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ePoster Display

1107P - Durvalumab plus tremelimumab in patients with grade 3 neuroendocrine neoplasms of gastroenteropancreatic origin: Updated results from the multicenter phase II DUNE trial (GETNE 1601)

Date

16 Sep 2021

Session

ePoster Display

Presenters

Jaume Capdevila

Citation

Annals of Oncology (2021) 32 (suppl_5): S906-S920. 10.1016/annonc/annonc678

Authors

J. Capdevila1, S. Landolfi2, J. Hernando1, A. Teule3, R. Garcia-Carbonero4, A. Custodio5, A. Cubillo6, T. Alonso-Gordoa7, A. Carmona-Bayonas8, G. Crespo9, M. Blanco10, A. Viudez11, A. La Casta12, I. Sevilla13, Á. Segura14, C. López15, M. Benavent Viñuales16, P. Nuciforo17, J.L. Manzano18

Author affiliations

  • 1 Medical Oncology Department, Vall Hebron University Hospital, Vall Hebron Institute of Oncology (VHIO), 8035 - Barcelona/ES
  • 2 Pathology Department, Vall Hebron University Hospital, Barcelona/ES
  • 3 Medical Oncology Department, Institut Català d´Oncologia (ICO) - IDIBELL, Hospitalet de Llobregat/ES
  • 4 Medical Oncology Department, Hospital Universitario 12 de Octubre, Imas12, UCM, CNIO, 28041 - Madrid/ES
  • 5 Medical Oncology Department, Hospital Universitario La Paz, Madrid/ES
  • 6 Medical Oncology Department, Hospital Universitario HM Sanchinarro, 28050 - Madrid/ES
  • 7 Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid/ES
  • 8 Hematology And Medical Oncology Department, Hospital Universitario Morales Meseguer. UMU. IMIB, 30008 - Murcia/ES
  • 9 Medical Oncology Department, Complejo Asistencial Universitario de Burgos, Burgos/ES
  • 10 Medical Oncology Department, Hospital Universitario Gregorio Marañon, Madrid/ES
  • 11 Medica Oncology Department, Complejo Hospitalario de Navarra, Pamplona/ES
  • 12 Medical Oncology Department, Hospital Universitario Donostia, San Sebastián/ES
  • 13 Medical Oncology Department, Investigación Clínica y Traslacional en Cáncer / Instituto de Investigaciones Biomédicas de Málaga (IBIMA) / Hospitales Universitarios Regional y Virgen de la Victoria de Málaga, Málaga/ES
  • 14 Medical Oncology Department, Hospital Universitario la Fe, Valencia/ES
  • 15 Medical Oncology Department, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander/ES
  • 16 Medical Oncology Department, University Hospital Virgen del Rocío, Instituto de Biomedicina de Sevilla (IBIS), Seville/ES
  • 17 Molecular Oncology Group, Vall Hebron Institute of Oncology (VHIO), Barcelona/ES
  • 18 Medical Oncology Department, Institut Català d'Oncologia (ICO) - Badalona, Hospital Germans Trias i Pujol, Badalona/ES
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Abstract 1107P

Background

Previously reported treatment efficacy with durvalumab (D) plus tremelimumab (T) showed limited activity in patients (pts) with well differentiated neuroendocrine tumors (NETs). However, primary endpoint was achieved in grade 3 (G3) neuroendocrine neoplasms (NENs) suggesting a promising overall survival rate in a pretreated population. Here we update the results of the G3 cohort with central pathological review.

Methods

DUNE was a prospective open-label trial that recruited pts with advanced NENs after progression to standard therapies in four cohorts (C1-4): typical/atypical lung carcinoids (C1), G1/2 gastrointestinal (C2), G1/2 pancreatic (C3), and G3 NENs of gastroenteropancreatic origin after progression to first-line platinum-based chemotherapy (C4). Pts received 1500 mg durvalumab (D) (up to 13 cycles) plus 75 mg tremelimumab (T)(up to 4 cycles) once every 4 weeks. Primary objective for C4 was the 9 months (m) overall survival rate (OS) expected to be over 23%.

Results

From 2017 to 2019, 123 pts were enrolled. The C4 included 33 G3 NEN pts with a median age of 55-y, 67% male, ECOG 0 in 39%. By central pathological review, 18 (54.5%) were poorly differentiated neuroendocrine carcinomas (NECs) and 15 (45.5%) were G3 NETs. Ki67 between 20-50% was reported in 13 cases (39.4%) and 20 (60.6%) had Ki67 >50%. At the data cutoff point, 30 (91%) pts died, 2 were alive and 1 lost to follow up. The 9-m OS rate was 36.1%, with a median OS of 5.9 m (95%CI: 2-9.7). Ten (30%) pts had prolonged survival (> 12 m after initiation of D+T therapy). Of them, 7 had NECs and 3 NETs (p=0.28), and 6 had Ki67 >50%. PD-L1 combined positive score (tumor cells, lymphocytes and macrophages) determination was feasible in 21 pts (63.6%), being positive in 7 (33%) with no impact in survival (p=0.62). Overall response rate by irRECIST was 9.1%.

Conclusions

D+T reached the primary endpoint of OS rate at 9 months in G3 NENs. One third of treated pts experienced a prolonged OS of over one year regardless of tumor differentiation, Ki67 level or PD-L1 expression, confirmed by central pathological review. Immunotherapy deserves further evaluation in G3 NENs.

Clinical trial identification

EudraCT 2016-002858-20; NCT03095274.

Editorial acknowledgement

We acknowledge to 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

AstraZeneca.

Disclosure

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, Research Grant: Eisai; Financial Interests, Personal, Research Grant: AstraZeneca; Financial Interests, Personal, Research Grant: AAA; Financial Interests, Personal, Research Grant: Ipsen; Financial Interests, Personal, Research Grant: Pfizer; Financial Interests, Personal, Research Grant: Novartis; Non-Financial Interests, Personal, Member, Chair of GETNE: GETNE; Financial Interests, Personal, Member, Advisory member of ENETS: ENETS. 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. 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. 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: Merck; 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: GETNE; Non-Financial Interests, Personal, Member: ENETS; Non-Financial Interests, Personal, Member: EORTC; Non-Financial Interests, Personal, Member: ESMO; Non-Financial Interests, Personal, Member: ASCO; Non-Financial Interests, Personal, Member: SEOM; Non-Financial Interests, Personal, Member: TTD; Non-Financial Interests, Personal, Member: GEMCAD; Non-Financial Interests, Personal, Principal Investigator: Pfizer; Non-Financial Interests, Personal, Principal Investigator: BMS. 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, Other, Consultancy or advisory role: Roche; Financial Interests, Personal, Other, Consultancy or advisory role: Sanofi; Financial Interests, Personal, Other, Consultancy or advisory role: Bayer; Financial Interests, Personal, Other, Consultancy or advisory role: Astellas; Financial Interests, Personal, Other, Consultancy or advisory role: Janssen-Cilag; Financial Interests, Personal, Other, Consultancy or 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: Roche; Non-Financial Interests, Personal, Project Lead: Pfizer; Non-Financial Interests, Personal, Project Lead: Ipsen; Financial Interests, Personal, Member: Spanish Germ Tumors Board; Other, Personal, Advisory Role: SEOM. G. Crespo: Financial Interests, Personal, Other: BMS; Financial Interests, Personal, Other: Ipsen; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Eisai; Financial Interests, Personal, Other: SANOFI; Financial Interests, Personal, Other: Janssen; Financial Interests, Personal, Other: Pierre Fabre; Financial Interests, Personal, Other: EUSA Pharma. M. Blanco: Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Other, travel and congress attendance grants: Lilly; Financial Interests, Personal, Other, travel and congress attendance grants: Roche; Financial Interests, Personal, Other, travel and congress attendance grants: Ipsen; Financial Interests, Personal, Principal Investigator: Astellas; Financial Interests, Personal, Principal Investigator: AAA; Financial Interests, Personal, Principal Investigator: BMS; Financial Interests, Personal, Principal Investigator: Merck; Financial Interests, Personal, Principal Investigator: Daichi-Saiko; Financial Interests, Personal, Principal Investigator: Beigene. I. Sevilla: Financial Interests, Personal, Advisory Board: Ipsen; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Syrtex; Financial Interests, Personal, Invited Speaker: Pharmamar; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Invited Speaker: AAA. C. López: Financial Interests, Personal, Other, Honoraria for speaker, consultancy or advisory or similar activity: Ipsen; Financial Interests, Personal, Other, Honoraria for speaker, consultancy or advisory or similar activity: Roche; Financial Interests, Personal, Other, Honoraria for speaker, consultancy or advisory or similar activity: Eisai; Financial Interests, Personal, Other, Honoraria for speaker, consultancy or advisory or similar activity: Novartis; Financial Interests, Personal, Other, Honoraria for speaker, consultancy or advisory or similar activity: Pfizer; Financial Interests, Personal, Other, Honoraria for speaker, consultancy or advisory or similar activity: AAA; Financial Interests, Personal, Other, Direct research funding: Ipsen; Financial Interests, Personal, Other, Direct research funding: Roche; Financial Interests, Personal, Other, Direct research funding: Pfizer; Financial Interests, Personal, Other, Direct research funding: Novartis. M. Benavent Viñuales: Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Pfizer. P. Nuciforo: Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Institutional, Research Grant: Bayer. All other authors have declared no conflicts of interest.

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