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Proffered Paper session - Head and neck cancer, excl. thyroid

858O - Results of KEYNOTE-122: A phase III study of pembrolizumab (pembro) monotherapy vs chemotherapy (chemo) for platinum-pretreated, recurrent or metastatic (R/M) nasopharyngeal carcinoma (NPC)

Date

20 Sep 2021

Session

Proffered Paper session - Head and neck cancer, excl. thyroid

Presenters

Anthony T.C. Chan

Citation

Annals of Oncology (2021) 32 (suppl_5): S786-S817. 10.1016/annonc/annonc704

Authors

A.T.C.T.C. Chan1, V.H.F. Lee2, R. Hong3, M. Ahn4, W.Q. Chong5, S. Kim6, H. Gwo Fuang7, P.B. Caguioa8, N. Ngamphaiboon9, C. Ho10, M.A.S. Abdul Aziz11, Q.S. Ng12, C. Yen13, N. Soparattanapaisarn14, K.C.R. Ngan15, S.K. Kho16, R. Swaby17, S. Saraf18, J. Ge18, L.L. Siu19

Author affiliations

  • 1 Clinical Oncology Department, The Chinese University of Hong Kong - Sino Building, . - Sha Tin/HK
  • 2 Clinical Ocology Department, University of Hong Kong, Hong Kong/HK
  • 3 Oncology, National Taiwan University Hospital, 10002 - New Taipei city/TW
  • 4 Division Of Hematology-oncology, Samsung Medical Center, 06351 - Seoul/KR
  • 5 Haematology-oncology, National University Cancer Institute, 573972 - Singapore/SG
  • 6 Oncology Dept., Asan Medical Center - University of Ulsan College of Medicine, 138-931 - Seoul/KR
  • 7 Clinical Oncology, University Malaya Medical Centre, 50603 - Kuala Lumpur/MY
  • 8 Cancer Institute, St. Luke’s Medical Center, University of Santo Tomas Hospital, 1008 - Manila/PH
  • 9 Oncology, Ramathibodi Hospital, Mahidol University, 10400 - Bangkok/TH
  • 10 Medical Oncology Department, Univeristy of British Columbia, V5Z 4E6 - Vancouver/CA
  • 11 Clinical Research, Gleneagles Penang Clinical Research Center, Gleneagles Hospital Penang, -- - Kuala Lumpur/MY
  • 12 Medical Oncology, National Cancer Centre Singapore, 169610 - Singapore/SG
  • 13 Oncology, NCKUH - National Cheng Kung University Hospital, 704 - Tainan City/TW
  • 14 Medical Oncology, Mahidol University - Faculty of Medicine, 10700 - Bangkok/TH
  • 15 Department Of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong/HK
  • 16 Radiotherapy-oncology & Palliative Care, Hospital Umum Sarawak, Kuching, 93586 - Kuching/MY
  • 17 Clinical Oncology, Merck & Co., Inc., 07033 - Kenilworth/US
  • 18 Biostatistics, Merck & Co., Inc., 07033 - Kenilworth/US
  • 19 Princess Margaret Cancer Centre, University Health Network, Toronto/CA
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Resources

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Abstract 858O

Background

Treatment options for R/M NPC are limited. In the phase Ib KEYNOTE-028 trial, pembro showed antitumor activity and manageable safety in a cohort of 27 patients (pts) with R/M NPC. KEYNOTE-122 (NCT02611960) is a multicenter, open-label, randomized phase III study to evaluate the efficacy and safety of pembro monotherapy vs chemo in pts with platinum-pretreated, R/M NPC.

Methods

Pts with histologically confirmed non-keratinizing differentiated (WHO Class II) or undifferentiated (WHO Class III), platinum-pretreated, Epstein-Barr Virus positive R/M NPC, ECOG PS 0-1, and measurable disease per RECIST v1.1 were randomized 1:1 to pembro 200 mg Q3W for up to 35 cycles or investigator’s choice of standard doses of chemo (capecitabine [C], gemcitabine [G], or docetaxel [D]). Primary endpoint was OS (overall significance threshold: 0.025, one-sided). Secondary endpoints included PFS, ORR, and DOR (all per RECIST v1.1 by BICR).

Results

Between May 5, 2016 and May 28, 2018, 233 pts were randomized to pembro (N=117) or chemo (N=116; C: n=39; G, n=46; D, n=31). 74.4% pts in the pembro arm and 62.9% in the chemo arm had PD-L1 CPS≥1. Median time from the first dose to data cutoff (Nov 30, 2020) was 45.1 (range, 30.2-54.8) mo. In the ITT population, median OS was 17.2 months (95% CI, 11.7–22.9) with pembro and 15.3 months (10.9–18.1) with chemo (HR, 0.90; 95% CI, 0.67-1.19; P=0.2262; significance threshold for final analysis: 0.0187); OS rate at 24 months was 40.2% with pembro vs 32.2% with chemo. Other key efficacy outcomes are summarized in the table. Biomarker analyses are ongoing. Treatment-related AEs incidence was 61.2% with pembro and 87.5% with chemo (grade 3-5, 10.3% vs 43.8%).

Conclusions

Pembro monotherapy did not improve OS vs chemo in pts with platinum-pretreated R/M NPC. PD-L1 CPS ≥1 did not enrich for OS or ORR for pembro. Pembro showed manageable safety and a lower incidence of treatment-related AEs vs chemo. Table: 858O

ITT population Pembro Chemo
N=117 N=116
OS, median (95% CI), mo 17.2 (11.7–22.9) 15.3 (10.9–18.1)
HR (95% CI) 0.90 (0.67-1.19); P=0.2262
PFS, median (95% CI), mo 4.1 (2.1-5.6) 5.5 (4.0-8.1)
HR (95% CI) 1.28 (0.94-1.75)
ORR, % (95% CI) 21.4 (14.3-29.9) 23.3 (15.9-32.0)
DCR (CR+PR+SD), % (95% CI) 50.4 (41.0-59.8) 63.8 (54.4-72.5)
DOR, median (range), mo 12.0 (1.7+-49.7+) 13.1 (2.6-49.3+)
Patients with PD-L1 CPS≥1 n=87 n=73
OS, median (95% CI), mo 17.2 (10.0-27.0) 18.0 (12.1-23.9)
ORR, % (95% CI) 23.0 (14.6-33.2) 26.0 (16.5-37.6)

Clinical trial identification

NCT02611960.

Editorial acknowledgement

Medical writing assistance was provided by Yue Liu of Merck & Co., Inc., Kenilworth, NJ, USA.

Legal entity responsible for the study

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Funding

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Disclosure

A.T.C.T.C. Chan: Financial Interests, Institutional, Research Grant: Merck Serono, Merck Sharp & Dohme, Novartis, Pfizer, Eli Lilly, ; Financial Interests, Institutional, Funding: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Role: Merck Sharp & Dohme, Merck Serono, Cullinan Management Inc., Beigene, Springer, Pfizer, ; Financial Interests, Personal, Other, Travel: Bristol Myers Squibb, Merck Sharp & Dohme, Pfizer, Roche, Novartis, AstraZeneca; Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme, Tessa Therapeutics Ltd; Non-Financial Interests, Personal, Other: Immunomic Therpeutics, Inc Angene Biotechnology, Owlstone Medical Limited. V.H.F. Lee: Financial Interests, Institutional, Funding: Merck Sharp & Dohme; Financial Interests, Personal, Research Grant: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Role: Merck Sharp & Dohme. R. Hong: Financial Interests, Institutional, Funding: Merck Sharp & Dohme; Financial Interests, Institutional, Research Grant: Merck Sharp & Dohme. M. Ahn: Financial Interests, Personal, Other, Honoraria: AstraZeneca, Takeda, Merck Sharp & Dohme, Ono, Bristol Myers Squibb, Lilly, Amgen, Merck, Roche; Financial Interests, Personal, Advisory Role: AstraZeneca, Takeda, Merck Sharp & Dohme, Ono, Bristol Myers Squibb, Lilly, Amgen, Merck, Roche, Alpha Pharmaceuticals; Financial Interests, Personal, Research Grant: AstraZeneca, Roche, Merck Sharp & Dohme. W.Q. Chong: Financial Interests, Institutional, Funding: Merck Sharp & Dohme; Financial Interests, Personal, Other, Travel payment: Merck Sharp & Dohme, Amgen. S. Kim: Financial Interests, Institutional, Funding: Merck Sharp & Dohme; Financial Interests, Institutional, Research Grant: Novartis, Sanofi Aventis, Dongkook Pharm Co; Financial Interests, Personal, Advisory Role: Novartis, AstraZeneca, Lilly, DaeHwa Pharma Co.,Ltd, ISU Abix, Daiichi-Sankyo; Financial Interests, Personal, Stocks/Shares: Genopeaks, Neogene TC. H. Gwo Fuang: Financial Interests, Institutional, Research Grant: Merck Sharp & Dohme, AstraZenenca, Eli Lily, Arcus Biosciences, Inc., Pfizer, INEX EpiTherapeutics Pte. Ltd., Roche, Astella, Novartis, Tessa Therapeutics, Regeneron, Samsung Bioepis; Financial Interests, Personal, Invited Speaker: Eli Lily, Merck, Pfizer; Financial Interests, Personal, Other, Travel Expenses: AstraZenenca, Bristol-Myers Squibb Pte Ltd; Financial Interests, Personal, Advisory Board: Pfizer, Boehringer ingelheim, AstraZenenca, MIMS, Merck Sharp & Dohme, Eli Lily. P.B. Caguioa: Financial Interests, Personal, Other, honoraria: Roche, AstraZeneca, Novartis, Merck Sharp & Dohme; Financial Interests, Institutional, Funding: Merck Sharp & Dohme. N. Ngamphaiboon: Financial Interests, Institutional, Research Grant: Merck Sharp & Dohme, Roche, Exelixis, RAPT therapeutics, BeiGene, Pfizer; Financial Interests, Personal, Other, Honoraria: Roche, AstraZeneca, Amgen, Merck Sharp & Dohme, Taiho; Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme, Amgen, Novartis, Bayer, AstraZeneca, Claris, Elli-Lilly. C. Ho: Financial Interests, Institutional, Funding: Merck Sharp & Dohme; Financial Interests, Personal, Research Grant: AstraZeneca , Roche; Financial Interests, Personal, Other, Honoraria: AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Bayer, Eisai, EMD Serono, Merck, Novartis, Roche; Financial Interests, Personal, Other, Travel Payments: Roche. M.A.S. Abdul Aziz: Financial Interests, Institutional, Funding: Merck Sharp & Dohme. Q.S. Ng: Financial Interests, Institutional, Funding: Merck Sharp & Dohme; Financial Interests, Personal, Other, Travel: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme. C. Yen: Financial Interests, Institutional, Funding: Merck Sharp & Dohme. N. Soparattanapaisarn: Financial Interests, Institutional, Funding: Merck Sharp & Dohme; Financial Interests, Personal, Research Grant: Merck Sharp & Dohme ; Financial Interests, Personal, Research Grant: AstraZeneca ; Financial Interests, Personal, Research Grant: Roche ; Financial Interests, Personal, Research Grant: Bristol Myers Squibb. K.C.R. Ngan: Financial Interests, Institutional, Funding: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Role: Pfizer, Novartis, Sanofi, AstraZeneca, Lilly, Merck Sharp & Dohme, Zai Lab, Roche, Eisai; Financial Interests, Personal, Other, Honoraria: Novartis, AstraZeneca, Sanofi, Pfizer, Zai Lab, Eisai, Lilly, Merck Sharp & Dohme; Financial Interests, Personal, Other, Travel payments: Pfizer, Astellas, Novartis, Merck Sharp & Dohme, Roche, Esiai, Merck, Sanofi, Bristol Myers Squibb, Zai Lab; Financial Interests, Personal, Advisory Board: Nuance Biotech (Shenzhen, China); Financial Interests, Personal, Leadership Role: President, Hong Kong Breast Oncology Group. S.K. Kho: Financial Interests, Institutional, Funding: Merck Sharp & Dohme. R. Swaby: Financial Interests, Personal, Full or part-time Employment: Merck & Co., Inc.; Financial Interests, Personal, Stocks/Shares: Merck & Co., Inc. S. Saraf: Financial Interests, Personal, Full or part-time Employment: Merck & Co., Inc.; Financial Interests, Personal, Stocks/Shares: Merck & Co., Inc. J. Ge: Financial Interests, Personal, Full or part-time Employment: Merck & Co., Inc.; Financial Interests, Personal, Stocks/Shares: Merck & Co., Inc. L.L. Siu: Financial Interests, Institutional, Funding: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme; Financial Interests, Institutional, Funding: Novartis; Financial Interests, Institutional, Funding: Bristol Myers Squibb; Financial Interests, Institutional, Funding: Pfizer; Financial Interests, Institutional, Funding: Boerhinger-Ingelheim; Financial Interests, Institutional, Funding: GlaxoSmithKline; Financial Interests, Institutional, Funding: Roche/Genentech; Financial Interests, Institutional, Funding: Karyopharm; Financial Interests, Institutional, Funding: AstraZeneca; Financial Interests, Institutional, Funding: Astellas; Financial Interests, Institutional, Funding: Bayer; Financial Interests, Institutional, Funding: Abbvie; Financial Interests, Institutional, Funding: Amgen; Financial Interests, Institutional, Funding: Symphogen; Financial Interests, Institutional, Funding: Intensity Therapeutics; Financial Interests, Institutional, Funding: Mirati; Financial Interests, Institutional, Funding: Shattucks; Financial Interests, Institutional, Funding: Avid; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Celgene; Financial Interests, Personal, Advisory Role: Morphosys; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Oncorus; Financial Interests, Personal, Advisory Role: Symphogen; Financial Interests, Personal, Advisory Role: Seattle Genetics; Financial Interests, Personal, Advisory Role: GlaxoSmithKline; Financial Interests, Personal, Advisory Role: Voronoi; Financial Interests, Personal, Advisory Role: Treadwell Therapeutics; Financial Interests, Personal, Advisory Role: Arvinas; Financial Interests, Personal, Advisory Role: Tessa; Financial Interests, Personal, Advisory Role: Navire; Financial Interests, Personal, Advisory Role: Relay; Financial Interests, Personal, Advisory Role: Rubius; Financial Interests, Personal, Advisory Role: Daiichi Sankyo; Financial Interests, Personal, Advisory Role: Janpix.

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