Waterfall plot for best percentage change from baseline in sum of longest diameters based on local radiology review and swimmer plot for duration of exposure.
PD, death, BOR, SD
EVENTS, DISEASE, SOLID TUMOUR, DISEASE PROGRESSION
Figures 3a, c and e present waterfall plots for QD, BID, and RDE (300 mg BID) regimens, respectively. Patients with a best percentage change of ≥30% decrease from baseline in sum of longest diameters, which was not confirmed at the next scheduled evaluation were assessed as having a BOR of SD by the investigator per RECIST v1.1. Figure 3b, d and f present swimmer plots for QD, BID, and RDE (300 mg BID) regimens, respectively. The bars show the duration of exposure to study treatment. The first overall response of SD, unconfirmed PR, CR, or PD for each patient, as reported by the investigator per RECIST v1.1, is represented by a square, triangle, diamond, and circle, respectively. BID twice a day, BOR best overall response, CR complete response, CTLA4 cytotoxic T-lymphocyte-associated protein 4, PD progressive disease, PD-1 programmed cell death 1, PD-L1 programmed cell death ligand 1, PR partial response, QD once daily, RDE recommended dose for expansion, RECIST response evaluation criteria in solid tumours, SD stable disease, UNK unknown.No patients were censored and 100% of PFS events were reported as of the data cut-off date. Of the 68 events, 66 had disease progression and 2 patients had died. The estimated median PFS was 3.6 months (95% CI: 3.5–5.4) and the estimated PFS rate at 6 months by the KM method was 29.4% (95% CI: 19.1–40.4). In the BID schedule, the estimated median PFS was 4.1 months (95% CI: 3.5–7.2) and the estimated PFS rate at 6 months by the KM method was 33.3% (95% CI: 17.5–50). At the RDE of 300 mg BID, the estimated median PFS was 3.7 months (95% CI: 2.1–5.4) and the estimated PFS rate at 6 months by the KM method was 27.8% (95% CI: 10.1–48.9) (Table 