Table 1.

Summary of clinical trials

Endpoints
Randomized comparisonsIndicationPrimarySecondaryNumber of patientsRandomization ratioOS HRPFS HRORR ORResponse rates (trt vs. control)
1MelanomaPFS (IRC), OSORR (IRC)3591:10.860.5986.195722.5 vs. 4.5%
2MelanomaPFS (IRC), OSORR (IRC)3601:10.7710.4988.616328.7 vs. 4.5%
3MelanomaOS, PFS (IRC)ORR (IRC)5571:10.6730.5673.54241.3 vs. 16.6%
4MelanomaOS, PFS (IRC)ORR (IRC)5551:10.670.5813.340139.9 vs. 16.6%
5MelanomaORR (IRC), OSPFS (IRC)182a2:10.8640.7364.976231.2 vs. 8.3%
6MelanomaOSORR, PFS (INV)4181:10.4180.4324.114940 vs. 13.9%
7MelanomaPFS (INV), OSORR (INV)6311:10.7080.5723.294943.7 vs. 19%
8MelanomaPFS (INV), OSORR (INV)6291:10.7020.4325.783857.6 vs. 19%
9MelanomaORR (INV)PFS (INV)1422:10.7920.39613.565555.8 vs. 8.5%
10NSCLCbOS, PFS (IRC)ORR (IRC)6871:10.7320.8691.695125.5 vs. 16.8%
11NSCLCbOS, PFS (IRC)ORR (IRC)6891:10.6310.7881.69425.5 vs. 16.8%
12NSCLCcPFS (IRC)OS, ORR (IRC)3051:10.6140.4992.03247.6 vs. 30.9%
13NSCLCOSPFS, ORR (INV)2871:10.6750.9121.047615.3 vs. 14.7%
14NSCLC non-SQOSORR, PFS (INV)5821:10.750.9091.674219.2 vs. 12.4%
15NSCLC SQOSORR, PFS (INV)2721:10.590.632.604220 vs. 8.8%
16RCCOSORR, PFS (INV)8211:10.7580.8735.932325.1 vs. 5.4%
17SCCHNOSPFS, ORR (INV)3612:10.6910.8822.505513.3 vs. 5.8%
  • Abbreviations: INV, investigator; IRC, independent review committee; non-SQ, nonsquamous; RCC, renal cell carcinoma; SCCHN, squamous cell carcinoma of head and neck; SQ, squamous.

  • aOnly 182 patients who had at least 6-month follow-up were considered in the computation of OS, PFS HRs, and ORR OR.

  • bPatient population: NSCLC with PD-L1 positive at 1%.

  • cPatient population: NSCLC with PD-L1 positive at 50%.