Trial name | Year | Phase | RCT | Drug | Primary endpoint | No | PS 0–1 | No of sarcomatoid histology | ORR | mPFS (mo) | MST (mo) | Pneumonitis* | Ref. |
Frontline setting | |||||||||||||
DREAM | No | Durvalumab | PFS, OR | 54 | 100% | – | 48% | 6.9 | – | NR | 49 | ||
Salvage setting | |||||||||||||
<Single agent> | |||||||||||||
MERIT | 2018 | 2 | No | Nivolumab | OR | 34 | 100% | 3 (9%) | 29% | 6.1 | 17.3 | 6% | 54 |
NivoMes | 2018 | 2 | No | Nivolumab | DCR | 34 | 100% | 2 (6%) | 24% | 2.6 | 11.8 | 12% | 53 |
KN-028†,‡ | 2017 | 1b | No | Pembrolizumab | Safety | 25 | 100% | 2 (8%) | 20% | 5.4 | 18 | NR | 55 |
Chicago group | 2018 | 2 | No | Pembrolizumab | OR | 65 | 100% | 5 (8%) | 19% | 4.5 | 11.5 | 3% | 56 |
JAVELIN | 2019 | 1b | No | Avelumab | OR | 53 | 100% | 2 (4%) | 9% | 4.1 | 10.7 | 6% | 57 |
Italian group | 2013 | 2 | No | Tremelimumab | OR | 29 | 79% | 3 (10%) | 7% | 6.2 | 10.7 | NR | 58 |
Italian group | 2015 | 2 | No | Tremelimumab | irOR | 29 | 79% | 1 (3%) | 3% | – | – | NR | 59 |
DETERMINE | 2017 | 2b | Yes | Tremelimumab | OS | 382 | 99% | 22 (6%) | 5% | 2.8 | 7.7§ | NR | 60 |
Placebo | 189 | 100% | 16 (8%) | 1% | 2.7 | 7.3 | NR | ||||||
<Combination> | |||||||||||||
NIBIT-MESO-1¶ | 2018 | 2 | No | Tremelimumab/durvalumab | irOR | 40 | 100% | 2 (5%) | 28% | 5.7 | 16.6 | NR | 30 |
MAPS2 | 2019 | 2 | Yes | Nivolumab/ipilimumab | DCR | 62 | 98% | 9 (15%)** | 28% | 5.6 | 15.9 | 2% | 31 |
Nivolumab | 63 | 97% | 11 (17%)** | 19% | 4.0 | 11.9 | 2% | ||||||
INITIATE | 2019 | 2 | No | Nivolumab/ipilimumab | DCR | 34 | 100% | 3 (9%) | 29% | 6.2 | NR | NR | 32 |
*Any grade.
†Those with the following conditions were eligible: (1) failed standard therapy and (2) unable to receive standard therapy.
‡Those with PD-L1-positive tumors were registered.
§OS-HR of 0.92 with a 95% CI 0.76 to 1.12.
¶Subjects who refused the first line platinum-based chemotherapy, or those with disease progression after a maximum of one line of platinum-based therapy, were eligible.
**Including biphasic histology.
DCR, disease control rate; DREAM, Durvalumab with First-Line Chemotherapy in Mesothelioma; irOR, immune-related objective response; MST, median survival time; NR, not reported; ORR, objective response rate; OS, overall survival; PD-L1, programmed cell death ligand 1; PFS, progression-free survival; RCT, randomized controlled trial.