Pembrolizumab monotherapy versus chemotherapy in platinum-pretreated, recurrent or metastatic nasopharyngeal cancer (KEYNOTE-122): an open-label, randomized, phase III trial
Issued Date
2023-03-01
Resource Type
ISSN
09237534
eISSN
15698041
Scopus ID
2-s2.0-85147365199
Pubmed ID
36535566
Journal Title
Annals of Oncology
Volume
34
Issue
3
Start Page
251
End Page
261
Rights Holder(s)
SCOPUS
Bibliographic Citation
Annals of Oncology Vol.34 No.3 (2023) , 251-261
Suggested Citation
Chan A.T.C., Lee V.H.F., Hong R.L., Ahn M.J., Chong W.Q., Kim S.B., Ho G.F., Caguioa P.B., Ngamphaiboon N., Ho C., Aziz M.A.S.A., Ng Q.S., Yen C.J., Soparattanapaisarn N., Ngan R.K.C., Kho S.K., Tiambeng M.L.A., Yun T., Sriuranpong V., Algazi A.P., Cheng A., Massarelli E., Swaby R.F., Saraf S., Yuan J., Siu L.L. Pembrolizumab monotherapy versus chemotherapy in platinum-pretreated, recurrent or metastatic nasopharyngeal cancer (KEYNOTE-122): an open-label, randomized, phase III trial. Annals of Oncology Vol.34 No.3 (2023) , 251-261. 261. doi:10.1016/j.annonc.2022.12.007 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/82374
Title
Pembrolizumab monotherapy versus chemotherapy in platinum-pretreated, recurrent or metastatic nasopharyngeal cancer (KEYNOTE-122): an open-label, randomized, phase III trial
Author's Affiliation
Ramathibodi Hospital
Siriraj Hospital
Hospital Umum Sarawak
National Cheng Kung University Hospital
National Taiwan University Hospital
University of Santo Tomas, Manila
National Cancer Center, Gyeonggi
National Cancer Centre, Singapore
Universiti Malaya
Prince of Wales Hospital Hong Kong
University of California, San Francisco
King Chulalongkorn Memorial Hospital
Samsung Medical Center, Sungkyunkwan University
University of Toronto
Queen Elizabeth Hospital Hong Kong
Princess Margaret Hospital Hong Kong
Pantai Holdings Sdn Bhd
The University of British Columbia
Merck & Co., Inc.
City of Hope National Med Center
The University of Hong Kong
University of Ulsan College of Medicine
National University Cancer Institute
Cardinal Santos Medical Center
Siriraj Hospital
Hospital Umum Sarawak
National Cheng Kung University Hospital
National Taiwan University Hospital
University of Santo Tomas, Manila
National Cancer Center, Gyeonggi
National Cancer Centre, Singapore
Universiti Malaya
Prince of Wales Hospital Hong Kong
University of California, San Francisco
King Chulalongkorn Memorial Hospital
Samsung Medical Center, Sungkyunkwan University
University of Toronto
Queen Elizabeth Hospital Hong Kong
Princess Margaret Hospital Hong Kong
Pantai Holdings Sdn Bhd
The University of British Columbia
Merck & Co., Inc.
City of Hope National Med Center
The University of Hong Kong
University of Ulsan College of Medicine
National University Cancer Institute
Cardinal Santos Medical Center
Other Contributor(s)
Abstract
Background: Pembrolizumab previously demonstrated robust antitumor activity and manageable safety in a phase Ib study of patients with heavily pretreated, programmed death ligand 1 (PD-L1)-positive, recurrent or metastatic nasopharyngeal carcinoma (NPC). The phase III KEYNOTE-122 study was conducted to further evaluate pembrolizumab versus chemotherapy in patients with platinum-pretreated, recurrent and/or metastatic NPC. Final analysis results are presented. Patients and methods: KEYNOTE-122 was an open-label, randomized study conducted at 29 sites, globally. Participants with platinum-pretreated recurrent and/or metastatic NPC were randomly assigned (1 : 1) to pembrolizumab or chemotherapy with capecitabine, gemcitabine, or docetaxel. Randomization was stratified by liver metastasis (present versus absent). The primary endpoint was overall survival (OS), analyzed in the intention-to-treat population using the stratified log-rank test (superiority threshold, one-sided P = 0.0187). Safety was assessed in the as-treated population. Results: Between 5 May 2016 and 28 May 2018, 233 participants were randomly assigned to treatment (pembrolizumab, n = 117; chemotherapy, n = 116); Most participants (86.7%) received study treatment in the second-line or later setting. Median time from randomization to data cut-off (30 November 2020) was 45.1 months (interquartile range, 39.0-48.8 months). Median OS was 17.2 months [95% confidence interval (CI) 11.7-22.9 months] with pembrolizumab and 15.3 months (95% CI 10.9-18.1 months) with chemotherapy [hazard ratio, 0.90 (95% CI 0.67-1.19; P = 0.2262)]. Grade 3-5 treatment-related adverse events occurred in 12 of 116 participants (10.3%) with pembrolizumab and 49 of 112 participants (43.8%) with chemotherapy. Three treatment-related deaths occurred: 1 participant (0.9%) with pembrolizumab (pneumonitis) and 2 (1.8%) with chemotherapy (pneumonia, intracranial hemorrhage). Conclusion: Pembrolizumab did not significantly improve OS compared with chemotherapy in participants with platinum-pretreated recurrent and/or metastatic NPC but did have manageable safety and a lower incidence of treatment-related adverse events.