All times are listed in CEST (Central European Summer Time)
LBA41 - Nivolumab (nivo) ± ipilimumab (ipi) in pre-treated patients with advanced, refractory pulmonary or gastroenteropancreatic poorly differentiated neuroendocrine tumors (NECs) (GCO-001 NIPINEC)
- Thomas Walter (Paris, France)
Abstract
Background
Neuroendocrine Carcinomas (NECs) are a distinct family of poorly differentiated morphology, sharing molecular, clinical and outcome characteristics. No standard-of-care exists after the failure of first-line platinum-based chemotherapy (CT) regimens. Nivo±ipi has been reported to provide survival benefit versus standard CT in metastatic solid cancers.
Methods
GCO-001 NIPINEC is a multicenter, non-comparative, randomized (1:1) phase 2 trial with a two-step design (early stopping for futility after 50% of accrual). Main inclusion criteria were histologically proven NEC (large- and small-cell for gastroenteropancreatic (GEP) NECs, and large-cell for lung NECs), in 2nd or 3rd line refractory to platinum-based CT, and PS 0-2. Patients received nivo 3 mg/kg q2w ± ipi 1 mg/kg q6w, for 2 years or until progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) at 8 weeks assessed by investigators (power of 90%, alpha risk at 5% two-sided). Other endpoints included progression-free survival (PFS), overall survival (OS) and safety. NCT number: NCT03591731.
Results
From Dec 2018 to Mar 2021, 185 patients (93 GEP and 92 lung) were enrolled in 50 centers. Median age was 64.4 years (range 26.4–87.1), 71% males, 70% smokers, 91% with ECOG PS 0 or 1, 24% with asymptomatic brain metastases. 170 (92%) patients were evaluable for the primary endpoint. ORR at 8 weeks was 7.2% (95%CI [2.7-15.1]) with nivo and 14.9% (95%CI [8.2-24.2]) with nivo+ipi. Median PFS was 1.8 months (95%CI [1.7-2.0]) with nivo and 1.9 months (95%CI [1.6-2.1]) with nivo+ipi. Median OS was 7.2 months (95%CI [3.7-14.1]) with nivo and 5.8 months (95%CI [3.3-7.6]) with nivo+ipi. 3 patients (3.5%) and 7 patients (8.9%) experienced treatment discontinuation because of toxicity with nivo and nivo+ipi respectively. 2 treatment-related deaths were observed with nivo (meningoencephalitis and pneumonitis). Most frequent grade ≥ 3 AEs were asthenia (7.3%), anaemia (6.3%) and alkaline phosphatase increased (5.8%).
Conclusions
Nivo+Ipi only reached the primary endpoint in 2nd/3rd line NECs pts with acceptable toxicity.
Clinical trial identification
EudraCT 2017-003863-37.
Legal entity responsible for the study
Intergroupe Francophone de Cancérologie Thoracique.
Funding
BMS.
Disclosure
N. Girard: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Boehringer; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Teva; Financial Interests, Personal, Advisory Board: Seagen; Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Personal, Advisory Board: Grunenthal; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: AbbVie; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Principal Investigator: Roche; Financial Interests, Personal, Principal Investigator: Boehringer; Financial Interests, Personal, Principal Investigator: AstraZeneca; Financial Interests, Personal, Principal Investigator: MSD; Financial Interests, Personal, Principal Investigator: BMS; Financial Interests, Personal, Principal Investigator: Seagen; Financial Interests, Personal, Principal Investigator: Janssen; Financial Interests, Personal, Principal Investigator: Lilly; Financial Interests, Personal, Writing Engagements: Edimark; Financial Interests, Personal, Writing Engagements: Fréquence médicale; Other, Personal, Other: AstraZeneca. J. Mazieres: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Daiichi; Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Institutional, Research Grant: Pierre Fabre. H. Lena: Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Takeda; Non-Financial Interests, Institutional, Principal Investigator: BMS; Non-Financial Interests, Institutional, Principal Investigator: AstraZeneca; Non-Financial Interests, Institutional, Principal Investigator: Roche; Non-Financial Interests, Institutional, Principal Investigator: AbbVie; Non-Financial Interests, Institutional, Principal Investigator: GSK; Financial Interests, Personal, Advisory Board: Lilly; Non-Financial Interests, Institutional, Principal Investigator: Lilly; Non-Financial Interests, Institutional, Principal Investigator: Celgene; Non-Financial Interests, Institutional, Principal Investigator: Novartis; Financial Interests, Personal, Advisory Board: Pfizer; Non-Financial Interests, Institutional, Principal Investigator: Pfizer; Financial Interests, Personal, Advisory Board: Amgen; Non-Financial Interests, Institutional, Principal Investigator: Amgen; Non-Financial Interests, Institutional, Principal Investigator: Regeneron. C. Lepage: Financial Interests, Personal, Training: Bayer; Financial Interests, Personal, Training: Amgen; Financial Interests, Personal, Training: Ipsen; Financial Interests, Personal, Training: Pierre Fabre; Financial Interests, Personal, Other, Congress invitation: Novartis; Financial Interests, Personal, Other, Congress invitation: Merck; Financial Interests, Personal, Other, Congress invitation: Ipsen; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: ADVANCED ACCELERATOR APPLICATIONS (AAA). A. Madroszyk: Financial Interests, Personal, Other, Accomodation, lunch, transportation: BMS. P. Michel: Financial Interests, Personal, Advisory Board: Servier; Financial Interests, Personal, Advisory Board: BAYER; Financial Interests, Personal, Invited Speaker: MERCK. C. Louvet: Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Servier; Financial Interests, Personal, Advisory Board: Amgen. V. Westeel: Financial Interests, Personal, Other, Honoraria: AstraZeneca; Financial Interests, Personal, Other, Honoraria: BMS; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Institutional, Sponsor/Funding: Boehringer Ingelheim; Financial Interests, Institutional, Sponsor/Funding: MSD; Financial Interests, Personal, Other, Travel, accomodations, expenses: AstraZeneca; Financial Interests, Personal, Other, Travel, accomodations, expenses: BMS; Financial Interests, Personal, Other, Travel, accomodations, expenses: Pfizer; Financial Interests, Personal, Other, Travel, accomodations, expenses: Roche. T. Walter: Financial Interests, Personal, Advisory Board: Novartis - AAA; Non-Financial Interests, Personal, Funding: Ipsen; Non-Financial Interests, Institutional, Project Lead: Roche. All other authors have declared no conflicts of interest.
1098O - Nivolumab plus platinum-doublet chemotherapy as first-line therapy in unresectable, locally advanced or metastatic G3 neuroendocrine Neoplasms (NENs) of the gastroenteropancreatic (GEP) tract or unknown (UK) origin: Preliminary results from the phase II NICE-NEC trial (GETNE T1913)
- Maria Carmen Riesco-Martinez (Madrid, Ontario, Spain)
Abstract
Background
Grade 3 (G3) NENs encompass a heterogeneous group of tumors with aggressive behaviour and poor survival. Standard front-line platinum-based chemotherapy (CT) has limited efficacy, with an ORR of 31%, a median PFS of 4-5 m and a median OS of 11 m. G3 NENs are associated with a high mutational burden and PD-L1 expression that might lead to a favorable response to immunotherapy (IT). The aim of this study is to assess the safety and potential synergy of the combination of CT plus IT in patients with advanced CT-naïve G3 NENs.
Methods
NICE-NEC is a non-randomized, open-label, phase II trial that recruited patients (pts) with histologically confirmed metastatic or unresectable G3 NENs of GEP/UK origin, treatment-naïve and ECOG 0-2 across 12 centers belonging to the Spanish Taskforce of Neuroendocrine Tumors (GETNE). Pts received Nivolumab 360 mg iv d1/ Carboplatin AUC 5 iv d1/ Etoposide 100 mg/m2 d1-3 every 3 weeks (up to 6 cycles) followed by Nivolumab 480 mg every 4 weeks (up to 24 m) as maintenance tx. Primary endpoint was 12mOS rate. Secondary endpoints include ORR by RECIST 1.1, PFS and safety.
Results
From 2019-2021, 38 pts were enrolled. Median age was 61y, 68% male, 29% ECOG 0, 53% poorly differentiated and 66% Ki67 >55%. 81.6% were GEP; pancreas 37%, stomach 16% and colorectum 16% were the most common sites. 74% had ≥2 metastatic organs involved. With a median follow up of 6 m, disease control rate (DCR) was 84% including an ORR of 50% (47% PR; 3% CR). Median and 6m-PFS rate were 5.7 m (95%CI: 5.1-7.8) and 39% (95%CI: 25-62), respectively. ≥G3 AEs were reported in 61% pts. Most frequent toxicities were hematological: neutropenia (53%), febrile neutropenia (10%) and anemia (11%).
Conclusions
Preliminary results show promising activity of adding Nivolumab to CT as first-line therapy for G3 NENs, with DCR of 84% and greater ORR than benchmark studies. Nivolumab did not significantly increase the toxicity profile of standard CT. Final survival results require further follow-up and translational studies are ongoing.
Clinical trial identification
EudraCT 2019-001546-18; NCT03980925.
Editorial acknowledgement
We acknowledge MFAR Clinical Research staff for their assistance in the development of this abstract.
Legal entity responsible for the study
Grupo Español de Tumores Neuroendocrinos y Endocrinos (GETNE).
Funding
Bristol Myers Squibb (BMS).
Disclosure
M.C. Riesco-Martinez: Financial Interests, Personal, Invited Speaker: Servier; Financial Interests, Personal, Invited Speaker: Merk; Financial Interests, Personal, Advisory Role: AAA; Financial Interests, Institutional, Research Grant, Grant for investigator-initiated study.: BMS; Financial Interests, Institutional, Research Grant, Grant for investigator-initiated study.: MSD. J. Capdevila: Financial Interests, Personal, Other, Scientific consultancy role - Participation in speaker´s bureau: Amgen; Financial Interests, Personal, Other, Scientific consultancy role - Participation in speaker´s bureau: Bayer; Financial Interests, Personal, Other, Scientific consultancy role - Participation in speaker´s bureau: Eisai; Financial Interests, Personal, Other, Scientific consultancy role - Participation in speaker´s bureau: AAA; Financial Interests, Personal, Other, Scientific consultancy role - Participation in speaker´s bureau: Ipsen; Financial Interests, Personal, Other, Scientific consultancy role - Participation in speaker´s bureau: Pfizer; Financial Interests, Personal, Other, Scientific consultancy role - Participation in speaker´s bureau: Merck; Financial Interests, Personal, Other, Scientific consultancy role - Participation in speaker´s bureau: Sanofi; Financial Interests, Personal, Other, Scientific consultancy role - Participation in speaker´s bureau: Novartis; Financial Interests, Personal, Other, Scientific consultancy role - Participation in speaker´s bureau: Lilly; Financial Interests, Personal, Other, Scientific consultancy role - Participation in speaker´s bureau: ITM; Financial Interests, Personal, Other, Scientific consultancy role - Participation in speaker´s bureau: Hudchinson Pharma; Financial Interests, Personal, Other, Scientific consultancy role - Participation in speaker´s bureau: Exelixis; Financial Interests, Personal, Other, Receipt of grants / research supports: Eisai; Financial Interests, Personal, Other, Receipt of grants / research supports: AstraZeneca; Financial Interests, Personal, Other, Receipt of grants / research supports: AAA; Financial Interests, Personal, Other, Receipt of grants / research supports: Ipsen; Financial Interests, Personal, Other, Receipt of grants / research supports: Pfizer; Financial Interests, Personal, Other, Receipt of grants / research supports: Novartis; Non-Financial Interests, Personal, Member, Chair of GETNE: GETNE; Non-Financial Interests, Personal, Member, Advisory member: ENETS. P. Jimenez-Fonseca: Financial Interests, Personal, Advisory Role: Bristol; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Mylan; Financial Interests, Personal, Advisory Role: Baxter; Financial Interests, Personal, Invited Speaker: HRA Pharma; Financial Interests, Personal, Invited Speaker: LeoPharma; Financial Interests, Personal, Invited Speaker: Rovi; Financial Interests, Personal, Invited Speaker: Sanofi. A. Teule: Financial Interests, Personal, Other, Speaking, writing, public presentations, advisory service, travel grants: Novartis; Financial Interests, Personal, Other, Speaking, writing, public presentations, advisory service, travel grants: IPSEN; Financial Interests, Personal, Other, Speaking, writing, public presentations, advisory service, travel grants: AAA; Financial Interests, Personal, Other, Speaking, writing, public presentations, advisory service, travel grants: Pfizer; Financial Interests, Personal, Other, Speaking, writing, public presentations, advisory service, travel grants: AstraZeneca. E. Grande: Financial Interests, Personal, Invited Speaker: Adacap; Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb; Financial Interests, Institutional, Advisory Board: Caris Life Sciences; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Invited Speaker: Eusa Pharma; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Invited Speaker: Merk kGa; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Institutional, Advisory Board: ONCODNA (Biosequence); Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Sanofi-Genzyme; Non-Financial Interests, Institutional, Research Grant: Astellas; Non-Financial Interests, Institutional, Research Grant: AstraZeneca; Non-Financial Interests, Institutional, Other, Coordinating PI: Ipsen; Non-Financial Interests, Institutional, Research Grant: Lexicon; Non-Financial Interests, Institutional, Research Grant: MTEM/Threshold; Non-Financial Interests, Institutional, Research Grant: Nanostring technologies; Non-Financial Interests, Institutional, Research Grant: Pfizer; Non-Financial Interests, Institutional, Research Grant: Roche; Non-Financial Interests, Personal, Advisory Board: ENETS. I. Sevilla: Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Advisory Role: Ipsen; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Syrtex; Financial Interests, Personal, Invited Speaker: PharmaMar; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Invited Speaker: AAA. M. Benavent Viñuales: Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Novartis. T. Alonso-Gordoa: Financial Interests, Personal, Other, Speaker, consultancy or advisory role: Ipsen; Financial Interests, Personal, Other, Speaker, consultancy or advisory role: Pfizer; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Advisory Role: Bayer; Financial Interests, Personal, Advisory Role: Astellas; Financial Interests, Personal, Advisory Role: Janssen-Cilag; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Other, Speaker, consultancy or advisory role: BMS; Financial Interests, Personal, Other, Speaker, consultancy or advisory role: Eisai; Financial Interests, Institutional, Other, Clinical Trial: Roche; Financial Interests, Institutional, Other, Clinical Trial: AstraZeneca; Financial Interests, Institutional, Other, Clinical Trial: BMS; Financial Interests, Institutional, Other, Clinical Trial: MSD; Financial Interests, Institutional, Other, Clinical Trial: Eisai; Financial Interests, Institutional, Other, Clinical Trial: Pfizer; Financial Interests, Institutional, Other, Clinical Trial: Ipsen; Financial Interests, Institutional, Other, Clinical Trial: GSK-Novartis; Financial Interests, Institutional, Other, Clinical Trial: Clovis; Financial Interests, Institutional, Other, Clinical Trial: Nektar Therapeutics; Financial Interests, Institutional, Other, Clinical Trial: Janssen-Cilag; Financial Interests, Institutional, Other, Clinical Trial: Astellas; Financial Interests, Institutional, Other, Clinical Trial: Bayer; Non-Financial Interests, Personal, Project Lead: Pfizer; Non-Financial Interests, Personal, Project Lead: Roche; Non-Financial Interests, Personal, Project Lead: Ipsen; Non-Financial Interests, Personal, Member: Spanish Germ Cell Tumors Board; Non-Financial Interests, Personal, Advisory Role: SEOM. J. Hernando: Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: AAA; Financial Interests, Personal, Invited Speaker: Angelini. R. Garcia-Carbonero: Financial Interests, Personal, Other, Scientific Advice, Speakers Bureau, Honoraria: AAA; Financial Interests, Personal, Other, Scientific Advice, Speakers Bureau, Honoraria: Advanz Pharma; Financial Interests, Personal, Other, Scientific Advice, Speakers Bureau, Honoraria: Bayer; Financial Interests, Personal, Other, Scientific Advice, Speakers Bureau, Honoraria: BMS; Financial Interests, Personal, Other, Scientific Advice, Speakers Bureau, Honoraria: HMP; Financial Interests, Personal, Other, Scientific Advice, Speakers Bureau, Honoraria: Ipsen; Financial Interests, Personal, Other, Scientific Advice, Speakers Bureau, Honoraria: Merck; Financial Interests, Personal, Other, Scientific Advice, Speakers Bureau, Honoraria: Midatech Pharma; Financial Interests, Personal, Other, Scientific Advice, Speakers Bureau, Honoraria: MSD; Financial Interests, Personal, Other, Scientific Advice, Speakers Bureau, Honoraria: Novartis; Financial Interests, Personal, Other, Scientific Advice, Speakers Bureau, Honoraria: PharmaMar; Financial Interests, Personal, Other, Scientific Advice, Speakers Bureau, Honoraria: Pfizer; Financial Interests, Personal, Other, Scientific Advice, Speakers Bureau, Honoraria: Pierre Fabre; Financial Interests, Personal, Other, Scientific Advice, Speakers Bureau, Honoraria: Roche; Financial Interests, Personal, Other, Scientific Advice, Speakers Bureau, Honoraria: Sanofi; Financial Interests, Personal, Other, Scientific Advice, Speakers Bureau, Honoraria: Servier; Financial Interests, Personal, Other, Financial support to investigator-initiated trials: Pfizer; Financial Interests, Personal, Other, Financial support to investigator-initiated trials: BMS; Financial Interests, Personal, Other, Financial support to investigator-initiated trials: MSD; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: ARMO Biosciences; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: AstraZeneca; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: Pfizer; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: Novartis; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: Ipsen; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: Roche; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: Pharmacyclics; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: Boston Biomedicals; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: Merk; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: MSD; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: Amgen; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: Sanofi; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: Bayer; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: Bristol-Myers-Squibb; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: Boehringer; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: Sysmex; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: Gilead Sciences; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: Servier; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: Adacap; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: VCN; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: Lilly; Financial Interests, Institutional, Other, Institutional support for the conduct of clinical trials or for molecular diagnostic platforms: PharmaMar; Non-Financial Interests, Personal, Member, Member of the Executive Committee: GETNE; Non-Financial Interests, Personal, Member, Member of the Executive Committee: ENETS; Non-Financial Interests, Personal, Principal Investigator: Pfizer; Non-Financial Interests, Personal, Principal Investigator: BMS; Non-Financial Interests, Personal, Member: EORTC; Non-Financial Interests, Personal, Member: ASCO; Non-Financial Interests, Personal, Member: ESMO; Non-Financial Interests, Personal, Member: SEOM; Non-Financial Interests, Personal, Member: TTD; Non-Financial Interests, Personal, Member: GEMCAD. All other authors have declared no conflicts of interest.
Invited Discussant LBA41
- Angela Lamarca (Manchester, United Kingdom)
Q&A and live discussion
- Angela Lamarca (Manchester, United Kingdom)
1096O - Lanreotide autogel/depot (LAN) in patients with advanced bronchopulmonary (BP) neuroendocrine tumors (NETs): Results from the phase III SPINET study
- Dieter Horsch (Bad Berka, Germany)
Abstract
Background
Well-differentiated BP-NETs (typical and atypical carcinoid; TC and AC) account for ∼25% of all NETs. However, there is a lack of prospective data with somatostatin analogs (SSAs) in BP-NETs. SPINET evaluated LAN in advanced somatostatin receptor (SSTR)-positive TC and AC BP-NETs.
Methods
SPINET (EudraCT 2015-004992-62; NCT02683941) was a phase 3, randomized (2 LAN: 1 PBO, stratified by TC vs AC), double-blind (DB) study of LAN (120 mg/28 days), with optional open-label LAN treatment phase (OL-LAN). Enrollment was stopped due to slow accrual and ongoing patients in the DB phase could transition to open-label LAN. The primary endpoint was adapted: centrally assessed (RECIST 1.1) PFS during the DB/OL-LAN phases in patients randomized to LAN. Secondary endpoints included PFS and objective response rate (ORR) [central] and time to treatment failure (TTF) [local/central] in each treatment arm during DB phase, and safety.
Results
Overall, 77 patients were randomized and treated (intention-to-treat set: LAN, n=51; PBO, n=26; [OL-LAN, n=40]). Mean (SD) age was 66.2 (12.5) years and 42 (54.5%) were male; 45 (58.4%) and 32 (41.6%) patients had TC and AC respectively, all (Octreoscan) patients had a Krenning score ≥2, 6 (7.8%) had received prior cytotoxic chemotherapy, 71 (92.2%) had hepatic tumor load ≤25%, and 28 (57.1%) and 19 (38.8%) patients had liver and bone metastases, respectively. Median (95% CI) PFS in the LAN randomized group was 16.6 (12.8–21.9) months (TC 21.9 [12.8–not calculable (NC)] months; AC 14.1 [5.6–16.6] months). Key secondary endpoints are shown in the table. In the DB phase, PFS for LAN and PBO, respectively, was 21.9 (13.8–NC) vs 13.9 (13.4–NC) months in TC and 13.8 (5.6–16.6) vs 11.0 (2.8–16.9) months in AC. aLAN vs PBO; bExcludes death/progression (part of PFS assessment) TEAE, treatment-emergent adverse event.
DB LAN (n=51) PBO (n=26) HR [95% CI]a PFS (TC & AC), median (95% CI), mths 16.6 (11.3–21.9) 13.6 (8.3–NC) 0.90 [0.46–1.88] ORR, % (95% CI) 14.0 (5.8–26.7) 0 (0.0–13.7) – TTF, median (95% CI), mths 13.3 (5.6–14.1) 9.8 (5.4–13.6) 0.86 [0.50–1.50] DB OL-LAN TEAEs, n (%)b LAN (n=51) PBO (n=26) All pts (n=40) Any 49 (96.1) 25 (96.2) 26 (65.0) Related 38 (74.5) 14 (53.8) 13 (32.5) Grade Leading to study treatment withdrawal 2 (3.9) 3 (11.5) 0 Serious AEs 10 (19.6) 7 (26.9) 1 (2.5) Related 2 (3.9) 1 (3.8) 0
Conclusions
SPINET, the largest prospective study to date with a SSA in SSTR-positive BP-NETs, suggests that LAN 120 mg could be an appropriate treatment option, especially for TC.
Clinical trial identification
EudraCT 2015-004992-62; NCT02683941.
Editorial acknowledgement
Dr Nicky French of Oxford PharmaGenesis, Oxford, UK, provided medical writing and editorial support, which was sponsored by Ipsen.
Legal entity responsible for the study
Ipsen.
Funding
Ipsen.
Disclosure
E. Baudin: Financial Interests, Personal and Institutional, Expert Testimony, Advisory Board, Research grant, Principal Investigator: Novartis; Financial Interests, Personal and Institutional, Advisory Board, Research grant: HRA; Financial Interests, Personal and Institutional, Project Lead, Principal Investigator: Ipsen; Financial Interests, Personal and Institutional, Advisory Board, Research grant: AAA; Financial Interests, Personal and Institutional, Research Grant: Pfizer; Financial Interests, Personal and Institutional, Advisory Board: Hutchinson Pharma. D. Horsch: Financial Interests, Personal, Advisory Board: Advanz Pharma; Financial Interests, Personal, Advisory Board: Novartis Pharma GmbH; Financial Interests, Personal, Advisory Board: Ipsen Pharma GmbH; Financial Interests, Personal, Invited Speaker: Ipsen Pharma GmbH. S. Singh: Financial Interests, Institutional, Research Grant: AAA; Financial Interests, Institutional, Research Grant: Ipsen; Financial Interests, Personal, Advisory Board, Invited speaker: Ipsen. M.E. Caplin: Financial Interests, Personal, Speaker’s Bureau, Advisory Board, Research grant: Ipsen; Financial Interests, Personal, Speaker’s Bureau, Advisory Board: Novartis; Financial Interests, Personal, Speaker’s Bureau, Advisory Board, Research grant: Advanced Accelerator Applications; Financial Interests, Personal, Speaker’s Bureau, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Sirtex. D. Ferone: Other, Institutional, Invited Speaker, Advisory Board, Research grant: Ipsen; Other, Institutional, Invited Speaker, Advisory Board, Research grant: Novartis-AAA; Other, Institutional, Invited Speaker, Research grant: Pfizer; Other, Institutional, Advisory Board: Sandoz; Other, Institutional, Advisory Board: BMS; Other, Institutional, Advisory Board, Research grant: Camurus. E.M. Wolin: Non-Financial Interests, Personal, Advisory Board: Chiasma; Non-Financial Interests, Personal, Advisory Board: Progenics; Non-Financial Interests, Personal, Advisory Board: RadioMedix. J. Capdevila: Financial Interests, Personal, Speaker’s Bureau, Advisory Board, Invited speaker: Amgen; Financial Interests, Personal, Speaker’s Bureau, Advisory Board, Invited speaker: Bayer; Financial Interests, Personal, Speaker’s Bureau, Advisory Board, Invited speaker, Research grant: AAA; Financial Interests, Personal, Speaker’s Bureau, Advisory Board, Invited speaker, Research grant: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau, Advisory Board, Invited speaker, Research grant: Eisai; Financial Interests, Personal, Speaker’s Bureau, Advisory Board, Invited speaker: Exelixis; Financial Interests, Personal, Speaker’s Bureau, Advisory Board, Invited speaker, Research grant: Ipsen; Financial Interests, Personal, Speaker’s Bureau, Advisory Board, Invited speaker: ITM; Financial Interests, Personal, Speaker’s Bureau, Advisory Board, Invited speaker: Hudchinson Pharma; Financial Interests, Personal, Speaker’s Bureau, Advisory Board, Invited speaker: Lilly; Financial Interests, Personal, Speaker’s Bureau, Advisory Board, Invited speaker, Research grant: Merck; Financial Interests, Personal, Speaker’s Bureau, Advisory Board, Invited speaker, Research grant: Novartis; Financial Interests, Personal, Speaker’s Bureau, Advisory Board, Invited speaker, Research grant: Pfizer; Financial Interests, Personal, Speaker’s Bureau, Advisory Board, Invited speaker: Sanofi. M. Raderer: Financial Interests, Personal, Other, Honoraria: Gilead; Financial Interests, Personal, Other, Honoraria: Ipsen; Financial Interests, Personal, Other, Honoraria: Novartis; Financial Interests, Personal, Other, Honoraria: Eli Lilly; Financial Interests, Personal, Other, Honoraria: Eisai; Financial Interests, Personal, Other, Honoraria: Roche. C. Grohe: Financial Interests, Institutional, Research Grant: Ipsen. A. Houchard: Financial Interests, Institutional, Stocks/Shares: Ipsen. X. Truong Thanh: Financial Interests, Institutional, Full or part-time Employment, Project Lead, Stocks/Shares: Ipsen. D. Reidy-Lagunes: Financial Interests, Institutional, Principal Investigator, SPINET: Ipsen; Financial Interests, Personal and Institutional, Advisory Board, Research grant: Novartis; Financial Interests, Personal, Advisory Board: AAA; Financial Interests, Personal, Advisory Board: Chiasma. All other authors have declared no conflicts of interest.
1097O - The AXINET trial (GETNE1107): Axitinib plus octreotide LAR improves PFS by blinded central radiological assessment vs placebo plus octreotide LAR in G1-2 extrapancreatic NETs
- Rocio Garcia-Carbonero (Madrid, Spain)
Abstract
Background
Angiogenesis plays an important role in NET development and progression. Axitinib is a potent and selective VEGFR-1,2,3 inhibitor with proven activity against other vascular-dependent solid tumors. The aim of this double-blind phase II/III randomized study was to assess the efficacy of axitinib in patients (pts) with advanced G1-2 extra-pancreatic NETs.
Methods
Pts were randomized 1:1 to receive octreotide LAR (30 mg IM q4w) with axitinib (5 mg BID) or placebo BID until disease progression or unacceptable toxicity. Randomization was stratified by time from diagnosis to study entry (> or ≤ 12m), primary tumor site (GI tract vs non-GI) and Ki-67 index (≤ 5% vs > 5%). Prior therapy with SSA, IFN and up to 2 lines of systemic treatment was allowed, but not prior VEGF- or VEGFR-targeted drugs. Clinical and/or radiological disease progression within 12 months prior to study entry was required. The primary endpoint was progression-free survival (PFS). PFS results per investigator assessment were presented at ASCO GI 2021. Blinded independent central assessment of PFS is now presented.
Results
256 pts were enrolled, 126 randomized to axitinib and 130 to placebo (G1-2: 29%-71%). Most common primary tumor sites were SI (47%), lung (28%), rectum (6%), UK (8%), gastric (3%) and colon (2%). Prior therapies included SSA (48%), everolimus (13%), chemotherapy (13%), LR tx (7%) and PRRT (3%). ORR per independent radiological assessment was significantly greater in axitinib- vs placebo-treated patients (13.2% vs 3.2%, p=0.0045). PFS per blinded independent central review also significantly favored axitinib-treated patients (median PFS of 16.6 vs 9.9 months in the axitinib vs placebo arms, respectively, HR 0.687, p=0.01). Toxicity was manageable, as previously reported (ASCO GI 2021).
Conclusions
Axitinib demonstrated a significant improvement in PFS in combination with octreotide LAR in pts with advanced progressive G1-2 extra-pancreatic NETs as per independent radiological assessment blinded to treatment allocation, with a tolerable safety profile.
Clinical trial identification
NCT01744249.
Editorial acknowledgement
Daniela Morales-Espinosa MD, MSc.
Legal entity responsible for the study
GETNE (Grupo Español de Tumores Neuroendocrinos).
Funding
Pfizer.
Disclosure
R. Garcia-Carbonero: Financial Interests, Personal, Speaker’s Bureau, Scientific advice: AAA; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: Advanz Pharma; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: Bayer; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: BMS; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: HMP; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: Ipsen; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: Merck; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: Midatech Pharma; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: MSD; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: Novartis; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: PharmaMar; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: Pfizer; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: Pierre Fabre; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: Roche; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: Sanofi; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: Servier; Financial Interests, Personal, Funding, Financial support to IIT evaluating Axitinib in NETs: Pfizer; Financial Interests, Personal, Funding, Financial support to IIT evaluating Nivolumab in NECs: BMS; Financial Interests, Personal, Funding, Financial support to IIT evaluating Pembrolizumab-Olaparib in CRC: MSD; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: ARMO Biosciences; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Astra Zeneca; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Pfizer; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Novartis; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Ipsen; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Roche; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Pharmacyclics; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Boston Biomedicals; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Merck; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: MSD; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Amgen; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Sanofi; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Bayer; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Bristol-Myers-Squibb; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Boerhinger Ingelheim; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Sysmex; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Gilead Sciences; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Servier; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Adacap; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: VCN; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Lilly; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: PharmaMar; Non-Financial Interests, Personal, Leadership Role, Member of the executive committee: GETNE (Spanish Neuroendocrine Tumor Cooperative Group; Non-Financial Interests, Personal, Leadership Role, Member of the executive committee: ENETS; Non-Financial Interests, Personal, Principal Investigator, Global PI of clinical trial of Axitinib in NETs: Pfizer; Non-Financial Interests, Personal, Principal Investigator, Global PI of clinical trial of nivolumab and chemotherapy in NETs: BMS; Non-Financial Interests, Personal, Principal Investigator, Global PI of clinical trial of pembrolizumab-olaparib in CRC: MSD; Non-Financial Interests, Personal, Member: EORTC; Non-Financial Interests, Personal, Member: ASCO; Non-Financial Interests, Personal, Member: ESMO; Non-Financial Interests, Personal, Member: SEOM; Non-Financial Interests, Personal, Member: TTD; Non-Financial Interests, Personal, Member: GEMCAD. M. Benavent: Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Role: PFIZER; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Advisory Role: Ipsen; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: ROCHE; Financial Interests, Personal, Principal Investigator: Novartis; Financial Interests, Personal, Principal Investigator: Ipsen. D. Castellano: Financial Interests, Personal, Invited Speaker: full DOI at ESMO profile. T. Alonso-Gordoa: Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: Ipsen; Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: Pfizer; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Advisory Role: Bayer; Financial Interests, Personal, Advisory Role: Astellas; Financial Interests, Personal, Advisory Role: Janssen-Cilag; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: BMS; Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: Eisai; Financial Interests, Personal, Invited Speaker: Merck; Financial Interests, Institutional, Principal Investigator: Roche; Financial Interests, Institutional, Principal Investigator: Astra Zeneca; Financial Interests, Institutional, Principal Investigator: BMS; Financial Interests, Institutional, Principal Investigator: MSD; Financial Interests, Institutional, Principal Investigator: Eisai; Financial Interests, Institutional, Principal Investigator: Pfizer; Financial Interests, Institutional, Principal Investigator: Ipsen; Financial Interests, Institutional, Principal Investigator: GSK-Novartis; Financial Interests, Institutional, Principal Investigator: Clovis; Financial Interests, Institutional, Principal Investigator: Nektar Therapeutics; Financial Interests, Institutional, Principal Investigator: Janssen-Cilag; Financial Interests, Institutional, Principal Investigator: Astellas; Financial Interests, Institutional, Principal Investigator: Bayer; Non-Financial Interests, Institutional, Project Lead: Pfizer; Non-Financial Interests, Institutional, Project Lead: Roche; Non-Financial Interests, Institutional, Project Lead: Ipsen. A. Teulé: Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Astra Zeneca; Financial Interests, Personal, Invited Speaker: AAA; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Ipsen; Financial Interests, Personal, Advisory Role: Astra Zeneca; Financial Interests, Personal, Advisory Role: AAA; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Other, Travel grants: Novartis; Financial Interests, Personal, Other, Travel grants: Ipsen; Financial Interests, Personal, Other, Travel grants: Astra Zeneca; Financial Interests, Personal, Other, Travel grants: AAA; Financial Interests, Personal, Other, Travel grants: Pfizer. A. Custodio: Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: IPSEN; Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: Pfizer; Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: Novartis; Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: MSD; Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: BMS; Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: Lilly; Financial Interests, Institutional, Principal Investigator: Ipsen; Financial Interests, Institutional, Principal Investigator: MSD; Financial Interests, Institutional, Principal Investigator: BMS; Financial Interests, Institutional, Principal Investigator: EISAI; Financial Interests, Institutional, Principal Investigator: Astra Zeneca; Financial Interests, Institutional, Principal Investigator: Novartis; Financial Interests, Institutional, Principal Investigator: Astellas; Financial Interests, Institutional, Principal Investigator: BeiGene; Non-Financial Interests, Personal, Leadership Role, Member of the GETNE tumor board: GETNE. S. Tafuto: Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: AAA; Financial Interests, Personal, Principal Investigator: Ipsen; Financial Interests, Personal, Principal Investigator: Roche; Financial Interests, Personal, Principal Investigator: PFIZER; Financial Interests, Personal, Principal Investigator: Novartis. F. Spada: Financial Interests, Personal, Advisory Board, Travel grant: Ipsen; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Other, Travel grant: Pfizer; Financial Interests, Personal, Invited Speaker: AAA; Financial Interests, Personal, Invited Speaker: Merck; Financial Interests, Institutional, Principal Investigator: GETNE; Financial Interests, Institutional, Principal Investigator: Incyte; Financial Interests, Institutional, Principal Investigator: MSD; Non-Financial Interests, Personal, Leadership Role, Coordinator of Neuroendocrine Neoplasms guidelines: Italian Association of Medical Oncology (AIOM); Non-Financial Interests, Personal, Leadership Role, Executive board meamber: Italian Association of Neuroendocrine Tumors (ITANET). C. López: Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: AAA; Non-Financial Interests, Personal, Principal Investigator: Ipsen; Non-Financial Interests, Personal, Principal Investigator: ROCHE; Non-Financial Interests, Personal, Principal Investigator: Pfizer; Non-Financial Interests, Personal, Principal Investigator: Novartis. T. Ibrahim: Financial Interests, Personal, Other, Consultancy: EISAI; Financial Interests, Personal, Other, Consultancy: Amgen; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Other, Travel grant: Ipsen; Financial Interests, Personal, Other, Travel grant: Pharmamar; Financial Interests, Personal, Other, Travel grant: Novartis. M.J. Villanueva Silva: Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Glaxo-Smithkline; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Pfizer; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Roche; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Novartis; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Sanofi; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Celgene; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: AstraZeneca; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: BMS; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Merck Serono; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Merck Sharp and Dohme; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Janssen-Cilag; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Bayer. V. Iranzo: Financial Interests, Personal, Advisory Board: Advanced Accelerator Applications; Financial Interests, Personal, Invited Speaker: Astra Zeneca; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Advisory Board: Genomic Health; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Roche. P. García-Alfonso: Financial Interests, Personal, Invited Speaker: Ipsen. E. González-Flores: Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: AAA; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Novartis. E. Grande: Financial Interests, Personal, Invited Speaker: Adecap; Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Invited Speaker: Astra Zeneca; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb; Financial Interests, Institutional, Advisory Board: Caris Life Sciences; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Invited Speaker: Eusa Pharma; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Invited Speaker: Merck KGa; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: ONCODNA (Biosequence); Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Sanofi-Genzyme; Non-Financial Interests, Institutional, Research Grant: Astellas; Non-Financial Interests, Institutional, Research Grant: Astra Zeneca; Non-Financial Interests, Institutional, Principal Investigator: Ipsen; Non-Financial Interests, Institutional, Research Grant: Lexicon; Non-Financial Interests, Institutional, Research Grant: MTEM/Threshold; Non-Financial Interests, Institutional, Research Grant: Nanostring Technologies; Non-Financial Interests, Institutional, Research Grant: Pfizer; Non-Financial Interests, Institutional, Research Grant: Roche. G. Crespo: Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: IPSEN; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: EISAI; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Invited Speaker: EUSA Pharma; Financial Interests, Personal, Invited Speaker: Pierre Fabre. A. Carmona-Bayonas: Financial Interests, Personal, Project Lead: Lilly; Financial Interests, Personal, Project Lead: BMS. J. Capdevila: Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker: Amgen; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker: Bayer; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker - Research grant: AAA; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker - Research grant: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker - Research grant: Eisai; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker - Research grant: Ipsen; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker - Research grant: ITM; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker: Hudchinson Pharma; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker: Lilly; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker: Merck; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker - Research grant: NOVARTIS; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker - Research grant: Pfizer; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker: Sanofi. All other authors have declared no conflicts of interest.
Invited Discussant 1096O and 1097O
- Nicola Fazio (Milan, Italy)
Q&A and live discussion
- Nicola Fazio (Milan, Italy)