669P - Patient-reported outcomes with selpercatinib in patients with RET-driven cancers in the phase I/II LIBRETTO-001 trial

Background

Selpercatinib, a first-in-class highly selective and potent rearranged during transfection (RET)-inhibitor, demonstrated efficacy in treatment of RET-driven cancers in the phase 1/2 LIBRETTO-001 trial. We report patient-reported outcomes for non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC), non-MTC thyroid cancer (TC) (15 Jun 2021, data cut-off date) and tumor agnostic (TA) cohorts (24 Sep 2021, data cut-off date).

Methods

Patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) at baseline (BL), approximately every 8 weeks until cycle 13, and then every 12 weeks until end of treatment (EoT). Subscales were scored 0–100; higher scores indicate better functioning or more severe symptoms based on the subscale. Proportion of patients with improved, stable, or worsened status post-BL was assessed. For symptom subscales improved is 10-point decrease from BL, worsened is 10-point increase from BL, and stable is being within 10 points from BL. For other subscales improved is 10-point increase from BL, worsened is 10-point decrease from BL, and stable is being within 10 points from BL.

Results

For patients with NSCLC, MTC, TC, and TA, respectively, 200 (63%), 208 (71%), 32 (70%), and 28 (68%) patients completed BL assessment; compliance rate was 85%, 87%, 72%, and 86%. BL functional domain subscale scores were >65 points across cohorts. Mean (SD) BL global health status (GHS) scores were: NSCLC – 62 (24), MTC – 65 (24), TC – 73 (20), and TA – 59 (26). The highest BL symptom scores (mean [SD]) were: NSCLC – fatigue (37 [26]) and dyspnea (30 [29]), MTC – diarrhea (42 [38]) and fatigue (36 [27]), TC – insomnia (28 [27]) and fatigue (27 [24]), and TA – fatigue (40 [29]) and appetite loss (37 [36]). Change in post-BL status varied across cohorts (Table).

Table: 669P

Conclusions

The majority of patients with RET-driven cancers remained stable or improved on most QLQ-C30 domains during treatment with selpercatinib.

Clinical trial identification

NCT03157128.

Editorial acknowledgement

Leo J. Philip Tharappel, an employee of Eli Lilly Services India Private Limited provided medical writing and editorial assistance.

Legal entity responsible for the study

Eli Lilly and Company.

Funding

Eli Lilly and Company.

Disclosure

H. Kang: Financial Interests, Institutional, Research Funding, clinical trial contract: Eli Lilly and Company, Exelixis; Financial Interests, Personal, Speaker, Consultant, Advisor, honorarium: AXIS Med. L.E. Raez: Financial Interests, Personal and Institutional, Research Funding: Loxo, Eli Lilly and Company, Genentech, Pfizer, Novartis, Syndax, Guardant, Nanth Health, Natera, BMS, Merck, Velos. M. Khanal, Y. Han, S. Szymczak, S. Barker, A.M. Gilligan: Financial Interests, Personal, Full or part-time Employment: Eli Lilly and Company; Financial Interests, Personal, Stocks/Shares: Eli Lilly and Company. K. Wang: Financial Interests, Personal, Full or part-time Employment: TigerMed Grp. All other authors have declared no conflicts of interest.