Lenvima-Keytruda Combo Shows Superior Benefit Over Sutent Across Several Subgroups of Patients with Kidney Cancer

Treatment with Lenvima (lenvatinib) plus Keytruda (pembrolizumab) produced improved outcomes compared to Sutent (sunitinb) in patients with advanced renal cell carcinoma, including patients across various risk levels, according to findings from a phase 3 trial.

The data, which were recently presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, indicated that the combination was associated with better progression-free survival (time during and after treatment when the patient lives without disease progression), overall survival (time from diagnosis or treatment start when patients are alive) and overall reponse rate (a percentage of pateints with a partial or complete response to treatment) outcomes.

“Overall, our results indicated that (Lenvima) plus (Keytruda) has improved efficacy parameters and outcome parameters compared to (Sutent) in all subgroups of patients,” Dr. Viktor Grünwald, of the University Hospital Essen in Essen, Germany, explained in a presentation of the data.

Of the 1,069 patients enrolled in the study, 335 were assigned to Lenvima plus Keytruda (median age, 64 years) and 357 were assigned to Sutent (median age, 61 years). Pateints received either Lenvima delivered orally once daily plus intravenous Keytruda every three weeks, Lenvima plus the chemotherapy everolimusdelivered orally once daily, or oral Sutent once daily for four weeks on and two weeks off.

Patients in the Lenvima plus Keytruda group either had favorable-risk (31%), intermediate-risk (59.2%)or poor-risk disease (9.3%). As for patients in the Sutent group, 34.7% had favorable-risk, 53.8% had intermediate-risk, and 10.4% had poor-risk disease.

Pateints in the intermediate/poor risk subgroup treated with Lenvima plus Keytruda had a median progression-free survival of 22.1 months compared with 5.9 months for patients treated with Sutent. In the favorable risk subgroup, the median progression-free survival was 28.1 months compared with 12.9 months, respectively.

The overall survival data also favored Lenvima plus Keytruda in both the intermediate/poor risk and IMDC–favorable risk subgroups, although evaluating overall survival was considered inadequate due to too few events.

A 72.4% overall response rate was observed in the Lenvima plus Keytruda group compared with a 28.8% overall reponse rate in the Sutent group, when evaluating the intermediate/poor risk subgroup. For the favorable risk subgroup, the overall reponse rates were 68.2% and 50.8%, respectively.

The investigative team also analyzed efficacy data via target kidney lesions, with the median progression-free survival being superior in the Lenvima plus Keytruda group (22.1 months) over the Sutent group (7.5 months). For patients without target kidney lesions, corresponding medians were 25.8 months and 9.4 months, respectively.

The overall response rates were consistently better in the Lenvima plus Keytruda groups regardless of target kidney lesion status. Specifically, the overall reponse rate was 71.8% compared with 27% with target kidney lesions and 70.8% versus 38.5% without target kidney lesions.

In patients who received Lenvima plus Keytruda, complete responses were maintained in 79.3% of patients at 24 months and 74.3% of patients at 36 months.

Moreover, in the six-month landmark analysis, confirmed response or a reduction in target lesions of more than 75% were observed in 12.4% of patients in the Lenvima plus Keytruda group compared with 4.5% of patients in the Sutent group.

“Notably, patients with complete response or near complete response derived tremendous benefit from this type of combination,” continued Grünwald in his presentation.

These results, according to the study authors, suggest that Lenvima plus Keytruda could be considered as a potential new treatment option in the first-line setting for patients with advanced renal cell carcinoma.

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