LBA41 Nivolumab (nivo) ± ipilimumab (ipi) in pre-treated patients with advanced, refractory pulmonary or gastroenteropancreatic poorly differentiated neuroendocrine tumors (NECs) (GCO-001 NIPINEC)

Girard, Nicolas; Otto, Josiane; Léna, H.; Lepage, C.; Egenod, T.; Smith, Denis; Madelaine, J.; Gérinière, L.; Hajbi, Farid El; Ferru, Aurélie; Clément-Duchêne, Christelle; Madroszyk, Anne; Desrame, Jérôme; Morin, Franck; Langlais, Alexandra; Michel, Pierre; Louvet, Christophe; Westeel, Virginie; Walter, Thomas

doi:10.1016/j.annonc.2021.08.2119

Cited by 23 publications

(28 citation statements)

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“…17 Those findings led to undertaking prospective trials to evaluate immunotherapy safety and efficacy in LCNEC patients. 32 Our analysis has several limitations that support prudent interpretation of the results. The study was retrospective, with the investigator evaluating the ORR to treatment and PFS.…”

Section: Discussionmentioning

confidence: 88%

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PD-L1-expression patterns in large-cell neuroendocrine carcinoma of the lung: potential implications for use of immunotherapy in these patients: the GFPC 03-2017 “EPNEC” study

et al. 2020

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Background: Few data are available on programmed cell-death-protein-1–ligand-1 (PD-L1) expression on large-cell neuroendocrine carcinomas of the lung (LCNECs). We analyzed PD-L1 expression on tumor (TCs) and inflammatory cells (ICs) from LCNEC patients to assess relationships between this expression, clinical characteristics, and disease outcomes. Methods: PD-L1 expression was determined by immunohistochemistry with monoclonal antibody 22C3 in consecutive LCNEC patients managed in 17 French centers between January 2014 and December 2016. Results: After centralized review, only 68 out of 105 (64%) patients had confirmed LCNEC diagnoses. Median overall survival (OS) (95% CI) was 11 (7–16) months for all patients, 7 (5–10), 21 (10–not reached) and not reached months for metastatic, stage III and localized forms ( p = 0.0001). Respectively, 11% and 75% of the tumor samples were TC+ and IC+, and 66% had a TC–/IC+ profile. Comparing IC+ versus IC– metastatic LCNEC, the former had significantly longer progression-free survival [9 (4–13) versus 4 (1–8) months; p = 0.03], with a trend towards better median OS [12 (7–18) versus 9.5 (4–14) months; p = 0.21]. Compared to patients with TC– tumors, those with TC+ LCNECs tended to have non-significantly shorter median OS [4 (1–6.2) versus 11 (8–18) months, respectively]. Median OS was significantly shorter for patients with TC+/IC– metastatic LCNECs than those with TC–IC+ lesions (2 versus 8 months, respectively; p = 0.04). Conclusion: TC–/IC+ was the most frequent PD-L1–expression profile for LCNECs, a pattern quite specific compared with non-small-cell lung cancer and small-cell lung cancer. IC PD-L1 expression seems to have a prognostic role.

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Section: Discussionmentioning

confidence: 88%

“…17 Those findings led to undertaking prospective trials to evaluate immunotherapy safety and efficacy in LCNEC patients. 32…”

Section: Discussionmentioning

confidence: 99%

PD-L1-expression patterns in large-cell neuroendocrine carcinoma of the lung: potential implications for use of immunotherapy in these patients: the GFPC 03-2017 “EPNEC” study

et al. 2020

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“…77 Identification of targets predictive of immunotherapy may support the use of ICI as a secondline treatment. Lack of identification of these markers does not preclude patients from the possible benefit of ICI since reported RR and 6 m PFS rates for dual PD1/CTLA4 blockade are slightly higher in the largest ICI study in GEP NEC (12% and 15%) 78 as compared to reported mutation rates.…”

Section: Recommendationmentioning

confidence: 98%

“…A preliminary report of the prospective DUNE study with durvalumab plus tremelimumab in NEN G3 reported an objected response rate of 9% and 9 months survival rate of 36% among GEP NEN G3 patients 82 . In the NIPINEC phase II trial, 185 pts (93 GEP NEC /92 lung NEC) with platinum‐refractory disease were randomized between nivolumab alone versus nivolumab + ipilimumab 78 . The primary endpoint was RR at 8 weeks.…”

Section: Treatmentmentioning

confidence: 99%

“…82 In the NIPINEC phase II trial, 185 pts (93 GEP NEC /92 lung NEC) with platinum-refractory disease were randomized between nivolumab alone versus nivolumab + ipilimumab. 78 The primary endpoint was RR at 8 weeks. RR was 7.2% for nivolumab versus 14.9% for nivolumab/ipilimumab, PFS 1.8 versus 1.9 m and OS 7.2 m versus 5.8 m. SIx month PFS rate was 15%.…”

Section: Two Strategies In Using Ici For Nec: Adding Ici To First-lin...mentioning

confidence: 99%

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European Neuroendocrine Tumor Society (ENETS) 2023 guidance paper for digestive neuroendocrine carcinoma

Sørbye

Grande

Pavel

et al. 2023

J Neuroendocrinology

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This ENETS guidance paper, developed by a multidisciplinary working group, provides up‐to‐date and practical advice on the diagnosis and management of digestive neuroendocrine carcinoma, based on recent developments and study results. These recommendations aim to pave the road for more standardized care for our patients resulting in improved outcomes. Prognosis is generally poor for digestive NEC, most are advanced at diagnosis and median survival in metastatic disease is 11–12 months. Surgery can be of benefit for localized disease after extensive preoperative imaging. Carboplatin in combination with etoposide is recommended as first‐line treatment for metastatic disease. Irinotecan with fluoropyrimidines has the best evidence as second‐line treatment. Immunotherapy plays a minor role in biomarker‐unselected patients. Molecular profiling if available is encouraged to identify new targets. More prospective clinical trials are highly needed to fulfil the unmet needs in this field, especially on new predictive and prognostic biomarkers and to improve survival of patients with advanced disease.

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Potent molecular-targeted therapies for gastro-entero-pancreatic neuroendocrine carcinoma

Ooki

Osumi

Fukuda

et al. 2023

Cancer Metastasis Rev

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Neuroendocrine neoplasms (NENs), which are characterized by neuroendocrine differentiation, can arise in various organs. NENs have been divided into well-differentiated neuroendocrine tumors (NETs) and poorly differentiated neuroendocrine carcinomas (NECs) based on morphological differentiation, each of which has a distinct etiology, molecular profile, and clinicopathological features. While the majority of NECs originate in the pulmonary organs, extrapulmonary NECs occur most predominantly in the gastro-entero-pancreatic (GEP) system. Although platinum-based chemotherapy is the main therapeutic option for recurrent or metastatic GEP-NEC patients, the clinical benefits are limited and associated with a poor prognosis, indicating the clinically urgent need for effective therapeutic agents. The clinical development of molecular-targeted therapies has been hampered due to the rarity of GEP-NECs and the paucity of knowledge on their biology. In this review, we summarize the biology, current treatments, and molecular profiles of GEP-NECs based on the findings of pivotal comprehensive molecular analyses; we also highlight potent therapeutic targets for future precision medicine based on the most recent results of clinical trials.

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LBA41 Nivolumab (nivo) ± ipilimumab (ipi) in pre-treated patients with advanced, refractory pulmonary or gastroenteropancreatic poorly differentiated neuroendocrine tumors (NECs) (GCO-001 NIPINEC)

Cited by 23 publications

References 0 publications

PD-L1-expression patterns in large-cell neuroendocrine carcinoma of the lung: potential implications for use of immunotherapy in these patients: the GFPC 03-2017 “EPNEC” study

PD-L1-expression patterns in large-cell neuroendocrine carcinoma of the lung: potential implications for use of immunotherapy in these patients: the GFPC 03-2017 “EPNEC” study

European Neuroendocrine Tumor Society (ENETS) 2023 guidance paper for digestive neuroendocrine carcinoma

Potent molecular-targeted therapies for gastro-entero-pancreatic neuroendocrine carcinoma

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