Review of Gastrointestinal Carcinoid Tumors: Latest Therapies

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1 Review of Gastrointestinal Carcinoid Tumors: Latest Therapies Arvind Dasari, MD, MS Department of Gastrointestinal Medical Oncology The University of Texas MD Anderson Cancer Center Houston, TX, USA

2 Neuroendocrine Tumors (NET) Incidence Incidence Trends Incidence Trends of NETs and all malignant neoplasms from (age adjusted to 2000 US Standard Population) Incidence Trends of NETs and all malignant neoplasms from (age adjusted to 2000 US Standard Population) Surveillance Research Program, National Cancer Institute SEER*Stat software (seer.cancer.gov/seerstat) ver November 2014 Dasari et al. JAMA Oncol Oct 1;3(10):

3 NETs : Prevalence Incidence Trends of NETs and all malignant neoplasms from (age adjusted to 2000 US Standard Population) 20-year Limited Duration Prevalence projected into US Population on 1/1/2014 : 171,321 Surveillance Research Program, National Cancer Institute SEER*Stat software (seer.cancer.gov/seerstat) ver November 2014 Dasari et al. JAMA Oncol Oct 1;3(10):

4 NETs : Evolving Classification 2010 Grade 1 Grade 2 Grade 3 Ki-67 <3% 3-20% >20% Mitotic Index (10HPF) < >20 Differentiation Well Poor 2017 Ki-67 Grade 1 Grade 2 Grade 3 <3% 3-20% >20% >20% Mitotic Index (/10 HPF) <2/ >20 >20 Differentiation Well Well Well Poor Small Cell Large Cell Sorbye et al, Cancer 2014 Sept 15; 120(18): Kim et al, Ann Diagn Path 2017 Aug;29:11-16

5 Somatostatin Physiology Found in CNS and peripheral tissues Binds to five somatostatin receptors: sst1-5 Inhibitory effects on secretion & growth Aliment Pharmacol Ther Jan 15;31(2):169-88

6 Hormone Control Somatostatin Analogues Compound Peptide size (#Amino Acids) t 1/2, Delivery Long Acting Formula, Delivery Binding Affinity Somatostatin 14 / min, iv All receptors FDA Approved Indications Octreotide 8 2 hrs, sc Octreotide LAR, IM q 4 wks Lanreotide 8 2 hrs, sc Lanreotide PR: IM q 2 wks Lanreotide AG: SC q4 wks Pasireotide 6 12 hrs, sc Pasireotide LAR: IM sst2 >> sst5 sst2 >> sst5 sst 1,2,3,5 Acromegaly Carcinoid syndrome VIPomas Acromegaly Gastroenter opancreatic NETs Carcinoid Syndrome Acromegaly Enzler et al, Semin Oncol, 2017 April;44(2): Octreotide, Lanreotide & Pasireotide Package Inserts.

7 Lanreotide ELECT Trial Advanced NETs with carcinoid syndrome, n = 115 R Lanreotide 120 mg sc q28 d + sc octreotide Placebo + sc octreotide Primary Endpoint: Adjusted mean percent of days sc octreotide used over 16-weeks Percent of days of sc octreotide Number of days of sc octreotide use Complete Success: No use Partial success : 1-3 days Treatment Failure: > 3 days Odds of full / partial success: 2.4; p = Vinik et al Endocr Pract. 2016;22:

8 Diarrhea Control Telotristat 4 BM (Mean 5-6) Rescue sc octreotide and anti-diarrheals allowed Baseline Characteristics: Mean BM = 5-6 / day Flushing = 2-3 / day Urine 5-HIAA = (58% with elevation) Adapted from Dr. Kulke s presentation at 18 th ECCO-40 th ESMO European Cancer Congress, Sept 29, 2015

9 Diarrhea Control Telotristat Mean reduction in BM# Placebo Telotristat 250 tid Telotristat 500 tid Responders* Urine 5-HIAA #Hodges-Lehman estimator for reduction in BM: (250 mg) & (500 mg) *Defined as 30% reduction in BM for 50% days **Small number of patients with significant flushing and abdominal pain at baseline and no change during study period Adapted from Dr. Kulke s presentation at 18 th ECCO-40 th ESMO European Cancer Congress, Sept 29, 2015

10 Tumor Control Drug Approvals Approved agents for oncologic control before 2011 pnets: Streptozocin GI NETs: None Approved agents for oncologic control pnets: Everolimus, sunitinib, lanreotide GI NETs: Lanreotide, everolimus Lung Nets: Everolimus Other active agents pnets: Temozolomide GI NETs: Octreotide, (177)Lu-DOTATATE / / OCT SC CS 25,30 LAN symptom control 24 PROMID OCT LAR: Antitumor activity 9,31 CLARINET LAN GEP NET 16,17,29 RADIANT-4 EVE NF GI and lung NET 15,19 Treatments 1982 STZ pnet STZ combination: Survival benefit pnet 2 OCT LAR carcinoid tumors 23,26, /11 RADIANT-3 EVE in pnet 11,12,32,33 Sunitinib phase III pnet 13,31,34 ELECT LAN: Symptom control TELESTAR telotristat etiprate CS 20 NDA filed 3/30/16 US approval US/EU approval EU approval RADIANT-2 EVE + OCT, LAR in mnet w/cs 14 NETTER Lu-Dotatate midgut NET 18 AC, atypical carcinoid; AJCC; American Joint Committee on Cancer; CS, carcinoid syndrome; ENETS, European Neuroendocrine Tumor Society; ESMO; European Society for Medical Oncology; EVE, everolimus; GEP, gastroenteropancreatic; GI NETs, gastrointestinal neuroendocrine tumors; LAN, lanreotide; LAR, long-acting repeatable; m, metastatic; NANETS, North American Neuroendocrine Tumor Society; NEC, neuroendocrine carcinomas; NET, neuroendocrine tumors; NF, nonfunctional; OCT, octreotide; pnet, pancreatic NET; SC, subcutaneous; STZ, streptozocin; TC, typical carcinoid; UICC, Union for International Cancer Control; WHO, World Health Organization LAN symptom control

11 NETs : Pancreatic (pnet) vs Carcinoids Median overall survival (months) Lung Stomach Pancreas Small Intestine Cecum Colon Rectum Yao et al, 2008 J Clin Oncol 26(18):

12 pnet - Temozolomide Advanced pnet n = 143 Capecitabine 750 mg/m 2 BID Days 1-14 Temozolomide 200 mg/m 2 QD Days Median # of cycles = 9 Overall Survival 73.2 (95% CI ) months PFS 17 (95% CI 15 25) months Response Rate = 54% Cives et al. Endocr Relat Cancer 2016;23:

13 pnet - Temozolomide Advanced pnet n = 143 Capecitabine 750 mg/m 2 BID Days 1-14 Temozolomide 200 mg/m 2 QD Days Median # of cycles = 9 E2211: PI Pamela Kunz, MD Phase II Temozolomide + / - Capecitabine n = 138, Primary End Point: PFS Accrual Completed Overall Survival 73.2 (95% CI ) months PFS 17 (95% CI 15 25) months Response Rate = 54% Cives et al. Endocr Relat Cancer 2016;23:

14 pnet - Sunitinib Updated OS (2017) Sunitinib 38.6 mo Placebo 29.1 mo* HR 0.73, p = * 69% crossover Raymond et al. N Engl J Med 2011; Feb 10;364(6): Faivre et al. Ann Oncol 2017 Feb 1;28(2):

15 pnet Everolimus (RADIANT-3) *89% crossover Yao et al, 2011, N Engl J Med, Feb 10;364(6): Yao et al, 2016, J Clin Oncol Sep 12

16 Carcinoids Everolimus (RADIANT-4) Advanced, nonfunctioning, GI or Lung NETs N=302 R (2:1) Everolimus 10 mg QD Placebo Baseline Characteristics Variable Everolimus Placebo Male - n(%) 89 (43) 53 (55) Age - yr Time since diagnosis (median, mo) Prior SSA Therapy 109 (53%) 54 (56%) Origin n (%) Lung Midgut Hindgut Unknown/Other 63 (31) 72 (35) 34 (17) 36 (18) 27 (28) 32 (32) 19 (20) 19 (20) Yao et al. Lancet 2016 Mar 5;387(1022)

17 Carcinoids Everolimus (RADIANT-4) Yao et al. Lancet 2016 Mar 5;387(1022)

18 Everolimus Stomatitis (SWISH TRIAL) Rugo et al. J Clin Oncol.2016;34(suppl):Abstract 525

19 SSA for Tumor Control : PROMID Trial Advanced, mid-gut NETs N=85 R Octreotide 30 mg IM q28 d Placebo Overall Survival Time to Progression Rinke et al, Neuroendocrinology 2017;104(1):26-32 Rinke et al, J Clin Oncol 2009 Oct 1;27(28);

20 SSA for Tumor Control : CLARINET Trial Advanced, nonfunctioning Gastroenteropanc reatic NETs N=204 R Lanreotide 120 mg sc q28 d Placebo Baseline Characteristics Variable Lanreotide Placebo Male - n(%) 53 (52) 54 (52) Age - yr Time since diagnosis (median, mo) Origin n (%) Pancreas Midgut Hindgut Unknown/Other 42 (42) 33 (33) 11 (11) 15 (15) 49 (48) 40 (39) 3 (3) 11 (11) Tumor Progression: n (%) 4 (4) 5 (5) Caplin et al, N Engl J Med 2014;Jul 17;371(3)224-33

21 SSA for Tumor Control : CLARINET Trial Lanreotide Not reached Placebo 18.0 mo HR 0.47, p < Caplin et al, N Engl J Med 2014;Jul 17;371(3) Caplin et al. Endocr Relat Cancer 2016;23:

22 Peptide Receptor Radionuclide Therapy (PRRT) [ 111 In-DTPA 0 ]Octreotide [ 90 Y-DOTA 0,Tyr 3 ]Octreotide [ 177 Lu-DOTA0,Tyr 3 ]Octreotide [ 177 Lu-DOTA0,Tyr 3 ]Octreotate Bergsma et al, Best Practice & Research Clinical Gastroenterology 2012; 26:6,

23 PRRT Peptides and Radionuclides Affinity Profiles of Peptides, IC 50 (SEM) Profiles of Key Radionuclides Peptide sstr2 sstr5 Somatostatin 2.7 (0.3) 4 (0.30) Octreotide 2 (0.7) 22(6) Nuclide Indium t 1/2 days Emission Depth Electrons γ 10 μm 550 μm DOTA- [Tyr3]Octreotide DOTA- [Tyr3]Octreotate 14(2.6) 393(84) 1.5(0.4) 547(160) Yttrium β 12 mm Lutetium β, γ 3 mm Dash et al, 2015, Cancer Biotherapy and Radiopharmaceuticals, 2014, 30:47-70.

24 Kwekkeboom, JCO, 2008:2124 PRRT: Retrospective Data

25 NETTER-1 Study Design SSR +ve, progressive midgut carcinoids, n = Lu-DOTA- Octreotate x 4 cycles Octreotide LAR 60 mg IM every 4 weeks 177 Lu-DOTATE Therapy: Gbq (200mCi) iv over 30 min every 8 weeks - Amino Acid solution iv for 4 hours - Octreotide 30 mg LAR 24 hours after therapy, continued monthly Median Time Since Diagnosis (years) 177 Lu-Dotate (n = 116) Octreotide LAR 60 mg (n = 113) Ileum 86 (73%) 82 (73%) SRS, Krenning scale grade 2/3/4 (%) 9%/29%/61% 11%/30%/59% Grade 1 76 (66%) 81 (72%) Non-SSA Systemic Therapy 5-HIAA (mg/24 h), mean, SD* 41% 45% 100 (183) 77 (83) No. of PRRT of administrations = 4 78/102 (77%) Not applicable Strosberg et al, New Eng J Med Jan 12;376(2):

26 NETTER-1 Results: PFS Median PFS 8.4 m vs not reached (estimate 40 m); HR 0.21, p < Strosberg et al, New Eng J Med Jan 12;376(2):

27 NETTER-1 Results HR for death = 0.40; p = (O-Brien-Fleming threshold for significance = ) Strosberg et al, New Eng J Med Jan 12;376(2):

28 NETTER-1 Grade 3 / 4 Toxicities 177 Lu-Dotate* Control* p Value Nausea / Vomiting 12 (11) 3 < Lymphopenia 10 (9) 0 < Thrombocytopenia 2 (2) 1(1) <0.001 Leukopenia 1 (1) *n(%) Strosberg et al, New Eng J Med Jan 12;376(2):

29 NETTER-1 Grade 3 / 4 Toxicities 177 Lu-Dotate* Control* p Value Long term risk of MDS: ~ 2-3% AML: ~ 1% Nausea / Vomiting 12 (11) 3 < Lymphopenia 10 (9) 0 < Thrombocytopenia 2 (2) 1(1) <0.001 Leukopenia 1 (1) *n(%) Strosberg et al, New Eng J Med Jan 12;376(2):

30 NETTER-1 Grade 3 / 4 Toxicities Toxicity Traditional Therapy PRRT p Liver 23 (31%) 10(59%) <0.001 Bone Marrow 54 (71%) 12(71%) 0.97 Kidney 27(36%) 5(29%) 0.63 Riff et al. Clin Nucl Med Nov;40(11):845-50

31 Treatment Landscape of Advanced NETs Site Octreotide Lanreotide 177 Lu- DOTATATE Streptozocin Sunitinib Everolimus Disease status Tx naïve Stable Progressive over 3 yrs Historical Progressive over 12 mo Progressive over 6 mo* Lung RADIANT4 Stomach CLARINET RADIANT4 Pancreas CLARINET Historical Phase III RADIANT3* Small bowel Appendix PROMID CLARINET NETTER-1 RADIANT4 Colon CLARINET RADIANT4 Rectum CLARINET RADIANT4 Unknown 1 RADIANT4 *RADIANT-3 requires documentation of progressive disease (PD) in the prior 12 months. RADIANT-4 requires documentation of PD during prior 6 months. Rinke A, et al. J Clin Oncol Caplin ME, et al. N Engl J Med Strosberg J, et al. N Engl J Med Raymond E, et al. N Engl J Med Yao JC, et al. J Clin Oncol Yao JC, et al. N Engl J Med Yao JC, et al. Lancet

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