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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.
durvalumab plus tremelimumab (n=163) vs. Standard of Care (SoC) (n=162)
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 4 to 6 cycles of platinum-based doublet chemotherapy of the investigator’s choice : pemetrexed plus carboplatin and gemcitabine plus carboplatin (no % for this sub-population)
3 arms: durvalumab with or without tremelimumab vs platinum-based doublet chemotherapy
mNSCLC - L1 - PDL1 positive
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 (n=396) vs. pemetrexed plus platin (n=397)
randomized controlled trial
nivolumab plus ipilimumab
nivolumab (3 mg per kilogram of body weight every 2 weeks) plus ipilimumab (1 mg per kilogram every 6 weeks)
platinium chemotherapy
platinum doublet chemotherapy based on tumor histologic type every 3 weeks for up to four cycles : pemetrexed (500 mg per square meter of body-surface area) plus cisplatin (75 mg per square meter) or carboplatin (area under the concentration-time curve [AUC], 5 or 6), every3 weeks for up to four cycles
3 arms: Nivolumab, or Nivolumab Plus Ipilimumab. Crossover between treatment groups within the trial was not permitted.
mNSCLC - L1 - PDL1 positive
Patients with known EGFR mutations or ALK translocations sensitive to targeted therapy, an autoimmune disease, or untreated central nervous system metastases were excluded
open label
NA
P3/ two sided and one interim analysis. Repartition between coprimary end point and hierarchy with secondary endpoint. WARNING safety from ITT population
Progression-free survival was significantly longer with first-line nivolumab plus ipilimumab than with chemotherapy among patients with NSCLC and a high tumor mutational burden, irrespective of PD-L1 expression level
pembrolizumab plus ipilimumab (n=284) vs. pembrolizumab plus placebo (n=284)
randomized controlled trial
pembrolizumab plus ipilimumab
pembrolizumab at a dose of 200 mg on day 1 of each 3-week cycle for up to 35 cycles plus IV ipilimumab at a dose of 1 mg/kg on day 1 of each 6-week cycle for up to 18 cycles,
placebo plus pembrolizumab
saline placebo administered intravenously every 6 weeks for up to 18 doses pembrolizumab at a dose of 200 mg on day 1 of each 3-week cycle for up to 35 cycles in combination with placeb at the same dose and schedule.
mNSCLC - L1 - PDL1 positive
double blind
171 sites in 24 countries
P3/ one sided and OS and PFS interim analysis. Repartition between coprimay endpoint and reallocation with ORR, but the study stops for futility
The phase 3 KEYNOTE-598 study of pembrolizumab (Keytruda) plus ipilimumab (Yervoy) in a population of patients with metastatic non–small cell lung cancer (NSCLC) has been discontinued for futility
nivolumab plus ipilimumab (n=139) vs. pemetrexed plus platin (n=160)
randomized controlled trial
nivolumab plus ipilimumab
nivolumab (3 mg per kilogram of body weight every 2 weeks) plus ipilimumab (1 mg per kilogram every 6 weeks)
platinium chemotherapy
platinum doublet chemotherapy based on tumor histologic type every 3 weeks for up to four cycles : pemetrexed (500 mg per square meter of body-surface area) plus cisplatin (75 mg per square meter) or carboplatin (area under the concentration-time curve [AUC], 5 or 6), every3 weeks for up to four cycles
3 arms: Nivolumab, or Nivolumab Plus Ipilimumab. Crossover between treatment groups within the trial was not permitted.
mNSCLC - L1 - TMB>10Mb
Patients with known EGFR mutations or ALK translocations sensitive to targeted therapy, an autoimmune disease, or untreated central nervous system metastases were excluded.Tumor mutational burden was determined by the FoundationOne CDx assay,
open label
NA
P3/ two sided and one interim analysis. Repartition between coprimary end point and hierarchy with secondary endpoint.
Progression-free survival was significantly longer with first-line nivolumab plus ipilimumab than with chemotherapy among patients with NSCLC and a high tumor mutational burden, irrespective of PD-L1 expression level
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