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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.
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.
durvalumab plus tremelimumab (n=174) vs. Standard of Care (SoC) (n=118)
randomized controlled trial
durvalumab plus tremelimumab
durvalumab (10 mg/kg intravenously (i.v.) q2w for up to 12 months)plus tremelimumab (12 weeks durvalumab 20 mg/kg plus tremelimumab 1 mg/kg q4w then 34 weeks durvalumab 10 mg/kg q2w)
standard of care : erlotinib, gemcitabine or vinorelbine
1 of 3 SoC regimens: erlotinib (150 mg once a day by oral administration); gemcitabine (1000 mg/m2 i.v. over 30 minutes onDays 1, 8, and 15 of a 28-day cycle); or vinorelbine (30mg/m2 i.v. on Days 1, 8, 15, and 22 of a 28-day cycle. 69.2% (gemcitabine:41.5% vinorelbine: 22.0%), erlotinib: 29.7%
Dose reductions are not permitted for durvalumab or tremelimuab (mono and combi)
mNSCLC - L2 - PDL1 negative
patients with <25% of tumor cells (TCs) expressing programmed cell death ligand-1 (PD-L1). Patients who do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements
open label
205 study centers in 26 countries
P3/ two sided and no interim anaysis. Repartition between primary endpoint (0.04 OS and 0.01 PFS) for study B only
this study did not meet the primary endpoints of a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) and overall survival (OS).
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