The DOI matches its Crossref record; 8 of the 8 references it cites were found in a registry or an index.
Phase I Study of Pembrolizumab (MK-3475; Anti–PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors
Abstract
Purpose: This phase I study evaluated the safety, maximum tolerated dose, antitumor activity, and pharmacokinetics and pharmacodynamics of pembrolizumab in patients with advanced solid tumors. Experimental Design: In a 3 + 3 dose escalation study, 10 patients received pembrolizumab 1, 3, or 10 mg/kg intravenously every 2 weeks until progression or intolerable toxicity. Seven additional patients received 10 mg/kg every 2 weeks. Thirteen patients participated in a 3-week intrapatient dose escalation (dose range, 0.005–10 mg/kg) followed by 2 or 10 mg/kg every 3 weeks. Tumor response was assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Results: No dose-limiting toxicities were observed. Maximum administered dose was 10 mg/kg every 2 weeks. One patient with melanoma and one with Merkel cell carcinoma experienced complete responses of 57 and 56+ weeks' duration, respectively. Three patients with melanoma experienced partial responses. Fifteen patients with various malignancies experienced stable disease. One patient died of cryptococcal infection 92 days after pembrolizumab discontinuation, following prolonged corticosteroid use for grade 2 gastritis considered drug related. Pembrolizumab exhibited pharmacokinetic characteristics typical of humanized monoclonal antibodies. Maximum serum target engagement was reached with trough levels of doses greater than or equal to 1 mg/kg every 3 weeks. Mechanism-based translational models with a focus on intratumor exposure prediction suggested robust clinical activity would be observed at doses ≥2 mg/kg every 3 weeks. Conclusions: Pembrolizumab was well tolerated and associated with durable antitumor activity in multiple solid tumors. The lowest dose with full potential for antitumor activity was 2 mg/kg every 3 weeks. Clin Cancer Res; 21(19); 4286–93. ©2015 AACR. See related commentary by van Elsas et al., p. 4251
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Improved Survival with Ipilimumab in Patients with Metastatic Melanoma
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Safety and activity of anti-PD-L1 antibody in patients with advanced cancer
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., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1200694 · Cited by 7,945
Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients
Herbst, R. S., Soria, J.-C., Kowanetz, M., Fine, G. D., Hamid, O., Gordon, M. S., Sosman, J. A., McDermott, D. F., Powderly, J. D., Gettinger, S. N., et al. (2014) · Nature · doi:10.1038/nature14011 · Cited by 5,231
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PD-L2 is a second ligand for PD-1 and inhibits T cell activation
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Pembrolizumab for the Treatment of Non–Small-Cell Lung Cancer
Garon, E. B., Rizvi, N. A., Hui, R., Leighl, N., Balmanoukian, A. S., Eder, J. P., Patnaik, A., Aggarwal, C., Gubens, M., Horn, L., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1501824 · Cited by 6,198
Self-citationHallmarks of response, resistance, and toxicity to immune checkpoint blockade
Morad, G., Helmink, B. A., Sharma, P., & Wargo, J. A. (2021) · Cell · doi:10.1016/j.cell.2021.09.020 · Cited by 1,648
Barroso-Sousa, R., Barry, W. T., Garrido-Castro, A. C., Hodi, F. S., Min, L., Krop, I. E., & Tolaney, S. M. (2018) · JAMA Oncology · doi:10.1001/jamaoncol.2017.3064 · Cited by 1,115
RAS-targeted therapies: is the undruggable drugged?
Moore, A. R., Rosenberg, S. C., McCormick, F., & Malek, S. (2020) · Nature Reviews Drug Discovery · doi:10.1038/s41573-020-0068-6 · Cited by 1,103
Immune-checkpoint inhibitors: long-term implications of toxicity
Johnson, D. B., Nebhan, C. A., Moslehi, J. J., & Balko, J. M. (2022) · Nature Reviews Clinical Oncology · doi:10.1038/s41571-022-00600-w · Cited by 982
Metadata
- Authors
- Patnaik, A., Kang, S. P., Rasco, D., Papadopoulos, K. P., Elassaiss-Schaap, J., Beeram, M., Drengler, R., Chen, C., Smith, L., Espino, G., Gergich, K., Delgado, L., Daud, A., Lindia, J. A., Li, X. N., Pierce, R. H., Yearley, J. H., Wu, D., Laterza, O., Lehnert, M., Iannone, R., & Tolcher, A. W.
- Venue
- Clinical Cancer Research
- Published
- 2015-09-30
- Volume
- 21
- Issue
- 19
- Pages
- 4286-4293
- ISSN
- 1078-0432 (ISSN-L)
- 1557-3265
- OpenAlex
- W2150048477
- Cited by
- 807
- References
- 8
- FWCI
- 27.43
- Type
- journal article
- Language
- en
- Open access
- closed
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