medwireNews: The combination of pembrolizumab and lenvatinib has durable antitumor activity and promising survival outcomes in treatment-naïve patients with advanced non-clear-cell renal cell carcinoma (RCC), say the KEYNOTE-B61 investigators.
Moreover, the safety profile “was consistent with the known profile of each agent alone and with the safety profile previously observed when the agents are used together,” they add.
The team continues: “Results from KEYNOTE-B61 support the use of pembrolizumab plus lenvatinib as a first-line treatment option for these patients.”
As reported in The Lancet Oncology, the phase 2 study enrolled 158 patients who had not received prior systemic treatment for stage IV non-clear-cell RCC. Fifty-nine percent of the participants had papillary histology, 18% had chromophobe histology, 4% had translocation histology, and the remaining had either unclassified (13%) or other (6%) histology.
At a median follow-up of 14.9 months, treatment with pembrolizumab 400 mg every 6 weeks for up to 18 cycles alongside lenvatinib 20 mg/day resulted in an objective response rate of 49%, with complete responses in 6% and partial in 44%. The median duration of response was unreached.
A further 23% of participants had stable disease for at least 6 months, giving a clinical benefit rate of 72%, while the disease control rate was 82%.
Laurence Albiges, from Gustave Roussy in Villejuif, France, and team highlight that “[g]enerally consistent results were observed with pembrolizumab plus lenvatinib across subgroups including by histological subtype, IMDC risk category, and presence or absence of sarcomatoid features.”
They add that the “[s]urvival outcomes were also promising” in the study population, with median progression-free and overall survival durations of 18 months and unreached, respectively, and corresponding 12-month rates of 63% and 82%.
Just over half the patients (51%) had a treatment-related adverse event of grade 3–4, with the most common event being hypertension, in 23% of patients, followed by proteinuria and stomatitis, each in 4%.
Any-cause adverse events led to discontinuation of pembrolizumab in 15% of patients, lenvatinib in 14%, and both drugs in 7%. There were eight deaths due to adverse events, but none were considered related to study treatment by investigators.
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