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Safety and activity of anti-PD-L1 antibody in patients with advanced cancer
Open accessAbstract
BACKGROUND: Programmed death 1 (PD-1) protein, a T-cell coinhibitory receptor, and one of its ligands, PD-L1, play a pivotal role in the ability of tumor cells to evade the host's immune system. Blockade of interactions between PD-1 and PD-L1 enhances immune function in vitro and mediates antitumor activity in preclinical models. METHODS: In this multicenter phase 1 trial, we administered intravenous anti-PD-L1 antibody (at escalating doses ranging from 0.3 to 10 mg per kilogram of body weight) to patients with selected advanced cancers. Anti-PD-L1 antibody was administered every 14 days in 6-week cycles for up to 16 cycles or until the patient had a complete response or confirmed disease progression. RESULTS: As of February 24, 2012, a total of 207 patients--75 with non-small-cell lung cancer, 55 with melanoma, 18 with colorectal cancer, 17 with renal-cell cancer, 17 with ovarian cancer, 14 with pancreatic cancer, 7 with gastric cancer, and 4 with breast cancer--had received anti-PD-L1 antibody. The median duration of therapy was 12 weeks (range, 2 to 111). Grade 3 or 4 toxic effects that investigators considered to be related to treatment occurred in 9% of patients. Among patients with a response that could be evaluated, an objective response (a complete or partial response) was observed in 9 of 52 patients with melanoma, 2 of 17 with renal-cell cancer, 5 of 49 with non-small-cell lung cancer, and 1 of 17 with ovarian cancer. Responses lasted for 1 year or more in 8 of 16 patients with at least 1 year of follow-up. CONCLUSIONS: Antibody-mediated blockade of PD-L1 induced durable tumor regression (objective response rate of 6 to 17%) and prolonged stabilization of disease (rates of 12 to 41% at 24 weeks) in patients with advanced cancers, including non-small-cell lung cancer, melanoma, and renal-cell cancer. (Funded by Bristol-Myers Squibb and others; ClinicalTrials.gov number, NCT00729664.).
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“For example, it is now evident that simply combining two “off the shelf” immune checkpoint inhibitors to enhance effector T cell function – a strategy that has worked in several other solid cancers – has minimal to no impact in a disease where a multiplicity of immune defects co-exist283,284.”
From Pancreatic cancer: Advances and challenges (2023) · cites this paper as [283]
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“A promising aspect is that clinical blockade of B7-H1/PD-1, the key T cell exhaustion pathway, may rescue T cell effector functions in vivo, and results in significant objective clinical responses [32,33].”
From T cell anergy, exhaustion, senescence, and stemness in the tumor microenvironment (2013) · cites this paper as [32]
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“Nivolumab treatment exhibited 9% rate of treatmentrelated grade 3/4 AE [ 250 ], with three drugrelated deaths due to pneumonitis [ 147 ].”
BackgroundExhaustion of Activated CD8 T Cells Predicts Disease Progression in Primary HIV-1 Infection
Hoffmann, M., Pantazis, N., Martin, G. E., Hickling, S., Hurst, J. M., Meyerowitz, J., Willberg, C. B., Robinson, N., Brown, H. L., Fisher, M., et al. (2016) · PLoS Pathogens · doi:10.1371/journal.ppat.1005661 · Cited by 151
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Size matters: Dissecting key parameters for panel‐based tumor mutational burden analysis
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Bibliometric analysis of global research on PD-1 and PD-L1 in the field of cancer
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Emerging therapies for non-small cell lung cancer
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“NSCLC is one of the leading cancers implicated in molecular and immune checkpoint-targeted therapy, thereby achieving significant improvements in the clinical outcome of patients.(13,14,30) Among the immune checkpoints, the PD-1/PDL1 pathway has emerged as a strong immune target for NSCLC.”
BackgroundCXCR4 Ligands: The Next Big Hit?
Walenkamp, A., Lapa, C., Herrmann, K., & Wester, H. (2017) · Journal of Nuclear Medicine · doi:10.2967/jnumed.116.186874 · Cited by 156
“Nevertheless, it has become apparent that even if these T-cell checkpoint antagonists overcome some of the immunosuppressive effects of the tumor microenvironment, other, more fundamental inhibitory reactions in the tumor microenvironment may explain why most patients—especially those with microsatellite stable colore…”
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Progress in PD-1/PD-L1 pathway inhibitors: From biomacromolecules to small molecules
Lin, X., Lu, X., Luo, G., & Xiang, H. (2019) · European Journal of Medicinal Chemistry · doi:10.1016/j.ejmech.2019.111876 · Cited by 156
Telomere Stress Potentiates STING-Dependent Anti-tumor Immunity
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“Immunotherapies have revolutionized the treatment of many cancers in the immunooncology field (Brahmer et al., 2012; Hodi et al., 2010; Ribas and Wolchok, 2018; Topalian et al., 2012).”
Dietary Lactobacillus -Derived Exopolysaccharide Enhances Immune-Checkpoint Blockade Therapy
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“The blockade of immune checkpoints, critical immunosuppressive mechanisms for tumors, such as CTLA-4 and PD-L1/PD-1 induces robust anti-tumor immune responses (2, 3).”
Lesokhin, A. M., Callahan, M. K., Postow, M. A., & Wolchok, J. D. (2015) · Science Translational Medicine · doi:10.1126/scitranslmed.3010274 · Cited by 158
Inhibitory receptors as targets for cancer immunotherapy
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“However, despite the significant measurable responses observed clinically, treatment with inhibitors to PD-1 and CTLA-4 have only produced objective responses in 10–28% of patients treated when utilized as a monotherapy (Hodi et al., 2010; Brahmer et al., 2012; Topalian et al., 2012).”
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Cancer Treatment with Anti-PD-1/PD-L1 Agents: Is PD-L1 Expression a Biomarker for Patient Selection?
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“7 % with dacarbazine although the difference was not as marked [9].”
BackgroundBreast cancer genomics and immuno-oncological markers to guide immune therapies
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Immunotherapy for pancreatic cancer: Barriers and breakthroughs
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Cardiotoxicity of Immune Checkpoint Inhibitors
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“Hope was set on checkpoint blockade immunotherapy but these otherwise promising therapeutics failed to show significance in pancreatic cancer (6, 7).”
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Targeting the interleukin-17 immune axis for cancer immunotherapy
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“…in patients whose malignancies previously carried a dismal prognosis, providing hope for those with advanced and metastatic melanoma, renal, and lung cancers (Borghaei et al., 2015; Brahmer et al., 2015; Eggermont et al., 2016; Hodi et al., 2010; Robert et al., 2015; Brahmer, J., et al. 2017.”
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The interplay of effector and regulatory T cells in cancer
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Harnessing the Power of the Immune System to Target Cancer
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Trial Watch: Monoclonal antibodies in cancer therapy
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“5 Introduction The development of inhibitors of the programmed cell death protein 1 (PD-1) or its ligand (PD-L1) represents a paradigm shift in the treatment of advanced cancers, with significant clinical benefits demonstrated in patients with several different histologies (1-4).”
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Immune and molecular correlates in melanoma treated with immune checkpoint blockade
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“Immune-related adverse events may occur during either anti-CTLA4 or anti–PD-1/anti–PD-L1 therapy.(38,39)”
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“examined in trials in patients with melanoma, lung cancer, and other tumor types.(13,14) The Keynote-028 phase I study demonstrated promising response and disease control rates in a small number of patients with MPM,(15) prompting widespread interest in using checkpoint inhibitors in MPM.”
Metadata
- Authors
- Brahmer, J. R., Tykodi, S. S., Chow, L. Q. M., Hwu, W.-J., Topalian, S. L., Hwu, P., Drake, C. G., Camacho, L. H., Kauh, J., Odunsi, K., Pitot, H. C., Hamid, O., Bhatia, S., Martins, R., Eaton, K., Chen, S., Salay, T. M., Alaparthy, S., Grosso, J. F., Korman, A. J., Parker, S. M., Agrawal, S., Goldberg, S. M., Pardoll, D. M., Gupta, A., & Wigginton, J. M.
- Affiliations
- Johns Hopkins University (US)
- Seattle Cancer Care Alliance (US)
- The University of Texas MD Anderson Cancer Center (US)
- Baylor St. Luke's Medical Center (US)
- Winship Cancer Institute (US)
- Roswell Park Comprehensive Cancer Center (US)
- Mayo Clinic (US)
- Bristol-Myers Squibb (United States) (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2012-06-28
- Volume
- 366
- Issue
- 26
- Pages
- 2455-2465
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC3563263
- OpenAlex
- W2101653483
- Cited by
- 7,945
- References
- 39
- Citations by year
- 2026: 178 · 2025: 315 · 2024: 418 · 2023: 533 · 2022: 566 · 2021: 611 · 2020: 694 · 2019: 629 · 2018: 592 · 2017: 733 · 2016: 723 · 2015: 762 · 2014: 573 · 2013: 493 · 2012: 108
- FWCI
- 306.18
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (UL1TR000454)
- National Cancer Institute (U10CA180802, P30CA015704, R01CA142779, P30CA006973)
- National Center for Research Resources (UL1RR024148)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Life Sciences › Immunology and Microbiology › Immunology › T-cell and B-cell Immunology
- Keywords
- PD-L1 inhibitors, PD-L1 blockade, PD-1/PD-L1 axis, immune checkpoint inhibitors, advanced cancer, non-small cell lung cancer, melanoma, renal cell carcinoma, ovarian cancer, treatment safety, objective response rate, antitumor immunity
- MeSH terms
- Nivolumab, Adult, Antibodies, Monoclonal, Antineoplastic Agents, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Dose-Response Relationship, Drug, Female, Humans, Male, Melanoma, Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Colorectal Neoplasms, Programmed Cell Death 1 Receptor
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