On May 20, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that the latest data regarding its oncology pipeline and products including in-house discovered lenvatinib mesylate (multikinase inhibitor, product name: LENVIMA, "lenvatinib") and eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: HALAVEN, "eribulin") will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (2021 ASCO (Free ASCO Whitepaper) Annual Meeting*), to be held virtually from June 4 to 8, 2021 (Press release, Eisai, MAY 20, 2021, View Source [SID1234580340]).

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* Abstracts will be made available on demand via ASCO (Free ASCO Whitepaper)’s website at 5:00 PM on May 19th (ET).

At this meeting, there will be an oral presentation on the analysis of health-related quality-of-life (HRQoL) (Abstract No: 4502) of the pivotal Phase 3 CLEAR Study (Study 307/KEYNOTE-581) evaluating lenvatinib in combination with pembrolizumab (product name: KEYTRUDA, "pembrolizumab"), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) or in combination with everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma. Additionally, respective CLEAR poster presentations on analysis of depth of response and efficacy (Abstract No: 4560) and a post hoc analysis of effects of subsequent systemic anticancer medication (Abstract No: 4562) will be presented.

In addition, a poster presentation on the analysis of HRQoL (Abstract No: 5570) of the pivotal Phase 3 Study 309/KEYNOTE-775 evaluating lenvatinib in combination with pembrolizumab versus chemotherapy (treatment of physician’s choice [TPC]) for the treatment of patients with advanced endometrial carcinoma (advanced uterine body cancer in Japan), following at least one prior platinum-based regimen is planned.

An oral presentation on results of the latest analysis of a Phase 2 study (LEAP-004) evaluating lenvatinib in combination with pembrolizumab for the treatment of patients with advanced melanoma who had been treated with an anti-PD-1 or PD-L1 immune checkpoint inhibitor (Abstract No: 9504) is also planned.

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, 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.

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.

Lenvatinib Plus Pembrolizumab Combination Therapy Abstract Topics

Cancer Type Abstract Type
Abstract No. Presentation Topic

Renal Cell Carcinoma

Oral Presentation

Abstract No: 4502
Health‐related quality‐of‐life (HRQoL) analysis from the phase 3 CLEAR trial of lenvatinib (LEN) plus pembrolizumab (PEMBRO) or everolimus (EVE) vs sunitinib (SUN) for patients (pts) with advanced renal cell carcinoma (aRCC) (Study 307/KEYNOTE-581)

Presentation Session: June 7 (Mon.) 8:00-11:00 AM EDT
Poster

Abstract No: 4560
Analysis of the CLEAR study in patients (pts) with advanced renal cell carcinoma (RCC): depth of response and efficacy for selected subgroups in the lenvatinib (LEN) + pembrolizumab (PEMBRO) and sunitinib (SUN) treatment arms (Study 307/KEYNOTE-581)

Poster

Abstract No: 4562
Post hoc analysis of the CLEAR study in advanced renal cell carcinoma (RCC): Effect of subsequent therapy on survival outcomes in the lenvatinib (LEN) + everolimus (EVE) vs sunitinib (SUN) treatment arms (Study 307/KEYNOTE-581)

Online Publication

Abstract No: e16542
Lenvatinib (LEN) + pembrolizumab (PEMBRO) treatment in patients (pts) with metastatic clear cell renal cell carcinoma (RCC): Final results of a phase 1b/2 trial (Study 111/KEYNOTE-146)

Poster

Abstract No: TPS4594* A phase 1b/2 umbrella study of investigational immune and targeted combination therapies as first-line therapy for patients with advanced renal cell carcinoma (RCC)
Poster

Abstract No: TPS4595*
KEYNOTE-B61: Open-label phase 2 study of pembrolizumab in combination with lenvatinib as first-line treatment for non-clear cell renal cell carcinoma (nccRCC) (KEYNOTE-B61)

Endometrial Carcinoma

Poster

Abstract No: 5570
Health-related quality of life (HRQoL) in advanced endometrial cancer (aEC) patients (pts) treated with lenvatinib plus pembrolizumab or treatment of physician’s choice (TPC) (Study 309/KEYNOTE-775)

Online Publication

Abstract No: e17571 Systematic literature review of the real-world burden and use of chemotherapies for treatment of advanced or recurrent endometrial carcinoma
Poster

Abstract No: 5581 Treatment patterns and outcomes among patients with microsatellite stable (MSS) advanced endometrial cancer in the United States: Endometrial Cancer Health Outcomes (ECHO) retrospective chart review Study
Melanoma
Oral Presentation

Abstract No: 9504
Lenvatinib (LEN) plus pembrolizumab (pembro) for patients (pts) with advanced melanoma and confirmed progression on a PD-1 or PD-L1 Inhibitor: Updated findings of LEAP-004 (LEAP-004 Study)

Presentation Session: June 7 (Mon.) 8:00-11:00 AM EDT
Hepatocellular Carcinoma
Poster

Abstract No: 4084 Exploratory circulating biomarker analyses: lenvatinib + pembrolizumab (L + P) in a phase 1b trial in unresectable hepatocellular carcinoma (uHCC) (116 Study)
Gastric Cancer
Poster

Abstract No: 4030
LEAP-005: A phase 2 multicohort study of lenvatinib plus pembrolizumab in patients with previously treated selected solid tumors—Results from the gastric cancer cohort (LEAP-005 Study)

Colorectal Cancer
Poster

Abstract No: 3564
LEAP-005: A phase 2 multicohort study of lenvatinib plus pembrolizumab in patients with previously treated selected solid tumors—Results from the colorectal cancer cohort (LEAP-005 Study)

Biliary Tract Cancer
Poster

Abstract No: 4080
Lenvatinib plus pembrolizumab for patients with previously treated biliary tract cancers in the multicohort phase 2 LEAP-005 study

(LEAP-005 Study)
* The presentation with TPS (Trial in Progress Submission) attached to the abstract number indicates that the study is in the intermediate stage, and the presentation does not report the final study results.

Lenvatinib Monotherapy Poster Presentation Topics

Cancer Type Abstract Type
Abstract No. Presentation Topic

Hepatocellular

Carcinoma

Poster

Abstract No: 4098

The cost effectiveness of lenvatinib versus atezolizumab and bevacizumab or sorafenib in patients with unresectable hepatocellular carcinoma (uHCC) in Canada

Online Publication

Abstract No: e16129

Real-world effectiveness of lenvatinib monotherapy among previously treated unresectable hepatocellular carcinoma patients in United States clinical practices
Online Publication

Abstract No: e16119

Impact of bodyweight (BW)-based starting doses on safety and efficacy of lenvatinib (LEN) in patients (pts) with hepatocellular carcinoma (HCC (304/202 Study)
Online Publication

Abstract No:

e16151

The comparative efficacy of atezolizumab and bevacizumab vs. lenvatinib in patients with unresectable hepatocellular carcinoma (uHCC)
Online Publication

Abstract No:

e16118 A multicenter observational study of Lenvatinib for unresectable hepatocellular carcinoma in Japan

Eribulin Poster Presentation Topics

Cancer Type Abstract Type
Abstract No. Presentation Topic
Breast Cancer
Online Publication

Abstract No:

e13058
Real-world clinical effectiveness of eribulin in metastatic breast cancer patients with visceral metastases in the United States

Gastric Cancer
Poster

Abstract No:

4025
Phase 1 study of the liposomal formulation of eribulin (E7389-LF): Results from the advanced gastric cancer expansion cohort (Study 114)

Pipeline and Other Poster Presentation Topics

Abstract Type
Abstract No. Presentation Topic
Online Publication

Abstract No: e18836
Health care cost impact associated with adverse events (AEs) among treatments in third-line+ (3L+) relapsed/refractory follicular lymphoma (R/R FL)

Poster

Abstract No: 4090 Phase I study of H3B-6527 in hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC) (Study 101)
Online Publication

Abstract No: e13025 Phase 1b study of H3B-6545 in combination with palbociclib in women with metastatic estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative breast cancer (Study 102)
Online Publication

Abstract No: e13022 Relative bioavailability of H3B-6545 tablets versus capsules and drug-drug interaction between H3B-6545 and pantoprazole (Pharmacokinetics Study)
Poster

Abstract No: 1018 Phase I/II study of H3B-6545, a novel selective estrogen receptor covalent antagonist (SERCA), in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (Study 101)
Poster

Abstract No: 11039 Impact of #ASCO Twitter Impressions on the Oncology Community
Online Publication

Abstract No: e18521
Perspectives on under-representation of minority patients (pts) in clinical trials

About the Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Strategic Collaboration
In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., 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 LENVIMA (lenvatinib). Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with KEYTRUDA (pembrolizumab), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A.

In addition to ongoing clinical studies evaluating the LENVIMA plus KEYTRUDA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in 14 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer, pancreatic cancer and triple-negative breast cancer) across more than 20 clinical trials.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A.

On May 20, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on May 19, 2021 for FoundationOne Liquid CDx Cancer Genomic Profile to be used as a companion diagnostic for the PARP inhibitor, Lynparza (generic name: olaparib) for the treatment of BRCA-mutated castrate-resistant prostate cancer (mCRPC) with distant metastasis (Press release, Chugai, MAY 20, 2021, View Source [SID1234580339]). With this approval, patients with advanced prostate cancer who may be eligible for the treatment with olaparib can be identified through both tissue-based and liquid-based comprehensive genomic profiling (CGP) tests. Since tissue availability can be an issue for some metastatic prostate cancer patients, blood-based testing is an important option to consider and critically important for informing patient care.

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"We are pleased that the FoundationOne Liquid CDx Cancer Genomic Profiletest was approved as a companion diagnostic for olaparib for advanced metastatic prostate cancer, following the tissue-based FoundationOne CDx Cancer Genomic Profile approval in December last year," said Chugai’s President and CEO, Dr. Osamu Okuda. "Precision cancer medicine is rapidly changing the treatment strategy for mCRPC and it is very important to understand the genomic profile of a patient’s tumor in order to select the optimal treatment. The availability of both liquid and tissue-based companion diagnostics helps to identify patients who may be eligible for olaparib. We are committed to advancing personalized healthcare in cancer treatment."

The approval aims to expand the use of FoundationOne Liquid CDx Cancer Genomic Profile as a companion diagnostic for olaparib in advanced prostate cancer which progressed after treatment with enzalutamide or abiraterone. It identifies patients who my be eligible for the treatment by detecting BRCA1/2 gene alterations. The efficacy and safety of olaparib in mCRPC patients with BRCA1/2 alterations were investigated in the Phase III PROfound study and AstraZeneca K.K. received approval from the MHLW on December 25, 2020. Olaparib is jointly developed and commercialized by AstraZeneca (LSE/STO/Nasdaq: AZN) and MSD (Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA).

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized healthcare in oncology and contributing to patients and healthcare professionals through improving access to CGP.

Approval information The underlined part has been newly added.

Intended uses or indications

The Product is used for comprehensive genomic profiling of blood samples in patients with solid tumors.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesilate
EGFR exon 20 T790M alterations osimertinib mesilate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
ROS1 fusion genes entrectinib
NTRK1/2/3 fusion gene Solid tumors entrectinib
BRCA1/2 alterations Prostate cancer olaparib
About FoundationOne Liquid CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc. based in Cambridge, USA, FoundationOne Liquid CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device using blood samples for advanced cancer patients with solid tumors. It is intended to identify genomic alterations in 324 cancer-related genes through detection of circulating tumor DNA (ctDNA) in blood. The test is approved by the MHLW for use in cancer genome profiling to report substitutions, insertion and deletion alterations, and select gene rearrangements for short variants in 324 genes. It is also indicated for use as a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in Table above of Intended uses or indications). For the latest information about the product, including companion diagnostic indications, please refer to the prescribing information.

About BRCA alterations
BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genomic stability of cells. When either of these genes is mutated or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genomic alterations that can lead to cancer and confer sensitivity to PARP inhibitors including Lynparza.1-4

Trademarks used or mentioned in this release are protected by laws.

On May 20, 2021 Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, reported that William Feehery, Chief Executive Officer, and Andrew Schemick, Chief Financial Officer, will participate in the following virtual investor conferences (Press release, Certara, MAY 20, 2021, View Source [SID1234580338]):

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Fireside Chat on Tuesday, June 1st at 11:40 a.m. ET
Fireside Chat on Friday, June 4th at 10:00 a.m. ET
Live webcasts will be available on Certara’s investor relations website at View Source and will be available for replay for 90 days thereafter.

On May 20, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the U.S. Food and Drug Administration (US FDA) has provided details of the additional information it is requesting regarding its Chimeric Antigen Receptor-T cell therapy (CAR-T) being developed in partnership with Moffitt Cancer Center (Press release, Anixa Biosciences, MAY 20, 2021, View Source [SID1234580336]).

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The Investigational New Drug (IND) application for this study was submitted in March, and the US FDA subsequently requested additional information before approving the trial. The details of that information request have now been provided by the FDA. Anixa and Moffitt feel that the requested information can be assembled and provided to the FDA within approximately 30 days, after which the FDA will again respond within 30 days after the submission.

This technology is an autologous cell therapy that requires the manufacture of a unique drug product for each individual patient. The therapeutic product is comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunological levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone receptor, this technology is also known as CER-T (Chimeric Endocrine Receptor T-cell) therapy, a new type of CAR-T.

Dr. Amit Kumar, President and CEO of Anixa Biosciences, stated, "We are pleased to receive this letter with the detailed information request. While we hope to comply with the request within 30 days, certain assays may require additional time for validation before submission. We will strive to file our submission as soon as possible and we will seek to initiate this clinical trial before the end of the year."

On May 19, 2021 Duality Biologics (DualityBio or Company), an innovative biotech company, reported the completion of $90 million series B financing (Press release, Duality Biologics, MAY 19, 2021, View Source [SID1234596828]). This round of financing was led by Lilly Asia Ventures (LAV) and jointly invested by YUNION Healthcare Fund, Huagai Capital, NRL Capital, Green Pine Capital Partners, and Oriza Holdings, etc. Series A investor WuXi Biologics (2269.HK) continued to increase its stake in this round to accelerate DualityBio’s R&D progress leveraging its premier-quality integrated technology platforms. DualityBio has raised more than $120 million since its establishment in January 2020. Major investors in the previous round include King Star Capital, WuXi Biologics, 6 Dimensions Capital, and other investment institutions. The funds raised in this round will be mainly used for conducting preclinical research, clinical trials, and expanding pipeline through strategic in-licensing, out-licensing and research collaborations globally.

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Develop Novel Modality Drug to Meet Unmet Medical Needs

Focusing on the field of oncology and autoimmune diseases, DualityBio has developed a novel internal pipeline of nearly 10 Best-in-Class and First-in-Class bispecific antibodies (BsAbs) and Antibody-Drug Conjugate (ADC) drugs, to fulfill the unmet medical needs for patients worldwide. The company has successfully developed the next-generation ADC platform with global intellectual property rights. The value of the platform has been fully validated with several drug candidates under preclinical development. DualityBio will continue to expand and enrich its novel modality drug platforms through internal R&D and external collaborations. The company has built up a strong and highly experienced international team with proven track record in preclinical research, clinical development, and global business development.

Dr. John Zhu, founder and CEO of DualityBio said: "I am very grateful for the recognition and strong support from the top investors in the industry, and I appreciate very much our highly productive team for their unremitting efforts. The booming of biotechnology makes it possible to develop novel modality drugs, which is not only an opportunity but also our mission. The unmet needs of patients demand new therapeutic solutions. DualityBio is committed to be the leader of novel modality drug developers, and we will continue to develop innovative and breakthrough therapies, to live up to patients’ expectations."

"We hold strong conviction of innovative therapeutics for oncology and autoimmune diseases, which offer huge market potential and fulfill the unmet medical needs worldwide. Companies with truly exceptional capabilities in innovation and globalization will stand out, and DualityBio is clearly one of such companies." Dr. Yi Shi, the Founding Managing Partner of LAV, commented, "As a veteran of more than 20 years in the industry, John has both rich industry experience and great acuity for investment. He has successfully established and incubated a number of biotech companies. Within just over one year, DualityBio has not only established a world-class team with deep industry insights and excellent execution capabilities, but also forged a globally competitive drug development platform with a very strong pipeline. LAV will offer sustained support for DualityBio to become a global leader in the industry!"

Dr. Chris Chen, CEO of WuXi Biologics, said: "ADC has emerged as an exciting therapeutic modality which attracts increasing investment from pharmaceuticals and ventures. WuXi Biologics has established the integrated technology platforms for ADC, which allows global partners to develop innovative biologics leveraging our extensive expertise and capacity. We are glad to enable DualityBio to expedite the ADC development with lower cost as they strive to build robust biologics pipeline."

Xianghong Lin, the Founding Partner of King Star Capital, remarked: "John is not only an excellent investor but also a company builder in the biotech industry. We have worked together and helped multiple biotech startups quickly attained their "0" to "1" transformations, and successfully listed as public companies on the capital market. As an investor in the early stage of DualityBio, we believe in John’s proactive, innovative entrepreneurial spirit and rich industry experience, and will continue to support the company’s future growth."