Characterization and management of adverse reactions from the CLEAR study in advanced renal cell carcinoma treated with lenvatinib plus pembrolizumab
https://doi.org/10.17650/1726-9776-2023-19-2-29-40
About the Authors
R. MotzerUnited States
Department of Medicine
Competing Interests:
R. Motzer: финансирование исследований от Bristol Myers Squibb, Eisai, Exelixis, Genentech/Roche, Merck, Pfizer и Aveo Pharmaceuticals; консультант AstraZeneca, Aveo Pharmaceuticals, Eisai, EMD Serono, Exelixis, Genentech/Roche, Incyte, Lilly, Merck, Novartis, Pfizer и Takeda.
S. George
United States
Department of Medicine
Competing Interests:
S. George: финансирование исследований от Pfizer, Merck, Agensys, Novartis, Bristol Myers Squibb, Bayer, Eisai, Seattle Genetics/Astellas, Calithera Biosciences, Corvus Pharmaceuticals, Surface Oncology, Exelixis, Aravive, Aveo и Gilead Sciences; консультант Bristol Myers Squibb, Bayer, Pfizer, Exelixis, Corvus Pharmaceuticals, Sanofi, EMD Serono, Seattle Genetics/Astellas, Eisai, Merck, Aveo и QED Therapeutics.
J. R. Merchan
United States
Department of Medicine
Competing Interests:
J.R. Merchan: финансирование исследований от Corvus Pharmaceuticals, Eisai, Genentech/Roche, Lilly, Merck, Novartis, Peloton Therapeutics, Pfizer, Replimune, Seattle Genetics/Astellas, Sillajen, Tizona Therapeutics, Tocagen, Vyriad; консультант или советник Exelixis.
T. E. Hutson
United States
Department of Medical Oncology
Competing Interests:
T.E. Hutson: финансирование исследований от Bristol Myers Squibb, Eisai, Exelixis, Johnson & Johnson, Pfizer; консультант или советник Astellas Pharma, Bayer/Onyx, Bristol Myers Squibb, Eisai, Exelixis, Johnson & Johnson, Novartis, Pfizer; получение гонораров от Astellas Pharma, Bayer/Onyx, Bristol Myers Squibb, Eisai, Exelixis, Johnson & Johnson, Novartis, Pfizer; спикер Astellas Pharma, Bristol Myers Squibb, Eisai, Exelixis, Johnson & Johnson, Pfizer
X. Song
United States
Competing Interests:
X. Song: сотрудник Merck Sharp & Dohme LLC – дочерней компании Merck & Co., Inc. (Рауэй, Нью-Джерси, США).
R. F. Perini
United States
Competing Interests:
R.F. Perini: сотрудник Merck Sharp & Dohme LLC – дочерней компании Merck & Co., Inc. (Рауэй, Нью-Джерси, США).
R. Xie
United States
Competing Interests:
R. Xie: сотрудник Eisai Inc.
U. Bapat
United States
Competing Interests:
U. Bapat: бывший сотрудник Eisai Inc.
J. Puente
Spain
Department of Medical Oncology
Competing Interests:
J. Puente: финансирование исследований от Astellas Pharma, Pfizer; консультант или советник Pfizer, Astellas Pharma, Janssen-Cilag, Merck Sharp & Dohme, Bayer, Roche, Bristol Myers Squibb, Clovis Oncology, Ipsen, Eisai, Sanofi; получение гонораров от Pfizer, Bristol Myers Squibb, Ipsen, AstraZeneca, Roche, MSD Oncology, Janssen-Cilag, Astellas Pharma, EUSA Pharma, Eisai, Pierre Fabre, Sanofi, Bayer; покрытие проезда/проживания/расходов от Pfizer, Roche, Janssen-Cilag, Bristol Myers Squibb, MSD Oncology
References
1. Motzer R., Alekseev B., Rha S.Y. et al. Lenvatinib plus pembrolizumab or everolimus for advanced renal cell carcinoma. N Engl J Med 2021;384(14):1289–300. DOI: 10.1056/NEJMoa2035716
2. Lenvima® (lenvatinib) [prescribing information]. Nutley, NJ, USA: Eisai Inc., 2021.
3. Kisplyx 4 mg and 10 mg hard capsules [summary of product characteristics]. Frankfurt am Main, Germany: Eisai GmbH, 2021.
4. Keytruda® (pembrolizumab) [prescribing information]. Whitehouse Station, NJ, USA: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., 2022.
5. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry: adverse reactions section of labeling for human prescription drug and biological products – content and format 2006. Accessed June 1, 2022. Available at: https://www.fda.gov/media/72139/download.
6. Sher A.F., Golshani G.M., Wu S. Fatal adverse events associated with pembrolizumab in cancer patients: a meta-analysis. Cancer Invest 2020;38(2):130–8. DOI: 10.1080/07357907.2020.1721521
7. Hattersley R., Nana M., Lansdown A.J. Endocrine complications of immunotherapies: a review. Clin Med (Lond) 2021;21(2):e212–22. DOI: 10.7861/clinmed.2020-0827
8. Opdivo® (nivolumab) [prescribing information]. Princeton, NJ, USA: Bristol Myers Squibb Company, 2022.
9. Yervoy® (ipilimumab) [prescribing information]. Princeton, NJ, USA: Bristol Myers Squibb Company, 2022.
10. Inlyta® (axitinib) [prescribing information]. New York, NY, USA: Pfizer Labs, 2020.
11. Bavencio® (avelumab) [prescribing information]. Rockland, MA, USA: EMD Serono, Inc., 2022.
12. Rini B.I., Plimack E.R., Stus V. et al. Pembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med 2019;380(12):1116–27. DOI: 10.1056/nejmoa1816714
13. Choueiri T.K., Powles T., Burotto M. et al. Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med 2021;384(9):829–41. DOI: 10.1056/nejmoa2026982
14. Motzer R.J., Tannir N.M., McDermott D.F. et al. Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma. N Engl J Med 2018;378(14):1277–90. DOI: 10.1056/NEJMoa1712126
15. Motzer R.J., Penkov K., Haanen J. et al. Avelumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med 2019;380(12):1103–15. DOI: 10.1056/nejmoa1816047
16. Bianchi L., Rossi L., Tomao F. et al. Thyroid dysfunction and tyrosine kinase inhibitors in renal cell carcinoma. Endocr Relat Cancer 2013;20(5):R233–45. DOI: 10.1530/erc-13-0201
17. Rizzo A., Mollica V., Santoni M. et al. Risk of selected gastrointestinal toxicities in metastatic renal cell carcinoma patients treated with immuno-TKI combinations: a meta-analysis. Expert Rev Gastroenterol Hepatol 2021;15(10):1225–32. DOI: 10.1080/17474124.2021.1948328
18. Schlumberger M., Tahara M., Wirth L.J. et al. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med 2015;372(7):621–30. DOI: 10.1056/nejmoa1406470
19. Kudo M., Finn R.S., Qin S. et al. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet 2018;391(10126):1163–73. DOI: 10.1016/S0140-6736(18)30207-1
20. Makker V., Colombo N., Casado Herráez A. et al. Lenvatinib plus pembrolizumab for advanced endometrial cancer. N Engl J Med 2022;386(5):437–48. DOI: 10.1056/nejmoa2108330
21. Motzer R.J., Hutson T.E., Glen H. et al. Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial. Lancet Oncol 2015;16(15):1473–82. DOI: 10.1016/s1470-2045(15)00290-9
22. Motzer R.J., Taylor M.H., Evans T.R.J. et al. Lenvatinib dose, efficacy, and safety in the treatment of multiple malignancies. Expert Rev Anticancer Ther 2022;22(4):383–400. DOI: 10.1080/14737140.2022.2039123
Review
For citations:
Motzer R., George S., Merchan J.R., Hutson T.E., Song X., Perini R.F., Xie R., Bapat U., Puente J. Characterization and management of adverse reactions from the CLEAR study in advanced renal cell carcinoma treated with lenvatinib plus pembrolizumab. Cancer Urology. 2023;19(2):29-40. (In Russ.) https://doi.org/10.17650/1726-9776-2023-19-2-29-40