Efficacy

LUTATHERA in Newly Diagnosed Patients

Start with superior PFS results, start with LUTATHERA^1,2

LUTATHERA + SSA prolonged PFS in patients with newly diagnosed, grade 2/3 GEP-NETs^1,2

Statistically Significant Improvement in PFS (Primary End Point)^1,2

LUTATHERA + SSA prolonged PFS in patients with newly diagnosed, grade 2/3 GEP-NETs, with a 72% reduction in risk of progression or death (HR, 0.28 [95% CI, 0.182-0.418]; P<.0001). The median PFS in the LUTATHERA arm was 22.8 months (95% CI, 19.4-NE) vs 8.5 months (95% CI, 7.7-13.8) in the control arm of 60 mg octreotide

PFS was defined as the time from randomization to first documented disease progression or death due to any cause. Centrally assessed according to RECIST v1.1 criteria¹
The primary PFS analysis data cutoff was July 20, 2023. Median duration of follow-up was 23.2 months (from randomization to cutoff date)²

1st radioligand therapy with 1st-line evidence in newly diagnosed patients demonstrated in a phase 3 study^1-3,*

*In NETTER-2, 44 patients (19.5%) received prior treatment in the absence of progression, including CAPTEM (1 patient), everolimus (1 patient), and SSAs (42 patients, with the majority receiving 1 or 2 doses).^2,4

1L, first line; CAPTEM, capecitabine and temozolomide; GEP-NETs, gastroenteropancreatic neuroendocrine tumors; HR, hazard ratio; LAR, long-acting release; NE, not evaluable; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors; SSA, somatostatin analogue.

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Analysis of PFS across key clinical subgroups with LUTATHERA⁴

PFS Across Key Subgroups of Interest (Full Analysis Set)⁴

In a subgroup analysis of PFS in NETTER-2, hazard ratios favored the LUTATHERA arm across subgroups, including grade 2 or 3 tumors; pNET, small intestine, or other tumor origin; age group <65 or ≥65 years; and female or male sex.

In a subgroup analysis of PFS in NETTER-2, hazard ratios favored the LUTATHERA arm across subgroups, including race; tumor burden at baseline; CgA prior to randomization; and SSTR uptake per central review whether, including grade 3/4.

There are 2 separate scales for each section of this chart.

CgA, chromogranin A; pNET, pancreatic neuroendocrine tumor; SSTR, somatostatin receptor; ULN, upper limit of normal.

Analysis not powered to demonstrate a benefit between subgroups. Results should be interpreted with caution.

LUTATHERA delivered statistically significant, superior ORR⁴

Statistically significant increase (>4X) in ORR with LUTATHERA + 30 mg octreotide LAR compared with 60 mg octreotide LAR⁴

Objective Response Rate (Full Analysis Set)

43% overall response rate for LUTATHERA plus 30 mg octreotide, which is 4x greater than the overall response rate of 60 mg octreotide at 9.3%.

ORR, objective response rate.

LUTATHERA was studied as 1L therapy* in newly diagnosed patients¹

NETTER-2 is a phase 3, randomized, open-label, multicenter study in newly diagnosed, well-differentiated, grade 2/3 advanced GEP-NETs^1,2

In NETTER-2, patients (N=226) were randomized 2:1 to receive either LUTATHERA + 30 mg octreotide LAR (n=151) every 8 weeks for 4 cycles or 60 mg octreotide LAR (n=75) every 4 weeks.

^†Patients received an initial single dose at 30 mg before stepping up to 60 mg octreotide.¹

Primary end point¹	PFS (centrally assessed according to RECIST v1.1 and defined as time from randomization to first documented disease progression or death due to any cause)
Secondary end points¹	Objective response rate (ORR) Overall survival (OS) Time to deterioration (TTD) in select QOL scales Disease control rate Duration of response Safety
Additional information¹	Patients previously treated with an SSA without documented progression were allowed Crossover from the 60-mg octreotide LAR arm to LUTATHERA was allowed after patients experienced progression In the LUTATHERA arm, investigators had the option of enrolling patients for re-treatment with LUTATHERA if they had previously received and benefited from 4 doses as initial treatment (offering an additional 2-4 cycles of LUTATHERA) If progression occurred after the Week 72 primary end point analysis, the re-treatment decision was based on local assessment

GBq, gigabecquerel; mCi, millicurie; QOL, quality of life; SSTR+, somatostatin receptor-positive.

Follow-up for overall survival is ongoing. Data will be collected for a planned final analysis of OS in the follow-up period after patients completed their treatment, retreatment, or crossover phase

Characteristics of patients treated with LUTATHERA as 1L therapy¹

NETTER-2 demographics and disease characteristics were well balanced between arms⁴

Baseline Demographics and Disease Characteristics⁴

NETTER-2 baseline patient demographics and disease characteristics were well balanced between arms across median age, sex, Karnofsky PS, primary tumor site, extent of tumor burden, histopathology grade, mean Ki-67, and highest SSTR tumor uptake score.

^aOther includes Black or African American, American Indian or Alaska Native, Multiple, or Missing.⁴
^bExtent of tumor burden was based on central assessment.⁴
^cHighest SSTR tumor uptake score is based on local assessment.⁴

NETs, neuroendocrine tumors; PS, performance score; SD, standard deviation.

In the NETTER-2 trial, ~65% of patients had grade 2 NETs and ~35% had grade 3 NETs²

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Next page: LUTATHERA After SSA Progression

Efficacy

LUTATHERA in Newly Diagnosed Patients

Start with superior PFS results, start with LUTATHERA^1,2

LUTATHERA + SSA prolonged PFS in patients with newly diagnosed, grade 2/3 GEP-NETs^1,2

Analysis of PFS across key clinical subgroups with LUTATHERA⁴

LUTATHERA delivered statistically significant, superior ORR⁴

Statistically significant increase (>4X) in ORR with LUTATHERA + 30 mg octreotide LAR compared with 60 mg octreotide LAR⁴

LUTATHERA was studied as 1L therapy* in newly diagnosed patients¹

NETTER-2 is a phase 3, randomized, open-label, multicenter study in newly diagnosed, well-differentiated, grade 2/3 advanced GEP-NETs^1,2

Characteristics of patients treated with LUTATHERA as 1L therapy¹

NETTER-2 demographics and disease characteristics were well balanced between arms⁴

Baseline Demographics and Disease Characteristics⁴

Important Safety Information

Indication

Efficacy

LUTATHERA in Newly Diagnosed Patients

Start with superior PFS results, start with LUTATHERA1,2

LUTATHERA + SSA prolonged PFS in patients with newly diagnosed, grade 2/3 GEP-NETs1,2

Analysis of PFS across key clinical subgroups with LUTATHERA4

LUTATHERA delivered statistically significant, superior ORR4

Statistically significant increase (>4X) in ORR with LUTATHERA + 30 mg octreotide LAR compared with 60 mg octreotide LAR4

LUTATHERA was studied as 1L therapy* in newly diagnosed patients1

NETTER-2 is a phase 3, randomized, open-label, multicenter study in newly diagnosed, well-differentiated, grade 2/3 advanced GEP-NETs1,2

Characteristics of patients treated with LUTATHERA as 1L therapy1

NETTER-2 demographics and disease characteristics were well balanced between arms4

Baseline Demographics and Disease Characteristics4

Start with superior PFS results, start with LUTATHERA^1,2

LUTATHERA + SSA prolonged PFS in patients with newly diagnosed, grade 2/3 GEP-NETs^1,2

Analysis of PFS across key clinical subgroups with LUTATHERA⁴

LUTATHERA delivered statistically significant, superior ORR⁴

Statistically significant increase (>4X) in ORR with LUTATHERA + 30 mg octreotide LAR compared with 60 mg octreotide LAR⁴

LUTATHERA was studied as 1L therapy* in newly diagnosed patients¹

NETTER-2 is a phase 3, randomized, open-label, multicenter study in newly diagnosed, well-differentiated, grade 2/3 advanced GEP-NETs^1,2

Characteristics of patients treated with LUTATHERA as 1L therapy¹

NETTER-2 demographics and disease characteristics were well balanced between arms⁴

Baseline Demographics and Disease Characteristics⁴