Abstract 927TiP
Background
There are limited treatment options available for patients (pts) with R/M SCCHN. Despite improved survival with platinum-based chemotherapy regimens, outcomes are still poor and associated with substantial toxicity. Pembrolizumab is currently approved for pts with R/M SCCHN as 1L monotherapy (PD-L1+ tumours), and in combination with chemotherapy (regardless of PD-L1 status in US, and PD-L1+ tumours in EU). In the phase Ib PCD4989g (NCT01375842) study, atezo (anti-PD-L1) demonstrated encouraging clinical activity in a cohort of pts with previously treated R/M head and neck cancer. Targeted inhibition of the PD-L1/PD-1 pathway may be further amplified by combining with novel anti-TIGIT agents such as tira. A phase Ib dose-escalation and -expansion study (GO30103, NCT02794571) showed that atezo + tira was safe and tolerable and activity was seen in various tumour types, including SCCHN. In the phase II CITYSCAPE study (NCT03563716), atezo + tira showed an improved objective response rate (ORR) and a similar safety profile compared with atezo alone in 1L pts with metastatic PD-L1+ NSCLC. SKYSCRAPER-09 (NCT04665843) aims to evaluate the efficacy and safety of the chemo-free regimen of atezo + tira and atezo + placebo in pts with 1L R/M PD-L1+ SCCHN.
Trial design
In this global, phase II, randomised, double-blinded study, eligible pts (≥18 years) must have R/M SCCHN (measurable per RECIST v1.1) involving the oral cavity, oropharynx, larynx or hypopharynx; tumours with PD-L1 expression; R/M SCCHN that is considered incurable by local therapies and received no prior systemic therapy; and ECOG PS 0–1. Pts with oropharyngeal carcinoma must have known HPV status. Approximately 120 pts from ∼60 sites will be randomised 2:1 to receive atezo 1200mg IV + tira 600mg IV Q3W or atezo 1200mg IV + placebo IV Q3W, respectively. Treatment will continue until disease progression (per RECIST v1.1) or loss of clinical benefit. Primary endpoint: confirmed ORR. Key secondary endpoints: duration of response, progression-free and overall survival, safety and patient-reported outcomes. Recruitment is ongoing.
Clinical trial identification
NCT04665843 (BO42533).
Editorial acknowledgement
Medical writing support for the development of this abstract, under the direction of the authors, was provided by Demi Christofi, MSc, of Ashfield MedComms, an Ashfield Health company, and 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
J. Fayette: Financial Interests, Advisory Board: AstraZeneca, BMS, MSD, Innate, Roche, Merck; Non-Financial Interests, Principal Investigator: AstraZeneca; Financial Interests, Sponsor/Funding: Seagen. K.J. Harrington: Financial Interests, Invited Speaker: BMS, Merck-Serono, MSD; Financial Interests, Advisory Board: Arch Oncology, AstraZeneca, BMS, Boehringer Ingelheim, Merck-Serono, MSD, Oncolys, Pfizer, PsiVac, Replimune; Financial Interests, Research Grant: AstraZeneca, Boehringer Ingelheim, MSD, Replimune. M.L. Johnson: Financial Interests, Advisory Board: Abbvie, Amgen, Daiichi Sankyo, Editas Medicine, Eisai, G1 Therapeutics, GlaxoSmithKline, Ideaya Biosciences, Incyte, Ribon Therapeutics, and Roche; Financial Interests, Principal Investigator: Abbvie, Acerta, Adaptimmune, Amgen, Apexigen, Arcus Biosciences, Array BioPharma, Artios Pharma, AstraZeneca, Atreca, BeiGene, BerGenBio, Boehringer Ingelheim, Calithera, Checkpoint Therapeutics, Corvus Pharmaceuticals, Curis, CytomX, Daiichi Sankyo, Drac; Financial Interests, Advisory Role: AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, CytomX, EMD Serono, Genentech, Gritstone Oncology, Janssen, Lilly, Merck, Mirati, Novartis, Pfizer, Sanofi-Aventis and WindMIL Therapeutics. H. Kao: Financial Interests, Speaker’s Bureau: Roche, BMS, MSD; Non-Financial Interests, Advisory Board: Novartis; Financial Interests, Research Grant: MSD, Boehringer Ingelheim, BMS, Ono, Novartis. S. Lee: Financial Interests, Invited Speaker: AstraZeneca/MedImmune Novartis; Financial Interests, Advisory Board: Bristol-Myers Squibb, AstraZeneca/MedImmune Roche; Financial Interests, Research Grant: MSD. L.F. Licitra: Financial Interests, Advisory Board, Receipt of consultation fees for expert opinion in advisory boards: AstraZeneca, Bayer, BMS, Eisai, MSD, Merck–Serono, Boehringer Ingelheim, F. Hoffmann-La Roche Ltd, Novartis, Roche, Debiopharm International SA, Sobi, Incyte Biosciences Italy srl, Doxa Pharma srl, Amgen, Nanobiotics Sa, GSK; Financial Interests, Institutional, Research Grant, Receipt of grants/research supports (Funds received by my institution for clinical studies and research activities in which I am involved): AstraZeneca, BMS, Boehringer Ingelheim, Celgene International, Eisai, Exelixis inc, Debiopharm International SA, F. Hoffmann-La Roche ltd, IRX Therapeutics inc, Medpace inc, Merck–Serono, MSD, Novartis, Pfizer, Roche Spa; Non-Financial Interests, Member, Uncompensated membership: European Society for Medical Oncology (ESMO), Italian Association for Medical Oncology (AIOM), American Society for Clinical Oncology (ASCO), European Head and Neck Society (EHNS), Associazione Italiana di Oncologia Cervico Cefalica (AIOCC-IHNS). N. Ngamphaiboon: Financial Interests, Speaker’s Bureau: Roche, AstraZeneca, Amgen, MSD, Taiho; Financial Interests, Advisory Board: MSD, Amgen, Novartis, Bayer, AstraZeneca, Claris, Eli Lilly; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Principal Investigator: MSD, Roche, Exelixis, RAPT Therapeutics, BeiGene. A. Psyrri: Financial Interests, Invited Speaker: MSD, Merck Serono; Financial Interests, Advisory Board: AstraZeneca, BMS, eTheRNA immunotherapies, LEO, MSD, Pfizer, Rakuten, Sanofi; Financial Interests, Research Grant: BMS, KURA Oncology; Financial Interests, Personal and Institutional, Funding: Amgen, Boehringer Ingelheim, BMS, Demo, Genesis, Kura Oncology, Merck Serono, Oncolytics Biotech, Pfizer, Roche; Financial Interests, Institutional, Funding: Pfizer; Financial Interests, Project Lead, Medical Education with honoraria: Medscape; Non-Financial Interests, Principal Investigator, coordinating PI: AstraZeneca; Financial Interests, Personal and Institutional, Principal Investigator, local PI: Amgen, AstraZeneca, Boehringer Ingelheim, Debiopharm, Genesis, GSK, Incyte, Jannsen, Lilly, MSD, Novartis, Oncolytics Biotech, Peregrine, Pfizer, Regeneron, Roche, Sanofi ; Financial Interests, Personal and Institutional, Member, Steering Committee Member: Iovance, Kura oncology, Pfizer, Roche; Financial Interests, Personal, Other, Educational activity: Medscape, PrimeOncology. D.J. Wong: Financial Interests, Principal Investigator: Lilly, Merck Sharp and Dohme, Bristol-Myers Squibb, Genentech/Roche, Merck Serono, AstraZeneca, Kura Oncology, Regeneron, F-star, Astellas, Pfizer, Enzychem Lifesciences, ELevar Therapeutics; Financial Interests, Advisory Role: Bristol-Myers Squibb, Genentech/Roche, Sanfi-Aventis, Blueprint Medicine, Regeneron. M. Afshari: Financial Interests, Full or part-time Employment: Genentech, Inc. G.R. Goodman: Financial Interests, Full or part-time Employment: Genentech, Inc.; Financial Interests, Stocks/Shares, Stocks and Stock appreciation rights: F. Hoffmann-La Roche Ltd. K.M. Komatsubara: Financial Interests, Full or part-time Employment: Roche/Genentech; Financial Interests, Stocks/Shares: Roche/Genentech. C. Matheny: Financial Interests, Full or part-time Employment: Roche/Genentech. T.Q. Pham: Financial Interests, Full or part-time Employment: Genentech/Roche; Financial Interests, Stocks/Shares: Genentech/Roche. H. Tang: Financial Interests, Full or part-time Employment: IQVIA. L. Wang: Financial Interests, Full or part-time Employment: Roche/Genentech; Financial Interests, Stocks/Shares: Roche/Genentech. Y. Yan: Financial Interests, Full or part-time Employment: Roche/Genentech; Financial Interests, Stocks/Shares: Roche/Genentech. M. Gillison: Financial Interests, Advisory Role, Consultant: Mirati Therapeutics (pending approval), BioNTech AG, Shattuck Labs Inc., EMD Serono Inc., Debiopharm, Kura Oncology, Merck Co., Ipsen Biopharmaceuticals Inc., Bristol-Myers Squibb, Bicara Therapeutics, Bayer HealthCare Pharmaceuticals, Roche Diagnostics; Financial Interests, Sponsor/Funding: Genocea, Genentech, BMS and Kura; Financial Interests, Advisory Board, Scientific/Advisory Committee Member: Sensei; Financial Interests, Invited Speaker, Speaker/Preceptorship: Roche. All other authors have declared no conflicts of interest.