Abstract 22P
Background
In TROPION-LUNG01, Dato-DXd showed a clinically meaningful improvement in progression-free survival and a numerical benefit in overall survival vs. docetaxel in adults with previously treated advanced or metastatic NSQ NSCLC. Here, we report EORTC QLQ-C30 and QLQ-LC13 results from TROPION-LUNG01 for the NSQ population (N=468).
Methods
NSQ NSCLC patients (stage IIIB/C or IV) were stratified to Dato-DXd 6 mg/kg Q3W (every 3 weeks) or docetaxel 75 mg/m2 Q3W. PROs were measured at prespecified timepoints, using the European Organisation for Research and Treatment of Cancer (EORTC) core generic (QLQ-C30), and lung cancer (LC) specific module (QLQ-LC13). Changes from baseline using linear mixed effects model and time to first confirmed deterioration (TTD) were assessed.
Results
PRO questionnaire compliance was ≥94% in each arm at baseline and remained comparable throughout the study. Dato-DXd was associated with a reduced risk of deterioration as compared to docetaxel in dyspnea at rest (HR [95% CI]: 0.56 [0.35; 0.89]), overall dyspnea (0.61 [0.44; 0.85]), peripheral neuropathy (0.35 [0.23; 0.53]), physical functioning (0.57 [0.38; 0.86], social functioning (0.66 [0.44; 0.98]), pain (0.55 [0.37; 0.82]), and diarrhea (0.43 [0.25; 0.74]). Dato-DXd was associated with an increased risk of constipation (1.64 [1.09; 2.46]) and nausea/vomiting (1.67 [1.08; 2.59]) compared to docetaxel.
Conclusions
In patients with NSQ NSCLC, Dato-DXd was associated with lower deterioration in LC-specific and cancer generic symptoms vs docetaxel. PRO data also suggests an improved QoL in patients receiving Dato-DXd vs docetaxel, complementing the improvement in efficacy and manageable safety profile demonstrated in the primary analysis.
Clinical trial identification
NCT04656652; Protocol Number: DS1062-A-U301, first release date 11.30.2020.
Legal entity responsible for the study
Daiichi Sankyo Inc. 211 Mount Airy Road, Basking Ridge, New Jersey 07920. In July 2020, Daiichi Sankyo entered into a global development and commercialization collaboration with AstraZeneca for Dato-DXd.
Funding
Daiichi Sankyo Inc. 211 Mount Airy Road, Basking Ridge, New Jersey 07920. In July 2020, Daiichi Sankyo entered into a global development and commercialization collaboration with AstraZeneca for Dato-DXd.
Disclosure
R. Cornelissen: Financial Interests, Personal, Advisory Board: Johnson and Johnson, MSD, Pierre Faber, BMS; Financial Interests, Personal, Invited Speaker: BMS, Pfizer. E. Pons-Tostivint: Financial Interests, Personal, Advisory Board: AstraZeneca, Takeda, BMS, Sanofi, Roche, Daichi Sankyo, Amgen, Janssen; Financial Interests, Institutional, Invited Speaker: AstraZeneca, BMS, Daiichi Sankyo, Sanofi, PDC line, Takeda, Amgen, Janssen. M. Ahn: Financial Interests, Personal, Advisory Board: AstraZeneca, Takeda, MSD, Yuhan, Amgen, Alpha Pharmaceutical, Janssen, Bristol Myers Squibb, Roche, Daiichi Sankyo, Merck, Boronoi, Genexin, Boerhinger Ingelheim. Y. Le Guen: Financial Interests, Personal, Invited Speaker: Regeneron, AstraZeneca; Financial Interests, Personal, Advisory Board: Roche. E. Felip: Financial Interests, Personal, Advisory Board: AbbVie, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, F. Hoffmann-La Roche, Gilead, GSK, Janssen, Merck Sharp & Dohme, Novartis, Regeneron, Turning Point, Pfizer, Genmab, Daiichi Sankyo, Johnson & Johnson, ITeos Therapeutics, Pierre Fabre; Financial Interests, Personal, Invited Speaker: Amgen, Daiichi Sankyo, Genentech, Janssen, Medical Trends, Medscape, Merck Serono, PeerVoice, Pfizer, AstraZeneca, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Merck Sharp & Dohme, Gilead, Novartis, Regeneron, Johnson & Johnson, Pierre Fabre; Financial Interests, Personal, Member of Board of Directors, Independent member: Grifols; Financial Interests, Institutional, Invited Speaker, Clinical Trial: AstraZeneca AB, AbbVie, Amgen, Bayer Consumer Care AG, Beigene, Boehringer Ingelheim GmbH, Bristol Myers Squibb International Corporation, Daiichi Sankyo Inc., Exelixis Inc., F. Hoffmann-La Roche Ltd., Genentech Inc., GSK Research and Development Limited, Janssen Cilag International NV, Merck Sharp & Dohme Corp, Merck KGAA, Mirati Therapeutics Inc, Novartis Pharmaceutica SA, Pfizer, Takeda Pharmaceuticals International; Financial Interests, Institutional, Invited Speaker: Nuvalent; Non-Financial Interests, Personal, Leadership Role, President (2021–2023): SEOM (Sociedad Espanola de Oncologia Medica); Non-Financial Interests, Personal, Member, Member of Scientific Committee: ETOP (European Thoracic Oncology Platform); Non-Financial Interests, Personal, Member, Member of the Scientific Advisory Committee: CAC Hospital Universitari Parc Taulí. N. Girard: Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Roche, Pfizer, Janssen, Regeneron, AbbVie, Amgen, Lilly, Takeda, Owkin, Leo Pharma, Daiichi Sankyo, Ipsen, Pierre Fabre, Beigene; Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Pfizer, Amgen, MSD, Sanofi, Gilead, Janssen; Financial Interests, Personal, Officer: edimark; Financial Interests, Institutional, Research Grant, Local: Roche, Sivan, Janssen; Financial Interests, Institutional, Funding: BMS, Leo Pharma; Financial Interests, Institutional, Research Grant: MSD; Other, Personal, Other, Family member is an employee: AstraZeneca. I. Okamoto: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical, Boehringer Ingelheim, AstraZeneca, Bristol Myers Squibb, Takeda Pharmaceutical, Daiichi Sankyo, MSD, Pfizer, Taiho Pharmaceutical, Novartis; Financial Interests, Institutional, Invited Speaker: Chugai Pharmaceutical, Boehringer Ingelheim, AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, GSK, MSD, Taiho Pharmaceutical, Novartis. S. Sugawara: Financial Interests, Personal, Other, Lecture fee: AstraZeneca, Chugai Pharma, Nippon Boehringer Ingelheim, Taiho Pharmaceutical, Pfizer, Lilly, Novartis, Bristol Myers Squibb, Ono Pharmaceutical, MSD K.K, Kyowa Kirin, Takeda, Nippon Kayaku, Merck, Amgen, Thermo Fisher Scientific; Financial Interests, Personal, Other, Lecture Fee: Eisai, Sysmex; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Chugai Pharma, MSD K.K, Daiichi Sankyo, Bristol Myers Squibb, AnHeart, Ono Pharmaceutical, Nippon Boehringer Ingelheim, AbbVie, Parexel International, Amgen, Taiho Pharmaceutical, Accerise, A2 Healthcare, EPS Corporation, Syneos Health, PPD-SNBL. M.H. Hong: Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, Roche; Financial Interests, Personal, Invited Speaker: Merck, Yuhan, Janssen, Takeda, Amgen. V. Westeel: Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb, Pfizer; Financial Interests, Personal, Other, scientific committee and invited speaker: MSD; Financial Interests, Personal, Invited Speaker, and scientific committee: Roche, Amgen; Financial Interests, Personal, Invited Speaker, and board: Sanofi; Financial Interests, Institutional, Other, local PI: Bristol Myers Squibb; Financial Interests, Institutional, Invited Speaker: MSD, Roche, Daiichi Sankyo, Merck, Amgen, Seagen, Ose Immunotherapeutics; Other, Personal, Other, support for meeting attendance: AstraZeneca, Bristol Myers Squibb, Janssen; Other, Personal, Other, Support for meeting attendance: MSD, Amgen. L. Paz-Ares: Financial Interests, Personal, Advisory Board, Speaker fees: Roche, MSD, BMS, AstraZeneca, Lilly, PharmaMar, Beigene, Daiichi Sankyo, Medscape, PER; Financial Interests, Personal, Advisory Board: Merck Serono, Pfizer, Bayer, Amgen, Janssen, GSK, Novartis, Takeda, Sanofi, AbbVie, Gilead, Regeneron; Financial Interests, Personal, Other, Board member: Altum sequencing; Financial Interests, Personal, Other, lectures: AICME; Financial Interests, Personal, Other, Lectures: CCO; Financial Interests, Personal, Expert Testimony: Boehringer Ingelheim; Financial Interests, Personal, Member of Board of Directors, spinn off (I have arounfd 8% of stocks): Altum sequencing; Financial Interests, Personal, Member of Board of Directors: Stab therapeutics; Financial Interests, Personal, Ownership Interest, spin-off (10%): Stab Therapeutics; Financial Interests, Personal, Stocks/Shares, co-founder: Altum sequencing; Financial Interests, Institutional, Invited Speaker: Daiichi Sankyo, AstraZeneca, Merck Sharp & Dohme corp, BMS, Janssen-cilag international NV, NOvartis, Roche, Sanofi, Tesaro, Alkermes, Lilly, Takeda, Pfizer, PharmaMar, Cantargia; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Other, Member: AACR, ASCO, ESMO; Financial Interests, Personal, Other, Foundation Board Member: AECC; Financial Interests, Personal, Other, President: ASEICA (Spanish Association of Cancer Research); Financial Interests, Personal, Other, Foundation president: ONCOSUR; Financial Interests, Personal, Other, member: Small Lung Cancer Group; Non-Financial Interests, Personal, Other, Board member of this anti-cancer Charity: AECC; Non-Financial Interests, Personal, Member, Past-President: ASEICA (Spanish Cancer Research Association); Non-Financial Interests, Personal, Leadership Role, President: Oncosur Foundation. J. Sands: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Medtronic, Gilead, Lilly, Sanofi, AbbVie, G1 Therapeutics, Pharma Mar, Fosun, Merck, Mariana Oncology; Financial Interests, Institutional, Research Grant: Amgen, Harpoon, Novartis; Non-Financial Interests, Personal, Member of Board of Directors, President of medical society working to advance lung cancer screening: Rescue Lung Society. M. Chargualaf: Financial Interests, Personal, Full or part-time Employment: Daiichi Sankyo; Financial Interests, Personal, Stocks/Shares: Daiichi Sankyo. R. Joseph: Financial Interests, Institutional, Full or part-time Employment, Employee of Daiichi Sankyo: Daiichi Sankyo; Financial Interests, Institutional, Stocks/Shares: Daiichi Sankyo. F. Diamand: Financial Interests, Personal, Full or part-time Employment, I am employed by the pharmaceutical company Daiichi Sankyo from May 2021: Daiichi Sankyo Europe. L. Martin: Financial Interests, Personal, Full or part-time Employment: Daiichi Sankyo Schweiz; Financial Interests, Personal, Stocks/Shares: Daiichi Sankyo Schweiz. M. Lawrence: Financial Interests, Institutional, Full or part-time Employment, I am a full-time employee of IQVIA as a statistician: IQIVA. A.E. Lisberg: Financial Interests, Personal, Other, Consulting: Bayer, IQVIA, Leica Biosystems, Jazz Pharmaceuticals; Financial Interests, Personal, Other, Advisory Board and Consulting: Daiichi Sankyo, Inc., AstraZeneca, Novocure, Eli Lilly, Oncocyte, Novartis, Regeneron, Janssen Oncology, Sanofi group of companies, Molecular Axiom, Amgen, G1 Therapeutics, Bristol Myers Squibb, MorphoSys, Pfizer; Financial Interests, Personal, Other, Consulting, lectures, advising: Platformq; Financial Interests, Personal, Other, Consulting, advising, lectures: HMP Global, MJH Associates, Med Learning, Clinical Care Options, Physicians Educational Resources, Curio Sciences, Vaniam Group, Medscape, Projects in Knowledge, Aptitude Health, MOASC, SITC; Financial Interests, Personal, Invited Speaker: Research to Practice, DAVA, Research to Practice; Financial Interests, Personal, Full or part-time Employment, EmploymentImmediate family member (wife): Boston Scientific; Financial Interests, Personal, Stocks/Shares, Stock (