Eisai: New Data on LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Versus Sunitinib

In First-Line Treatment for Patients With Advanced Renal Cell Carcinoma From Pivotal Phase 3 CLEAR/KEYNOTE-581 Trial Presented at 2021 ASCO Annual Meeting

Results From New Analysis Evaluating Health-Related Quality of Life (HRQoL) Based on Patient-Reported Outcomes Using Three HRQoL Scales

TOKYO and KENILWORTH, N.J., June 8, 2021 - (JCN Newswire) - Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A. announced new investigational data from the pivotal Phase 3 CLEAR(Study 307)/KEYNOTE-581 trial, which evaluated the combinations of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A., and LENVIMA plus everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Results from a new analysis evaluating health-related quality of life (HRQoL) based on patient-reported outcomes are being presented during an oral abstract session at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #4502). Data from CLEAR/KEYTNOTE-581 were originally presented at the 2021 Genitourinary Cancers Symposium (ASCO GU) and published in the New England Journal of Medicine, and data from this trial are currently under review with the U.S. Food and Drug Administration (FDA).

"This new analysis expands our understanding of the results we've seen from the CLEAR/KEYNOTE-581 trial in the treatment of patients with advanced renal cell carcinoma," said Dr. Robert Motzer, Medical Oncologist, Kidney Cancer Section Head, Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center. "The additional data showed an improvement of specific health-related quality of life measures for patients who received LENVIMA plus KEYTRUDA compared with sunitinib, supporting the importance of this combination as a potential new first-line treatment option for patients."

"We continue to see an increasing number of patients diagnosed with advanced renal cell carcinoma and remain committed to improving outcomes for those facing this difficult-to-treat disease," said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck & Co., Inc., Kenilworth, N.J., U.S.A. Research Laboratories. "This new analysis builds on earlier findings from the CLEAR/KEYNOTE-581 trial and further supports the potential use of KEYTRUDA plus LENVIMA for the treatment of patients in the first-line setting."

"This analysis addresses questions of interest to healthcare professionals who treat patients with advanced renal cell carcinoma and reinforces the LENVIMA plus KEYTRUDA combination as a possible new treatment option for patients with this disease," said Dr. Takashi Owa, Chief Medicine Creation Officer and Chief Discovery Officer, Oncology Business Group at Eisai. "These results reflect Eisai and Merck's shared commitment to relentlessly pursue thorough scientific investigations with the goal of improving cancer care."

Data From Health-Related Quality-of-Life (HRQoL) Analysis From CLEAR/KEYNOTE-581
In an analysis of a secondary endpoint of HRQoL scores in the CLEAR/KEYNOTE-581 trial, LENVIMA plus KEYTRUDA and LENVIMA plus everolimus were evaluated to determine the impact on HRQoL compared to sunitinib in patients with advanced RCC. This was assessed based on patient-reported outcomes using three HRQoL and symptom measures: Functional Assessment of Cancer Therapy Kidney Symptom Index - Disease-Related Symptoms (FKSI-DRS), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer - Core 30 (EORTC QLQ-C30) and European Quality of Life Five-Dimensions - 3-Level System (EuroQoL EQ-5D-3L). Unless otherwise noted, HRQoL analyses were based on data from randomized patients who received at least one dose of study treatment. No adjustments for multiple testing or estimation were used; p-values (two-sided) and confidence intervals (CI) are nominal and descriptive. Longitudinal change from baseline was assessed by mixed model analysis. Least squares mean differences (LSMD) and 95% CI were calculated from baseline. Time to deterioration (based on changes in HRQoL and disease-related symptom scores >/= meaningful thresholds) was assessed using time to first deterioration (TTD), which is the number of weeks between randomization and the first deterioration event, and time until definitive deterioration (TUDD), which is the number of weeks between randomization and the earliest deterioration event with no subsequent recovery above the deterioration threshold or no subsequent HRQoL assessment data. All times to deterioration were calculated and compared using the Kaplan-Meier method, stratified log-rank tests and Cox models.

LENVIMA plus KEYTRUDA demonstrated similar changes from baseline at mean follow-up (Week 46) on 14 out of 18 HRQoL and disease-related symptom scores and better HRQoL and disease-related symptom scores for the following measures ( LSMD [95% CI]): physical functioning (3.01 [0.48, 5.54]), fatigue (-2.80 [-5.52, -0.08]), dyspnea (-2.79 [-5.33, -0.25]) and constipation (-2.19 [-4.19, -0.18]), as measured by the QLQ-C30, versus sunitinib. LENVIMA plus everolimus demonstrated similar changes from baseline at mean follow-up (Week 46) on 14 out of 18 HRQoL and disease-related symptom scores and worse HRQoL and disease-related symptom scores in the following measures (LSMD [95% CI]): Global Health Score/QoL (-2.81[-5.08, -0.54]), pain (2.80 [0.11, 5.49]), appetite loss (4.23 [1.34, 7.13]) and diarrhea (5.26 [2.61, 7.91]) compared to sunitinib.

LENVIMA plus KEYTRUDA demonstrated a similar TTD in 14 out of 18 HRQoL and disease-related symptom scores, and a delay in TTD for physical functioning, dyspnea, appetite loss, and EQ-5D visual analog scale compared to sunitinib. LENVIMA plus KEYTRUDA demonstrated a delay in TUDD in 16 out of 18 HRQoL and disease-related symptom scores and a similar TUDD for cognitive functioning and financial difficulties compared to sunitinib.

For more information, visit https://www.eisai.com/news/2021/news202140.html.

Source: Eisai

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