Abstract 669P
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
Proportion of patients with post-BL response (Cycle 3 to EoT), mean (SD) | ||
NSCLC | ||
GHS | Improved | 42 (9) |
Stable | 42 (10) | |
Worsened | 17 (8) | |
Fatigue | Improved | 44 (7) |
Stable | 27 (5) | |
Worsened | 29 (9) | |
Dyspnea | Improved | 34 (6) |
Stable | 57 (5) | |
Worsened | 9 (4) | |
MTC | ||
GHS | Improved | 37 (7) |
Stable | 45 (4) | |
Worsened | 19 (7) | |
Fatigue | Improved | 46 (6) |
Stable | 28 (5) | |
Worsened | 26 (8) | |
Diarrhea | Improved | 53 (5) |
Stable | 35 (3) | |
Worsened | 12 (4) | |
TC | ||
GHS | Improved | 21 (9) |
Stable | 54 (8) | |
Worsened | 25 (6) | |
Fatigue | Improved | 39 (10) |
Stable | 32 (14) | |
Worsened | 30 (11) | |
Insomnia | Improved | 24 (14) |
Stable | 56 (7) | |
Worsened | 21 (13) | |
TA | ||
GHS | Improved | 39 (10) |
Stable | 44 (8) | |
Worsened | 17 (4) | |
Fatigue | Improved | 49 (12) |
Stable | 19 (9) | |
Worsened | 33 (11) | |
Appetite loss | Improved | 44 (9) |
Stable | 51 (13) | |
Worsened | 5 (6) |
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.
Resources from the same session
690P - Ifinatamab deruxtecan (I-DXd; DS-7300) in patients with advanced solid tumors: Updated clinical and biomarker results from a phase I/II study
Presenter: Manish R Patel
Session: Poster session 17
691P - Efficacy of ABBV-400 monotherapy in patients with MET gene amplified advanced solid tumors
Presenter: John Strickler
Session: Poster session 17
692P - First-in-human study of ELU001, a targeted nanoparticle drug conjugate, in subjects with folate receptor α (FRα) overexpressing solid tumors
Presenter: Wen wee Ma
Session: Poster session 17
693P - Preclinical activity of HLX43, a PD-L1-targeting ADC, in multiple PD-1/PD-L1 refractory/resistant models
Presenter: Yongqiang Shan
Session: Poster session 17
694P - Full efficacy analysis of phase I/II trial investigating bexmarilimab, a novel macrophage-guided immunotherapy in refractory solid tumors
Presenter: Petri Bono
Session: Poster session 17
695P - A phase I/Ib study evaluating the safety and tolerability of NIZ985 alone and in combination with spartalizumab (anti–PD-1) in patients (pts) with solid tumors or lymphoma
Presenter: Elena Garralda
Session: Poster session 17
696P - SIM1811-03 (SIM0235), an anti-tumor necrosis factor receptor-2 (TNFR2) monoclonal antibody, in patients with advanced solid tumor and/or cutaneous T cell lymphomas (CTCL): Preliminary results from an on-going first-in-human phase I trial in China
Presenter: Furong Liu
Session: Poster session 17
699P - Immunogenicity and reactogenicity of BNT162b2 COVID-19 mRNA vaccine in long-survivor (LS) patients with metastatic lung cancer (mLC) after primary immunization (PV) and booster (BD): COVALENCE study
Presenter: Emanuele Vita
Session: Poster session 17