Table 2.
Summary of the studies with ICI monotherapy in patients with NSCLC and BM.
| Trial | Patients in BM subgroup (n, %) |
The patients excluded in BM | PD-L1 TPS % |
Study Arms | OS m, HR PFS m, HR |
|---|---|---|---|---|---|
| Keynote 024 (32) | 28 (9,18%) | Untreated or active | >50% | Pemb vs Platinum based CT | OS: NA; HR 0,73 (0,2-2,62) PFS: NA; HR NA |
| Keynote 042 (30) | 70 (5,49%) | Untreated or active | > = 1% | Pemb vs Platinum based CT | OS: NA; HR NA PFS: NA; HR NA |
| Keynote 010 (30) | 152 (14,7%) | Untreated or active | > = 1% | Pemb 2/10mg/m2 vs Docetaxel | OS: NA; HR NA PFS: NA; HR NA |
| Pool analysis 024, 001, 042 and 010 (30) | 293 (9,24%) | Untreated or active | > = 1% | Pemb vs CT | OS: TPS>50% 19 ms vs 9,7 m HR 0,7 TPS>1% 13 m vs 10,3 HR 0,96 (NS) PFS: TPS>50% 4,1 m vs 4,6m HR 0,7 (NS) TPS >1% 2,3 m vs 5,2 m HR 0,96 (NS) |
| OAK (35) | 118 (9,6 %) |
Untreated or symptomatic | Any | Atz vs Docetaxel | OS: 16,1m vs 8,6 m; HR 0,59 PFS: NA; HR NA |
| Pool análisis OAK, FIR, POPPLAR, BRICH (36) | 85 (10%) |
Untreated or symptomatic | Any | Atz vs Docetaxel | OS: NA; HR NA PFS: NA; HR NA |
| CM-057 (37) | 68 (11,68%) | Unstable or untreated | Any | Nivo vs Docetaxel | OS: 7,6m vs 7,3m; HR 1,04 NS |
| CM-017 (38) | 17 (6,25%) | Unstable or untreated | Any | Nivo vs Docetaxel | OS: 4,9 m vs 3,8 m |
| Pool analysis 063, 017 and 057 (39) | 88 (9,06%) | Unstable or untreated | Any | Nivo vs Docetaxel | OS: 8,4 m vs 6,2 m |
| Real life study (Gauvain) | 63 | No exclusion | Any | Nivolumab | OS 7,5 m PFS 3,5 m ORR intracranial 13%, DCR intracranial 51% |
| A french EAP (40) | 197 (21%) | No exclusion | Any | Nivolumab | ORR intracranial 16%, DCR intracranial 17% |
| An italian EAP | 409 (27, 5%) | Unstable or untreated | Any | Nivolumab | OS: 8,6 m PFS:3,6 m ORR intracranial 68%, DCR intracranial 40 % |
BM, brain metastasis; Pemb, Pembrolizumab; Atz, Atezolizumab; CT, Chemotherapy; Nivo, Nivolumab; OS, Overall survival; PFS, Progression Free Survival; NA, non available; NS, Non significant.