Ongoing and future clinical investigation in GEP NENs
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1 ESMO PRECEPTORSHIP PROGRAMME Multidisciplinary management, standards of care and future perspectives Lugano, Switzerland April 2018 CHAIR: Nicola Fazio, Italy George Pentheroudakis, Greece Ongoing and future clinical investigation in GEP NENs Nicola Fazio, M.D., Ph. D. SPEAKERS: Pier Luigi Filosso, Italy Andrea Frilling, United Kingdom Rocio Garcia-Carbonero, Spain Massimo Milione, Italy Marianne Pavel, Germany Aviral Singh, Germany Anders Sundin, Sweden Christos Toumpanakis, United Kingdom European Institute of Oncology Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors European Institute of Oncology Milan, Italy
2 Disclosure! Novartis, Ipsen, Pfizer, AAA, Merck Serono: consulting and advisory services! Novartis, Merck Serono: Research funds (to the institution)!
3 Investigation lines in GEP NENs SSA Sequence PRRT High grade New drugs Immunotherapy
4 Investigation lines in GEP NENs SSA Sequence PRRT High grade New drugs Immunotherapy
5 Efficacy and Safety of Lanreotide Autogel 120 mg Administered Every 14 Days in Well Differentiated, Metastatic or Locally Advanced, Unresectable Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel 120 mg Administered Every 28 Days CLARINET FORTE Histopathologically confirmed, grade 1 or 2, metastatic or locally advanced, unresectable pnet (pnet cohort) or midgut NET (midgut cohort) with or without hormone related syndromes, with a proliferation index (Ki67) 20%. Positive somatostatin receptors type patients
6 European, prospective, multicentre, double-blind randomised study evaluating lanreotide Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET) Inclusione criteria: Documented stable disease or objective response after first-line treatment (chemotherapy or biotherapy for 6 months), within 4 weeks (28 days) prior to randomisation Treatment: Lanreotide 120 mg every 28 days until disease progression versus placebo
7 Investigation lines in GEP NENs SSA Sequence PRRT High grade New drugs Immunotherapy
8 GETNE 1206 (SEQTOR) phase III trial in pa;ents with advanced pannets enrolling Arm A: Everolimus Everolimus Progression Arm B: STZ + 5-FU STZ + 5-FU Primary end point: rate of second PFS at 84 weeks of treatment
9 Investigation lines in GEP NENs SSA Sequence PRRT High grade New drugs Immunotherapy
10 A prospective, randomised, Controlled, Open-label, Multicentre phase III study to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177 Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptorpositive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP- NET). COMPETE trial 177 Lu-edotreotide G1- G2 advanced progressive GEP NET Rand. Phase III Everolimus
11 COMPETE Worldwide Initiated & Sites Ready for Initiation Australia, Austria, France, Germany, Netherlands, South Africa, Switzerland, UK Review in progress Italy, Poland EC / CA submissions to be done US
12 Investigation lines in GEP NENs SSA Sequence PRRT High grade New drugs Immunotherapy
13 Phase II trial Everolimus and Temozolomide in Advanced GEP NECs (G3) Histologically proven neuroendocrine carcinoma with a Ki67 of 20-55%. Primary GEP NET or unknown primary where metastases are mainly abdominal
14 Randomized phase II study of cisplatin and etoposide versus temozolomide and capecitabine in patients (pts) with advanced G3 non-small cell gastroenteropancreatic neuroendocrine carcinomas (GEPNEC): A trial of the ECOG-ACRIN Cancer Research Group (EA2142). G3 (only large cell) GEP NEC Ki % First- line CDDP / VP-16 Rand. Phase II 126 pts CAP / TEM
15 Prospec;ve Interna;onal Phase II Mul;- centre Trial 177 Lu- DOTA- octreotate (LuTate) PRRT Vs Capecitabine Temozolomide chemotherapy for Grade 3 GEP NEN (Ki %) LUCAT Trial PI: Grace Kong, Michael Michael, Rod Hicks Peter MacCallum Cancer Center, Melbourne, Australia Primary objec;ve PFS. 56 pa;ents 1 st or 2 nd line
16 Investigation lines in GEP NENs SSA Sequence PRRT High grade New drugs Immunotherapy
17 Novel TKIs in GEP NETs Compound VEGFR PDGFR FGFR CSF1R KIT FLT-3 RET MET α β Sunitinib Pazopanib Cabozantinib Lenvatinib Sulfatinib
18 SulfaTnib in GEP NET 81 NET pts (41 pnet) Jia, ENETS 2017, Oral presentation
19 SulfaTnib in GEP NET Jia, ENETS 2017, Oral presentation
20 CabozanTnib in GEP NET Phase II trial 41 carcinoids 20 pnets PR 15% SD 63% mpfs 31 mo PR 15% SD 75% mpfs 22 mo Chan et al., ASCO GI 2017, Poster
21 TALENT trial Phase II with LENVATINIB in GEP NETs Lenvatinib binds to RET, VEGFR and FGFR Pancreatic G1/G2 cohort (n=55) Gastrointestinal G1/G2 cohort (n=55)
22 Table 1. Inhibitory concentrations (IC50 in nmol) for targets with multitargeted TKIs. Drug VEGFR1 VEGFR2 VEGFR3 PDGFR PDGFR c-kit RET RAF FLT3 Axitinib NA 1000 Pazopanib NA 1000 Sunitinib NA 1 10 Sorafenib 26 NA AXITINIB
23 A PHASE II/III RANDOMIZED DOUBLE-BLIND STUDY OF SANDOSTATIN LAR IN COMBINATION WITH AXITINIB VERSUS SANDOSTATIN LAR WITH PLACEBO IN PATIENTS WITH ADVANCED G1-G2 NEUROENDOCRINE TUMOURS (WHO 2010) OF NON-PANCREATIC ORIGIN N=!253! Arm$A$ with!progression!of!disease!in! the!previous!12!mo!! Age!!18!years! With!or!without!previous! chemotherapy! Ki67!<!20%!!! *!RANDOMIZATION! N! Axitinib!+! Sandostatin!LAR! Placebo!+! Sandostatin!LAR! Arm$B$
24 CDK 4/6 inhibitors in NETs
25 CDK 4/6 inhibition in NET: preclinical studies with ribociclib and pabociclib CDK4/6 controls cell cycle progression from G1 to S phase by regulating the activity of Rb Prada et al, Neuroendocrinology 2016 Tang L. et al., Clin Cancer Res 2012
26 Ribociclib in NET: preclinical study GOT-1 H727 QGP-1 BON-1 Ribociclib sensitivity was associated with high expression of cyclin-1 and Rb Ribociclib/Everolimus or 5-FU combinations were superior to the single-agent therapies, by downregulating mtor and MEK pathways Prada et al, Neuroendocrinology 2016
27 Abstract 429O A phase II trial of palbociclib in metastatic grade 1/2 pancreatic neuroendocrine tumors: the PALBONET study on behalf of the Spanish Taskforce Group of Neuroendocrine Tumors (GETNE) Enrique Grande 1, Alexandre Teulé 2, Teresa Alonso-Gordoa 1, Paula Jiménez-Fonseca 3, Marta Benavent 4, Jaume Capdevila 5, Ana Custodio 6, Ruth Vera 7, Javier Munárriz 8, Adelaida La Casta-Muñoa 9, Rocío García-Carbonero 10 Patients treated 21 N % Partial response (PR) 0 0 Stable disease (SD) Progression disease (PD) 9 45 mpfs: 2.6 months (95% CI )
28 A Phase II Study of LEE011 (Ribociclib) in Patients with Advanced Neuroendocrine Tumors of Foregut Origin (CLEE011 XUS02T) US only
29 Research lines in GEP NENs SSA PRRT High grade New drugs Immunotherapy
30 Yao, ENETS 2017, Oral presentations
31 PDR001 in GEP and Lung NET/NEC Phase II multi-cohort international study PDR001 binds to PD-1 so blocking both PD-L1 and PD-L2 Well differentiated: GI cohort (n=30) Pancreatic cohort (n=30) Thoracic cohort (n=30) Poorly differentiated: GEP cohort (n=20)
32 A multicohort phase II study of durvalumab plus tremelimumab for the treatment of patients (PTS) with advanced neuroendocrine neoplasms (NENs) of gastroenteropancreatic (GEP) or lung origin (the DUNE trial-getne1601-). Single-arm Phase II 126 pts Well differentiated: GI cohort (n=30) Pancreatic cohort (n=30) Thoracic cohort (n=30) Durvalumab Poorly differentiated: GEP cohort (n=20) Tremelimumab
33 European Institute of Oncology, IEO, Milan, Italy ENETS Center of Excellence for GEP NETs IEO NET MDT
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