10. Pembrolizumab clinical development programme Description Design Updated Phase of of d / description Actual (data cut off 31 up July 2014) Melanoma P001 Phase I 24 m1 December KEYNOTE001 Parts Study of Label 1246 2016 was the initial B and Single Agent pts phase I study D MK-3475 in that was Patients expanded to 1191 with include cohorts pts Progressive of melanoma Locally (for and NSCLC Advanced or all patients. Cohort Metastatic P001) B and D include Carcinoma, 656 melanoma Melanoma, patients and Non- including Small Cell Lung and Carcinoma; Phase I naïve patients. P002 Randomised Open 24 m June 2016 KEYNOTE002 is Phase II label 510 an ongoing Study of (MK pts; clinical versus dose is comparing two blinded doses of 540 in pembrolizumab pts Patients (2 mg/kg Q3W with or 10 mg/kg Advanced Q3W) versus Melanoma; investigator’s Phase II choice of standard of care chemotherapy in patients who have failed prior ipilimumab treatment. These data include 449 patients who received pembrolizumab including 91 patients who crossed over to pembrolizumab after
10. Pembrolizumab clinical development programme Phase Design of of up / Actual Updated description (data cut off 31 July 2014) Melanoma P001 Parts B and D Phase I Study of Single Agent MK-3475 in Patients with Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, and Non- Small Cell Lung Carcinoma; Phase I 1246 pts 1191 pts (for all P001) 24 m1 December 2016 KEYNOTE001 was the initial phase I study that was expanded to include cohorts of melanoma and NSCLC patients. Cohort B and D include 656 melanoma patients including and patients. P002 Phase II Study of versus in Patients with Advanced Melanoma; Phase II Open label (MK dose is 510 pts; 540 pts 24 m June 2016 KEYNOTE002 is an ongoing clinical comparing two doses of pembrolizumab (2 mg/kg Q3W or 10 mg/kg Q3W) versus investigator’s choice of standard of care chemotherapy in patients who have failed prior ipilimumab treatment. These data include 449 patients who received pembrolizumab including 91 patients who crossed over to pembrolizumab after Randomised blinded Label naïve Description d
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