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Proffered Paper session: Head & neck cancer

650O - A phase II study of nivolumab for high-risk oral leukoplakia

Date

12 Sep 2022

Session

Proffered Paper session: Head & neck cancer

Topics

Clinical Research;  Immunotherapy

Tumour Site

Head and Neck Cancers

Presenters

Glenn Hanna

Citation

Annals of Oncology (2022) 33 (suppl_7): S295-S322. 10.1016/annonc/annonc1056

Authors

G.J. Hanna1, A. Villa2, R. Shi3, A. ONeill3, M. Liu3, C.T. Quinn4, R.K. Curtin5, M. Flynn5, N.S. Treister6, H.Y. Sroussi6, P. Vacharotayangul6, L.A. Goguen7, D.J. Annino7, E.M. Rettig8, V.Y. Jo9, K. Wong9, R. Uppaluri10, R. Haddad4, S. Woo11

Author affiliations

  • 1 450 Brookline Avenue, Dana Building, 2nd Floor, Room 2-140, Dana Farber Cancer Institute, 02215 - Boston/US
  • 2 Chief Of The Sol Silverman Oral Medicine Clinic, UCSF - University of California San Francisco, CA, 94143 - San Francisco/US
  • 3 Data Science, Dana Farber Cancer Institute, 02215 - Boston/US
  • 4 Medical Oncology, Dana Farber Cancer Institute, 02215 - Boston/US
  • 5 Medical Oncology, Dana Farber Cancer Institute, 02215 - BOSTON/US
  • 6 Oral Medicine, Dana Farber Cancer Institute, 02215 - Boston/US
  • 7 Otolaryngology-head And Neck Surgery, Brigham and Women's Hospital, 2115 - Boston/US
  • 8 Otolaryngology-head And Neck Surgery, Dana Farber Cancer Institute, 02215 - Boston/US
  • 9 Pathology, Brigham and Women's Hospital, 2115 - Boston/US
  • 10 Surgery, Brigham and Women's Hospital, MA 02120 - Boston/US
  • 11 Oral Medicine, Brigham and Women's Hospital, 2115 - Boston/US
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Resources

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Abstract 650O

Background

Oral proliferative leukoplakia (PL) is an aggressive precancerous disease characterized by multifocal lesions and a high-risk of transformation to oral squamous cell carcinoma (OSCC). There are no effective therapies that prevent progression to oral cancer. PL demonstrates a rich immune microenvironment, providing strong rationale to evaluate PD-1 blockade as preventative immunotherapy.

Methods

This single-arm, phase 2 trial investigated nivolumab (N) among patients (pts) with PL (multifocal, contiguous, or a single lesion ≥4 cm with any degree of epithelial dysplasia); a history of previously treated early-stage OSCC was permitted. Pts underwent pre-treatment biopsy of 1-3 sites then received 4 doses of N (480 mg IV) every 28-days, followed by re-biopsy. Intraoral photographs and bidirectional measurements occurred at each visit. Primary endpoint: change in composite score (size and degree of dysplasia) pre- to post-treatment (CR: >80% decrease in score; PR: 40-80% decrease; PD: ≥10% increase in composite score or new OSCC). Secondary endpoints: safety, cancer-free survival (CFS). Exploratory aims: PD-L1 status, genomic and immune profiling parameters.

Results

Between 1/2019 and 12/2021, 33 pts enrolled; 30 evaluable to date. Median age: 64 (range: 32-80), mostly women (18, 60%), 16 (53%) former/current smokers; oral tongue (13, 43%) was the main disease subsite; 8 (27%) had prior OSCC. A decrease of ≥40% in composite score was observed in 37% of pts (3 CRs and 8 PRs); 14 (47%) had stable disease, 4 experienced PD. 26 (86%) completed all 4 doses of N; 2 (7%) discontinued for toxicity, 2 (7%) for PD. Grade 3-4 irAEs were noted among 7 (23%) pts (hyperglycemia, colitis, hepatitis). At median follow-up of 16.3 mos (4.1-34.3+), median CFS was not reached, with 7 (23%) cancer events observed (3 among prior responders); 1-year CFS: 76.5% (95%CI 54.5-88.8). All pts are alive at last follow-up. Baseline median PD-L1 CPS trended higher among responders (15 vs. 5, p=0.10).

Conclusions

Nivolumab yielded a best response of PL regression among 37% of pts with a favorable overall CFS. This is the first study to demonstrate evidence of efficacy using preventative immunotherapy for high-risk oral precancerous disease.

Clinical trial identification

NCT03692325.

Editorial acknowledgement

Legal entity responsible for the study

G.J. Hanna, MD and BMS.

Funding

Bristol-Myers Squibb.

Disclosure

G.J. Hanna: Financial Interests, Institutional, Sponsor/Funding: BMS; Financial Interests, Institutional, Research Grant: Bicara, Exicure, Gateway for Cancer Research, GSK, Kite, NantKwest, Regeneron, Sanofi Genzyme; Financial Interests, Personal, Advisory Board: Coherus, Maverick, Merck. A. Villa: Financial Interests, Institutional, Research Grant: PCCA, Merck. N.S. Treister: Financial Interests, Personal, Advisory Role: MuReva Phototherapy; Financial Interests, Institutional, Research Grant: THOR Photomedicine Ltd; Financial Interests, Personal, Advisory Board: Alosa Health. R. Uppaluri: Financial Interests, Personal and Institutional, Research Grant, Advisory Board: Merck. R. Haddad: Non-Financial Interests, Personal, Member: NCCN; Financial Interests, Personal and Institutional, Advisory Role: Celgene, Merck, BMS, AstraZeneca, Pfizer, Genentech, Boehringer Ingelheim; Financial Interests, Personal, Advisory Role: Eisai, Loxo, Immunomic Therapeutics, GSK, Gilead, Vaccinex, EMD Serono, BioNTech AG, Achilles Therapeutics, Bayer, Coherus, MIRATI; Financial Interests, Institutional, Research Grant: Kura. All other authors have declared no conflicts of interest.

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