TOKYO, Feb 15, 2021 - (JCN Newswire) - Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced the first presentation of new investigational data from the pivotal Phase 3 CLEAR study (Study 307/KEYNOTE-581) in an oral presentation session (Abstract #269) at the virtual 2021 Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in the New England Journal of Medicine(1). The trial 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). LENVIMA plus KEYTRUDA demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS; HR=0.39 [95% CI: 0.32-0.49]; p

"Continued efforts to improve outcomes in patients with advanced renal cell carcinoma are critical, considering that the number of people diagnosed with the disease has more than doubled over the last 50 years, and almost one-third of these patients are diagnosed at an advanced stage," said Dr. Robert Motzer, Medical Oncologist, Kidney Cancer Section Head, Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center. "KEYTRUDA plus LENVIMA demonstrated a median progression-free survival of nearly two years, and seven in 10 patients experienced an objective response. This combination also significantly improved overall survival compared with sunitinib, with a 34% reduction in risk of death. These results suggest that this combination has the potential to impact clinical practice for this type of devastating cancer."

In the trial's primary endpoint of PFS, as assessed by independent review per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, LENVIMA plus KEYTRUDA reduced the risk of disease progression or death by 61% (HR=0.39 [95% CI: 0.32-0.49]; p

"These promising results are a testament to our company's commitment to help improve outcomes for patients diagnosed with cancer," said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck & Co., Inc., Kenilworth, N.J., U.S.A. Research Laboratories. "In this trial, KEYTRUDA plus LENVIMA demonstrated superior efficacy benefits compared with sunitinib. If approved, we believe this combination has the potential to be an important new treatment option for patients with advanced renal cell carcinoma in the first-line setting."

In the trial's second experimental treatment arm, LENVIMA plus everolimus reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI: 0.53-0.80]; p

"These investigational data from the CLEAR study (Study 307/KEYNOTE-581) represent a significant milestone in our clinical research efforts in advanced renal cell carcinoma, with encouraging Phase 3 results in this population for the LENVIMA plus KEYTRUDA combination and with more than 700 patients having received LENVIMA plus everolimus in the clinical trial setting," said Dr. Takashi Owa, Vice President, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai. "Our progress thus far also reflects the significant contributions of dedicated patients, healthcare staff and researchers who continued to support this study during the global pandemic, to whom we extend our deepest gratitude."

In the LENVIMA plus KEYTRUDA arm, treatment-related adverse events (TRAEs) led to discontinuation of LENVIMA in 18.5% of patients, of KEYTRUDA in 25.0% of patients, and of both in 9.7% of patients. In the LENVIMA plus everolimus arm, TRAEs led to discontinuation of LENVIMA in 16.1% of patients, of everolimus in 19.2% of patients, and of both in 13.5% of patients. In the sunitinib arm, TRAEs led to discontinuation of sunitinib in 10.0% of patients. Grade 5 TRAEs occurred in 1.1% of patients in the LENVIMA plus KEYTRUDA arm and 0.8% of patients in the LENVIMA plus everolimus arm, versus 0.3% of patients in the sunitinib arm. Grade >/=3 TRAEs occurred in 71.6% of patients in the LENVIMA plus KEYTRUDA arm, in 73.0% of patients in the LENVIMA plus everolimus arm, and in 58.8% of patients in the sunitinib arm. The most common TRAEs of any grade occurring in at least 20% of patients in the LENVIMA plus KEYTRUDA arm were diarrhea (54.5%), hypertension (52.3%), hypothyroidism (42.6%), decreased appetite (34.9%), fatigue (32.1%) and stomatitis (32.1%). In the LENVIMA plus everolimus arm, the most common TRAEs of any grade occurring in at least 20% of patients were diarrhea (59.7%), stomatitis (45.6%), hypertension (43.1%), fatigue (36.6%), decreased appetite (34.9%) and proteinuria (31.8%). In the sunitinib arm, the most common TRAEs of any grade occurring in at least 20% of patients were diarrhea (44.4%), hypertension (39.1%), stomatitis (37.4%), hand-foot syndrome (35.9%), fatigue (32.1%) and nausea (27.6%).

(1) Motzer R. et al. Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. The New England Journal of Medicine

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