Table 1

Food and Drug Administration-calculated ORR and DOR by iRECIST and RECIST V.1.1 by treatment group

iRECISTRECIST
All treated patients, n=7920
 Responses (n)20071951
 ORR (95% CI)25.3% (24.4% to 26.3%)24.6% (23.7% to 25.6%)
 DOR* months (range)8.3 (0–33)7.4 (0–33)
Anti-PD-1/PD-L1 antibodies, n=4751
 Responses (n)14971449
 ORR (95% CI)31.5% (30.2% to 32.9%)30.5% (29.2% to 31.8%)
 DOR* months (range)10.1 (0–33)9.2 (0–33)
Anti-CTLA-4 antibodies, n=613
 Responses (n)121118
 ORR (95% CI)19.7% (16.7% to 23.1%)19.2% (16.2% to 22.6%)
 DOR* months (range)11.6 (0–31)8.5 (0–31)
Chemotherapy arms, n=2556
 Responses (n)389384
 ORR (95% CI)15.2% (13.8% to 16.7%)15.0% (13.7% to 16.5%)
 DOR* months (range)4.2 (0–28)4.1 (0–28)
  • *DOR is based on actual time; some observations were censored.

  • DOR, duration of response; ORR, objective response rate; RECIST, Response Evaluation Criteria in Solid Tumours.