909P - Immunoscore-IC predicts nivolumab efficacy as adjuvant treatment after salvage surgery in head and neck cancer squamous cell carcinoma: The ADJORL1 trial

Background

Locoregional failures or second primary in head and neck squamous cell carcinoma (HNSCC) have a 2 year DFS from 10 to 30% and OS from 30 to 60% with conventional therapies (reirradiation or wait and see strategy). Adjuvant anti-PD1 immunotherapy after salvage surgery could be an alternative to reirradiation and provide better survival with less toxicities. Biomarkers could help select patients who will benefit. Immunoscore Immune Checkpoint (Immunoscore IC® test, Veracyte ; IS-IC) is an in vitro quantification of CD8+ and PDL1+ expressing cells in the tumor environment. In non-small cell lung cancers and colorectal cancers, a high IS-IC score is associated with better outcomes. We aimed to identify if IS-IC and CPS (Combined positive score) could predict better outcomes for local relapses of HNSCC treated with adjuvant anti-PD1.

Methods

This multicentric phase II trial was conducted between 2018 and 2021. Inclusion criteria were recurrence or second primary of HNSCC in irradiated area, operated by salvage surgery. Pathological bad prognosis factors justifying adjuvant treatment were needed, with no distant metastases. Adjuvant treatment with Nivolumab was given for 6 months. Primary endpoint was two-year DFS. IS-IC and CPS performed on relapsing tumor material to identify biomarkers predictive of outcomes.

Results

57 patients were treated. The 2-years DFS and 2-years OS were respectively 46.6%, 90%CI [36.1-57.5%] and 67.3%, 95%CI [54.2-78.2%]. IS-IC was available for 48 patients. A high IS-IC was associated with an improved OS compared to a low IS-IC (HR=0.12 [95%CI, 0.03-0.40]). High IS-IC was also associated with an improved DFS compared to a low IS-IC (HR=0.22 [95%CI, 0.09-0.51]). A high CPS was significantly associated with an improvement of DFS. For patients with a CPS <1, [1-19] and >19, the 2-years DFS were respectively 12.5% IC95%[2.2;47.1], 43.5% IC95%[25.0;64.0] and 63.6% IC95%[43.0;80.3].

Conclusions

These results show that IS-IC and CPS informs on the prognosis of relapsing HNSCC patients treated with anti-PD1 and could be used to select patients who will benefit from adjuvant immunotherapy after salvage surgery.

Clinical trial identification

EudraCT 2017-001277-17 n° CSET: 2017/2536.

Editorial acknowledgement

Legal entity responsible for the study

Gustave Roussy.

Funding

Gustave Roussy Pharma company: BMS (Bristol Myers Squibb).

Disclosure

A. Marhic: Non-Financial Interests, Institutional, Coordinating PI: BMS. A. Daste: Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Advisory Board: MSD, BMS, Merus. J. Fayette: Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Innate Pharma, Merck Serono, Roche, Pfizer, Hookipa; Non-Financial Interests, Principal Investigator: AstraZeneca, MSD, Pfizer, Meru, Calliditas, Isa. F. Rolland: Financial Interests, Personal, Advisory Board: Pfizer, Eisai, MSD, Merck SERONO; Financial Interests, Institutional, Coordinating PI: Exelixis; Financial Interests, Institutional, Local PI: BMS, Ipsen. A.C. Johnson: Financial Interests, Institutional, Invited Speaker: Gilead, Lilly; Financial Interests, Personal, Invited Speaker: Seagen; Financial Interests, Institutional, Local PI, Skyscraper 09 trial: Roche; Financial Interests, Institutional, Local PI, Buran trial: Adlai Nortye; Other, Conference & travel expenses: Lilly, Gilead, AstraZeneca, Pfizer. A. Marabelle: Financial Interests, Personal, Advisory Board: Innate Pharma, Deka Biosciences, Hotspot Therapeutics, Johnson & Johnson, Bioline Rx, Grey Wolf Therapeutics, Lytix Biopharma, HiFiBiO Therapeutics, ImCheck Therapeutics, Shattuck Labs, Marengo Therapeutics, Medicxi, Guidepoint, Pathios Therapeutics, Asgard Therapeutics, Adagene, Daiichi Sankyo; Financial Interests, Personal, Other, Associate Editor: European Journal of Cancer; Financial Interests, Personal, Stocks/Shares: HiFiBiO Therapeutics, Deka Biosciences, HotSpot Therapeutics, Shattuck Labs, Marengo Tx, Phoenix, Centessa, Adagene, IMCheck; Financial Interests, Institutional, Research Grant: BMS, MSD, Boehringer Ingelheim; Non-Financial Interests, Other, Associate Editor: IOTECH Journal; Non-Financial Interests, Leadership Role, Vice President and Co-Founder: French Society for Cancer Immunotherapy (FITC); Non-Financial Interests, Institutional, Product Samples: BMS, Idera, MSD, Transgene; Non-Financial Interests, Leadership Role: Société Française d'Immunothérapie des Cancers; Non-Financial Interests, Member: American Association for Cancer Research, American Society for Clinical Oncology, European Society for Medical Oncology, Society for Immunotherapy of Cancer (SITC). C. Even: Financial Interests, Personal, Advisory Board: BMS, MSD, Innate Pharma, Merck Serono; Financial Interests, Institutional, Advisory Board: F Star Therapeutics, Novartis, Elevar, Bicara, PDS Biotechnology, GSK, Merus; Financial Interests, Institutional, Local PI: BMS, AstraZeneca, ISA pharmaceutics, MSD, Debiopharma, Ayala, Gilead, GSK, Beigene, Takeda, Genmab, Seagen, Nykode; Financial Interests, Institutional, Coordinating PI: BMS, Novartis, Sanofi. All other authors have declared no conflicts of interest.