Pembrolizumab versus Ipilimumab in Advanced Melanoma
Open accessAbstract
BACKGROUND: The immune checkpoint inhibitor ipilimumab is the standard-of-care treatment for patients with advanced melanoma. Pembrolizumab inhibits the programmed cell death 1 (PD-1) immune checkpoint and has antitumor activity in patients with advanced melanoma. METHODS: In this randomized, controlled, phase 3 study, we assigned 834 patients with advanced melanoma in a 1:1:1 ratio to receive pembrolizumab (at a dose of 10 mg per kilogram of body weight) every 2 weeks or every 3 weeks or four doses of ipilimumab (at 3 mg per kilogram) every 3 weeks. Primary end points were progression-free and overall survival. RESULTS: The estimated 6-month progression-free-survival rates were 47.3% for pembrolizumab every 2 weeks, 46.4% for pembrolizumab every 3 weeks, and 26.5% for ipilimumab (hazard ratio for disease progression, 0.58; P<0.001 for both pembrolizumab regimens versus ipilimumab; 95% confidence intervals [CIs], 0.46 to 0.72 and 0.47 to 0.72, respectively). Estimated 12-month survival rates were 74.1%, 68.4%, and 58.2%, respectively (hazard ratio for death for pembrolizumab every 2 weeks, 0.63; 95% CI, 0.47 to 0.83; P=0.0005; hazard ratio for pembrolizumab every 3 weeks, 0.69; 95% CI, 0.52 to 0.90; P=0.0036). The response rate was improved with pembrolizumab administered every 2 weeks (33.7%) and every 3 weeks (32.9%), as compared with ipilimumab (11.9%) (P<0.001 for both comparisons). Responses were ongoing in 89.4%, 96.7%, and 87.9% of patients, respectively, after a median follow-up of 7.9 months. Efficacy was similar in the two pembrolizumab groups. Rates of treatment-related adverse events of grade 3 to 5 severity were lower in the pembrolizumab groups (13.3% and 10.1%) than in the ipilimumab group (19.9%). CONCLUSIONS: The anti-PD-1 antibody pembrolizumab prolonged progression-free survival and overall survival and had less high-grade toxicity than did ipilimumab in patients with advanced melanoma. (Funded by Merck Sharp & Dohme; KEYNOTE-006 ClinicalTrials.gov number, NCT01866319.).
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Responses to immune checkpoint inhibitors in melanoma and other cancers are heterogeneous and often not durable.
“however responses to these therapies are often heterogeneous and not durable (1–3).”
From Gut microbiome modulates response to anti-PD-1 immunotherapy in melanoma patients (2018) · cites this paper as [2]
The Rates of Response section (page unavailable) shows varied response rates in advanced melanoma, but the Discussion (page unavailable) explicitly says responses appeared durable in all treatment groups: 93.0% of pembrolizumab responses and 87.8% of ipilimumab responses were ongoing at data cutoff. This contradicts the claim that responses were often not durable. The trial did not study other cancers. (LLM, conf=0.87)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredClinical trials of ICPis excluded patients with pre-existing active autoimmune diseases because of concerns of high susceptibility to severe irAEs.
“Clinical trials of ICPis excluded patients with pre-existing active autoimmune diseases because of concerns of a high susceptibility to severe irAEs [49,50].”
From Graves’ Disease during Immune Checkpoint Inhibitor Therapy (A Case Series and Literature Review) (2021) · cites this paper as [50]
The Patients section (page unavailable) says this trial excluded people with a history of serious autoimmune disease. It does not limit that exclusion to active disease or state that concern about heightened susceptibility to severe immune-related adverse events was the reason. The Adverse Events section (page unavailable) reports immune-related events but does not establish that rationale. (LLM, conf=0.87)
Experimental — accuracy not yet measuredAnti-PD-1 and anti-PD-1/CTLA-4 combination therapy are the most effective immunotherapies.
“with anti-PD-1 and anti-PD-1/CTLA-4 combination therapy emerging as most effective [3, 4].”
From Relating the gut metagenome and metatranscriptome to immunotherapy responses in melanoma patients (2019) · cites this paper as [3]
The Discussion reports that pembrolizumab, an anti-PD-1 therapy, improved progression-free and overall survival compared with ipilimumab in advanced melanoma. The study did not test anti-PD-1/CTLA-4 combination therapy or establish that these are the most effective immunotherapies overall. (LLM, conf=0.88)
Experimental — accuracy not yet measuredResponse rate was 38%, in line with published clinical data of anti-PD-1 therapy in metastatic melanoma patients.
“There were 16 responders (from here on, referred to as R) and 26 nonresponders (NR), yielding a response rate of 38%, which is in line with published clinical data of anti–PD-1 therapy in metastatic melanoma patients (5, 6).”
From The commensal microbiome is associated with anti-PD-1 efficacy in metastatic melanoma patients (2018) · cites this paper as [6]
Anti-PD-1 therapy gives long-term clinical benefit to about 40% of patients with advanced melanoma.
“Immune checkpoint blockade with monoclonal antibodies (mAbs) targeting programmed cell death protein 1 (PD-1) provides long-term clinical benefits to nearly 40% of patients with advanced melanoma (1–5).”
From Fecal microbiota transplant overcomes resistance to anti–PD-1 therapy in melanoma patients (2021) · cites this paper as [5]
Severe adverse reactions to immune checkpoint inhibitors include severe diarrhea, colitis, increased alanine aminotransferase levels, inflammation pneumonitis, and interstitial nephritis.
“Severe adverse reactions include severe diarrhea, colitis, increased alanine aminotransferase levels, inflammation pneumonitis, and interstitial nephritis (67, 73, 99).”
From Anti-PD-1 and Anti-CTLA-4 Therapies in Cancer: Mechanisms of Action, Efficacy, and Limitations (2018) · cites this paper as [73]
In a phase III trial, more than 30% of advanced melanoma patients achieved objective response with pembrolizumab monotherapy versus 12% with ipilimumab alone.
“In the subsequent phase III clinical trial, more than 30% of patients with advanced melanoma achieved an objective response following pembrolizumab monotherapy compared with 12% of patients treated with ipilimumab alone (58).”
From Immune Checkpoint Inhibitors for the Treatment of Cancer: Clinical Impact and Mechanisms of Response and Resistance (2021) · cites this paper as [58]
Response rates to ICIs range from 15-30% in most solid tumors to 45-60% in melanoma and MSI-H tumors.
“Response rates range from 15 to 30% (in most solid tumors) to 45–60% (in melanoma and MSI-H tumors).”
From Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors (2019) · cites this paper as [2]
Patients with preexisting autoimmune disorders (ADs) or those receiving systemic immunosuppression for organ transplantation have been universally excluded from clinical trials.
“In order to limit the risk of severe immune-related adverse events (irAEs) or exacerbation of underlying autoimmune or inflammatory disease, patients with preexisting autoimmune disorders (ADs) or those receiving systemic immunosuppression for organ transplantation have been universally excluded from clinical trials.3,4”
From Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: Review of the literature and personalized risk-based prevention strategy (2020) · cites this paper as [4]
Antibodies blocking PD-1 or PD-L1 have been approved to treat various solid and hematologic malignancies.
“At present, antibodies blocking PD-1 or its ligand PD-L1 have been approved to treat various solid and hematologic malignancies (Table 1) [7–12].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [11]
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- Authors
- Robert, C., Schachter, J., Long, G. V., Arance, A., Grob, J. J., Mortier, L., Daud, A., Carlino, M. S., McNeil, C., Lotem, M., Larkin, J., Lorigan, P., Neyns, B., Blank, C. U., Hamid, O., Mateus, C., Shapira-Frommer, R., Kosh, M., Zhou, H., Ibrahim, N., Ebbinghaus, S., & Ribas, A.
- Affiliations
- Université Paris-Sud (FR)
- Sheba Medical Center (IL)
- Hospital Clínic de Barcelona (ES)
- Hôpital de la Timone (FR)
- Centre Hospitalier Universitaire de Lille (FR)
- University of California, San Francisco (US)
- Royal Prince Alfred Hospital (AU)
- Hadassah Medical Center (IL)
- Royal Marsden Hospital (GB)
- University of Manchester (GB)
- Universitair Ziekenhuis Brussel (BE)
- The Netherlands Cancer Institute (NL)
- Angeles Clinic and Research Institute (US)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- University of California, Los Angeles (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-06-25
- Volume
- 372
- Issue
- 26
- Pages
- 2521-2532
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2152897456
- Semantic Scholar
- 0dac3ea80083f0a86598cb9af0a205554280551b
- Cited by
- 5,887
- References
- 26
- Citations by year
- 2026: 234 · 2025: 298 · 2024: 374 · 2023: 421 · 2022: 471 · 2021: 568 · 2020: 659 · 2019: 585 · 2018: 684 · 2017: 761 · 2016: 628 · 2015: 188 · 2014: 5 · 2013: 2
- FWCI
- 329.15
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- UWA Profiles and Research Repository (UWA) (submittedVersion, other-oa)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- Research Explorer (The University of Manchester) (submittedVersion)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- Funders
- Amgen
- Bristol-Myers Squibb
- Pfizer
- GlaxoSmithKline
- Genentech
- Kite Pharma
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Melanoma and MAPK Pathways
- Keywords
- ipilimumab, advanced melanoma, immune checkpoint inhibitors, anti-PD-1 therapy, CTLA-4 inhibition, progression-free survival, overall survival, dosing frequency, treatment-related adverse events, immune-related adverse events, response rate
- MeSH terms
- Ipilimumab, Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Agents, Female, Humans, Male, Melanoma, Middle Aged, Skin Neoplasms, Survival Analysis, Young Adult, Programmed Cell Death 1 Receptor, Antibodies, Monoclonal, Humanized
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