Clinical Data Updated Efficacy Data
Efficacy data as of the data cutoff showed:

• The median OS for patients in the TIBSOVO® arm was 10.3 months compared to 7.5 months for patients in the placebo arm (HR=0.79; 95% CI [0.56–1.12], 1-sided p=0.093).
• After adjusting for crossover from placebo to TIBSOVO® using the pre-specified analysis of rank-preserving structural failure time (RPSFT), the median OS for patients in the placebo arm was 5.1 months (HR=0.49; 95% CI [0.34–0.70], 1-sided p<0.0001).
• The 6-month survival rate for patients in the TIBSOVO® arm was 69 percent compared to 57 percent of patients in the placebo arm, not adjusted for crossover.
• The 12-month survival rate for patients in the TIBSOVO® arm was 43 percent compared to 36 percent for patients in the placebo arm, not adjusted for crossover.
• Treatment with TIBSOVO® preserved patients’ physical functioning from baseline, as assessed by the EORTC QLQ-C30 questionnaire, whereas patients in the placebo arm experienced decline from baseline at cycle 2, day 1 (2-sided p=0.002) and cycle 3, day 1 (2-sided p=0.004).
• Treatment with TIBSOVO® improved patients’ pain at cycle 2, day 1 compared to placebo, as assessed by the EORTC QLQ-BIL21 questionnaire (2-sided p=0.039); no difference was observed at cycle 3, day 1.
• Neither arm was favored on other pre-specified quality-of-life subscales (QLQ-C30 Appetite Loss and QLQ-BIL21 Pain and Eating).
  

Updated Safety Data

• Grade 3 or above treatment-emergent adverse events (TEAE) were reported in 53 percent of total TIBSOVO® patients, which includes patients originally randomized to TIBSOVO® and those who crossed over from placebo to TIBSOVO®, compared to 37.3 percent of patients on placebo, with the most common being ascites (9.0% total TIBSOVO® vs. 6.8% placebo), anemia (7.2% total TIBSOVO® vs. 0% placebo) and increased blood bilirubin (5.4% total TIBSOVO® vs. 1.7% placebo).
• TEAEs leading to discontinuation were more common with placebo compared with total TIBSOVO® (8.5% vs. 6.6%).
• TEAEs leading to dose reductions (3.0% vs. 0%) and interruptions (30.1% vs. 18.6%) were more common with total TIBSOVO® compared with placebo.
• The most common TEAEs of any grade for total TIBSOVO® were nausea (38.0%), diarrhea (33.1%) and fatigue (28.9%).