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Merck, Eisai Get Japanese Nod for Lenvima Label Expansion
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Merck and Co. (MRK - Free Report) along with its Japanese partner Eisai Co., Ltd. announced that the latter’s anti-cancer drug Lenvima has received approval in Japan for an expanded indication. The tyrosine kinase inhibitor, Lenvima has been approved in Japan for the first line treatment of unresectable hepatocellular carcinoma (HCC), a type of liver cancer.
The approval was based on positive data from a phase III clinical study (Study 304/REFLECT study) which showed that Lenvima demonstrated statistically significant non-inferiority of overall survival (OS) (13.6 months) compared to Bayer AG’s (BAYRY - Free Report) Nexavar (12.3 months). The study also showed that Lenvima demonstrated highly statistically significant and clinically meaningful improvements as compared to Nexavar in the secondary endpoints of progression-free survival. Regulatory applications seeking approval of Lenvima for HCC are also in the United States and EU.
Following the approval in Japan, Eisai will receive a development milestone payment from Merck.
Over the past year, Merck’s shares have declined 14.9% as against the industry’s 2.8% gain.
This is the first approval for Lenvima after the two companies struck a global strategic collaboration last month to jointly develop and commercialize the drug both as a monotherapy as well as in combination with Merck’s anti-PD-1 therapy, Keytruda, for several types of cancer.
Lenvima, developed by Eisai, is presently approved for the treatment of thyroid cancer as a monotherapy and second-line treatment of renal cell carcinoma (RCC) — a type of kidney cancer — in combination with Novartis’ (NVS - Free Report) Afinitor (everolimus). Also, late-stage studies are already ongoing to evaluate Lenvima in separate combination studies with Keytruda and Afinitor for RCC. Meanwhile, the Keytruda/Lenvima combination enjoys Breakthrough Therapy Designation from FDA in RCC.
Merck and Eisai plan to jointly develop Lenvima across six cancer types and 11 potential indications. The companies will share global development and marketing costs, as well as gross profits from Lenvima equally. However, Eisai will book Lenvima worldwide product sales both as a monotherapy and in combination.
Meanwhile, Keytruda is being studied for more than 30 types of cancer, exceeding 700 studies, including in excess of 400 combination studies. Merck is collaborating with companies like Amgen, Inc. (AMGN - Free Report) , Incyte, Glaxo and Pfizer separately for the evaluation of Keytruda in combination with other regimens.
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Merck, Eisai Get Japanese Nod for Lenvima Label Expansion
Merck and Co. (MRK - Free Report) along with its Japanese partner Eisai Co., Ltd. announced that the latter’s anti-cancer drug Lenvima has received approval in Japan for an expanded indication. The tyrosine kinase inhibitor, Lenvima has been approved in Japan for the first line treatment of unresectable hepatocellular carcinoma (HCC), a type of liver cancer.
The approval was based on positive data from a phase III clinical study (Study 304/REFLECT study) which showed that Lenvima demonstrated statistically significant non-inferiority of overall survival (OS) (13.6 months) compared to Bayer AG’s (BAYRY - Free Report) Nexavar (12.3 months). The study also showed that Lenvima demonstrated highly statistically significant and clinically meaningful improvements as compared to Nexavar in the secondary endpoints of progression-free survival. Regulatory applications seeking approval of Lenvima for HCC are also in the United States and EU.
Following the approval in Japan, Eisai will receive a development milestone payment from Merck.
Over the past year, Merck’s shares have declined 14.9% as against the industry’s 2.8% gain.
This is the first approval for Lenvima after the two companies struck a global strategic collaboration last month to jointly develop and commercialize the drug both as a monotherapy as well as in combination with Merck’s anti-PD-1 therapy, Keytruda, for several types of cancer.
Lenvima, developed by Eisai, is presently approved for the treatment of thyroid cancer as a monotherapy and second-line treatment of renal cell carcinoma (RCC) — a type of kidney cancer — in combination with Novartis’ (NVS - Free Report) Afinitor (everolimus). Also, late-stage studies are already ongoing to evaluate Lenvima in separate combination studies with Keytruda and Afinitor for RCC. Meanwhile, the Keytruda/Lenvima combination enjoys Breakthrough Therapy Designation from FDA in RCC.
Merck and Eisai plan to jointly develop Lenvima across six cancer types and 11 potential indications. The companies will share global development and marketing costs, as well as gross profits from Lenvima equally. However, Eisai will book Lenvima worldwide product sales both as a monotherapy and in combination.
Meanwhile, Keytruda is being studied for more than 30 types of cancer, exceeding 700 studies, including in excess of 400 combination studies. Merck is collaborating with companies like Amgen, Inc. (AMGN - Free Report) , Incyte, Glaxo and Pfizer separately for the evaluation of Keytruda in combination with other regimens.
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Merck carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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