 1mg/kg of tremelimumab every 4 weeks for up to 4 doses
platinum-based doublet chemotherapy
4 to 6 cycles of platinum-based doublet chemotherapy of the investigator’s choice : pemetrexed plus carboplatin (138 of 253 patients [54.5%]) and gemcitabine plus carboplatin (49 of 99 patients [49.5%])
3 arms: durvalumab with or without tremelimumab vs platinum-based doublet chemotherapy
mNSCLC - L1 - all population
only patient with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type were included
open-label
203 cancer treatment centers in 17 countries
P3/ two sided and two interim analysis. A hierarchical multiple testing procedure with a gatekeeping strategy was used to control family-wise type I error at a twosided 5% significance level.
The phase 3 MYSTIC study did not meet its primary end points of improved OS with durvalumab vs chemotherapy or improved OS or PFS with durvalumab plus tremelimumab vs chemotherapy in patients with ≥25% of tumor cells expressing PD-L1.
nivolumab plus ipilimumab plus SoC (n=361) vs. Standard of Care (SoC) (n=358)
randomized controlled trial
nivo plus ipi and chemo (2 cycle)
nivolumab (360 mg intravenously every 3 weeks) plus ipilimumab (1 mg/kg intravenously every 6 weeks) combined with histology-based, platinum doublet chemotherapy (intravenously every 3 weeks for two cycles; experimental group)(permetrexed plus platine or paclitaxel and carboplatine)
chemotherapy platine combination
4 cycles of chemotherapy combination (permetrexed plus platine (68.8%) or paclitaxel plus carboplatine(31.2%))
Pts with nonsquamous NSCLC in the chemo-only arm could receive optional pemetrexed maintenance. Crossover between the treatment groups was not permitted;
mNSCLC - L1 - all population
Exclusion criteria included known EGFR mutations and ALK translocations that were sensitive to targeted therapy
open label
103 hospitals in 19 countries
P3 / two sided with one interim analysis. Hierarchical testing procedure with primary endpoint OS and secondary endpoints PFS then ORR
AI 1 stopped : a statistically significant improvement in OS, PFS and ORR was observed with NIVO plu IPI in with a limited course of chemo vs chemo (4 cycles) in 1L advanced NSCLC.
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