{"classes":[{"categories":[{"measurements":[{"comment":"The KM estimation method on a sample of \\<5 responders is not valid because too few participants were responders.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The KM estimation method on a sample of \\<5 responders is not valid because too few participants were responders.","groupId":"OG005","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The KM estimation method on a sample of \\<5 responders is not valid because too few participants were responders.","groupId":"OG007","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.","groupId":"OG008","lowerLimit":"4.2","upperLimit":"NA","value":"12.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"1"},{"groupId":"OG008","value":"5"}],"units":"Participants"}],"description":"DOR was defined as the number of months from the date of the first documentation of an objective response (CR or PR per RECIST v1.1) to the date of the first documentation of disease progression or death, whichever occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \\<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Pleural mesothelioma will be evaluated using modified RECIST criteria. Kaplan-Meier (KM) product-limit estimates with a log-log transformation were used for 95% confidence interval calculation.","dispersionType":"95% Confidence Interval","groups":[{"description":"INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.","id":"OG000","title":"Part 1A: INCB001158 50 mg"},{"description":"INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.","id":"OG001","title":"Part 1A: INCB001158 75 mg"},{"description":"INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.","id":"OG002","title":"Part 1A: INCB001158 100 mg"},{"description":"INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.","id":"OG003","title":"Part 1A: INCB001158 150 mg"},{"description":"INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).","id":"OG004","title":"Part 1B: INCB001158 50 mg + Pembrolizumab"},{"description":"INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.","id":"OG005","title":"Part 1B: INCB001158 75 mg + Pembrolizumab"},{"description":"INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.","id":"OG006","title":"Part 1B: INCB001158 100 mg + Pembrolizumab"},{"description":"INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.","id":"OG007","title":"Part 2: INCB001158 100 mg"},{"description":"INCB001158 was administered orally at 100 mg BID (50 mg BID for Part 1c renally impaired participants) in combination with pembrolizumab at 200 mg IV Q3W to participants with squamous cell carcinoma of the head and neck (SCCHN).","id":"OG008","title":"Part 1c and Part 3, SCCHN: INCB001158 100 mg + Pembrolizumab"}],"paramType":"MEDIAN","populationDescription":"REEP. Only participants with CR or PR were analyzed, and only cohorts with ≥5 objective responders were analyzed. Part 1c participants had renal impairment and received INCB001158 50 mg + pembrolizumab (half the RP2D of INCB001158). It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function. Two participants evaluable for PFS were not evaluable for response.","reportingStatus":"POSTED","timeFrame":"Until disease progression/study discontinuation (up to approximately 5 years)","title":"Duration of Response (DOR)","type":"SECONDARY","unitOfMeasure":"months"}