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. 2022 Aug 24;12:935383. doi: 10.3389/fonc.2022.935383

Table 2.

Study endpoints.

Primary endpoint

  • PFS, defined as the time from the date of randomization until disease progression according to RECIST v1.1 by BICR or death from any cause
Key secondary endpoint

  • OS, defined as the time from the date of randomization until death from any cause
Secondary endpoints

  • ORR, defined as the percentage of patients having a CR or PR, according to RECIST v1.1 as determined by BICR

  • Duration of response, defined as the time from the first documented response (CR or PR) according to RECIST v1.1 until disease progression as determined by BICR or death from any cause

  • Disease control rate, defined as the number of patients maintaining either an objective response (CR, PR) or stable disease according to RECIST v1.1 as determined by BICR

  • Number of patients experiencing AEs

  • Number of patients discontinuing study drug because of AEs

  • Population pharmacokinetics, including C max, t max, C min, and AUC0– t

Exploratory endpoints

  • PFS 2, defined as the time from randomization to subsequent disease progression after initiation of new anticancer therapy (second disease progression), or death owing to any cause, whichever occurs first, as assessed by investigator review using RECIST v1.1

  • ORR crossover, defined as the percentage of patients in the crossover period having a CR or PR, according to RECIST v1.1 as assessed by investigator review using RECIST v1.1

  • Blood and/or tumor analytes, immune cell profiles, viral profiles, and other relevant markers

  • Immunogenicity, defined as the occurrence of specific antidrug antibodies to retifanlimab

  • HR-PRO assessments scheduled to align with tumor response

  • HIV viral load and CD4+ counts in patients who are known to be HIV-positive

AE, adverse event; AUC0–t , area under the plasma or serum concentration–time curve from time = 0 to the last measurable concentration at time = t; BICR, blinded independent central radiographic review; C max, maximum observed plasma or serum concentration; C min, minimum observed plasma or serum concentration; CR, complete response; HIV, human immunodeficiency virus; HR-PRO, health-related patient-reported outcomes; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; t max, time to maximum concentration.