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Mini Oral session: Head & neck cancer

658MO - Pembrolizumab (pembro) vs standard-of-care (SOC) in previously treated recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): 6-year follow-up of KEYNOTE-040

Date

10 Sep 2022

Session

Mini Oral session: Head & neck cancer

Topics

Tumour Site

Head and Neck Cancers

Presenters

Denis Soulieres

Citation

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

Authors

D. Soulieres1, K.J. Harrington2, C. Le Tourneau3, J.D. Silva4, L.F. Licitra5, M. Ahn6, A. Soria Rivas7, J. Machiels8, N. Mach9, R. Mehra10, B. Burtness11, J. Lin12, N. Lerman12, B. Gumuscu12, E.E..W. Cohen13

Author affiliations

  • 1 Medicine, CHUM (Centre Hospitalier de l’Université de Montréal), H2X 3E4 - Montreal/CA
  • 2 Division Of Radiotherapy And Imaging, The Institute of Cancer Research, SW3 6JB - London/GB
  • 3 Department Of Drug Development And Innovation (d3i), Institut Curie, 75005 - Paris/FR
  • 4 Medical Oncology, Instituto Português de Oncologia do Porto Francisco Gentil, 4200-072 - Porto/PT
  • 5 Head And Neck Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, 20133 - Milan/IT
  • 6 Hematology & Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 06351 - Seoul/KR
  • 7 Medical Oncology, Hospital Universitario Ramón y Cajal, 28034 - Madrid/ES
  • 8 Medical Oncology, Cliniques Universitaires Saint-Luc, 1200 - Brussels/BE
  • 9 Oncology, Geneva University Hospital, 1211 - Geneva/CH
  • 10 Medicine, University of Maryland Greenebaum Comprehensive Cancer Center, 21201 - Baltimore/US
  • 11 Department Of Internal Medicine, Yale School of Medicine, 06520-8028 - New Haven/US
  • 12 Medical Oncology, Merck & Co., Inc., 07065 - Rahway/US
  • 13 Medicine, Moores Cancer Center, UC San Diego Health, 92037 - La Jolla/US

Resources

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Abstract 658MO

Background

Pembro monotherapy is a SOC for R/M HNSCC that has progressed following platinum-containing chemo. In the phase 3 KEYNOTE-040 trial (NCT02252042), pembro had clinically meaningful prolonged OS and a favorable safety profile compared with SOC at the time (HR, 0.80; 95% CI, 0.65-0.98) in platinum-refractory R/M HNSCC. OS benefit was greater in patients (pts) with higher PD-L1 expression. Results of KEYNOTE-040 are presented after 6 years of follow-up.

Methods

Pts with incurable R/M HNSCC that progressed on or after platinum-containing chemo or ≤6 mo of prior platinum-containing multimodal therapy were randomized 1:1 to receive pembro 200 mg Q3W or investigator’s choice of methotrexate, docetaxel, or cetuximab. Primary end point was OS. Secondary end points were OS (PD-L1 CPS ≥1), ORR, DOR, PFS, and safety. Efficacy end points were evaluated in the ITT, PD-L1 TPS ≥50%, and PD-L1 CPS ≥1 populations.

Results

Of 495 pts, 15 (6.1%) and 5 (2.0%) were still being followed up in the pembro and SOC arms, respectively, as of the February 3, 2022, data cutoff date. Median follow-up was 74.8 mo (range, 68.8-85.4). Efficacy data are shown in the table. The 6-year OS rate for pembro vs SOC was 6.5% vs 2.4% for ITT, 8.9% vs 6.3% for TPS ≥50%, and 7.1% vs 2.1% for CPS ≥1 populations. Median OS for pembro vs SOC was 8.4 mo vs 7.1 mo (HR, 0.79; 95% CI, 0.66-0.94) for ITT, 11.6 mo vs 7.9 mo (HR, 0.62; 95% CI, 0.43-0.90) for TPS ≥50%, and 8.7 mo vs 7.1 mo (HR, 0.72; 95% CI, 0.59-0.89) for CPS ≥1 populations. Any-grade treatment-related AEs (TRAEs) occurred in 64.2% of pts in the pembro arm and 83.3% of pts in the SOC arm. Grade 3-5 TRAEs occurred in 13.4% of pts in the pembro arm and 36.8% in the SOC arm. Table: 658MO

Pembro SOC
ITT, n 247 248
OS, median, mo 8.4 7.1
HR (95% CI) 0.79 (0.66-0.94)
6-y OS rate, % 6.5 2.4
6-y PFS rate, % 3.3 0.4
ORR, % 15.4 8.9
DOR, median (range), mo 18.4 (0.0+ to 65.8+) 3.6 (0.0+ to 18.8)
PD-L1 TPS ≥50%, n 64 65
OS, median, mo 11.6 7.9
HR (95% CI) 0.62 (0.43-0.90)
6-y OS rate, % 8.9 6.3
6-y PFS rate, % 4.7 1.6
ORR, % 28.1 9.2
DOR, median (range), mo 15.1 (0.0+ to 65.1+) 4.2 (0.8-18.8)
PD-L1 CPS ≥1, n 196 191
OS, median, mo 8.7 7.1
HR (95% CI) 0.72 (0.59-0.89)
6-y OS rate, % 7.1 2.1
6-y PFS rate, % 3.7 0.5
ORR, % 18.4 8.9
DOR, median (range), mo 18.4 (0.0+ to 65.8+) 4.2 (0.7-18.8)

“+” indicates response is ongoing

Conclusions

Pembro continued to show OS benefit compared with SOC in R/M HNSCC, regardless of PD-L1 expression, after long-term follow-up. OS hazard ratios were similar over time. These results further support the use of pembro as second-line treatment in R/M HNSCC.

Clinical trial identification

NCT02252042, release date: September 29, 2014.

Editorial acknowledgement

Medical writing and/or editorial assistance was provided by Mallory Campbell, PhD and Matthew Grzywacz, PhD of ApotheCom (Yardley, PA, USA).

Legal entity responsible for the study

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Funding

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Disclosure

D. Soulieres: Financial Interests, Institutional, Research Grant: Adlai-Nortye, BMS, GSK; Financial Interests, Institutional, Leadership Role: Adlai-Nortye. K.J. Harrington: Financial Interests, Institutional, Research Grant: AstraZeneca, Boehringer Ingelheim, MSD, Replimune; Financial Interests, Institutional, Other, Consulting fees: AstraZeneca, Boehringer Ingelheim, BMS, Codiak, Idera, Inzen, ISA Pharmaceuticals, MSD, Merck-Serono, Pfizer, Replimune; Financial Interests, Institutional, Other, Honoraria: BMS, Merck-Serono, MSD. C. Le Tourneau: Financial Interests, Personal and Institutional, Advisory Board: MSD, BMS, Merck Serono, Roche, Celgene, Seattle Genetics, Nanobiotix, AstraZeneca. J.D. Silva: Financial Interests, Personal, Advisory Board: Roche, PharmaMar, BMS, Merck-Serono, MSD; Financial Interests, Personal, Principal Investigator: Roche, Boehringer Ingelheim, MSD; Financial Interests, Personal, Other, Travel expenses, including accommodation and congress fee: PharmaMar. L.F. Licitra: Financial Interests, Institutional, Research Grant: AstraZeneca, BMS, Boehringer Ingelheim, Celgene International, Eisai, Exelixis inc, Debiopharm International SA, Hoffmann-La Roche ltd, IRX Therapeutics inc, Medpace inc, Merck–Serono, MSD, Novartis, Pfizer, Roche Spa, Buran; Financial Interests, Personal, Other, Honoraria for public speaking/teaching in medical meetings and or for expert opinion in advisory boards: AstraZeneca, Bayer, BMS, Eisai, MSD, Merck–Serono, Merck Healthcare KGaA, Boehringer Ingelheim, Hoffmann-La Roche Ltd, Novartis, Roche, Debiopharm International SA, Sobi, Incyte Biosciences Italy srl, Doxa Pharma srl, Amgen, Nanobiotics Sa, GSK; Financial Interests, Personal, Other, Honoraria for public speaking/teaching from research companies & commercial education providers: AccMed, Medical Science Fundation G. Lorenzini, Associazione Sinapsi, Think 2 IT, Aiom Servizi, Prime Oncology, WMA Congress Education, Fasi, DueCi promotion Srl, MI&T, Net Congress & Education, PRMA Consulting, Kura Oncology, Health & Life srl, Ipsen Inn; Financial Interests, Personal, Other, Travel expenses: AstraZeneca, BMS, Eisai, MSD, Merck Serono. M. Ahn: Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Merck, Takeda, Daiichi Sankyo, Lilly, Roche, YUHAN, Amgen, Pfizer, Alpha Pharmaceuticals; Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, Amgen, Merck, Takeda, Lilly, YUHAN. A. Soria: Financial Interests, Institutional, Invited Speaker: Merck Sharp & Dohme, Bristol Myers Squibb, Novartis Pharma, Merck-Serono, Sanofi Aventis; Financial Interests, Institutional, Expert Testimony: Merck Sharpe & Dohme, Bristol Myers Squibb, Novartis Pharma, Merck-Serono, Sanofi Aventis; Financial Interests, Institutional, Advisory Board: Merck Sharp & Dohme, Bristol Myers Squibb, Novartis Pharma, Merck Serono, Sanofi Aventis; Financial Interests, Institutional, Writing Engagements: Bristol Myers Squibb; Financial Interests, Institutional, Research Grant: Sanofi Aventis. J. Machiels: Financial Interests, Institutional, Advisory Board, Advisory board member or speaker with honoraria (managed by my institution): Pfizer, Roche, AstraZeneca, Bayer, Innate, Merck Serono, Boerhinger, BMS, Novartis, Janssen, Incyte, Cue Biopharma, ALX Oncology, iTEOS, eTheRNA, Nektar; Financial Interests, Personal, Other, Travel expenses: Amgen, BMS, Pfizer, MSD; Financial Interests, Personal, Other, Data safety monitoring board with honoraria: Psioxus; Financial Interests, Institutional, Research Grant: Pfizer, Roche, AstraZeneca, Bayer, Innate, Merck Serono, Boerhinger, BMS, Novartis, Janssen, Incyte, Cue Biopharma, ALX Oncology, iTEOS, eTheRNA, Nektar, Amgen, BMS, Psioxus; Non-Financial Interests, Personal, Advisory Role, Uncompensated: MSD. N. Mach: Financial Interests, Personal, Stocks/Shares: MaxiVAX. R. Mehra: Non-Financial Interests, Personal, Advisory Board: AstraZeneca; Non-Financial Interests, Personal, Advisory Role: AstraZeneca; Other, Personal, Other: AstraZeneca; Financial Interests, Personal, Advisory Board: Coherus; Financial Interests, Personal, Advisory Role: Coherus; Other, Institutional, Research Grant: Merck; Other, Institutional, Principal Investigator: Merck. B. Burtness: Financial Interests, Personal, Advisory Board: Merck, Vaccinex, Coherus; Financial Interests, Personal, Invited Speaker: Genentech. J. Lin: Financial Interests, Personal, Full or part-time Employment: Merck & Co., Inc.. N. Lerman: Financial Interests, Personal, Full or part-time Employment: Merck & Co., Inc.; Financial Interests, Personal, Stocks/Shares: Merck & Co., Inc.. B. Gumuscu: Financial Interests, Personal, Full or part-time Employment: Merck & Co., Inc.; Financial Interests, Personal, Stocks/Shares: Merck & Co., Inc.. E.E..W. Cohen: Non-Financial Interests, Personal, Advisory Role: Axelia, Cel Sci, Eisai, Hoopika, ImmunoSensor, Istari, Janssen, Kahr Medical, Mana Therapeutics, Merck, Mirati, MSD, Nectin Tx, Pangea Therapeutics, Roche; Non-Financial Interests, Personal, Member of the Board of Directors: Therapeutics, NCCN; Financial Interests, Personal, Stocks/Shares: Kinnate Biopharma, Primmune Therapeutics; Non-Financial Interests, Personal, Leadership Role: Ayala, Kura, Kinnate Biopharma.

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