STARTER-NET (JCOG1901) Trial

[Slide 1] 14 Key Takeaway Points/Conclusions Promising but not practice-changing There is PFS benefit in the combination arm SSA alone has comparable or better PFS in the first line setting in patients with Ki67 <10% Consider in high-risk patients Higher hyperglycemia, fatigue, mucositis, Ki-67 >10-20% diarrhea and anorexia RR intriguing: potential option when Even if improved PFS but worse AE's true response is the objective for non value in first line setting is unknown. pancreatic or hindgut ASCO Gastrointestinal Cancers Symposium #GI25 PRESENTED BY Shagufta Shaheen, MD ASCO SOCIETY CLINICAL Pressoriation is property of and ASCO KNOWLEDGE CONQUERS CANCER

[Slide 1] JCOG1901 (STARTER-NET): Trial design N = 250 EVE arm Treatment until disease Key inclusion criteria Everolimus (10 mg/day) progression or Histologically proven GEP-NETs Monotherapy unacceptable toxicity with G1/2 (2019 WHO classification) Unresectable or recurrent disease R Tumor assessment Non-functional 1:1 every 12 weeks up to 48 Ki-67 5%-20% or Ki-67 <5% with EVE/LAN arm weeks, then every 16 diffuse liver metastases Everolimus (10 mg/day) weeks per RECIST v1.1 No prior treatment for metastatic or Adjustment factors + Lanreotide (120 mg every recurrent disease Institution 28 days) Toxicities graded per ECOG PS of 0-2 Primary organ (pancreas CTCAE v5.0 vs. duodenum, jejunum, Aged 20 ileum, cecum, appendix vs. stomach, colon, rectum) Study endpoints Ki-67 LI(Ki-67 LI 10% vs. 5% S Ki-67 LI < 10% Primary: PFS vs. Ki-67 LI < 5%) Key secondary: os Other secondary: ORR, DCR, safety ASCO Gastrointestinal SUSUMU HIJIOKA, National Cancer Center Hospital, Tokyo, Japan PRESENTED BY ASCO AMERICAN SOCIETY or CUNICAL CHICOLOGY #GI25 Cancers Symposium Presentation . property ASCO contact KNOWLEDGE CONQUERS CANCER --- [Slide 2] Overall survival (Nov. 2024 ) 11 N = 168 1.0 Everolimus + Lanreotide mOS 1-year survival 97.0% 0.8 LIIIII EVE NE Everolimus [88.4-99.2%] 0.6 96.2% EVE/LAN NE [88.8-98.8%] 0.4 0.2 HR 0.74 [95% CI: 0.25-2.24] Number of observed events: 13 0.0 11 deaths from the primary disease 0 6 12 18 24 30 36 42 48 54 1 death from other disease Months after randomization 1 unknown Pts. at risk EVE 83 75 56 40 32 24 13 6 0 0 EVE/LAN 85 75 59 43 33 23 18 8 1 0 ASCO Gastrointestinal SUSUMU HIJIOKA, . National Cancer Center Hospital, Tokyo, Japan #GI25 ASCO SOCIETY or PRESENTED BY CUNICAL ONCOUOOK Cancers Symposium Presentation . property of the author and ASCO Permission required to dontar KNOWLEDGE CONOUERS CANCER --- [Slide 3] Updated PFS (Nov. 2024 ) 10 N = 168 1.0 Everolimus + Lanreotide mPFS 95% CI 0.8 EVE 13.6 m 9.1-19.4 0.6 EVE/LAN 29.7 m 21.4-38.2 0.4 0.2 Everolimus Stratified HR 0.44 [95% CI: 0.28-0.69] One-sided P = 0.00016 0.0 0 6 12 18 24 30 36 42 48 54 Months after randomization Pts. at risk EVE 83 60 31 19 9 8 6 3 0 0 EVE/LAN 85 70 44 33 21 14 10 3 0 0 ASCO Gastrointestinal SUSUMU HIJIOKA, National Cancer Center Hospital, Tokyo, Japan #G125 PRESENTED BY ASCO AMOUCAN SOCKTY CLINICAL OHCOLOGY Cancers Symposium Presentation . property of the author and ASOO Permission required to record contact - KNOWLEDGE CONOUERS CANCER --- [Slide 4] JCOG1901 (STARTER-NET): Trial design N = 250 EVE arm Treatment until disease Key inclusion criteria Everolimus (10 mg/day) progression or Histologically proven GEP-NETs Monotherapy unacceptable toxicity with G1/2 (2019 WHO classification) Unresectable or recurrent disease R Tumor assessment Non-functional 1:1 every 12 weeks up to 48 Ki-67 5%-20% or Ki-67 <5% with EVE/LAN arm weeks, then every 16 diffuse liver metastases Everolimus (10 mg/day) weeks per RECIST v1.1 No prior treatment for metastatic or Adjustment factors + Lanreotide (120 mg every recurrent disease Institution 28 days) Toxicities graded per ECOG PS of 0-2 Primary organ (pancreas CTCAE v5.0 vs. duodenum, jejunum, Aged ≥ 20 ileum, cecum, appendix vs. stomach, colon, rectum) Study endpoints Ki-67 LI(Ki-67 LI ≥ 10% vs. 5% â Ki-67 LI < 10% Primary: PFS vs. Ki-67 LI < 5%) Key secondary: OS Other secondary: ORR, DCR, safety ASCO Gastrointestinal Cancers Symposium #GI25 PRESENTED BY SUSUMU HIJIOKA, National Cancer Center Hospital, Tokyo, Japan ASCO AMERICAN SOCIETY or CLINICAL CHICOLOGY Presentation - property of the - and ASCO Permission request - - contact KNOWLEDGE CONQUERS CANCER --- [Slide 5] Updated PFS (Nov. 2024) 10 N= 168 1.0 0.8 Everolimus + Lanreotide mPFS 95% CI Progression-free survival EVE 13.6 m 9.1-19.4 0.6 EVE/LAN 29.7 m 21.4-38.2 0.4 0.2 Everolimus Stratified HR 0.44 [95% Cl: 0.28-0.69] One-sided P= 0.00016 0.0 0 6 12 18 24 30 36 42 48 54 Months after randomization Pts. at risk EVE 83 60 31 19 9 8 6 3 0 0 EVE/LAN 85 70 44 33 21 14 10 3 0 0 ASCO Gastrointestinal SUSUMU HIJIOKA, National Cancer Center Hospital, Tokyo, Japan #GI25 PRESENTED BY ASCO AMERICAN SOCKYY or CLINICAL ONCOLOGE Cancers Symposium Presentation - property of the - and ASCO Permission - for - contact KNOWLEDGE CONQUERS CANCER --- [Slide 6] Overall survival (Nov. 2024 ) 11 N = 168 1.0 Everolimus + Lanreotide mos 1-year survival 97.0% 0.8 EVE NE [88.4-99.2%] Everolimus Overall survival 0.6 96.2% EVE/LAN NE [88.8-98.8%] 0.4 0.2 HR 0.74 [95% Cl: 0.25-2.24] Number of observed events: 13 0.0 11 deaths from the primary disease 0 6 12 18 24 30 36 42 48 54 1 death from other disease Months after randomization 1 unknown Pts. at risk EVE 83 75 56 40 32 24 13 6 0 0 EVE/LAN 85 75 59 43 33 23 18 8 1 0 ASCO Gastrointestinal SUSUMU HIJIOKA, National Cancer Center Hospital, Tokyo, Japan #GI25 PRESENTED BY, ASCO AMERICAN SOCIETY or CLINICAL ONCOLOGY Cancers Symposium Presentation - property - - - and ASCO Permission required " - - KNOWLEDGE CONQUERS CANCER --- [Slide 7] Objective response rate (ORR) and disease control rate (DCR) All patients EVE (n = 84) EVE/LAN (n = 87) Best overall response, n (%) CR 0 (0.0) 0 (0.0) PR 7 (8.3) 20 (23.0) SD 64 (76.2) 60 (69.0) PD 9 (10.7) 2 (2.3) NE 4 (4.8) 5 (5.7) ORR, n (%) [95% CI] 8.3% [3.4-16.4] 23.0% [14.6-33.3] p-value* 0.011 DCR, n (%) [95% CI] 84.5% [75.0-91.5] 92.0% [84.1-96.7] p-value* 0.16 "Fisher's two-sided p-value for the direct probability test ASCO Gastrointestinal SUSUMU HIJIOKA, National Cancer Center Hospital, Tokyo, Japan #GI25 PRESENTED BY ASCO AMERICAN SOCIETY or CUNICAL DIVCOLOGY Cancers Symposium - - property - - - and ASCO Permison regurred - - - - KNOWLEDGE CONQUERS CANCER

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