New targets in endometrial and ovarian cancer
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1 New targets in endometrial and ovarian cancer SAMO Interdisciplinary Workshop on Gynecologic Tumors Luzern, January 16-17, 2016 C. Sessa IOSI Bellinzona
2 Outline New targets in ovarian cancer - Cell cycle checkpoint New targets in endometrial cancer - VEGFR - FGFR
3 AZD1775 sensitizes TP53-mutant tumors <br />to DNA-damaging agents Presented By Amit Oza at 2015 ASCO Annual Meeting
4 AZD1775: Preclinical and Phase I studies Presented By Amit Oza at 2015 ASCO Annual Meeting
5 Study design: International, multicenter, <br />Phase II trial Presented By Amit Oza at 2015 ASCO Annual Meeting
6 Enhanced RECIST versus RECIST 1.1 Presented By Amit Oza at 2015 ASCO Annual Meeting
7 Primary objective: Progression-free survival by enhanced RECIST Presented By Amit Oza at 2015 ASCO Annual Meeting
8 Multicenter randomized phase II study of AZD 1775 plus chemotherapy versus chemotherapy alone in patients with platinum-resistant TP53 mutated epithelial ovarian, fallopian tube, or primary peritoneal cancer Eligibility Platinum resistance TP53 mutation measurable disease ECOG 0-1 Tumor biopsies R Part 1 69 pts AZD paclitaxel AZD GEM AZD Carboplatin Best combination R Part pts AZD CT CT Primary endpoint: RR Primary endpoint: PFS PD of specific biomarkers PD of specific biomarkers
9 Phase II study with Wee1 inhibitor AZD1775 (MK-1775)<br />plus carboplatin in patients with p53 mutated ovarian cancer <br />refractory or resistant (<3 months) to standard first line therapy Presented By Suzanne Leijen at 2015 ASCO Annual Meeting
10 Treatment schedule Presented By Suzanne Leijen at 2015 ASCO Annual Meeting
11 Eligibility criteria Presented By Suzanne Leijen at 2015 ASCO Annual Meeting
12 Patient characteristics Presented By Suzanne Leijen at 2015 ASCO Annual Meeting
13 Clinical activity <br />Time on study & objective response Presented By Suzanne Leijen at 2015 ASCO Annual Meeting
14 Summary: AZD carboplatin Presented By Ryan Corcoran at 2015 ASCO Annual Meeting
15 Combination with bevacizumab in advanced endometrial cancer GOG-86P MITO-END 2 Randomized PhII 3 arm 2 arm No of pts treated Regimens CP-B, CP-TEM and IP-B CP-B vs CP OR (%) Median PFS (mos) HR Median OS (mos) 60 vs 55 vs 53 12, 8, ( ) 34, 25, ( ) 71 vs vs ( ) 23.5 vs ( ) Treatment with CP-B was associated with a favorable safety profile and a promising antitumor activity The results should be confirmed in a randomized Phase III trial
16 Fibroblast growth factor signalling FGFR structure FGFR specificity Turner, NatRevCancer, 2010
17 FGFR signalling network Turner, NatRevCancer, 2010
18 FGFR1-3 and VEGFR1-3 inhibitors In vitro targets (IC 50 µm) Drug FGFR1 FGFR2 FGFR3 VEGFR2 PD ~ Lucitanib BGJ µm Dovitinib /01/
19 Phase II study of dovitinib in FGFR2-mutated or non mutated advanced endometrial cancer (EC) Advanced and/or metastatic EC after 1 prior CT FGFR2 MUT (group 1) or WT (group2) RECIST measurable disease Treatment - Dovitinib 500 mg/day dx5/wk Endpoints - 18 week PFS (primary), OR, PFS, OS 18/01/20 16
20 Phase II study of dovitinib in FGFR2-mutated or non mutated advanced/metastatic EC Study design Stage I FGFR2 mut N=20 pts FGFR wt N=20 pts INTERIM ANALYSIS If 8 progression free after 18 wks If 8 progression free after 18 wks Stage II N= 40 pts N= 40 pts 18/01/
21 Phase 2 study of dovitinib in endometrial cancer Trial profile Konecny, Lancet Oncol, 2015
22 Phase 2 study of dovitinib in endometrial cancer Best change from baseline in target lesions Konecny, Lancet Oncol, 2015
23 Personalized medicine in endometrial cancer - Complex heterogeneous disease - Different hystological entities with different genetic aberrations and distinct dysfunctional signalling pathways - Promising targeted agents - Identification of biomarkers and implementation in clinical studies - Retrospective population-based biomarkers studies - Standards for reproducibility and quality - Tumor specimens for predictive biomarkers - Prospective multicentric studies to test biomarkers in routine clinical practice 18/01/ Salvesen, Lancet Oncol, 2012
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