On May 25, 2018 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada), reported that the U.S. Food and Drug Administration (FDA) has extended the action date for the supplemental New Drug Application (sNDA) for the multiple receptor tyrosine kinase inhibitor LENVIMA (generic name: lenvatinib mesylate) for the potential first-line treatment of patients with unresectable hepatocellular carcinoma (HCC) (Press release, Eisai, MAY 25, 2018, View Source [SID1234526896]).

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The FDA has indicated that the extension of the Prescription Drug User Fee Act (PDUFA) date is needed to allow additional time for review of the application. The agency expects to complete the review on or before August 24, 2018, thus extending the target action date by a standard extension period of three months from the original PDUFA action date of May 24, 2018.
Eisai, as the marketing authorization holder, is working closely with the FDA to support the continued review of this application.

LENVIMA is approved by the U.S. FDA for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). LENVIMA is also approved by the U.S. FDA in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy.

Media Inquiries:
Eisai Co., Ltd.

Public Relations Department
+81-(0)3-3817-5120

About LENVIMA (lenvatinib mesylate)
Discovered by Eisai, LENVIMA is an orally administered multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2 and VEGFR3) and fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3 and FGFR4) in addition to other pathway-related RTKs (including the platelet-derived growth factor (PDGF) receptor PDGFRα; KIT; and RET) involved in tumor angiogenesis, tumor progression and modification of tumor immunity.
Currently, LENVIMA is approved as a treatment for refractory thyroid cancer in over 50 countries, including the United States, Japan, in Europe and Asia. Additionally, Eisai has obtained approval for the agent in combination with everolimus as a treatment for renal cell carcinoma (second-line) in over 40 countries, including the United States and in Europe. In Europe, the agent was launched under the brand name Kisplyx for renal cell carcinoma.
LENVIMA is approved as a monotherapy for unresectable hepatocellular carcinoma in Japan (March 2018).
Eisai has submitted applications for an indication covering hepatocellular carcinoma in the United States and Europe (July 2017), China (October 2017), Taiwan (December 2017) and other countries

On May 25, 2018 IMMUTEP Presented 3rd Annual Advances in Immuno-Oncology Congress Presentation (Presentation, Immutep, MAY 25, 2018, View Source [SID1234526995]).

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On May 25, 2018 IntegraGen reported it will be in attendance at 2018 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held in Chicago from June 1st to June 5th (Press release, Integragen, MAY 25, 2018, View Source [SID1234526899]). The Annual ASCO (Free ASCO Whitepaper) Meeting brings together more than 32,000 oncology professionals from around the world to discuss state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field.

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On May 24, 2018 Merus N.V. (Nasdaq:MRUS), a clinicalstage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics), reported that the first patient has been dosed in a Phase 1, first-in human clinical trial of MCLA158 in patients with solid tumors with an initial focus on metastatic colorectal cancer (Press release, Merus, MAY 24, 2018, View Source [SID1234532108]). The trial will be conducted in Europe, where several Clinical Trial Applications (CTAs) have been approved to date. The Company also announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MCLA-158, which was accepted by the FDA in April 2018. With this acceptance, Merus plans to open additional sites for this trial in the United States.

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MCLA-158 is designed to bind to cancer stem cells expressing leucine-rich repeat-containing G proteincoupled receptor 5 (Lgr5) and epidermal growth factor receptors (EGFR). MCLA-158 was identified from a large library of bispecific antibodies targeting molecules belonging to the Wnt and receptor tyrosine kinase signaling pathways as part of work performed by the suppresSTEM consortium, a project that was funded by the European Union. Functional evaluation of patient-derived colorectal tumors, including those harboring RAS and/or PI3K mutations, demonstrated that MCLA-158 was more effective at inhibiting tumor growth and promoting apoptosis than an approved targeted therapy comparator for metastatic colorectal cancer, cetuximab. In preclinical studies, Merus also observed that the growth inhibitory activity of MCLA-158 was greater for colon tumors compared to normal colon tissue, consistent with its good safety profile in non-human primates.

"The commencement of our Phase 1 clinical trial of MCLA-158 is an important milestone for the advancement of our pipeline of bispecific antibodies obtained from our Biclonics technology platform," said Ton Logtenberg, Ph.D., Chief Executive Officer. "We believe MCLA-158 has the potential to address features that limit currently approved colorectal cancer-targeted therapies, including issues with offtarget toxicity and inability to target tumor stem cells, and thus, potentially treat a broader population of patients more effectively."

The Phase 1, open-label, multicenter clinical trial of MCLA-158 consists of two parts, a dose escalation and a dose expansion. The dose escalation part is intended to determine the appropriate dose of MCLA158. The dose expansion part will evaluate the safety and tolerability of the defined dose of MCLA-158 in patients with solid tumors. The dose escalation and expansion parts of the trial will also examine the preliminary antitumor activity of single-agent MCLA-158.

On May 24, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported it will hold an investor event on Monday, June 4, 2018 at 8:30 p.m. EDT (7:30 p.m. CDT) to discuss data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago (Press release, Bristol-Myers Squibb, MAY 24, 2018, View Source [SID1234526883]). Company executives will provide an overview of data presented from the company’s oncology portfolio, and address questions from investors and analysts.

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Investors and the general public are invited to listen to a live webcast of the event at investor.bms.com. Materials related to the event will be available at the same website prior to the event. A replay of the event will be available and can be accessed at investor.bms.com.