Clinical Data  As previously reported, the ECHELON-1 trial achieved its primary endpoint with the combination of ADCETRIS plus AVD resulting in a statistically significant improvement in modified PFS versus the control arm of ABVD as assessed by independent review facility (IRF; hazard ratio [HR] 0.77; p-value=0.035). Modified PFS was defined as time to progression, death, or evidence of non-complete response after completion of frontline therapy per IRF followed by subsequent anticancer therapy. Key findings from these analyses include:

• The three-year PFS for all patients in the ADCETRIS plus AVD arm was 83.1 percent compared to 76 percent in the ABVD arm (HR 0.70), a difference of 7.1 percent.
• PFS benefit at three-years for ADCETRIS plus AVD was observed for all patients independent of PET2 status, including in patients who are less than 60 years old.
  • PET2-negative result was 85.8 percent in the ADCETRIS plus AVD arm compared to 79.5 percent in the ABVD arm (HR 0.69), a difference of 6.3 percent.
  • PET2-positive result was 67.7 percent in the ADCETRIS plus AVD arm compared to 51.5 percent in the ABVD arm (HR 0.59), a difference of 16.2 percent.
• Consistent improvement in PFS was observed among patients treated with ADCETRIS plus AVD compared with ABVD across the majority of pre-specified subgroups, including disease stage, age and prognostic score.
• As previously reported at the primary analysis, on the ADCETRIS plus AVD arm, peripheral neuropathy events were observed in 67 percent of patients compared to 43 percent in the ABVD arm. The three-year analysis shows that among patients with peripheral neuropathy, 78 percent of in the ADCETRIS plus AVD arm and 83 percent in the ABVD arm reported complete resolution or improvement at last follow-up.