NEOSPHERE (WO20697) TRYPHAENA (BO22280) CLEOPATRA (WO20698) Neoadjuvant treatment period Neoadjuvant treatment period (%) Overall (%) treatment Arm A Arm B Arm A Arm B Arm C period (%) Arm C Arm D T+D Ptz + Ptz + T Ptz + D Ptz Ptz Pla +T Ptz + T+D N=108 N=94 + T +T+D +TCH + D T + D + N=75 N=107 N=76 + T+D Any AE 98.1 97.2 70.4 98.9 96.0 100 98.7 100.0 Grade > 74.8 60.7 11.1 71.3 69.4 60.0 73.7 76.2 3 Related 97.2 95.3% 66.7 97.9 94.7 100.0 97.3 AE 0 AE disc 0 1.9 2.8 2.1 5.6 6.7 7.9 28.8 30.6 AE i/m 34.6 32.7 14.8 43.6 36.1 29.3 50.0 54.3 61.8 SAE 16.8 11.2 3.7 17.0 27.8 20.0 35.5 29.0 36.3 AE 0.9 0 0 0 0 0 3.0 2.0 death Death, 0 0 0 0 0 0 0 34.3 24.5 PD 0 0.9 0 0 0 0 0 4.0 3.2 AE disc =any AE leading to discontinuation of one or more study drugs; AE i/m= any AE leading to interruption or modification; SAE=any SAE; AEdeath=AE with outcome of death (i.e. Grade 5); Death, PD=death due to progressive disease; Death, other=death due to causes other than progressive disease Risk management plan The RMP evaluator identified that there were still outstanding issues: The Delegate does not consider the data currently support a contraindication for concomitant use of pertuzumab with anthracyclines; however, there are insufficient data presented to support its use and it is not currently proposed in the Clinical Trials
NEOSPHERE (WO20697) Neoadjuvant treatment period (%) Arm A Arm B Arm C Arm D TRYPHAENA (BO22280) Neoadjuvant treatment period (%) Arm A Arm B Arm C CLEOPATRA (WO20698) Overall treatment period (%) T+D Ptz + T+D N=107 Ptz + T N=108 Ptz + D N=94 Ptz + T + + T+D +T+D N=75 Ptz +TCH N=76 Pla +T + D Ptz + T + D Any AE 98.1 97.2 70.4 98.9 96.0 100 98.7 100.0 Grade > 3 74.8 60.7 11.1 71.3 69.4 60.0 73.7 76.2 Related AE 97.2 95.3% 66.7 97.9 94.7 100.0 97.3 AE disc 0 1.9 2.8 2.1 5.6 6.7 7.9 28.8 30.6 AE i/m 34.6 32.7 14.8 43.6 36.1 29.3 50.0 54.3 61.8 SAE 16.8 11.2 3.7 17.0 27.8 20.0 35.5 29.0 36.3 AE death 0 0.9 0 0 0 0 0 3.0 2.0 Death, PD 0 0 0 0 0 0 0 34.3 24.5 0 0.9 0 0 0 0 0 4.0 3.2 AE disc =any AE leading to discontinuation of one or more study drugs; AE i/m= any AE leading to interruption or modification; SAE=any SAE; AEdeath=AE with outcome of death (i.e. Grade 5); Death, PD=death due to progressive disease; Death, other=death due to causes other than progressive disease Risk management plan The RMP evaluator identified that there were still outstanding issues: The Delegate does not consider the data currently support a contraindication for concomitant use of pertuzumab with anthracyclines; however, there are insufficient data presented to support its use and it is not currently proposed in the Clinical Trials
auspar-pertuzumab-160616.docx