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Endocrine and neuroendocrine tumours

2308 - Efficacy and safety of pasireotide LAR or everolimus alone, or in combination in patients with advanced carcinoids (NET) of the lung/thymus: Results from the randomized, phase 2 LUNA study

Date

10 Oct 2016

Session

Endocrine and neuroendocrine tumours

Presenters

Piero Ferolla

Citation

Annals of Oncology (2016) 27 (6): 136-148. 10.1093/annonc/mdw369

Authors

P. Ferolla1, M.P. Brizzi2, T. Meyer3, W. Mansoor4, J. Mazieres5, C.D. Cao6, H. Lena7, A. Berruti8, V. Damiano9, W. Buikhuisen10, M. Stankovic11, N. Singh12, E. Chiodini13, G. Gislimberti14, K. Oberg15, E. Baudin16

Author affiliations

  • 1 Dept. Of Medical Oncology, Multidisciplinary NET Group, Umbria Regional Cancer Network and University of Perugia, 06126 - Perugia/IT
  • 2 Department Of Oncology, University of Torino, Torino/IT
  • 3 Oncology, Royal Free Hospital and UCL, London/GB
  • 4 Department Of Medical Oncology, The Christie NHS Foundation Trust, Manchester/GB
  • 5 Medical Oncology, CHU Toulouse, Hôpital de Larrey, Toulouse/FR
  • 6 Medical Oncology, CHRU Lille, Lille/FR
  • 7 Pneumologie, Centre Hospitalier Universitaire, Rennes/FR
  • 8 Medical Oncology, University of Brescia, Brescia/IT
  • 9 Department Dip.oncol. Endocr.molec.clinic, Azienda Ospedaliera Universitaria Policlinico Federico II-AOU Federico II, 80131 - Napoli/IT
  • 10 Department Of Thoracic Oncology, The Netherlands Cancer Institute, Amsterdam/NL
  • 11 Medical Affairs, Novartis Pharma Services Inc, Novi Beograd/RS
  • 12 Pls Clinical Project Mgt, Cognizant Technology Solutions, Mumbai/IN
  • 13 Clinical, Parexel, Origgio/IT
  • 14 Oore-gmo, Gislimberti, Origgio/IT
  • 15 Dep Of Medical Sciences, Uppsala University Hospital, Uppsala/SE
  • 16 Endocrinology, Institut Gustave Roussy, Villejuif/FR
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Resources

Abstract 2308

Background

Advanced lung/thymus carcinoid is an area of high unmet medical need. In recent phase 3 RADIANT-4 study, everolimus (E) showed progression-free survival (PFS) benefit in patients (pts) with GI/lung NET. Pasireotide LAR (P, somatostatin analog [SSA]), has also shown potential antitumor activity in previous studies in NET. This phase 2 study evaluated efficacy and safety of E, P, and P + E in pts withprogressive carcinoids of lung/thymus.

Methods

Adult pts with metastatic RECIST progressive carcinoids of lung/thymus were randomized (1:1:1) to P (60 mg/month [mo] i.m.), E (10 mg/day orally) and P + E. Primary endpoint was progression free rate at mo 9 (PFR-9): proportion of pts at mo 9 with complete (CR), partial (PR) response or stable disease (SD) according to RECIST v.1.1. Key secondary end points were PFS, disease control rate and safety.

Results

124 pts were randomized to P (41), E (42), P + E (41). Median age = 64 yrs; atypical/typical carcinoid = 68.5%/31.5%; WHO performance status: 0/1/2 = 64%/34%/2%; primary tumor site: lung/thymus = 93.5%/6.5%; prior treatment (Tx): medication = 44%; radiotherapy = 27%; surgery/locoregional therapy = 97%; prior SSA = 48%. Tx discontinuation was seen in 65% pts (during core phase of 12 mos), mainly due to adverse events (AEs; 27%) and disease progression (PD; 27%). Primary endpoint, PFR-9: P = 39.0% (95% CI, 24.2, 55.5); E = 33.3% (19.6, 49.5); P + E = 58.5% (42.1, 73.7). Best overall response (9-mo) in all arms are listed in the table. AEs were primarily grade 1/2 in each arm; most common AEs regardless of study drug relationship in the P + E arm were hyperglycemia (88%), diarrhea (78%), weight decrease (56%), asthenia (37%), and stomatitis (34%).

P E P + E
CR, % 0 0 0
PR, % 2 2 2
SD, % 34 31 49
PD, % 17 2 0
Not assessed, % 44 60 42

Conclusions

LUNA study is the first randomized trial designed for lung and thymic carcinoids. The study met its primary endpoint showing promising PFR-9 in all Tx arms; particularly in the combination arm. No new safety signals were observed.

Clinical trial identification

EUDRACT number: 2011-002872-17

Legal entity responsible for the study

Novartis Pharma

Funding

Novartis Pharma

Disclosure

P. Ferolla: The study was sponsored by Novartis; Participation to Advisory boards and Steering Comitees for Novartis, Ipsen; Pfizer, Lexicon, Italfarmaco.

M. Stankovic, G. Gislimberti: "Other" from Novartis Pharma Inc, as Novartis Employee.

K. Oberg: Other from IPSEN, other from Novartis, outside the submitted work; .

E. Baudin: Personal fees from Novartis, during the conduct of the study.

All other authors have declared no conflicts of interest.

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