Table 3. Prospective studies evaluating PD-1/PD-L1 inhibition in the first-line setting of PS 2 patients.
| Study | Country | Patients | PD-L1 status and drug | Main findings |
|---|---|---|---|---|
| Middleton, Lancet Resp Med 2020, PePS2 (61) | UK | 24 | Any PD-L1, Pembrolizumab | Good tolerability profile |
| DCB 38% (n =9; 21–57) | ||||
| ORR 21% (n =5; 9–40) | ||||
| mPFS 4.3 months (1.9–13.1) | ||||
| mOS 7.9 months (2.6–NR) | ||||
| Mark, Cancer Immunol Immunother 2020, SAKK 19/17 (63) | Switzerland | 21 | PD-L1 ≥25%, Durvalumab | 13 out of 21 treated patients died (62%) |
| Seven deaths (7/13; 54%) observed during the first five weeks | ||||
| Barlesi, WCLC 2019, CheckMate 817 (62) | Europe/USA | 139 | Any PD-L1, Nivolumab + ipilimumab | Good tolerability profile |
| ORR 19% | ||||
| mPFS 3.6 months (2.8–5.4) | ||||
| mDOR 14.2 months (10.0–NR) |
Data included in parenthesis indicate 95% confidence interval. DCB, durable clinical benefit, i.e., lack of progression at the 18th week; ORR, objective response rate; mPFS, median progression-free survival; mOS, median overall survival; NR, not reached; mDOR, median duration of response.