Found 1 Presentation For Request "984p"
984P - Relationship between RET fusion partner and treatment outcomes in patients (pts) with non-small cell lung cancer (NSCLC) from the phase I/II ARROW study and real-world data (RWD)
- Shirish M. Gadgeel (Detroit, United States of America)
Abstract
Background
The ARROW study is assessing the anti-tumour activity of pralsetinib, a highly-selective RET inhibitor in advanced solid tumours, including
Methods
In phase 2 of ARROW, 233 pts with
Results
Baseline characteristics by RET fusion partner were balanced across subgroups within ARROW. ORR was similar with KIF5B and CCDC6, but lower with Other RET fusions (Table); the same trend was seen in treatment-naïve and prior treatment subgroups. Disease control rate (DCR) was high in all pts, but lowest in the Other RET fusions subgroup. Median duration of response (DOR) and progression-free survival (PFS) were higher with CCDC6 vs KIF5B RET fusions irrespective of prior treatment. OS data are immature. In the RWD cohort, median OS was numerically longer in CCDC6 and Other RET fusions vs KIF5B NA, not achieved.
Fusion partner ORR, n/N (%) [95% CI] DCR, n (%) [95% CI] DOR, months [95% CI] PFS, months [95% CI] Overall Treatment-naïve Prior treatment KIF5B 111/164 (67.7) [60.0–74.8] 37/50 (74.0) [59.7–85.4] 74/114 (64.9) [55.4–73.6] 151 (92.1) [86.8–95.7] 15.1 [11.0–NA] 12.8 [9.1–17.1] CCDC6 28/41 (68.3) [51.9–81.9] 11/13 (84.6) [54.6–98.1] 17/28 (60.7) [40.6–78.5] 37 (90.2) [76.9–97.3] 22.3 [22.3–NA] NA [18.8–NA] Other 11/28 (39.3) [21.5–59.4] 6/12 (50.0) [21.1–78.9] 5/16 (31.2) [11.0–58.7] 23 (82.1) [63.1–93.9] NA [10.6–NA] 16.5 [3.7–NA]
Conclusions
Pralsetinib is active in
Clinical trial identification
NCT03037385.
Editorial acknowledgement
Third-party medical writing assistance, under the direction of authors, was provided by Fiona Duthie, PhD, of Ashfield MedComms, an Ashfield Health company, and was funded by F. Hoffmann-La Roche Ltd.
Legal entity responsible for the study
F. Hoffmann-La Roche Ltd.
Funding
F. Hoffmann-La Roche Ltd.
Disclosure
S.M. Gadgeel: Financial Interests, Personal, Advisory Board: AstraZeneca, Amgen, Genentech/Roche, Bristol Myers Squibb, Pfizer, Novartis, Blueprint, Daichii; Financial Interests, Personal, Other, Data Safety Monitoring Board: AstraZeneca. J. Gainor: Financial Interests, Advisory Role, Consulted and/or had advisory roles: Agios, Amgen, Array BioPharma, Blueprint Medicines Corporation, BMS, Genentech, Gilead Sciences, Jounce Therapeutics, Lilly, Loxo Oncology, Merck, Mirati, Silverback Therapeutics, GlydeBio, Moderna Therapeutics, Oncorus, Regeneron, Takeda, Nuvalent, iTeo; Financial Interests, Stocks/Shares: Ironwood Pharmaceuticals; Financial Interests, Ownership Interest: Ironwood Pharmaceuticals; Financial Interests, Other, Received Honoraria: Ariad, Incyte, Merck, Novartis, Pfizer, and Takeda; Financial Interests, Research Grant, Received research funding: Adaptimmune, ALX Oncology, Ariad, Array BioPharma, AstraZeneca, Blueprint Medicines Corporation, BMS, Genentech, Jounce Therapeutics, Merck, Novartis, and Tesaro; Non-Financial Interests, Other, Has an immediate family member who is an employee of Ironwood Pharmaceuticals: Ironwood Pharmaceuticals. F. Cappuzzo: Financial Interests, Invited Speaker: Roche, AstraZeneca, BMS, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, Mirati, and MSD; Financial Interests, Speaker’s Bureau: Roche, AstraZeneca, BMS, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, PharmaMar, Novocure, Mirati, Galecto, Ose, MSD; Financial Interests, Advisory Board: Roche, AstraZeneca, BMS, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, PharmaMar, Novocure, Mirati,Galecto, Ose, MSD; Non-Financial Interests, Principal Investigator: Roche, AstraZeneca, BMS, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, PharmaMar, Novocure, Mirati, Galecto, Ose and MSD. E. Garralda: Financial Interests, Personal, Advisory Board: Genentech, F.Hoffmann/La Roche, Neomed Therapeutics1 Inc, Boehringer Ingelheim, Janssen Global Services, Alkermes, Thermo Fisher, Mab Discovery, Anaveon, Lilly, Hengrui; Financial Interests, Personal, Invited Speaker: Ellipses Pharma, Seattle Genetics, Bristol Myers Squibb, MSD, F-Star Therapeutics; Financial Interests, Institutional, Funding: Novartis, Roche, Thermo Fisher, AstraZeneca, Taiho. D.H. Lee: Financial Interests, Advisory Board: Boehringer Ingelheim, Bristol Myers Squibb, CJ Healthcare, Eli Lilly, ChongKeunDang, Janssen, Merck, MSD, Mundipharma, Novartis, Ono, Pfizer, Roche, Samyang Biopharm, ST Cube, AbbVie, Takeda, Genexine, Menarini, Blueprint Medicine, BC Pharma. J. Mazieres: Financial Interests, Invited Speaker: Roche, AstraZeneca, BMS, MSD, Daiichi, Novartis, Amgen; Financial Interests, Advisory Board: Roche, AstraZeneca, Pierre Fabre, Takeda, BMS, MSD, Jiangsu Hengruii, Blueprint, Daiichi, Novartis, Amgen, Lilly, Merck; Financial Interests, Research Grant: Roche, AstraZeneca, Pierre Fabre, BMS; Non-Financial Interests, Principal Investigator: Roche, AstraZeneca, Pierre Fabre, Takeda, BMS, MSD, Jiangsu Hengruii, Blueprint, Daiichi, Novartis, Amgen, Sanofi, Pfizer, Merck. D. Kim: Financial Interests, Invited Speaker: Korean Association for Lung Cancer, Korean Cancer Association, Korean Society of Medical Oncology, Taiwan Lung Cancer Society, Asian Thoracic Oncology Research Group; Financial Interests, Writing Engagements, Other: medical writing assistance: Amgen, AstraZeneca, Boehringer Ingelheim, BMS, Chong Keun Dang, Daiichi Sankyo, GSK, Pfizer, MSD, Meck, Novartis, Roche, Takeda, Yuhan; Non-Financial Interests, Advisory Board: Amgen, AstraZeneca, BMS/Ono Pharmaceuticals, Daiichi Sankyo, GSK, Janssen, Meck, MSD, Pfizer, SK Biopharm, Takeda; Other, Member of the Board of Directors, Other: Member of Board of Directors: Asian Thoracic Oncology Research Group, Korean Association for Lung Cancer, Korean Cancer Association, Korean Society of Medical Oncology; Financial Interests, Research Grant, Financial: to my institution: Alpha Biopharma, Amgen, AstraZeneca/MedImmune, Boehringer Ingelheim, BMS, Bridge BioTherapeutics, Chong Keun Dang, Daiichi Sankyo, GSK, Hanmi, Janssen, Merck, Merus, Mirati Therapeutics, MSD, Novartis, Ono Pharmaceutical, Pfizer, Roche/Genentech, Takeda; Other, Principal Investigator, Other: coordinating PI: Chong Keun Dang; Financial Interests, Advisory Role: Scientific advisor for Health insurance review and assessment service, Korea; Other: Travel support: Amgen, Daiichi Sankyo, International Association for the Study of Lung Cancer, Asian Thoracic Oncology Research Group, Taiwan Lung Cancer Society. V. Zhu: Financial Interests, Invited Speaker: AstraZeneca, Blueprint, Roche-Foundation Medicine, Roche/Genentech, Takeda; Financial Interests, Speaker’s Bureau: AstraZeneca, Blueprint, Roche/Genentech, Takeda; Financial Interests, Full or part-time Employment, Full-time Nuvalent employee: Nuvalent; Financial Interests, Stocks/Shares, Nuvalent stock ownership; TP Therapeutics stock ownership until May 2020: Nuvalent, TP Therapeutics; Financial Interests, Advisory Role: AstraZeneca, BeiGene, Roche/Genentech, Takeda, TP Therapeutics, Xcovery. G. Lopes: Financial Interests, Stocks/Shares: Lucence Diagnostics, Xilis; Financial Interests, Ownership Interest: Lucence Diagnostics, Xilis; Financial Interests, Other, Honoraria: Boehringer Ingelheim, Blueprint Medicines, AstraZeneca, Merck; Financial Interests, Advisory Role, Consulting or Advisory Role: Pfizer, AstraZeneca; Financial Interests, Research Grant, Research funding: AstraZeneca, Lucence, Xilis, E.R. Squibb Sons, LLC, Merck Sharp & Dohme, EMD Serono, Blueprint Medicines, Tesaro, Bavarian Nordic, Novartis, G1 Therapeutics, Adaptimmune, BMS, GSK, AbbVie, Rgenix, Pfizer, Roche, Genentech, Lilly, Janssen; Financial Interests, Other, Travel, accommodation, expenses: Boehringer Ingelheim, Pfizer, E.R. Squibb Sons, LLC, Janssen, Seattle Genetics, Celgene, Ibsen, Pharmacyclics, Merck, AstraZeneca, Seagen; Financial Interests, Other: Mirati Therapeutics. S. Miller: Financial Interests, Full or part-time Employment: Blueprint Medicines; Financial Interests, Stocks/Shares: Blueprint Medicines. M. Nowicka: Financial Interests, Full or part-time Employment: F. Hoffmann-La Roche; Financial Interests, Stocks/Shares: F. Hoffmann-La Roche. H. Trinh: Financial Interests, Full or part-time Employment: Roche/Genentech Inc; Financial Interests, Stocks/Shares: Roche/Genentech Inc. A. Rahman: Financial Interests, Full or part-time Employment: F. Hoffmann-La Roche, Ltd; Financial Interests, Stocks/Shares: Merck/MSD, F. Hoffmann-La Roche, Ltd. J. Noe: Financial Interests, Full or part-time Employment: F. Hoffmann-La Roche, Ltd. Q. Zhang: Financial Interests, Full or part-time Employment: Roche/Genentech; Financial Interests, Stocks/Shares: Roche, Regeneron, BMS, Pfizer, BioNTech, AC Immune. 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; 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. All other authors have declared no conflicts of interest.