. 2021 Feb:144:182-191.

doi: 10.1016/j.ejca.2020.11.010. Epub 2020 Dec 24.

Long-term safety of pembrolizumab monotherapy and relationship with clinical outcome: A landmark analysis in patients with advanced melanoma

Caroline Robert¹, Wen-Jen Hwu², Omid Hamid³, Antoni Ribas⁴, Jeffrey S Weber⁵, Adil I Daud⁶, F Stephen Hodi⁷, Jedd D Wolchok⁸, Tara C Mitchell⁹, Peter Hersey¹⁰, Roxana Dronca¹¹, Richard W Joseph¹², Celine Boutros¹³, Le Min¹⁴, Georgina V Long¹⁵, Jacob Schachter¹⁶, Igor Puzanov¹⁷, Reinhard Dummer¹⁸, Jianxin Lin¹⁹, Nageatte Ibrahim²⁰, Scott J Diede²¹, Matteo S Carlino²², Anthony M Joshua²³

Affiliations

¹ Department of Oncology, Service of Dermatology, Institut de Cancérologie Gustave Roussy, 114 Rue Edouard Vaillant, Gustave Roussy, Villejuif, 94805, France; Paris-Saclay University, CNRS UMR 3348, Orsay, France. Electronic address: caroline.robert@gustaveroussy.fr.
² Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA. Electronic address: hwu.wenjen@gmail.com.
³ Department of Hematology/Oncology, The Angeles Clinic and Research Institute, a Cedars-Sinai Affiliate, 11800 Wilshire Blvd Suite 300, Los Angeles, CA, 90025, USA. Electronic address: ohamid@theangelesclinic.org.
⁴ Department of Medicine and the Jonsson Comprehensive Cancer Center, University of California, Los Angeles (UCLA), 11-934 Factor bldg., Los Angeles, CA, 90095, USA. Electronic address: aribas@mednet.ucla.edu.
⁵ Department of Medicine, Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, 522 First Avenue, 1310 Smilow Building, New York, NY, 10016, USA. Electronic address: Jeffrey.Weber@nyulangone.org.
⁶ Department of Medicine, University of California San Francisco, 1600 Divisadero St, San Francisco, CA, 94158, USA. Electronic address: adaud@medicine.ucsf.edu.
⁷ Melanoma Center and Center for Immuno-Oncology, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, USA. Electronic address: Stephen_Hodi@dfci.harvard.edu.
⁸ Department of Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY, 10065, USA. Electronic address: wolchokj@mskcc.org.
⁹ Division of Hematology and Oncology, Abramson Cancer Center, University of Pennsylvania, 3400 Civic Center Blvd South Pavilion, Flr 10, Philadelphia, PA, 19104, USA. Electronic address: tara.mitchell@uphs.upenn.edu.
¹⁰ Department of Medicine, The University of Sydney, Camperdown, NSW, 2006, Australia; Centenary Institute, Misendon Rd, Bldg 93, Camperdown, NSW, 2050, Australia; Melanoma Institute Australia, The University of Sydney, 40 Rocklands Rd, Wollstonecraft, NSW, 2065, Australia. Electronic address: peter.hersey@sydney.edu.au.
¹¹ Department of Hematology/Oncology, Mayo Clinic, 200 1st St. SW, Rochester, MN, 55905, USA. Electronic address: Dronca.Roxana@mayo.edu.
¹² Division of Cancer Medicine, Mayo Clinic Cancer Center-Florida, 4500 San Pablo Rd, Jacksonville, FL, 32224, USA. Electronic address: joseph.richard@mayo.edu.
¹³ Department of Oncology, Service of Dermatology, Institut de Cancérologie Gustave Roussy, 114 Rue Edouard Vaillant, Gustave Roussy, Villejuif, 94805, France. Electronic address: celine.boutros@gustaveroussy.fr.
¹⁴ Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, 221 Longwood Avenue, Boston, MA, 02115, USA. Electronic address: lmin@bwh.harvard.edu.
¹⁵ Melanoma Institute Australia, The University of Sydney, 40 Rocklands Rd, Wollstonecraft, NSW, 2065, Australia; Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065, Australia; Mater Hospital, Wollstonecraft, NSW, 2065, Australia; Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, 2006, Australia. Electronic address: Georgina.Long@melanoma.org.au.
¹⁶ Division of Oncology, Level 2 Cancer Center, Sheba Medical Center, Tel HaShomer Hospital, Emek HaEla Street 1, Tel HaShomer, Ramat Gan, 52621, Israel. Electronic address: jacob.schachter@sheba.health.gov.il.
¹⁷ Melanoma Section Department of Medicine, Roswell Park Comprehensive Cancer Center, 915 CSC Building, Elm & Carlton Streets, Buffalo, NY, 14263, USA. Electronic address: Igor.Puzanov@RoswellPark.org.
¹⁸ Department of Dermatology, University Hospital Zürich, University of Zurich, Rämistrasse 100, Zürich, 8091, Switzerland. Electronic address: reinhard.Dummer@usz.ch.
¹⁹ Department of Clinical Oncology, Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: jianxin_lin@merck.com.
²⁰ Department of Clinical Oncology, Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: nageatte.ibrahim@merck.com.
²¹ Department of Clinical Oncology, Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: scott.diede@merck.com.
²² Department of Medicine, The University of Sydney, Camperdown, NSW, 2006, Australia; Melanoma Institute Australia, The University of Sydney, 40 Rocklands Rd, Wollstonecraft, NSW, 2065, Australia; Department of Medical Oncology, The Crown Princess Mary Cancer Centre, Westmead Hospital, 12 Moris Road, Westmead, NSW, 2145, Australia; Blacktown Hospital, 18 Blacktown Road, Blacktown, NSW, 2148, Australia. Electronic address: matteo.carlino@sydney.edu.au.
²³ Melanoma Institute Australia, The University of Sydney, 40 Rocklands Rd, Wollstonecraft, NSW, 2065, Australia; Department of Medical Oncology, Princess Margaret Cancer Centre, University Health Network, 610 University Ave, Toronto, ON, M5G2C1, Canada; The Kinghorn Cancer Centre at St Vincent's Hospital, 370 Victoria St, Darlinghurst, NSW, 2010, Australia; St Vincent's Clinical School, UNSW Sydney, Victoria St, Darlinghurst, NSW, 2010, Australia. Electronic address: Anthony.joshua@svha.org.au.

PMID: 33360855
PMCID: PMC8388128
DOI: 10.1016/j.ejca.2020.11.010

Long-term safety of pembrolizumab monotherapy and relationship with clinical outcome: A landmark analysis in patients with advanced melanoma

Caroline Robert et al. Eur J Cancer. 2021 Feb.

. 2021 Feb:144:182-191.

doi: 10.1016/j.ejca.2020.11.010. Epub 2020 Dec 24.

Authors

Affiliations

¹ Department of Oncology, Service of Dermatology, Institut de Cancérologie Gustave Roussy, 114 Rue Edouard Vaillant, Gustave Roussy, Villejuif, 94805, France; Paris-Saclay University, CNRS UMR 3348, Orsay, France. Electronic address: caroline.robert@gustaveroussy.fr.
² Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA. Electronic address: hwu.wenjen@gmail.com.
³ Department of Hematology/Oncology, The Angeles Clinic and Research Institute, a Cedars-Sinai Affiliate, 11800 Wilshire Blvd Suite 300, Los Angeles, CA, 90025, USA. Electronic address: ohamid@theangelesclinic.org.
⁴ Department of Medicine and the Jonsson Comprehensive Cancer Center, University of California, Los Angeles (UCLA), 11-934 Factor bldg., Los Angeles, CA, 90095, USA. Electronic address: aribas@mednet.ucla.edu.
⁵ Department of Medicine, Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, 522 First Avenue, 1310 Smilow Building, New York, NY, 10016, USA. Electronic address: Jeffrey.Weber@nyulangone.org.
⁶ Department of Medicine, University of California San Francisco, 1600 Divisadero St, San Francisco, CA, 94158, USA. Electronic address: adaud@medicine.ucsf.edu.
⁷ Melanoma Center and Center for Immuno-Oncology, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, USA. Electronic address: Stephen_Hodi@dfci.harvard.edu.
⁸ Department of Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY, 10065, USA. Electronic address: wolchokj@mskcc.org.
⁹ Division of Hematology and Oncology, Abramson Cancer Center, University of Pennsylvania, 3400 Civic Center Blvd South Pavilion, Flr 10, Philadelphia, PA, 19104, USA. Electronic address: tara.mitchell@uphs.upenn.edu.
¹⁰ Department of Medicine, The University of Sydney, Camperdown, NSW, 2006, Australia; Centenary Institute, Misendon Rd, Bldg 93, Camperdown, NSW, 2050, Australia; Melanoma Institute Australia, The University of Sydney, 40 Rocklands Rd, Wollstonecraft, NSW, 2065, Australia. Electronic address: peter.hersey@sydney.edu.au.
¹¹ Department of Hematology/Oncology, Mayo Clinic, 200 1st St. SW, Rochester, MN, 55905, USA. Electronic address: Dronca.Roxana@mayo.edu.
¹² Division of Cancer Medicine, Mayo Clinic Cancer Center-Florida, 4500 San Pablo Rd, Jacksonville, FL, 32224, USA. Electronic address: joseph.richard@mayo.edu.
¹³ Department of Oncology, Service of Dermatology, Institut de Cancérologie Gustave Roussy, 114 Rue Edouard Vaillant, Gustave Roussy, Villejuif, 94805, France. Electronic address: celine.boutros@gustaveroussy.fr.
¹⁴ Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, 221 Longwood Avenue, Boston, MA, 02115, USA. Electronic address: lmin@bwh.harvard.edu.
¹⁵ Melanoma Institute Australia, The University of Sydney, 40 Rocklands Rd, Wollstonecraft, NSW, 2065, Australia; Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065, Australia; Mater Hospital, Wollstonecraft, NSW, 2065, Australia; Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, 2006, Australia. Electronic address: Georgina.Long@melanoma.org.au.
¹⁶ Division of Oncology, Level 2 Cancer Center, Sheba Medical Center, Tel HaShomer Hospital, Emek HaEla Street 1, Tel HaShomer, Ramat Gan, 52621, Israel. Electronic address: jacob.schachter@sheba.health.gov.il.
¹⁷ Melanoma Section Department of Medicine, Roswell Park Comprehensive Cancer Center, 915 CSC Building, Elm & Carlton Streets, Buffalo, NY, 14263, USA. Electronic address: Igor.Puzanov@RoswellPark.org.
¹⁸ Department of Dermatology, University Hospital Zürich, University of Zurich, Rämistrasse 100, Zürich, 8091, Switzerland. Electronic address: reinhard.Dummer@usz.ch.
¹⁹ Department of Clinical Oncology, Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: jianxin_lin@merck.com.
²⁰ Department of Clinical Oncology, Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: nageatte.ibrahim@merck.com.
²¹ Department of Clinical Oncology, Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: scott.diede@merck.com.
²² Department of Medicine, The University of Sydney, Camperdown, NSW, 2006, Australia; Melanoma Institute Australia, The University of Sydney, 40 Rocklands Rd, Wollstonecraft, NSW, 2065, Australia; Department of Medical Oncology, The Crown Princess Mary Cancer Centre, Westmead Hospital, 12 Moris Road, Westmead, NSW, 2145, Australia; Blacktown Hospital, 18 Blacktown Road, Blacktown, NSW, 2148, Australia. Electronic address: matteo.carlino@sydney.edu.au.
²³ Melanoma Institute Australia, The University of Sydney, 40 Rocklands Rd, Wollstonecraft, NSW, 2065, Australia; Department of Medical Oncology, Princess Margaret Cancer Centre, University Health Network, 610 University Ave, Toronto, ON, M5G2C1, Canada; The Kinghorn Cancer Centre at St Vincent's Hospital, 370 Victoria St, Darlinghurst, NSW, 2010, Australia; St Vincent's Clinical School, UNSW Sydney, Victoria St, Darlinghurst, NSW, 2010, Australia. Electronic address: Anthony.joshua@svha.org.au.

PMID: 33360855
PMCID: PMC8388128
DOI: 10.1016/j.ejca.2020.11.010

Abstract

Objective: Long-term safety of pembrolizumab in melanoma was analyzed in KEYNOTE-001, KEYNOTE-002, and KEYNOTE-006.

Patients and methods: Analysis involved patients who received ≥1 pembrolizumab dose. Lead-time bias was addressed via landmark analyses in patients who were progression-free before day 147.

Results: Adverse events (AEs) were analyzed for 1567 patients (median follow-up, 42.4 months). Most AEs were mild/moderate; grade 3/4 treatment-related AEs occurred in 17.7% of patients. Two pembrolizumab-related deaths occurred. Any-grade immune-mediated AEs (imAEs) occurred in 23.0%, most commonly hypothyroidism (9.1%), pneumonitis (3.3%), and hyperthyroidism (3.0%); grade 3/4 imAEs occurred in 6.9% of patients. Most imAEs occurred within 16 weeks of treatment. In landmark analysis, patients who did (n = 79) versus did not (n = 384) develop imAEs had similar objective response rates (ORRs) (64.6% versus 63.0%); median time to response (TTR), 5.6 months for both; median duration of response (DOR), 20.0 versus 25.3 months; median progression-free survival (PFS), 17.0 versus 17.7 months; median overall survival (OS), not reached (NR) versus 43 months (p = 0.1104). Patients who did (n = 17) versus did not (n = 62) receive systemic corticosteroids had similar ORRs (70.6% vs. 62.9%) and median TTR (6.4 vs. 5.6 months) but numerically shorter median PFS (9.9 vs. 17.0 months); median DOR, 14.2 months versus NR; median OS, NR for both.

Conclusions: These results enhance the knowledge base for pembrolizumab in advanced melanoma, with no new toxicity signals after lengthy follow-up of a large population. In landmark analyses, pembrolizumab efficacy was similar regardless of imAEs or systemic corticosteroid use.

Clinical trial registry: NCT01295827, NCT01704287, NCT01866319.

Keywords: Advanced melanoma; Corticosteroid use; Immune-checkpoint inhibitors; Immune-related adverse events; Immunomodulating drugs; PD-1 inhibitors; Pembrolizumab.

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Conflict of interest statement

Conflict of interest statement C.R. has participated in advisory boards for Roche; Pierre Fabre; Merck; Novartis; Amgen; Bristol-Myers Squibb; Novartis; Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, U.S.A. (MSD); and Sanofi. O.H. reports personal fees from Merck for consulting during the conduct of the study; as well as contracted research for his institution from Arcus, Aduro, Akeso, Amgen, Array, Bristol-Myers Squibb, CytomX, Exelixis, Genentech, GSK, Immunocore, Incyte, Iovance, Merck, Moderna, Merck Serono, NextCure, Novartis, Regeneron, Roche, Seattle Genetics, Torque, and Zelluna outside the submitted work. A.R. has received personal fees as honoraria for consulting from Amgen, Chugai, Genentech-Roche, Novartis, and Merck; and personal fees, as a scientific advisory member and stockholder from Arcus, Bi-oncotech, Compugen, CytomX, Five Prime, FLX-Bio, Merus, Rgenix, PACT Pharma, and Tango Therapeutics, outside the submitted work. J.S.W. reports personal fees for honoraria for advisory boards and transportation from Merck, Bristol-Myers Squibb, Genentech, Celldex, Pfizer, and AstraZeneca, outside the submitted work. In addition. J.S.W. has a patent named on a PD-1 biomarker patent by Biodesix issued. I.D. reports grants from Merck, Bristol-Myers Squibb, Incyte, OncoSec, and Regeneron, and personal fees from Regeneron, during the conduct of the study. F.S.H. reports other from Merck to their institution for clinical trial support during the conduct of the study; grants, personal fees, and consulting from Bristol-Myers Squibb; personal fees from Merck, EMD Serono, Genentech/Roche, Bayer, Partners Therapeutics, Sanofi, Pfizer, and Kairos for consulting; grants and personal fees from Novartis for consulting; personal fees from Takeda, Surface, Compass Therapeutics, Verastem, and Rheos for advisory boards; personal fees from Apricity and Bicara for scientific advisory board and equity; personal fees from Aduro for advisor consulting; personal fees from Pionyr for advisory board and equity; personal fees from 7 Hills Pharma for advisor; other from Torque for scientific advisory board and equity; outside the submitted work. In addition, F.S.H. has a patent for Methods for Treating MICA-Related Disorders (#20100111973) with royalties paid, a patent for Tumor antigens and uses thereof issued (#7250291), a patent for Angiopoieten-2 Biomarkers Predictive of Anti-immune checkpoint response pending (#20170248603), a patent for Compositions and Methods for Identification, Assessment, Prevention, and Treatment of Melanoma using PD-L1 Isoforms pending (#20160340407), five patents for Therapeutic peptides pending (#20160046716, #20140004112, #20170022275, #20170008962, #9402905), and a patent for “methods of using pembrolizumab and trebananib.” J.D.W. reports personal fees for consulting from Adaptive Biotech, Amgen, Apricity, Ascentage Pharma, Astellas, AstraZeneca, Bayer, BeiGene, Bristol-Myers Squibb, Celgene, Chugai, Eli Lilly, F-star, Imvaq, Kyowa Hakko Kirin, Linnaeus, MedImmune, Merck, Neon Therapeutics, Ono, Polaris Pharma, Polynoma, PsiOxus, Puretech, Recepta, Takara Bio, Trieza, Truvax, Serametrix, Surface Oncology, Syndax, and Syntalogic; research support from Bristol-Myers Squibb and AstraZeneca; and equity in Potenza Therapeutics, Tizona Pharmaceuticals, Adaptive Biotechnologies, Imvaq, BeiGene, Trieza, and Linnaeus. T.C.M. reports personal fees for honorarium from Bristol-Myers Squibb, Aduro, Merck, and Incyte outside the submitted work. R.W.J. reports other from Bristol-Myers Squibb, and Gilead for consulting, outside the submitted work. C.B. reports personal fees from Bristol-Myers Squibb (board advisor), speaker fees from Merck, and travel fees from Amgen and Sandoz outside the submitted work. GVL is consultant advisor for Aduro Biotech Inc, Amgen Inc, Array Biopharma inc, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb, Highlight Therapeutics S.L., MSD, Novartis Pharma AG, Pierre Fabre, QBiotics Group Limited, Regeneron Pharmaceuticals Inc, SkylineDX B.V. I.P. is a consultant for Amgen, Merck, and Iovance, outside the submitted work. R.Dummer reports intermittent, project focused consulting and/or advisory relationships with Novartis, MSD, Bristol-Myers Squibb, Roche, Amgen, Takeda, Pierre Fabre, Sun Pharma, Sanofi, Catalym, Second Genome, Regeneron, Alligator, MaxiVAX SA and touchIME outside the submitted work. J.L. reports employment at MSD, and GSK. S.J.D. reports personal fees as an employee of MSD, and shareholder inMerck & Co., Inc., Kenilworth, NJ, USA. M.S.C. has served on advisory boards for Bristol-Myers Squibb, MSD, Amgen, Novartis, Pierre Fabre, Roche, Sanofi, Merck, Ideaya, Regeneron, Nektar, Eisai, Oncosec and Qbiotics., outside the submitted work. A.J. reports consulting and/or advisory role for Neolukin, Janssen Oncology, Ipsen, AstraZeneca, Sanofi, Noxopharm, IQvia, Pfizer, Novartis, Bristol-Myers Squibb, and Merck Serono, outside the submitted work. A.J. also reports research funding from Bristol-myers Squibb, Janssen Oncology, MSD, Mayne Pharma, Roche/Genentech, Bayer, Macrogenics, Lilly, Pfizer, AstraZeneca, and Corvus Pharmaceuticals. All remaining authors have declared no conflicts of interest.

Figures

**Fig. 1.**
Incidence of any-grade imAEs^a occurring in at least one patient (N = 1567) (A); median (range) time to onset (B) and resolution (C) of any-grade imAEs (incidence >0%). imAEs, immune-mediated adverse events. ^aEndocrine AEs that were managed with hormone supplements might have been categorized as resolved or unresolved by different investigators.

**Fig. 2.**
First occurrence of imAEs^a of any grade over time (A) and median (range) time to resolution of imAEs of any grade with corticosteroids (B). AEs, adverse events; imAEs, immune-mediated adverse events. ^aEndocrine AEs that were managed with hormone supplements might have been categorized as resolved or unresolved by different investigators.

**Fig. 3.**
Kaplan-Meier plot of PFS in patients with or without imAEs who were receiving pembrolizumab before week 21. imAEs, immune-mediated adverse events; PFS, progression-free survival.

See this image and copyright information in PMC

References

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Long-term safety of pembrolizumab monotherapy and relationship with clinical outcome: A landmark analysis in patients with advanced melanoma

Affiliations

Long-term safety of pembrolizumab monotherapy and relationship with clinical outcome: A landmark analysis in patients with advanced melanoma

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

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