1446P - Preliminary efficacy and safety of rilvegostomig (AZD2936), a bispecific antibody targeting PD-1 and TIGIT, in checkpoint inhibitor (CPI)-pretreated advanced/metastatic non-small-cell lung cancer (NSCLC): ARTEMIDE-01

Background

Rilvegostomig is a bispecific, humanised IgG1 targeting PD-1 and TIGIT, receptors that suppress antitumour T cell activity. Initial data from the first-in-human study showed favourable tolerability and early antitumour activity in patients (pts) with CPI-pretreated advanced/metastatic NSCLC. Here we report updated data from dose escalation and expansion (Parts A + B).

Methods

Pts in the initial phase of this open-label, multicentre study had stage III unresectable or stage IV NSCLC, PD-L1 tumour proportion score ≥1%, and primary or secondary CPI resistance. Part A evaluated 70–1500 mg IV Q3W; Part B evaluated the recommended phase 2 dose (RP2D). Primary and secondary endpoints included safety, tolerability, preliminary efficacy, and PK.

Results

As of 13 Apr 2023, 83 pts were enrolled (Part A, n=51; Part B, n=32). Pts were 63.9% male, median age was 63.0 yr, and 22.9% had squamous histology. Overall, 22.9% had 1 prior line of therapy, 34.9% had 2, 24.1% had 3, and 18.1% had >3. Median duration of therapy was 12.4 wk. Rilvegostomig was well tolerated (Table); RP2D was 750 mg. Four pts had confirmed partial responses (PRs) and 33 had stable disease (SD); 6-month disease control rate (DCR) was 31.3%. Median progression-free survival was 2.1 mo (95% CI, 2.0, 4.1). Updated clinical and translational data (e.g. molecular response based on ctDNA) will be presented.

Conclusions

Rilvegostomig was well tolerated and had antitumour activity in heavily pretreated pts who had progressed on CPI therapy. Further investigation is ongoing in CPI-naïve cancer patients.

Table: 1446P

Safety and efficacy of rilvegostomig

*No Grade 4 or 5 treatment-related AEs were reported.

Clinical trial identification

NCT04995523; 9 August, 2021.

Editorial acknowledgement

Medical writing support for this abstract was provided by Eric Exner of Ashfield MedComms (Milwaukee, WI, USA), an Inizio company, and was funded by AstraZeneca.

Legal entity responsible for the study

AstraZeneca.

Funding

AstraZeneca.

Disclosure

M. Brandão: Financial Interests, Personal, Invited Speaker, Speaker at a symposium at the AORTIC Conference 2019 : Roche; Financial Interests, Institutional, Invited Speaker, December 2021 : Janssen; Financial Interests, Institutional, Advisory Board, 03/2023: Sanofi; Financial Interests, Institutional, Invited Speaker, 01/2023: Takeda; Financial Interests, Institutional, Invited Speaker, 05/2023: Pfizer; Financial Interests, Institutional, Local PI: AstraZeneca, Roche, Boehringer, Sanofi; Non-Financial Interests, Leadership Role, EORTC Lung Cancer Group - Young and Early Career group Chair (since January 2022): EORTC. J.T.J.N. Hiltermann: Financial Interests, Institutional, Advisory Board: BMS, Roche, MSD, Pfizer; Financial Interests, Institutional, Research Grant: AstraZeneca, Roche, BMS; Non-Financial Interests, Principal Investigator: AstraZeneca, GSK, Merck Serono, Roche, BMS, Amgen; Non-Financial Interests, Member: ASCO, ESMO, IASLC, AACR, NVALT; Financial Interests, Personal, Advisory Role: CieBOM. E. Wauters: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Institutional, Research Grant: AstraZeneca, MSD; Financial Interests, Institutional, Funding: MSD; Financial Interests, Personal, Other: AstraZeneca, Boehringer Ingelheim, MSD, BMS, Daiichi Sankyo. B.J. Solomon: Financial Interests, Institutional, Advisory Board: AstraZeneca, Novartis, Merck, Bristol Myers Squibb; Financial Interests, Personal, Invited Speaker: Pfizer, AstraZeneca, Roche/Genentech; Financial Interests, Personal, Advisory Board: Amgen, Roche-Genentech, Eli Lilly, Takeda, Janssen; Financial Interests, Personal, Full or part-time Employment, Employed as a consultant Medical Oncologist at Peter MacCallum Cancer Centre: Peter MacCallum Cancer Centre; Financial Interests, Personal, Member of Board of Directors: Cancer Council of Victoria, Thoracic Oncology Group of Australasia; Financial Interests, Personal, Royalties: UpToDate; Financial Interests, Institutional, Steering Committee Member, Principal Investigator and Steering committee Chair: Roche/Genentech, Pfizer; Financial Interests, Institutional, Steering Committee Member: Novartis. E. Castanon Alvarez: Financial Interests, Personal, Advisory Board: MSD, Roche, BMS; Financial Interests, Personal, Invited Speaker: GSK; Non-Financial Interests, Principal Investigator: AZ, BMS, Roche, MSD, GSK, ARC. E. Felip: Financial Interests, Personal, Advisory Board: AbbVie, Amgen, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Gilead, GSK, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis, Peptomyc, Regeneron, Sanofi, Takeda, Turning Point, Pfizer; Financial Interests, Personal, Invited Speaker: Amgen, Daiichi Sankyo, Genentech, Janssen, Medical Trends, Medscape, Merck Serono, PeerVoice, Pfizer, Sanofi, Takeda, Touch Oncology, AstraZeneca, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Merck Sharp & Dohme; Financial Interests, Personal, Member of Board of Directors, Independent member: Grifols; Financial Interests, Institutional, Local PI, 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; Non-Financial Interests, Leadership Role, President (2021-2023): SEOM (Sociedad Espanola de Oncologia Medica); Non-Financial Interests, Member, Member of Scientific Committee: ETOP (European Thoracic Oncology Platform); Non-Financial Interests, Member, Member of the Scientific Advisory Committee: CAC Hospital Universitari Parc Taulí. H. Izumi: Financial Interests, Institutional, Local PI: Amgen Inc, Eisai, AbbVie; Financial Interests, Personal and Institutional, Local PI, Invited Speaker: Ono Pharmaceutical Company, AstraZeneca; Financial Interests, Personal, Other, Invited Speaker: Chugai Pharmaceutical Co., Merck Biopharma Co., Takeda Pharmaceutical Co.; Financial Interests, Personal, Other, Advisory board: Amgen. D. Kim: Financial Interests, Personal, Invited Speaker: Korean Cancer Association, Korean Society of Medical Oncology, Korean Association for Lung Cancer, Taiwan Lung Cancer Society, Japan Cancer Association; Financial Interests, Personal, Other, Scientific Advisor: Health Insurance Review & Assessment Service, Korea; Financial Interests, Personal, Writing Engagement, Medical writing assistance: Amgen, AstraZeneca, Boehringer Ingelheim, BMS, Chong Keun Dang, Daiichi Sankyo, GSK, Pfizer, MSD, Merck, Novartis, Roche, Takeda, Yuhan; Financial Interests, Institutional, Local PI, Clinical Trial Funding: Alpha Biopharma, Amgen, AstraZeneca/Medimmune, Boehringer Ingelheim, Daiichi Sankyo, Hanmi, Janssen, Merus, MIrati Therapeutics, MSD, Novartis, Ono Pharmaceutical, Pfizer, Roche/Genentech, Takeda, TP Therapeutics, Xcovery, Yuhan, Bridge BioTherapeutics, GSK; Financial Interests, Institutional, Coordinating PI, Clinical Trial Funding: Chong Keun Dang; Financial Interests, Institutional, Research Grant, Laboratory research funding to my institution: InnoN; Non-Financial Interests, Advisory Role: Amgen, BMS / Ono Pharmaceuticals, Daiichi Sankyo, Janssen, GSK, Pfizer, AstraZeneca, SK Biopharm, Takeda, Yuhan; Non-Financial Interests, Member of Board of Directors: Korean Cancer Association, Korean Society of Medical Oncology, Korean Association for Lung Cancer, Asian Thoracic Oncology Research Group; Other, Travel support for advisory board meeting attendance: Amgen, Daiichi Sankyo; Other, Clinical trial research funding to my institution: Asian Thoracic Oncology Research Group. L. Paz-Ares: Financial Interests, Personal, Advisory Board, Speaker fees: Roche, MSD, BMS, AZ, Lilly, PharmaMar, BeiGene, Daiichi, Medscape, Per; Financial Interests, Personal, Advisory Board: Merck Serono, Pfizer, Bayer, Amgen, Janssen, GSK, Novartis, Takeda, Sanofi, Mirati; Financial Interests, Personal, Other, Board member: Genomica, Altum sequencing; Financial Interests, Institutional, Coordinating PI: Daiichi Sankyo, AstraZeneca, Merck Sharp & Dohme Corp, BMS, Janssen-Cilag International NV, Novartis, Roche, Sanofi, Tesaro, Alkermes, Lilly, Takeda, Pfizer, PharmaMar; Financial Interests, Personal, Coordinating PI: Amgen; Financial Interests, Other, Member: AACR, ASCO, ESMO; Financial Interests, Other, Foundation Board Member: AECC; Financial Interests, Other, President. ASEICA (Spanish Association of Cancer Research): ASEICA; Financial Interests, Other, Foundation president: ONCOSUR; Financial Interests, Other, member: Small Lung Cancer Group. K.S. Rohrberg: Financial Interests, Personal, Invited Speaker: Bayer, Amgen, MSD, GSK; Financial Interests, Personal, Advisory Board: AbbVie; Financial Interests, Institutional, Coordinating PI, Compensation for conduction of clinical trial: Lilly, Roche/Genentech, Bristol Myers Squibb, Symphogen, Pfizer, Novartis, Alligator Bioscience, Genmab, Bioinvent, Monta Bioscience; Financial Interests, Institutional, Other, Compensation for conduction of clinical trial: Bayer, Incyte, Puma Biotechnology, Orion Clinical. T. Yoshida: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Chugai, Novartis, Pfizer, Takeda, Lilly, MSD, Ono, Daiichi Sankyo, BMS; Financial Interests, Personal, Advisory Board: Amgen, MSD, Pfizer; Financial Interests, Principal Investigator: AstraZeneca, Amgen, Daiichi Sankyo, Chugai, Novartis, MSD, Ono, Blueprint, AbbVie, BMS. H. Chen, S. Colebrook, I. Achour: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. M. Origuchi, F. Aroldi: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. B.C. Cho: Financial Interests, Personal, Other, Consulting role: Abion, BeiGene, Novartis, AstraZeneca, Boehringer Ingelheim, Roche, BMS, CJ, CureLogen, Cyrus Therapeutics, Ono, Onegene Biotechnology, Yuhan, Pfizer, Eli Lilly, GI-Cell, Guardant, HK Inno-N, Imnewrun Biosciences Inc., Janssen, Takeda, MSD, Janssen; Financial Interests, Personal, Advisory Board: Kanaph Therapeutic Inc, BridgeBio Therapeutics, Cyrus Therapeutics, Guardant Health, Oscotec Inc; Financial Interests, Personal, Other, Advisory role: Medpacto, Blueprint medicines, RandBio, Hanmi; Financial Interests, Personal, Member of Board of Directors: Interpark Bio Convergence Corp., J Ints Bio; Financial Interests, Personal, Stocks/Shares: TheraCanVac Inc, Gencurix Inc, BridgeBio Therapeutics, Kanaph Therapeutic Inc, Cyrus Therapeutics, Interpark Bio Convergence Corp., J Ints Bio; Financial Interests, Personal, Royalties: Champions Oncology, Crown Bioscience, Imagen; Financial Interests, Institutional, Research Grant: MOGAM Institute, LG Chem, Oscotec, Interpark Bio Convergence Corp, GIInnovation, GI-Cell, Abion, AbbVie, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim, Champions Onoclogy, CJ Bioscience, CJ Blossom Park, Cyrus, Dizal Pharma, Genexine., Janssen, Lilly, MSD, Novartis, Nuvalent, Oncternal, Ono, Regeneron, Dong-A ST, BridgeBio Therapeutics, Yuhan, ImmuneOncia, Illumina, Kanaph Therapeutics, Therapex, JINTSbio, Hanmi, CHA Bundang Medical Center; Other, Founder: Daan BioTherapeutics. All other authors have declared no conflicts of interest.