Found 1 Presentation For Request "980P"

NSCLC, metastatic

980P - Continuation of selpercatinib beyond progression in RET fusion-positive NSCLC: Data from LIBRETTO-001 study

Presentation Number
980P
Speakers
  • Alexander E. Drilon (New York, United States of America)
Date
Mon, 12.09.2022

Abstract

Background

Selpercatinib, a first-in-class highly selective RET kinase inhibitor with CNS activity, is approved in various regions for patients (pts) with RET fusion+ NSCLC. In other oncogene-addicted NSCLC settings, targeted treatment beyond RECIST progression (PD) in the case of solitary site or oligoprogression is commonly utilized and endorsed by guidelines.

Methods

Pts were treated on the phase I/II LIBRETTO-001 trial (NCT03157128) and were permitted to continue selpercatinib beyond PD if the pt derived ongoing benefit according to the investigator (INV) and with Sponsor approval. Outcomes of this practice were retrospectively analyzed utilizing a data cut of 15JUN2021.

Results

Of the 169 RET fusion+ NSCLC pts who progressed per INV assessment, 120 (71%) continued selpercatinib post-progressive disease (post-PD; including pts with prior platinum-based chemotherapy [n=86] and treatment-naïve [n=22]). Baseline characteristics in these 120 pts were similar to the overall intent-to-treat NSCLC population (n=355), except for a higher rate of CNS metastases at enrollment in the post-PD cohort (43% vs 30%, respectively). Median duration of treatment (DOT) prior to PD was 10.9 months (mo; range [0.6-39.5]). The median DOT post-PD was 5.0 mo (95%CI: 3.3, 7.4). At 6 mo post-PD 45% (95%CI: 35.3, 53.4) of pts remained on treatment, and at 9 mo post-PD 34.3% (95%CI: 25.3, 43.4) of pts remained on treatment. Of the 120 post-PD pts, 40 (33%) received localized therapy for progressing lesions, including 36 pts who received radiotherapy (RT) of whom 12 pts received brain RT. Median time on treatment post-PD for the 40 pts was 5.4 mo (0.03-25.6). The safety profile in post-PD pts was generally consistent with the overall safety profile. No new selpercatinib safety signals were identified in this population.

Conclusions

In this posthoc analysis, a subset of pts with RET fusion+ NSCLC appear to derive ongoing clinical benefit from continuing selpercatinib treatment beyond PD. Analysis of outcomes in patients who had widespread progression versus oligometastatic or solitary site progression is ongoing.

Clinical trial identification

NCT03157128.

Editorial acknowledgement

Medical writing assistance provided by Kristi Gruver, an employee of Eli Lilly and Company.

Legal entity responsible for the study

Eli Lilly and Company.

Funding

Eli Lilly and Company.

Disclosure

A.E. Drilon: Financial Interests, Personal, Advisory Board: Ignyta/Genentech/Roche, Loxo/Bayer/Lilly, Takeda/Ariad/Millennium, TP Therapeutics, AstraZeneca, Pfizer, Blueprint Medicines, Helsinn, BeiGene, BerGenBio, Hengrui Therapeutics, Exelixis, Tyra Biosciences, Verastem Oncology, MORE Health, AbbVie, 14ner/Elevation Oncology, Remedica Ltd., ArcherDX, Monopteros, Novartis, EMD Serono, Melendi, Liberum, Repare RX, Amgen, Janssen; Financial Interests, Personal, Other, CME: Medscape, Onclive, PeerVoice, Physicians Education Resources, Targeted Oncology, Research to Practice, PeerView Institute, Paradigm Medical Communications, WebMD, MJH Life Sciences, Med Learning, Imedex, Answers in CME, Medscape, Clinical Care Options; Financial Interests, Personal, Other, CME, Consulting: Axis; Financial Interests, Personal, Other, Consulting: Nuvalent, Merus, mBrace, EPG Health, Harborside Nexus, Ology, TouchIME, Entos, Treeline Bio, Prelude, Applied Pharmaceutical Science, Inc; Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical, Remedica Ltd, RV More; Financial Interests, Personal, Stocks/Shares: Treeline Biosciences; Financial Interests, Personal, Royalties: Wolters Kluwer; Financial Interests, Institutional, Funding, Research funding: Pfizer, Exelixis, PharmaMar, GlaxoSmithKline, Teva, Taiho; Financial Interests, Personal, Funding, Research: Foundation Medicine; Other, Food/Beverage: Merck, PUMA, Merus; Other: Boehringer Ingelheim. J. Sands: Financial Interests, Personal, Advisory Board, Consulting/Advisory Board: AstraZeneca, Blueprint Medicines, Curadev, Daiichi Sankyo, Jazz Pharmaceuticals, Medtronic, Pharma Mar, Takeda. D.S.W. Tan: Financial Interests, Institutional, Research Grant: Amgen, Pfizer, Novartis; Financial Interests, Institutional, Other, Consulting fees: Novartis, Bayer, Boehringer Ingelheim, AstraZeneca, Eli Lilly and Company, MSD, GlaxoSmithKline, Loxo; Financial Interests, Institutional, Writing Engagements, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events,: Merck, Pfizer, Novartis, Boehringer Ingelheim, Roche, Takeda. J. Weiss: Financial Interests, Personal, Stocks/Shares, to an immediate family member: Achilles Therapeutics; Financial Interests, Personal, Stocks/Shares: Nektar, Vesselon, Nuvalent, Lyell Immunopharma, En Fuego Therapeutics; Financial Interests, Personal, Advisory Role, Consulting/Advisory Role: AstraZeneca, EMD Serono, Genentech, G1 Therapeutics, Jounce Therapeutics, AbbVie, Nanobiotix, Azitra, Eli Lilly and Company, Blueprint Medicines, Pfizer, Saatchi Wellness, Jazz Pharmaceuticals, Boehringer Ingelheim, Regeneron, Genmab, SDP Oncology, BeiGen; Financial Interests, Personal, Research Grant, Research funding: Mirati Therapeutics, Sumitomo Dainippon Pharma Oncology, Boehringer Ingelheim, PDS Biotechnology; Financial Interests, Institutional, Research Grant, Research funding: Merck, AstraZeneca/MedImmune, Amgen, Carefusion, G1 Therapeutics, Immunicum, Loxo/Lilly; Financial Interests, Personal, Other, travel, accommodations, expenses: Mirati Therapeutics. B. Solomon: Financial Interests, Personal, Advisory Board: AstraZeneca, Bayer; Financial Interests, Institutional, Invited Speaker: Daiichi Sankyo, Iovance, GSK, Mirati, ImmunityBio, AstraZeneca, Amgen; Non-Financial Interests, Member: ASCO, AACR, ESMO. M.L. Johnson: Financial Interests, Institutional, Research Grant, Research funding: AbbVie, Acerta, Adaptimmune, Amgen, Apexigen, Arcus Biosciences, Array BioPharma, Artios Pharma, AstraZeneca, Atreca, BeiGene, BerGenBio, BioAtla, Boehringer Ingelheim, Calithera Biosciences, Checkpoint Therapeutics, Corvus Pharmaceutic; Financial Interests, Institutional, Advisory Role, Consulting/advisory role: AbbVie, Amgen, Astellas, AstraZeneca, Axelia Oncology, Black Diamond, Boehringer Ingelheim, Bristol-Myers Squibb, Calithera Biosciences, Checkpoint Therapeutics, CytomX Therapeutics, Daiichi Sankyo, EcoR1, Editas Medicine, Eisai, EMD Se. T. Puri: Financial Interests, Personal, Full or part-time Employment: Eli Lilly and Company; Financial Interests, Personal, Stocks/Shares: Eli Lilly and Company. M.A. Sarno: Financial Interests, Personal, Full or part-time Employment: Eli Lilly and Company; Financial Interests, Personal, Stocks/Shares: Eli Lilly and Company. S. Kang: Financial Interests, Personal, Full or part-time Employment: Eli Lilly and Company; Financial Interests, Personal, Stocks/Shares: Eli Lilly and Company. V. Soldatenkova: Financial Interests, Personal, Full or part-time Employment: Eli Lilly and Company; Financial Interests, Personal, Stocks/Shares: Eli Lilly and Company. C. Duann: Financial Interests, Personal, Full or part-time Employment: Eli Lilly and Company; Financial Interests, Personal, Stocks/Shares: Eli Lilly and Company. S. Szymczak: Financial Interests, Personal, Full or part-time Employment: Eli Lilly and Company; Financial Interests, Personal, Stocks/Shares: Eli Lilly and Company. V. Subbiah: Financial Interests, Personal, Advisory Board, One time advisory board: Incyte, Novartis, Eli Lilly/ Loxo Oncology; Financial Interests, Personal, Advisory Board, One time ad board: Roche, Pfizer; Financial Interests, Personal, Advisory Board, Ad hoc advisory board: Relay Therapeutics; Financial Interests, Institutional, Invited Speaker, Research funding to conduct Clinical trial: Eli Lilly/Loxo Oncology, Blueprint medicines, Novartis, Boston Pharmaceuticals, Pfizer, Turning Point Therapeutics, Amgen, Bayer, Roche/ Genentech, Exelixis, Berg Pharma, N W Biotherapeutics, Relay Therapeutics, AbbVie, Agensys, Inhibrx, Dragonfly Therapeutics, Takeda; Financial Interests, Institutional, Invited Speaker, Research funding to conduct clinical trial: Shasqi; Other, I am employed at the University of Texas MD Anderson Cancer Center: The University of Texas MD Anderson Cancer Center; Other: I receive research funding from NCI: National Cancer Institute, USA. B. Besse: Financial Interests, Institutional, Funding: 4D Pharma, AbbVie, Amgen, Aptitude Health, AstraZeneca, BeiGene, Blueprint Medicines, Boehringer Ingelheim, Celgene, Cergentis, Cristal Therapeutics, Daiichi Sankyo, Eli Lilly, GSK, Janssen, Onxeo, Ose Immunotherapeutics, Pfizer, Roche-Genentech, Sanofi, Takeda, Tolero Pharmaceuticals; Financial Interests, Institutional, Research Grant: Chugai Pharmaceutical, EISAI, Genzyme Corporation, Inivata, Ipsen, Turning Point Therapeutics. All other authors have declared no conflicts of interest.

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