Claudio Zamagni Milano 16 giugno 2018 AIOM Post-ASCO BREAST CANCER HIGHLIGHTS ASCO 2018
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1 Claudio Zamagni Milano 16 giugno 2018 AIOM Post-ASCO BREAST CANCER HIGHLIGHTS ASCO 2018
2 (Neo)Adjuvant Advanced De-escalation ER+ve HER2 ve Node ve TAILORx HER2 +ve Persephone PerElisa PARPi in gbrcam HER2 -ve MDACC talazoparib CDK4/6i in ER+ve/HER2-ve MBC MONARCH-2 pre-perimenopausal MONALEESA-3 PI3Ki/mTORi in ER+ve/HER2-ve MBC BOLERO-6 SANDPIPER AKTi in TNmBC PAKT LOTUS Claudio Zamagni Milano 16 giugno 2018 AIOM Post-ASCO
3 (Neo)Adjuvant Advanced De-escalation ER+ve HER2 ve Node ve TAILORx HER2 +ve Persephone PerElisa PARPi in gbrcam HER2 -ve MDACC talazoparib CDK4/6i in ER+ve/HER2-ve MBC MONARCH-2 pre-perimenopausal MONALEESA-3 PI3Ki/mTORi in ER+ve/HER2-ve MBC BOLERO-6 SANDPIPER AKTi in TNmBC PAKT LOTUS Claudio Zamagni Milano 16 giugno 2018 AIOM Post-ASCO
4 Slide 1 Presented By Joseph Sparano at 2018 ASCO Annual Meeting
5 Background: Rationale for Design of TAILORx Precision Medicine Trial Biomarker Directed Chemotherapy Presented By Joseph Sparano at 2018 ASCO Annual Meeting
6 TAILORx Methods: Treatment Assignment & Randomization<br />Accrued between April 2006 October 2010 Primary endpoints: RS11-25: IDFS RS0-10: DRFS Presented By Joseph Sparano at 2018 ASCO Annual Meeting
7 TAILORx Methods: Statistical Analysis Plan for RS Presented By Joseph Sparano at 2018 ASCO Annual Meeting
8 TAILORx Results ITT Population: Demographics & Treatment in RS Arms (N=6,711) Presented By Joseph Sparano at 2018 ASCO Annual Meeting
9 TAILORx Results - ITT Population: RS (Arms B & C)<br />836 IDFS events (after median of 7.5 years), including 338 (40.3%) with recurrence as fist event, of which 199 (23.8%) were distant<br /> Presented By Joseph Sparano at 2018 ASCO Annual Meeting
10 Slide 11 Presented By Joseph Sparano at 2018 ASCO Annual Meeting
11 Slide 12 Presented By Joseph Sparano at 2018 ASCO Annual Meeting
12 TAILORx Results: Association between Continuous RS and 9-Year Distant Recurrence Rate by Treatment Arms Stratified by Age (</=50 vs.>50 Years)<br /> Presented By Joseph Sparano at 2018 ASCO Annual Meeting
13 TAILORx Results: Summary D 2% DRFI events D 6% IDFS events, mainly distant Presented By Joseph Sparano at 2018 ASCO Annual Meeting
14 PERSEPHONE: 6 versus 12 months of adjuvant trastuzumab in patients with HER2 positive early breast cancer: Randomised phase 3 non-inferiority trial with definitive 4-year diseasefree survival results Presented By Helena Earl at 2018 ASCO Annual Meeting
15 Persephone Study Design Presented By Helena Earl at 2018 ASCO Annual Meeting
16 Statistical Considerations Presented By Helena Earl at 2018 ASCO Annual Meeting
17 Persephone Study Patient Characteristics Accrual: 4088 from 2007 to sites in the UK T1 48% N ve 59% ER +ve 69% Concurrent CHT/T 47% Claudio Zamagni Milano 16 giugno 2018 AIOM Post-ASCO H. Earl et al ASCO 2018
18 Disease-free survival Presented By Helena Earl at 2018 ASCO Annual Meeting
19 DFS:<br /><br />Pre-defined subgroup analysis Presented By Helena Earl at 2018 ASCO Annual Meeting
20 Overall survival Presented By Helena Earl at 2018 ASCO Annual Meeting
21 OS:<br /><br />Pre-defined subgroup analysis Presented By Helena Earl at 2018 ASCO Annual Meeting
22 Cardiotoxicity Presented By Helena Earl at 2018 ASCO Annual Meeting
23 PerElisa Study plan Presented By Valentina Guarneri at 2018 ASCO Annual Meeting
24 N=44 Outcomes: molecular responders Presented By Valentina Guarneri at 2018 ASCO Annual Meeting
25 N=17 Outcomes: molecular non responders Presented By Valentina Guarneri at 2018 ASCO Annual Meeting
26 PAM50 and pcr: molecular responders Presented By Valentina Guarneri at 2018 ASCO Annual Meeting
27 (Neo)Adjuvant Advanced De-escalation ER+ve HER2 ve Node ve TAILORx HER2 +ve Persephone PerElisa PARPi in gbrcam HER2 -ve MDACC talazoparib CDK4/6i in ER+ve/HER2-ve MBC MONARCH-2 pre-perimenopausal MONALEESA-3 PI3Ki/mTORi in ER+ve/HER2-ve MBC BOLERO-6 SANDPIPER AKTi in TNmBC PAKT LOTUS Claudio Zamagni Milano 16 giugno 2018 AIOM Post-ASCO
28 Neoadjuvant Talazoparib for Early Stage Breast Cancer Patients with a BRCA Mutation Presented By Jennifer Litton at 2018 ASCO Annual Meeting
29 Background PARP Inhibitors Presented By Jennifer Litton at 2018 ASCO Annual Meeting
30 Study Design Presented By Jennifer Litton at 2018 ASCO Annual Meeting
31 Pathologic Results Presented By Jennifer Litton at 2018 ASCO Annual Meeting
32 Pathologic Results- Number of Patients Confirmatory trial (NCT ) ongoing Presented By Jennifer Litton at 2018 ASCO Annual Meeting
33 Toxicities Hematologic Presented By Jennifer Litton at 2018 ASCO Annual Meeting
34 (Neo)Adjuvant Advanced De-escalation ER+ve HER2 ve Node ve TAILORx HER2 +ve Persephone PerElisa PARPi in gbrcam HER2 -ve MDACC talazoparib CDK4/6i in ER+ve/HER2-ve MBC MONARCH-2 pre-perimenopausal MONALEESA-3 PI3Ki/mTORi in ER+ve/HER2-ve MBC BOLERO-6 SANDPIPER AKTi in TNmBC PAKT LOTUS Claudio Zamagni Milano 16 giugno 2018 AIOM Post-ASCO
35 Slide 4 Presented By Patrick Neven at 2018 ASCO Annual Meeting
36 Slide 7 Presented By Patrick Neven at 2018 ASCO Annual Meeting
37 Slide 8 Presented By Patrick Neven at 2018 ASCO Annual Meeting
38 MONALEESA-3: Phase III placebo-controlled study of ribociclib + fulvestrant Presented By Dennis Slamon at 2018 ASCO Annual Meeting
39 Prior endocrine therapy status criteria Presented By Dennis Slamon at 2018 ASCO Annual Meeting
40 Patient demographics and baseline characteristics Presented By Dennis Slamon at 2018 ASCO Annual Meeting
41 Slide 11 Presented By Dennis Slamon at 2018 ASCO Annual Meeting
42 Slide 13 Presented By Dennis Slamon at 2018 ASCO Annual Meeting
43 PFS by prior endocrine therapy status Presented By Dennis Slamon at 2018 ASCO Annual Meeting
44 Conclusions Presented By Dennis Slamon at 2018 ASCO Annual Meeting
45 (Neo)Adjuvant Advanced De-escalation ER+ve HER2 ve Node ve TAILORx HER2 +ve Persephone PerElisa PARPi in gbrcam HER2 -ve MDACC talazoparib CDK4/6i in ER+ve/HER2-ve MBC MONARCH-2 pre-perimenopausal MONALEESA-3 PI3Ki/mTORi in ER+ve/HER2-ve MBC BOLERO-6 SANDPIPER AKTi in TNmBC PAKT LOTUS Claudio Zamagni Milano 16 giugno 2018 AIOM Post-ASCO
46 PI3K signaling is frequently dysregulated1 and PI3K inhibition augments ER function and dependence in hormone receptor-positive breast cancer2,3 Presented By Jose Baselga at 2018 ASCO Annual Meeting
47 Rationale for SANDPIPER: Taselisib is a mutant-selective <br />next-generation PI3K inhibitor Presented By Jose Baselga at 2018 ASCO Annual Meeting
48 SANDPIPER study design Presented By Jose Baselga at 2018 ASCO Annual Meeting
49 PRIMARY ENDPOINT: <br />INV-PFS in patients with PIK3CA-mutant tumors Presented By Jose Baselga at 2018 ASCO Annual Meeting
50 Summary of AEs (safety-evaluable patients; regardless of causality) Presented By Jose Baselga at 2018 ASCO Annual Meeting
51 Randomized, Open-Label, Phase II Study Presented By Guy Jerusalem at 2018 ASCO Annual Meeting
52 Primary Objective <br />Estimated HR of PFS for EVE + EXE vs EVE alone<br />EVE + EXE offers a PFS benefit vs EVE alone Presented By Guy Jerusalem at 2018 ASCO Annual Meeting
53 Key Secondary Objective<br />Estimated HR of PFS for EVE + EXE vs CAP<br />CAP may have been favored by baseline imbalances and potential informative censoring Presented By Guy Jerusalem at 2018 ASCO Annual Meeting
54 Deaths Presented By Guy Jerusalem at 2018 ASCO Annual Meeting
55 (Neo)Adjuvant Advanced De-escalation ER+ve HER2 ve Node ve TAILORx HER2 +ve Persephone PerElisa PARPi in gbrcam HER2 -ve MDACC talazoparib CDK4/6i in ER+ve/HER2-ve MBC MONARCH-2 pre-perimenopausal MONALEESA-3 PI3Ki/mTORi in ER+ve/HER2-ve MBC BOLERO-6 SANDPIPER AKTi in TNmBC PAKT LOTUS Claudio Zamagni Milano 16 giugno 2018 AIOM Post-ASCO
56 The PI3K/AKT survival pathway is activated in response <br />to chemotherapy Presented By Rebecca Dent at 2018 ASCO Annual Meeting
57 Ipatasertib: selective targeting of AKT Presented By Rebecca Dent at 2018 ASCO Annual Meeting
58 LOTUS (NCT ) randomized phase II trial Presented By Rebecca Dent at 2018 ASCO Annual Meeting
59 Primary analysis: IPAT effect on PFS enhanced in PIK3CA/AKT1/PTEN-altered subgroup (Foundation Medicinea) Presented By Rebecca Dent at 2018 ASCO Annual Meeting
60 OS according to IHC PTEN status (Ventana) Presented By Rebecca Dent at 2018 ASCO Annual Meeting
61 Updated safety: Most commona adverse events (all grades) Presented By Rebecca Dent at 2018 ASCO Annual Meeting
62 Conclusions Presented By Rebecca Dent at 2018 ASCO Annual Meeting
63 PAKT Study Design Presented By Peter Schmid at 2018 ASCO Annual Meeting
64 PFS by investigator assessment (ITT) Presented By Peter Schmid at 2018 ASCO Annual Meeting
65 Overall Survival (ITT Population) Presented By Peter Schmid at 2018 ASCO Annual Meeting
66 PIK3CA/AKT1/PTEN alterations Presented By Peter Schmid at 2018 ASCO Annual Meeting
67 PFS by tumour PIK3CA/AKT1/PTEN status Presented By Peter Schmid at 2018 ASCO Annual Meeting
68 Overall Survival by PIK3CA/AKT1/PTEN status Presented By Peter Schmid at 2018 ASCO Annual Meeting
69 Summary and Conclusions Presented By Peter Schmid at 2018 ASCO Annual Meeting
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