On May 26, 2022 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported the presentation of research across various types of cancer from its oncology portfolio during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (#ASCO22), which is taking place virtually and in-person in Chicago from June 3 to 7 (Press release, Eisai, MAY 26, 2022, View Source [SID1234615166]). Notable presentations include a poster discussion of safety and efficacy data (NCT03386942(New Window); Abstract: #5513) from the platinum-resistant ovarian cancer cohort expansion of a Phase 1 study evaluating the antibody drug conjugate (ADC) co-developed by Eisai and Bristol Myers Squibb (Headquarters: the United States), farletuzumab ecteribulin (MORAb-202), as well as a poster presentation featuring dose optimization findings for farletuzumab ecteribulin (NCT03386942(New Window); Abstract: #3090).

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"Safety and efficacy analyses in platinum-resistant ovarian cancer for farletuzumab ecteribulin suggest antibody drug conjugates may represent a promising therapeutic strategy for these patients with limited treatment options," said Dr. Takashi Owa, President, Oncology Business Group at Eisai. "Eisai’s first antibody drug conjugate combines our in-house developed anti-folate receptor alpha antibody and our anticancer agent eribulin using an enzyme cleavable linker, illustrating our dedication to building on our medicines to improve cancer care for more patients."

New research from the LEAP (LEnvatinib And Pembrolizumab) clinical program evaluating lenvatinib (LENVIMA) plus pembrolizumab (KEYTRUDA), the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, includes subgroup analyses from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial evaluating the combination in patients with advanced renal cell carcinoma (RCC) and Phase 3 Study 309/KEYNOTE-775 trial evaluating the combination in patients with advanced endometrial carcinoma (EC). A poster discussion will evaluate the impact of subsequent therapies in patients with advanced RCC receiving the combination (NCT02811861(New Window); Abstract: #4514); while a poster presentation will discuss the efficacy of next line therapy after treatment with lenvatinib plus pembrolizumab in advanced EC (NCT03517449(New Window); Abstract: #5587).

"The combination of lenvatinib plus pembrolizumab has helped to expand physicians’ arsenal of treatment options for patients living with advanced renal cell carcinoma and advanced endometrial carcinoma around the world," said Richard C. Woodman, MD, Chief Clinical Officer, Oncology Business Group at Eisai. "Our data at ASCO (Free ASCO Whitepaper) 2022 demonstrate our commitment to continuing to investigate the combination through post-hoc analyses with the goal of providing healthcare professionals with tools to support them in making better-informed treatment decisions for their patients."

In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with pembrolizumab. To date, more than 20 trials have been initiated under the LEAP clinical program, which is evaluating the combination across more than 10 different tumor types.

In June 2021, Eisai and Bristol Myers Squibb entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of farletuzumab ecteribulin, a folate receptor alpha (FRα)-targeting ADC. Eisai and Bristol Myers Squibb are currently investigating farletuzumab ecteribulin in FRα-positive solid tumors (inclusive of endometrial, ovarian, lung and breast cancers) in two studies: a Phase 1 clinical study in Japan and a Phase 1/2 clinical study in the United States.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

The full list of Eisai presentations is included below. The majority of abstracts have been made available on Thursday, May 26, 2022, at 5:00 PM EDT and will be available on demand via ASCO (Free ASCO Whitepaper)’s website.

　

Cancer Type Study/Compound Abstract Title Abstract Type & Details
Pipeline
Gynecologic Cancer Farletuzumab Ecteribulin Safety and Efficacy of MORAb-202 in Patients (pts) With Platinum-Resistant Ovarian Cancer (PROC): Results From the Expansion Part of a Phase 1 Trial.
Poster Discussion
Abstract #5513
June 4, 2022
5:30 PM EDT

Shin Nishio, MD, PhD
Kurume University School of Medicine

Farletuzumab Ecteribulin Dose Optimization for MORAb-202, an Antibody-Drug Conjugate (ADC) Highly Selective for Folate Receptor-Alpha (FRα), Using Population Pharmacokinetic (PPK) and Exposure-Response (E-R) Efficacy and Safety Analyses.
Poster Presentation
Abstract #3090
June 5, 2022
9:00 AM EDT

Seiichi Hayato
Eisai
Lenvatinib Combinations

(Plus Pembrolizumab, Pembrolizumab and Chemotherapy or Pembrolizumab and Belzutifan)

Genitourinary Cancer CLEAR (Study 307)/ KEYNOTE-581 Impact of subsequent therapies in patients (pts) with advanced renal cell carcinoma (aRCC) receiving lenvatinib plus pembrolizumab (LEN + PEMBRO) or sunitinib (SUN) in the CLEAR study
Poster Discussion
Abstract #4514
June 4, 2022
5:42 PM EDT

Martin H. Voss, MD
Memorial Sloan Kettering Cancer Center
Gynecologic Cancer Study 309/ KEYNOTE-775 Efficacy of next line of therapy after treatment with lenvatinib (LEN) in combination with pembrolizumab (pembro) versus treatment of physician’s choice (TPC) in patients (pts) with advanced endometrial cancer (aEC): exploratory analysis of Study 309/KEYNOTE-775
Poster Presentation
Abstract #5587
June 4, 2022
2:15 PM EDT

Vicky Makker, MD
Memorial Sloan Kettering Cancer Center
Gastrointestinal Cancers LEAP-014 First-line lenvatinib plus pembrolizumab plus chemotherapy in esophageal squamous cell carcinoma: LEAP-014 trial in progress
Poster Presentation
Abstract #TPS4167
June 4, 2022
9:00 AM EDT

Jong-Mu Sun, MD
Samsung Medical Center, Sungkyunkwan University School of Medicine
MK-6482-016 Phase 2 Open-label Study of Pembrolizumab Plus Lenvatinib and Belzutifan in Patients With Advanced Solid Tumors
Poster Presentation
Abstract #TPS4173
June 4, 2022
9:00 AM EDT

Robin K. Kelley, MD
University of California San Francisco
Lenvatinib
Gastrointestinal Cancer REFLECT Characterization of tumor responses in patients (pts) with unresectable hepatocellular carcinoma (uHCC) treated with lenvatinib in REFLECT
Poster Presentation
Abstract #4078
June 4, 2022
9:00 AM EDT

Masatoshi Kudo, MD
Kindai University Faculty of Medicine
Additional Research
Gynecologic Cancer ECHO EU Treatment Pattern Treatment patterns and outcomes among patients with recurrent or advanced endometrial cancer in Europe: Endometrial Cancer Health Outcomes Europe (ECHO EU) Study
Online Publication
Abstract #e17627
May 26, 2022
5:00 PM EDT

Vimalanand S Prabhu, PhD
Merck & Co., Inc., Rahway, NJ, USA
Genitourinary Cancer Translational Research Exploratory analysis on crosstalk between intra-tumor immunity and FGF/FGFR pathway in clear cell renal cell carcinoma
Online Publication
Abstract #e16525
May 26, 2022
5:00 PM EDT

Takafumi Narisawa, MD
Yamagata University Faculty of Medicine