Lenvatinib plus pembrolizumab showed significantly improved progression-free and overall survival outcomes compared with sunitinib in patients with advanced renal cell carcinoma in the CLEAR study (NCT02811861). Here, we used CLEAR data to characterize common adverse reactions (ARs; adverse-event preferred terms grouped in accordance with regulatory authority review) associated with lenvatinib plus pembrolizumab and review management strategies for select ARs.
Safety data from the 352 patients who received lenvatinib plus pembrolizumab in the CLEAR study were analyzed. Key ARs were chosen based on frequency of occurrence (≥30%). Time to first onset and management strategies for key ARs were detailed.
The most frequent ARs were fatigue (63.1%), diarrhea (61.9%), musculoskeletal pain (58.0%), hypothyroidism (56.8%), and hypertension (56.3%); grade ≥3 severity ARs that occurred in ≥5% of patients were hypertension (28.7%), diarrhea (9.9%), fatigue (9.4%), weight decreased (8.0%), and proteinuria (7.7%). Median times to first onset of all key ARs were within approximately 5 months (approximately 20 weeks) of starting treatment. Strategies for effectively managing ARs included baseline monitoring, drug-dose modifications, and/or concomitant medications.
The safety profile of lenvatinib plus pembrolizumab was consistent with the known profile of each monotherapy; ARs were considered manageable with strategies including monitoring, dose modifications, and supportive medications. Proactive and prompt identification and management of ARs are important for patient safety and to support continued treatment.
NCT02811861.
The oncologist. 2023 Mar 02 [Epub ahead of print]
Robert Motzer, Saby George, Jaime R Merchan, Thomas E Hutson, Xun Song, Rodolfo F Perini, Ran Xie, Urmi Bapat, Javier Puente
Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA., Department of Medicine, University of Miami Sylvester Comprehensive Cancer Center, Miami, FL, USA., Department of Medical Oncology, Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, TX, USA., Clinical Research, Merck & Co., Inc., Rahway, NJ, USA., Biostatistics, Eisai Inc., Nutley, NJ, USA., Clinical Research, Eisai Inc., Nutley, NJ, USA., Department of Medical Oncology, Hospital Clinico Universitario San Carlos, Madrid, Spain.