Addressing the Challenges of Treating Highly Proliferative Neuroendocrine Tumours: Review of the Latest Evidence

Simron Singh, MD, MPH discusses neuroendocrine tumours (NETs) in this IME activity titled "Addressing the Challenges of Treating Highly Proliferative Neuroendocrine Tumours: Review of the Latest Evidence." For the full presentation, please visit us at www.peervoice.com/XJN870.

1. PeerVoice

Addressing the Challenges of Treating Highly Proliferative
Neuroendocrine Tumours: Review of the Latest Evidence

Learning Objectives

Discuss the benefits and limitations of current therapeutic management of G2
and G3 advanced gastroenteropancreatic neuroendocrine tumours (GEP-NETs)

Identify emerging treatment strategies for patients with G2 and G3 advanced
GEP-NETs

Translate the clinical data for emerging treatment strategies for grade 2 and 3
advanced GEP-NETs in context of current unmet needs

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2. PeerVoice

Part 1 of 2: The Challenges in the Therapeutic Management of
Grade 2 and 3 Advanced GEP-NETs

e
à

£ 2"

Simron Singh, MD, MPH
University of Toronto

Sunnybrook Odette Cancer Centre and Susan Leslie Clinic for Neuroendocrine Cancers
Toronto, Ontario, Canada

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3. PeerVoice

Simron Singh, MD, MPH, has a financial interest/relationship or affiliation in
the form of:

Consultant for Camurus AB; Crinetics Pharmaceuticals, Inc.; Ipsen
Biopharmaceuticals, Inc.; and Novartis AG.

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4. PeerVoice

Classification of Gastroenteropancreatic Neuroendocrine

Tumours (GEP-NETs)

WHO 2022

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‘Appei

gl

ceci (A)

Esophageal (E)
Gastric (G)

Small intestine (SI)
Colorectal (CR)
Pancreatic (P)

Extrahepatic bile duct/
gallbladder (EHBD/GB)

Hepatic (H)

Neuroendocrine neoplasm (NEN)

Neuroendocrine tumour (NET)

+ G1(Ki-67 <3%, MI <2)

+ G2 (Ki-67 3%-20%, MI 2-20)
+ G3 (Ki-67 >20%, MI >20)

Neuroendocrine carcinoma (NEC)
+ High grade (Ki-67 >20%, MI >20)
- SC

- LC
Mixed endocrine non-endocrine
neoplasm (MINEN)
+ 61-3

(Ki-67 <3% to >20%, MI <2 to >20)

G1/G2/G3: Well-differentiated NETs

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5. PeerVoice

Overall Survival of Patients With GEP-NETs, Stratified by Stage

Patients With Grade 2 GEP-NET

Patients With Grade 3 GEP-NET
wo vo
% %
e ed ®
5 50 o so
8 ö
25 25
o o
o 2 4 6 y o o 2 y 5 3 »
Duration of follow-up, y Duration of follow-up, y
Atrisk,n Atriskn
StagelV 361 180 60 2 9 5 Stage IV 1291120 68 38

5-year OS: 38%; 10-year OS: 19%

— Stage!
Stage Il

— Stage unknown

2
5-year OS: 5%; 10-year OS: 2%

— Stage Il
— Stage IV

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6. PeerVoice

Systemic Therapy for Tumour Control in Well-Differentiated GE

NETs

== ==

Si-NETS [_Pan-ners
I I
+
ner 2-67 MM ssra- ssTR- platin or
205% or negative negative Y carboplatin +

rapid growth

etopo

Locoregional

therapy

Watch
and wait

4 Locoregional therapy
+

SUN

PRRT

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7. PeerVoice

Benefits of Current Therapeutic Management for Advanced GEP-NETs

Popultion(A) amen Keyetiniesloutcomes | Mojorsido efecto

PROMID! Intestinal NETS F/NF Octreotide LAR MPFS: 143 ve 6 months Diarrhoea, flatulence, cholelithiasis
(85) Placebo

CLARINET? NF intestinal/ Lanreotido autogel Median NRvs1Bmonths Diarrhoea, flatulence, cholelithiasis,

Phase 3RCT pancreatic NETs(204) Placebo hyperglycaemia

RADIANT-4? | Lungfintestinal NETS || Everolimus ‘mPFS: 1 vs 8.9 months Stomatitis, diarrhoea, infections, fever,

Phase 3RCT (802) Placebo hyperglycaemia

sun Pancreatic NETS(17)) Sunitinib mPFS:IL4vs5.4months Diarrhoea, nausea, asthenia, vomiting,

Phase 3RCT Placebo fatigue, HTN, neutropenia, stomatitis,

palmar-plantar erythrodysesthaesia

CABINETS | Advanced NETS Cabozenti MPFS (month 12.6) in epNET: | Hypertension fatigue, diarrhoea, rash
Phase 3RCT | progressed on prior Placebo 82 vs 32 months;

therapy (290 [pNET,n 'MPFS (month 10.1) in pNET:

= 93; epNET, n = 197) 137 vs 3 months
NETTER-19_ MidgutNETs(229) VLu-dotatate + octreotide LAR; — MPFS(month 20):65.2% vs — Nausea, vomiting fatigue, diarrhoea,
Phase 3 RCT High-dose octreotide LAR 108% thrombocytopaenia, musculoskeletal

Response rate: 18% vs 3% pain

NETTER-27 | Newly diagnosedG2 VLu-dotatate + octreotide LAR; | mPFS:22.8vs 8.5 months Grade 3/4 leucopenia, anaemia, and
Phase 3RCT and G3 advanced High-dose octreotide LAR thrombocytopenia, each affecting <3

GEP-NETS (226) patients

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Emerging Therapies for GEP-NETs

+ Alkylating agent

Femozolomide or temozolomide and capecitabine TKI monott

(NCTO1824875) TKI 7 VEGFR multi Eihase inhibitors
remain; pes Axitinib (NCTO1435122)

Lenvatinib
GEP-NET cell (NCTO2678780)

Novel PRRT therapies

+ PRRT
wiLu-edotreotide
(COMPOSE trial; NCTO4919226)

(COMPETE trial; NCTO3049189) Cabozantinib

+ PRRT (NCTO1466096)
2MPb-DOTAMTATE Pazopanib (NCTOI841736)
(ALPHAMEDIX-02; NCTOS153772)

+ PRRT Immunotherapy/VEGF
225¢-DOTATATE inhibitor combination
(ACTION- trial; NCTO5477576) + Bevacizumab + atezolizumab

+ PRRT + chemotherapy S (NCTO3074513)
VILu-DOTATOC + CAPTEM
(NCTOA194125) Immunothera]

+ PRRT + PARPI + PD-1/PD-LTa,
™Lu-DOTATATE + olaparib Durvalumab + tremelimumab
(NCTO4086485) ; Y (NCTO3095274)

+ PRRT+RNRi + SVN53-67 + montanide Nivolumab + temozolomide
vILy-DOTATATE + triapine © Somatostatin receptor ISA 51 (NCTO3879694) (NCTO3728361)

(NCTOA234568) ID VEGF receptor Spartalizumab (NCTO2955069)

+ PRRT+DNA-PKi ue Nivolumab + ipilimumab
™Lu-DOTATATE + peposertib. a as (NCTO3420521)
(NCTO4750954) S Survivin

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Abbreviations and References

Classification of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs)
Abbreviation(s): LC: large cell; MI: myocardial infarction; SC: small cell; WHO: World Health Organization.
Reference(s): Helderman NC et al. Neuroendocrinology. 2024:114:120-133.

Overall Survival of Patients With GEP-NETs, Stratified by Stage

Abbreviation(s): GEP-NET: gastroenteropancreatic neuroendocrine tumour.
Reference(s): Poleé IN et al. Eur J Cancer. 2022;172:252-263.

Systemic Therapy for Tumour Control in Well-Differentiated GEP-NETs

Abbreviation(s): 5-FU: 5-fluorouracil; CAP: capecitabine; CAPTEM: capecitabine and temozolomide; EVE: everolimus;
FOLFIRI: 5-fluorouracil, leucovorin, and irinotecan; FOLFOX: 5-fluorouracil, leucovorin, and oxaliplatin;

GEP-NEN: gastroenteropancreatic neuroendocrine neoplasm; IFN-a: interferon alpha; NEC: neuroendocrine carcinoma;
NET: neuroendocrine tumour; Pan-NET: pancreatic neuroendocrine tumour; PRRT: peptide receptor radionuclide
therapy; Si-NET: small intestinal neuroendocrine tumour; SSA: somatostatin analogue; SSTR: somatostatin receptor;
STZ: streptozotocin; SUN: sunitinib; TEM: temozolomide.

Reference(s): Pavel Met al. Ann Oncol. 2020;31:844-860.

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Abbreviations and References (Cont'd)

Benefits of Current Therapeutic Management for Advanced GEP-NETs

Abbreviation(s): epNET: extra-pancreatic neuroendocrine tumour; F:fibromatosis; HTN: hypertension; LAR: long-acting
: neurofibromatosis; pNET: pancreatic neuroendocrine tumour; RCT: randomised control trial.

Rinke A et al. J Clin Oncol, 2009;27:4656-4663.

2. Caplin ME et al. N Engl J Med. 2014;371:224-233.

3. Yao JC et al. Lancet. 2016;387:968-977.

4, Raymond E et al. N Engl J Med. 2011:364:501-13;

5. Chan J et al. Ann Oncol. 2023,34(suppl_2):51292. doi:10.1016/,annone.2023.10.047.

6. Strosberg J et al. N Engl J Med. 2017 Jan 12:376:125-135.

7. Singh S et al. Lancet. 2024;403:2807-2817.

Emerging Therapies for GEP-NETs

Abbreviations): DNA-PKi: DNA-dependent protein kinase inhibitor; PARPi: poly adenosine diphosphate-ribose
polymerase inhibitor; RNRi: ribonucleotide reductase inhibitor; TKI: tyrosine kinase inhibitor; VEGF: vascular endothelial
growth factor; VEGFR: VEGF receptor.

Reference(s): Das S, Dasari A. Ther Adv Med Oncol. 2021;13:-15.

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Part 2 of 2: Can We Improve Outcomes in Advanced GEP-NETs?
Evaluating the Latest Evidence

Simron Singh, MD, MPH

University of Toronto

Sunnybrook Odette Cancer Centre and Susan Leslie Clinic for Neuroendocrine Cancers
Toronto, Ontario, Canada

Copyright © 2010-2024,

12. PeerVoice

Simron Singh, MD, MPH, has a financial interest/relationship or affiliation in
the form of:

Consultant for Camurus AB; Crinetics Pharmaceuticals, Inc.; Ipsen
Biopharmaceuticals, Inc.; and Novartis AG.

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NETTER-2: Phase 3 Study Design

First-line efficacy of ”’Lu-dotatate in patients with advanced, well-differentiated, grade 2 or 3 GEP-NETs

Screening

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Randomised treatment

VILu-dotatate
(7.4 GBq [200 mCi))
Q8W x 4 cy:

LAR (60 mg)
Qaw

Optional treatment extension

Retreatment with
™Lu-dotatate
(7.4 GBq [200 mCi])
Q8W x 2-4 cycles

Crossover treatment
with 7/Lu-dotatate
(7.4 GBq [200 mci))
QBW x 4 cycles +
octreotide LAR (30 mg)

Follow-up

1ths for 3 years

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14. PeerVoice

NETTER-2: PFS in Patients With Grade 2 and Grade 3 NETs

Grade 2 NET Grade 3 NET

E 100 E 00

ae q e

Se 5 0

a a

2 «0 3

2 g

m a #

Bg go
Eee ec rr rere ers) INERTE TIT

Time, mo Time, mo
™Lu-dotetate (n/N = 29/99) mm "”Lu-dotatate (n/N = 26/52)

mPFS: 29.0 mo mPFS: 22.2 mo

High-dose octreotide LAR (n/N = 25/48) High-dose octreotide LAR (n/N = 21/27)
mPFS: 13.8 mo mPFS: 5.6 mo

HR: 0.306 HR: 0.266

95% C 0.176, 0.530 95% Cl: 0.145, 0.489

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NETTER-2: PFS in Patients With Pancreatic and Small-Intestine

NETs

Pancreatic NETs Small-Intestine NETs
x 100 æ m
2 =
3 3
30 5 ©
5 È
El 8
lo on
¿o o
IEEE TEE ETT wma «SOD aaa
Time, mo Time, mo
mm "Lu-dotatate (n/N = 39/82) mm Lu-dotatate (n/N = 11/45)
mPFS: 19.4 mo mPFS: 29.0 mo
À High-dose octreotide LAR (n/N = 27/41) a High-dose octreotide LAR (n/N = 10/21)
mPFS: 85 mo mPFS: 8.4 mo
HR: 0.336 HR: 0.305
95% CH 0.200, 0.562 95% Cl: 0.126, 0.738

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NETTER-2: ORR Across NET Origin and Grade

Complets
pest

NET grade: 2
"ILy-dotatate

High-dose octreotide LAR
NET grade: 3
"Ly-dotatate

High-dose octreotide LAR
NET origin: pancreas
"Lu-dotatate

High-dose octreotide LAR
NET origin: small intestine
1Lu-dotatate

High-dose octreotide LAR

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6 (6.1)
o
2(3.8)
o
5 (6.1)
o

1(2.2)
o

Respons.

Partial

(%)

34 (34.3)
5 (10.4)

23 (44.2)
2(7.4)

37 (45.1)
5 (122)

11 (24.4)
1(4.8)

40/99
5/48

25/52
2/27

42/82
5/41

12/45
12

(E ORR Odds Ratio
al N (95% Cl) (95% Cl)

40.4 (30.7, 50.7) 5.83

10.4 (35,227) (212.16.00)
48.1(34.0, 62.4) 1.57

74(09,243) (2.48, 53.97)
51.2 (39.9, 62.4) 7.56

122(41,262) (270,2119)
267(148,419) (Gas

48 (0.1, 23.8) 60.24)

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NETTER-2: Response Across Subgroups

Subgroup

NET grade: 2
Events/patients, n (%)
Median duration of response (95% Cl), mo.

NET grade: 3
Events/patients, n (%)
Median duration of response (95% Cl), mo

NET origin: pancreas
Events/patients, n (%)
Median duration of response (95% Cl), mo

NET origin: small intestine
Events/patients, n (%)
Median duration of response (95% Cl), mo

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Responders Only
7Lu-Dotatate (!

10/40 (25.0)
24.9 (23.3, NE)

9/25 (36.0)
19.3 (17.8, NE)

17/42 (40.5)
18.4 (11.3, 23.3)

1/12 (8.3)
NE (24.9, NE)

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ALPHAMEDIX 02: Phase 2 Study Design

Safety, tolerability and efficacy of ?'?Pb-DOTAMTATE in unresectable or metastatic SSTR+ GEP-NETs

Population

Phase 2, open-label, multicentre
study

Safety, tolerability and efficacy of
*Pb-DOTAMTATE evaluated in
PRRT-nalve (Cohort 1, N = 36) and
PRRT-rofractory (Cohort 2, N =

30) patients
Patients had histologically
confirmed unresectable or
metastatic SSTR+ GEP-NETs and
at least | site of measurable
disease per RECIST 11

Treatment

22Pb-DOTAMTATE
676 uCi/kg per cycle
Every 8 weeks for up to 4 cycles

Concomitant therapy with somatostatin analogues
was allowed for symptom control but not mandatory

Endpoints

Primary
+ ORR per RECIST 11
+ Incidence and severity of AEs

Secondary

+ PES

+ 0s

+ Health-related quality of life

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ALPHAMEDIX 02: Efficacy in PRRT-Naive Patients With

Metastatic SSTR+ GEP-NETs

ALPHAMEDIX 01 ALPHAMEDIX 02 Pooled Results 01/02

Patients, n ES 36 44

ORR, n/N 5/8 20/36 25/44

% (95% Cl) 62.5 (30.6-86.3) 55.6 (39.6-70.5) 56.8 (42.2-70.3)
mDoR, mo NE 7 NE

DoR, mo (95 Cl) 15.2, NE 17.0, NE 15.2, NE

% with observed DOR

cose 100 (5 of 5) 100 (17 of 17) 100 (22 of 22)
% with observed DOR

of 212 mos 100 (4 of 4) 91(10 of 11) 93 (14 of 15)

The combined ORR from both phase 1 and phase 2 is 56.8% (95% CI:

> GEP-NET patients at RP2D. ® Landmark analysis. © Asymmetrical

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ALPHAMEDIX 02: Preliminary PFS and OS in PRRT-Naive Patients
With Metastatic SSTR+ GEP-NETs (Phase 1 and Phase 2)

100

100
x ® 90.7% at 24mo
E E
5
5 74.3% at 24 mo 5
5 50 5 5
2
3
El
3
E
&
0 o
0 10 20 30 40 0 20 40 60
Time, mo Time, mo

Pooled PFS and OS results from phase 1 and cohort 1 of phase 2

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ALPHAMEDIX 02: Safety

(n=8) (n=36) (N=44)
Grade 3-4 AEs, n (%) 2(25) 21(58) 23 (52)
SAEs, n (%) 2 (25) n(31) 13 (30)
Fatal AEs, n (%) 0(0) 3(8) 3 (7)
AE (26 Patients, (6) [creces | Grade 3-4 | a races | Grade 3-4 | al Grades | Grade 2-4 |
Alopecia 8 (100) 33 (92) o(0) 41(93) o on
Nausea 7(88) o ae 34. (94) 1(3) 41 (93) 1(2)
Fatigue 5 (63) 0(0) 34 (94) 2(6) 39 (89) 2(5)
Decreased appetite 103) 0(0) 19 (53) 1(3) 20 (45) 12)
Diarrhoea 2(25) 00) 18 (50) 0(0) 20 (45) 00)
Dysphagia 0(0) 0(0) 15 (42) 16) 15 (34) 12)
Decreased lymphocyte count 3 (38) 2 (25) 12(83) 9(25) 15 (84) 1(25)
Abdominal pain 1(13) 0(0) 13 (86) 0(0) 14 (82) 0(0)
Vomiting 2 (25) 00) nen 00) 13 (80) o(0)
Decreased weight 3(38) 0(0) 9(25) 0(0) 12 (27) 0(0)
Increased blood glucose 3 (38) 0(0) 6 (17) 00) 9(20) 00)

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ACTION-1: Phase 1b/3 Study Design

Phase Ib portion of the ACTION-1 phase 1b/3 trial of RYZIOI in GEP-NET progressing after "Lu
somatostatin analogue (SSA) therapy: Safety and Efficacy findings

Population Treatment Endpoints

Key eligibility criteria ae oy o Primary

+ Age 218 years n= 6) . ir
Haley proven grade 2, 120 kBa/kg 25 D pm
well-differentiated GEP-NETS (32 uci) «4 decrease | Window

67 520% Secondary!

Progressive GEP-NET based on EA exploratory
RECIST v.11 (centrally confirmed) oe) + Safety
after 2-4 cycles of Lu SSA 90 kBa/kg + Pharmacokinetics
(must have had disease control (2.4 uCi) x4 decrease . Dosimetry

fo alone ment aftr Lu A Efficacy

RECIST vi measurable SSTR+ (n=6)
disease within 4 weeks prior to 60 kBq/kg

randomisation and no RECIST- ESS

measurable SSTR-metast
disease

ECOG performance status <2
CrCl 250 ml/min

No prior external beam radiation
therapy

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ACTION-1: Response

Response, n (%) Overall (N = 17)

ORR 7 (412)
CR 1(6.9)
PR 6 (35.3)

Confirmed CR or PR 5 (29.4)

Stable disease 7 (41.2)

Progressive disease 3 (17.6)

Disease control rate 14 (82.4)

One patient had a PR confirmed after data cutoff date (14 Dec 2023); including this CPR, the confirmed ORR would be 36.3% (6 of 17 patients).

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ACTION-1: Safety

RYZ101120 of RYZ101120

Anaemia 10 (688) | Constipation 4(235)
Nausea 10(68.8) | Vomiting 4(235)
Fatigue 9(529) | Decreased white blood cell count 4(235)
Decreased weight 8 (471) Alopecia 3(17.6)
Decreased creatinine renal clearance 6 (353) | increased blood creatinine 3(17.6)
Hyperglycaemia 6(353) | Diabetes mellitus 317.6)
Decreased lymphocyte count 6 (353) | Diarrhoea 3(17.6)
‘Abdominal pain 5(294) Dyspnoea 3(17.6)
Increased blood alkaline phosphatase 5 (29.4) | Hypertension 3(17.6)
Hyponatraemia 5(294) Hypokalaemia 317.6)
Decreased platelet count 5 (29.4)

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Abbreviations and References

NETTER-2: Phase 3 Study Design

Abbreviation(s): GEP-NET: gastroenteropancreatic neuroendocrine tumour; LAR: long-acting repeatable; PRRT: peptide
receptor radionuclide therapy; SSTR: somatostatin receptor.
Reference(s): Singh S et al. Ann Oncol. 2024;35(suppl_1}S94-S105. doi10.1016/annonc/annonc1479.

NETTER-2: PFS in Patients With Grade 2 and Grade 3 NETs

Abbreviation(s): NET: neuroendocrine tumour.

Reference(s): Singh $ et al. Ann Oncol. 2024;35(suppl_1):594-S105. doi:10.1016/annonc/annonc1479.
NETTER-2: PFS in Patients With Pancreatic and Small-Intestine NETs

Reference(s): Singh $ et al. Ann Oncol. 2024;35(suppl_1}S84-S105. doi:10.1016/annonc/annonc1479.

NETTER-2: ORR Across NET Origin and Grade

Abbreviation(s): ORR: overall response rate.
Reference(s): Singh $ et al. Ann Oncol. 2024;35(suppl_1):S94-S105. doi:10.1016/annonc/annonc1479.

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Abbreviations and References (Cont'd)

NETTER-2: Response Across Subgroups

Abbreviation(s): NE: not estimable.

Reference(s): Singh S et al. Ann Oncol. 2024;35(suppl_1):S94-S105. doi:10.1016/annonc/annonc1479.
ALPHAMEDIX 02: Phase 2 Study Design

Abbreviation(s): OS: overall survival; PFS: progression-free survival; RECIST: response evaluation criteria in solid
tumours.

Reference(s): Strosberg JR et al. J Clin Oncol. 2024;42(suppl_16):4020. doi10.1200/JCO.2024.42.16_suppl.4020.
ALPHAMEDIX 02: Efficacy in PRRT-Naive Patients With Metastatic SSTR+ GEP-NETs
Abbreviation(s): DoR: duration of response; mDoR: median duration of response; RP2D: recommended phase 2 dose.
Reference(s): Strosberg JR et al. J Clin Oncol. 2024;42(suppl_16):4020. doi:10.1200/JC0.2024.42.16_suppl.4020.
ALPHAMEDIX 02: Preliminary PFS and OS in PRRT-Naive Patients With Metastatic

SSTR+ GEP-NETs (Phase 1 and Phase 2)

Reference(s): Strosberg JR et al. J Clin Oncol. 2024;42(suppl_16):4020. doi:10.1200/JC0.2024.42.16_suppl.4020.

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Abbreviations and References (Cont'd)

ALPHAMEDIX 02: Safety

Abbreviation(s): SAE: significant adverse event.

Reference(s): Strosberg JR et al. J Clin Oncol. 2024;42(suppl_16):4020. doi:10.1200/JC0.2024.42.16_suppl.4020.
ACTION-1: Phase 1b/3 Study Design

Abbreviation(s): BOIN: Bayesian optimal interval design; CrCl: creatinine clearance: DLT: dose:
RP3D: recommended phase 3 dose; SSA: somatostatin analogue.
Reference(s): Halperin DM et al. J Clin Oncol. 2024;42(suppl_16):3091. doi:10.1200/JCO.2024.42.26_suppl.3091,

iting toxici

ACTION-1: Response

Abbreviation(s): CPR: confirmed partial response; CR: complete response; PR: partial response.
Reference(s): Halperin DM et al. J Clin Oncol. 2024;42(suppl_16):3091. doi:10.1200/JC0.2024.42.26_suppl.3091.

ACTION-1: Safety
Reference(s): Halperin DM et al. J Clin Oncol. 2024;42(suppl_16):3091. d

.1200/JC0.2024.42.26_suppl.3091.

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