QOL Improvements in NETTER-1 Phase III Trial in Patients With Progressive Midgut Neuroendocrine Tumors

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1 QOL Improvements in NETTER-1 Phase III Trial in Patients With Progressive Midgut Neuroendocrine Tumors Abstract C-33 Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum RP, Kunz P, Hobday T, Hendifar A, Oberg K, Sierra ML, Ruszniewski P, Krenning E

2 NETTER -1 Study Design Aim Evaluate the efficacy and safety of Lu-Dotatate + SSAs (symptoms control) compared to octreotide LAR 60 mg (off-label use) 1 in patients with inoperable, somatostatin receptor positive, midgut NET, progressive under octreotide LAR 30 mg (label use) Design International, multicenter, randomized, comparator-controlled, parallel-group Treatment and Assessments Progression-free survival (RECIST criteria) every 12 weeks Dose 1 Dose 2 Dose 3 Dose 4 n = 115 n = administrations of 7.4 GBq of Lu-Dotatate every 8 weeks + SSAs (symptoms control) Octreotide LAR (high dose - 60mg every 4 weeks1) 5 years follow-up LAR, long-acting release; NET, neuroendocrine tumor; RECIST, response evaluation criteria in solid tumors; SSA, somatostatin analog Strosberg J et al. N Engl J Med (2):

3 NETTER-1 Endpoints and Inclusion Criteria Study Endpoints Primary endpoint Progression-free survival (PFS) Secondary endpoints Response rate Overall survival Safety and tolerability Health-related quality of life (HRQoL) Main Inclusion Criteria Patients >18 years of age Metastatic or locally advanced, inoperable, well-differentiated midgut NET Ki67 index 20% (grade1-2) Progressive disease (RECIST Criteria 1.1 centrally confirmed) on uninterrupted fixed dose of octreotide LAR (20-30 mg) every 3-4 weeks) Somatostatin receptor positive disease Karnofsky Performance Score 60

4 HRQoL Assessment Patients completed the EORTC QLQ C-30 and G.I. NET-21 questionnaires every 12 +/- 1 weeks The questionnaire results were converted to a 100-point scale per the EORTC manual In the QLQ C30 questionnaire, the Global Health Status and five Function Scale (FS) domains are positive scales in which higher scores translate into higher quality of life The symptom scales (SS) are negative scales in which a higher score corresponds to a higher level of symptoms/problems

5 Time to Deterioration (TTD) in HRQoL We present the Quality of Life (QoL) results obtained in the NETTER-1 study comparing treatment with Lu-DOTATATE to octreotide LAR on the time to clinically relevant change (deterioration) in health-related QoL (HRQoL). The method used for this assessment is a time-to-event methodology, where the event is defined as a deterioration in the patient s QoL Time to QoL deterioration (TTD): Time from randomization to the first QoL deterioration 10 points for each patient in the corresponding domain scale For each domain, a Kaplan-Meier plot was produced showing time to event by treatment arm. Kaplan-Meier methods were used to generate a point estimate of the median time to event with corresponding 95% confidence interval (CI) The main analysis was conducted in the population that comprises all randomized patients as per intent to treat (ITT) principles

6 Analysis cut-off date was June 30, 2016 In total, 231 patients were randomized in the study (117 in Lu-Dotatate arm and 114 in the high-dose octreotide LAR arm) HRQoL Assessment Overall compliance rates for patients completing questionnaires were high, with >80% return rates in both arms during the first year

7 Global Health Status Time-to-Deterioration (TTD) How would you rate your overall health during the past week? How would you rate your overall quality of life during the past week? HR 0.40; P =.0006 Lu-Dotatate (12.0;28.8) (0.239;0.691).0006 Octreotide LAR (5.75;22.25)

8 Physical Functioning TTD HR 0.518; P =.0147 Do you have any trouble doing strenuous activities like carrying a heavy shopping bag or suitcase Do you have any trouble taking a long walk Do you have any trouble taking a short walk outside of the house Do you need to stay in bed or a chair during the day Do you need help with eating, drinking, washing yourself or using the toilet Lu-Dotatate (Limits: ;.) (Limits: 0.289; 0.868).0096 Octreotide LAR (Limits: ;.)

9 Role-Functioning TTD Were you limited in doing either your work or other daily activities? Were you limited in pursuing your hobbies or other leisure time activities? HR 0.580; P =.0298 Lu-Dotatate (Limits: 7.12;.) (Limits: 0.353; 0.956).0298 Octreotide LAR (Limits: 8.31; 14.19)

10 Diarrhea TTD Pain TTD HR 0.473; P =.0107 Lu-Dotatate (Limits:. ;.) 0.47 (Limits: 0.263; 0.853).0107 Lu-Dotatate (Limits: ;.) 0.57 (Limits: 0.342; 0.938).0247 Octreotide LAR (Limits: 5.78;.) Octreotide LAR (Limits: ; )

11 Fatigue Flushing/Sweats HR 0.621; P =.0297 Lu-Dotatate Octreotide LAR (Limits: ; ) 5.98 (Limits: ; ) 0.62 (Limits: 0.402; 0.960).0297 Lu-Dotatate Octreotide LAR (Limits: ;.) (Limits: ;.) 0.89 (Limits: 0.517; 1.545).6862

12 Conclusions: The results confirm a statistically significant and robust beneficial effect of Lu-Dotatate on time to deterioration for nearly all clinically relevant parameters In the QoL domains where the improvement of TTD did not reach statistical significance between the arms, it primarily favored the Lu-Dotatate arm Unlike many oncologic drugs, the superior efficacy of Lu- Dotatate is not achieved at the expense of deterioration in QoL, which is not only maintained but improved In conclusion, this analysis demonstrates that Lu-Dotatate provides a significant quality of life benefit for patients with progressive midgut NETs

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