TOKYO, Japan I October 12, 2016 I Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that a presentation on the results of a Phase Ib clinical study of its in-house developed multiple receptor tyrosine kinase inhibitor lenvatinib mesylate (lenvatinib) in combination with the anti-PD-1 antibody pembrolizumab developed by Merck & Co., Inc. (Kenilworth, New Jersey, U.S.A.), known as MSD outside the United States and Canada, in patients with selected solid tumors was given at the European Society for Medical Oncology (ESMO) Congress held from October 7 to 11. Development of this combination regimen is being conducted jointly under the cooperation of both companies.
This investigational study is a multicenter, open-label Phase Ib/II clinical study to evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab. In the Phase Ib part of the study, which was conducted to determine and confirm the maximum tolerated dose (MTD), 13 patients with selected solid tumors (8 patients with renal cell carcinoma, 2 patients with endometrial cancer, 2 patients with non-small cell lung cancer and 1 patient with melanoma) that had progressed after treatment with approved therapies or for which there are no standard effective therapies available were administered lenvatinib (either 24 mg or 20 mg daily) and pembrolizumab (200 mg intravenously every three weeks).
According to the latest results of the Phase Ib part of the study as of August 2016, dose-limiting toxicities (DLTs) were reported in 2 of 3 patients in the lenvatinib 24 mg / pembrolizumab 200 mg group. No DLTs were reported in the lenvatinib 20 mg / pembrolizumab 200 mg group (10 patients), and the MTD was confirmed as 20 mg of lenvatinib per day / 200 mg of pembrolizumab every three weeks. The objective response rate, one of the study’s secondary endpoints, was 69.2% (n of 13 patients). Grade 3 or higher Treatment-Emergent Adverse Events (TEAEs) were observed in 69.2% of patients, and no patients had discontinued treatment due to TEAEs. The three most frequently observed adverse events were decreased appetite, diarrhea and fatigue.
Takashi Owa, Ph.D, Chief Medicine Creation Officer of Eisai’s Oncology Business Group, commented “From the results of this study for patients who had progressed after treatment with approved therapies or for which there are no standard effective therapies available, we are encouraged to further explore the combination of lenvatinib and pembrolizumab in the next stage of clinical development.”
Currently, the Phase II part of the study is underway in the United States, while preparations to initiate a Phase Ib clinical study in Japan are also underway.
Eisai regards oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai remains committed to providing further clinical evidence for lenvatinib aimed at maximizing value of the drug as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.
SOURCE: Eisai
Post Views: 146
TOKYO, Japan I October 12, 2016 I Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that a presentation on the results of a Phase Ib clinical study of its in-house developed multiple receptor tyrosine kinase inhibitor lenvatinib mesylate (lenvatinib) in combination with the anti-PD-1 antibody pembrolizumab developed by Merck & Co., Inc. (Kenilworth, New Jersey, U.S.A.), known as MSD outside the United States and Canada, in patients with selected solid tumors was given at the European Society for Medical Oncology (ESMO) Congress held from October 7 to 11. Development of this combination regimen is being conducted jointly under the cooperation of both companies.
This investigational study is a multicenter, open-label Phase Ib/II clinical study to evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab. In the Phase Ib part of the study, which was conducted to determine and confirm the maximum tolerated dose (MTD), 13 patients with selected solid tumors (8 patients with renal cell carcinoma, 2 patients with endometrial cancer, 2 patients with non-small cell lung cancer and 1 patient with melanoma) that had progressed after treatment with approved therapies or for which there are no standard effective therapies available were administered lenvatinib (either 24 mg or 20 mg daily) and pembrolizumab (200 mg intravenously every three weeks).
According to the latest results of the Phase Ib part of the study as of August 2016, dose-limiting toxicities (DLTs) were reported in 2 of 3 patients in the lenvatinib 24 mg / pembrolizumab 200 mg group. No DLTs were reported in the lenvatinib 20 mg / pembrolizumab 200 mg group (10 patients), and the MTD was confirmed as 20 mg of lenvatinib per day / 200 mg of pembrolizumab every three weeks. The objective response rate, one of the study’s secondary endpoints, was 69.2% (n of 13 patients). Grade 3 or higher Treatment-Emergent Adverse Events (TEAEs) were observed in 69.2% of patients, and no patients had discontinued treatment due to TEAEs. The three most frequently observed adverse events were decreased appetite, diarrhea and fatigue.
Takashi Owa, Ph.D, Chief Medicine Creation Officer of Eisai’s Oncology Business Group, commented “From the results of this study for patients who had progressed after treatment with approved therapies or for which there are no standard effective therapies available, we are encouraged to further explore the combination of lenvatinib and pembrolizumab in the next stage of clinical development.”
Currently, the Phase II part of the study is underway in the United States, while preparations to initiate a Phase Ib clinical study in Japan are also underway.
Eisai regards oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai remains committed to providing further clinical evidence for lenvatinib aimed at maximizing value of the drug as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.
SOURCE: Eisai
Post Views: 146
