On September 6, 2022 Sysmex Corporation (HQ: Kobe, Chairman and CEO: Hisashi Ietsugu) reported that applied on September 2, 2022 for a partial change of the manufacturing and marketing approval for the OncoGuide NCC Oncopanel System, a gene mutation analysis set (the "System") to include its use as a companion diagnostic for patients with advanced biliary tract cancer harboring FGFR2 gene1 rearrangements, including gene fusions (Press release, Sysmex, SEP 6, 2022, View Source [SID1234619009]).

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Biliary tract cancer2 is known to develop in approximately 26,000 patients annually in Japan,3 with a 5-year relative survival rate4 of less than 30%,5 and has the second poorest prognosis of any cancer after pancreatic cancer. At present, this disease has few treatment options, and no standard treatment has been sufficiently established for locally advanced or metastatic biliary tract cancer which progresses after first-line treatment. Development is actively underway in pursuit of molecular-targeted therapeutic agents that target specific genetic abnormalities such as FGFR2 gene rearrangements, which are believed to be closely related to cancer cell survival and proliferation.

In 2018, Sysmex became the first company in Japan to receive manufacturing and marketing approval for such a system for use in cancer genome profiling.6 The company has since contributed to the promotion of cancer genomic medicine by promptly delivering the System to various medical institutions. Sysmex has also been working on the development of a companion diagnostic device aimed at commercialization, jointly with Taiho Pharmaceutical Co., Ltd. (HQ: Chiyoda-ku, Tokyo; President and Representative Director: Masayuki Kobayashi), which is developing futibatinib7 (generic name), an FGFR inhibitor for the treatment of locally advanced or metastatic biliary tract cancer harboring FGFR2 gene rearrangements, including gene fusions, in Japan.

Sysmex has recently applied for a partial change of the System’s approval in Japan to include its use as a companion diagnostic for patients with biliary tract cancer, to determine indications of futibatinib. Taiho Pharmaceutical applied on July 28, 2022, for manufacturing and marketing approval for futibatinib for the treatment of previously treated locally advanced or metastatic biliary tract cancer harboring FGFR2 gene rearrangements, including gene fusions. If, through these initiatives, the System can be used to determine indications for the use of futibatinib in the future, it will provide another treatment option to patients with locally advanced or metastatic biliary tract cancer.

Sysmex will continue to work on the early commercialization of high-value testing and diagnostic technologies that will lead to offering optimal treatment for each patient, while also contributing to the development and evolution of personalized medicine.

FGFR2 gene:
Four types of fibroblast growth factor receptors (FGFRs), FGFR1-4, have been identified. These are proteins involved in cell growth and proliferation. When FGFR genes with abnormalities including fusion, mutation, and amplification are activated, they are thought to lead to cancer cell proliferation, survival, migration, tumor angiogenesis, drug resistance, etc.
In a study in Japan of patients with unresectable bile duct cancer, the positivity rate of FGFR2 gene rearrangement was reported to be 7.4% for intrahepatic cholangiocarcinoma and 3.6% for extrahepatic cholangiocarcinoma (hilar region). (Source: Maruki Y, et al., "Molecular detection and clinicopathological characteristics of advanced/recurrent biliary tract carcinomas harboring the FGFR2 rearrangements: a prospective observational study" (PRELUDE Study), J Gastorenterol. 2021 Mar; 56 (3): 250-260)

Biliary tract cancer:
A generic term for cancers that develop in the biliary tract, which are classified into bile duct cancer (including intrahepatic cholangiocarcinoma, which occurs in the bile ducts within the liver), gallbladder cancer, or papillary carcinoma, depending on their primary sites.

Calculated based on the Cancer Information Service, National Cancer Center, Japan, Cancer Statistics (National Cancer Registry), National Cancer Incidence Data (2016-2018), and the Annual Report of Hospital-Based Cancer Registries, 2020 Nation-wide Aggregate Results (Tumor information).

5-year relative survival rate:
An index that indicates how much lower the percentage of individuals diagnosed with a certain type of cancer who are alive after five years is than the percentage of the entire Japanese population who are alive after five years.

Five-year relative survival rates in the 2013-2014 diagnosis are 20.6% for intrahepatic cholangiocarcinoma and 29.4% for gallbladder cancer, according to the Cancer Information Service, National Cancer Center, Japan, "Annual Survival Report of Hospital-Based Cancer Registries".

Cancer genome profiling:
A test designed to obtain a comprehensive cancer genome profile in tumor tissues for analysis of solid tumors, including advanced biliary tract cancer. Analyzing abnormalities in cancer-specific genes provides useful information for determining treatment methods, including diagnosis and selection of potentially effective anti-cancer drugs.

Futibatinib (development code: TAS-120):
A novel oral anticancer drug currently under development by Taiho Pharmaceutical for the treatment of patients with advanced solid tumors with FGFR1-4 genetic aberrations, including biliary tract cancer, who were previously treated with chemotherapy or other therapies. In May 2018, futibatinib was granted orphan drug status for the treatment of cholangiocarcinoma, and also received Breakthrough Designation for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions in April 2021 from the US FDA. In March 2022, the FDA accepted the New Drug Application (NDA) for futibatinib for priority review.

On September 6, 2022 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported the presentation of research across various types of cancer from its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, which is taking place virtually and in-person in Paris, France from September 9 to 13 (Press release, Eisai, SEP 6, 2022, View Source [SID1234619006]).

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A late-breaking oral presentation of detailed results from the LEAP (LEnvatinib And Pembrolizumab) clinical program including the final analysis of the Phase 3 LEAP-002 trial will be featured in a Proffered Paper session (NCT03713593(New Window); Presentation: #LBA34). The study evaluated the combination of lenvatinib plus anti-PD-1 antibody pembrolizumab from Merck & Co., Inc., Rahway, NJ, USA versus lenvatinib monotherapy as a first-line treatment for patients with unresectable hepatocellular carcinoma. Additionally, two mini-oral presentations will feature updated efficacy and safety data from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial evaluating the combination in patients with advanced renal cell carcinoma (NCT02811861(New Window); Presentation: #1449MO) and Phase 3 Study 309/KEYNOTE-775 trial evaluating the combination in patients with advanced endometrial carcinoma (NCT03517449(New Window); Presentation: #525MO).

In addition, a new post-hoc analysis of three pivotal Phase 3 studies (Study 301/NCT00337103(New Window), Study 304/NCT02225470(New Window) and the EMBRACE trial/Study 305/NCT00388726(New Window)) evaluating the efficacy of eribulin (HALAVEN) versus other chemotherapies (capecitabine, vinorelbine and Treatment of Physician’s Choice [TPC], respectively) in patients living with metastatic breast cancer whose tumors have low or no HER2-expression will be presented during a poster session (Presentation: #259P).

"We look forward to presenting data at ESMO (Free ESMO Whitepaper), showcasing Eisai’s latest research on both lenvatinib and eribulin, with the goal of continuing to help people living with various types of cancer," said Dr. Takashi Owa, Chief Scientific Officer, Deep Human Biology Learning, Senior Vice President, Eisai Co., Ltd. "Presentations on the LEAP clinical program as well as new analyses for eribulin reinforce our commitment to the ongoing research of our portfolio in an effort to better serve patients and healthcare providers."

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 15 trials have been initiated under the LEAP clinical program, which is evaluating the combination across multiple tumor types.

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. All regular abstracts are available. All late-breaking abstracts will be made available Thursday, September 8, 2022, at 12:05 AM CEST.

Cancer Type Study Abstract Title Abstract Type & Details
LEAP clinical program
Gastrointestinal Cancers LEAP-002 Primary results from the phase 3 LEAP-002 study: lenvatinib plus pembrolizumab versus lenvatinib as first-line (1L) therapy for advanced hepatocellular carcinoma (aHCC)
Proffered Paper Session
Presentation #LBA34
September 10, 2022
8:30-8:40 AM CEST

Richard S. Finn, MD
Geffen School of Medicine, University of California, Los Angeles

LEAP-015 First-line lenvatinib (Len) + pembrolizumab (pembro) + chemotherapy vs. chemo in advanced/metastatic gastroesophageal adenocarcinoma: LEAP-015 safety run-in
Poster Session
Presentation #1223P
September 12, 2022
12:00-12:20 PM CEST

Kohei Shitara, MD
National Cancer Center Hospital East, Kashiwa, Japan

Genitourinary Cancer CLEAR (Study 307)/
KEYNOTE-581 Updated efficacy of lenvatinib (LEN) + pembrolizumab (PEMBRO) vs sunitinib (SUN) in patients (pts) with advanced renal cell carcinoma (aRCC) in the CLEAR study
Mini Oral Session
Presentation #1449MO
September 11, 2022
2:45-2:55 PM CEST

Camillo G. Porta, MD
Interdisciplinary Department of Medicine, University of Bari

Gynecologic Cancer Study 309/
KEYNOTE-775 Updated efficacy and safety of lenvatinib (LEN) + pembrolizumab (pembro) vs treatment of physician’s choice (TPC) in patients (pts) with advanced endometrial cancer (aEC): Study 309/KEYNOTE-775
Mini Oral Session
Presentation #525MO
September 11, 2022
4:30-4:35 PM CEST

Vicky Makker, MD
Medical Oncology, Memorial Sloan Kettering Cancer Center

Eribulin
Breast Cancer Study 301, Study 304 and EMBRACE trial/Study 305 Efficacy of eribulin mesylate in HER2-low metastatic breast cancer (MBC): results from three phase 3 studies
Poster Session
Presentation #259P
September 10, 2022
11:20-11:40 AM CEST

Peter A. Kaufman, MD
Division of Hematology and Oncology, University of Vermont Cancer Center

On September 6, 2022 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, reported that BTK inhibitor orelabrutinib has been granted priority review for the treatment of relapsed or refractory Marginal Zone Lymphoma (R/R MZL) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), which accepted the supplemental New Drug Application (sNDA) of orelabrutinib for the treatment of R/R MZL recently (Press release, InnoCare Pharma, SEP 6, 2022, View Source [SID1234618999]).

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Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said: "We are so inspired by this excited news. This is the third indication of orelabrutinib granted priority review. There are unmet medical needs for patients with R/R MZL. We hope orelabrutinib can bring better treatment options to benefit patients with R/R MZL."

The sNDA of Orelabrutinib for the treatment of R/R MZL was accepted by the CDE on August 12. This NDA was submitted based on data from an open multi-center Phase II clinical study to investigate the safety and efficacy of orelabrutinib for the treatment of R/R MZL.

Current treatment options for R/R MZL are quite limited. So far, no BTK inhibitor has ever been approved for treating patients with R/R MZL in China, and hope that orelabrutinib can fill the gap in this therapeutic area.

About Orelabrutinib

Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.

On Dec. 25 2020, orelabrutinib received conditional approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients.

In addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies.

Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA).

In addition, orelabrutinib is also being evaluated in global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE, Primary Immune Thrombocytopenia (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) in China.

On September 5, 2022 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reported the presentation of two new analyses from the Phase 3 Atalante-1 study of immunotherapy Tedopi, in patients with advanced non-small cell lung cancer (NSCLC) in secondary resistance after failure of previous checkpoint inhibitor treatments, at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held September 9-13, in Paris (Press release, OSE Immunotherapeutics, SEP 5, 2022, View Source [SID1234646962]).

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Alexis Vandier, Chief Executive Officer of OSE Immunotherapeutics, commented: "In patients with no treatment option after failure of two therapeutic classes, in particular post-checkpoint inhibitors, Tedopi has shown an overall clinical benefit in this phase 3 study, integrating both efficacy and tolerance compared to chemotherapy treatments. This new specific immunotherapy offers prospects for therapeutic management, both in monotherapy and in combination, and we will do our best to make this treatment available as soon as possible for these patients."

The first analysis compared Tedopi to the Standard of Care (SoC) in patients with advanced NSCLC after secondary resistance to sequential use of chemotherapy followed by immunotherapy (CT-IO).

The results have shown that in advanced HLA-A2+ NSCLC patients with IO secondary resistance after sequential CT-IO (n=118), overall survival (OS) was longer with Tedopi versus SoC regardless of the use (or not) of post progression anticancer treatment (with 13.5 months versus 10.6, HR=0.71; without 6.3 months versus 4.5, HR=0.76).

This analysis will be presented by Dr Maria Rosario Garcia Campelo (Head of Medical Oncology Department, Thoracic Tumors Unit, Investigator of Atalante-1 study, University Hospital A Coruña, Spain).

Dr Garcia Campelo said: "There is a strong medical need for a new therapeutic alternative in these heavily pretreated NSCLC patients, aiming not only at a prolonged survival but desiring a maintained global health status."

The second analysis assessed the overall benefit/risk of Tedopi versus SoC chemotherapy in patients with NSCLC who failed therapy with immune checkpoint inhibitors. The Net Treatment Benefit (NTB)*, a new statistical method combining efficacy, safety and quality of life, was assessed in the overall population (n=219). NTB of Tedopi was of 19% and reached statistical significance (p=0.035).

This analysis will be presented by Dr Marc Buyse, (Founder and Chief Scientific Officer, International Drug Development Institute (IDDI), Brussels, Belgium).

Poster presentation details:
Title: Pattern of clinical activity of anticancer vaccine OSE2101 in HLA-A2+ non-small cell lung cancer (NSCLC) patients after failure to immune checkpoint inhibitors (IO) in Phase 3 Atalante-1 randomized trial
Presentation Number: 1019P
Speaker: Maria Rosario Garcia Campelo (A Coruña, Spain)
Date: Monday, September 12th, 2022

Title: Net Treatment Benefit of OSE2101 in HLA-A2+ non-small cell lung cancer (NSCLC) patients after failure to immune checkpoint inhibitors (IO) in Phase 3 Atalante-1 randomized trial
Presentation Number: 1024P
Speaker: Marc E. Buyse (Louvain-la-Neuve, Ottignies, Belgium)
Date: Monday, September 12th, 2022

On September 5, 2022 Chiome Bioscience Inc.("Chiome") reported that Chiome will present preclinical data supporting development of its proprietary anti-CDCP1 antibody drug conjugate named PCDC as a therapeutic candidate at the 13th World ADC San Diego 2022 (venue: September 6th-9th, 2022) (Press release, Chiome Bioscience, SEP 5, 2022, View Source [SID1234625708]). As this anti-CDCP1 antibody is characterized for its internalization into cancer cell we have tested several payloads and conjugates in vitro and in vivo. Chiome will present data on anti-CDCP1 antibody conjugated with several payloads such as PBD, MMAE, and amanitin. Each ADC has shown significant anti-tumor activities in vitro and in vivo on multiple models. In addition, Non-GLP toxicity study using cynomolgus monkey showed that amanitin conjugated antibody exhibited tolerability in the expected therapeutics dose.

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➢ Poster Presentation

Date: September 7th, 2022 AM10:00-PM7:00
Place: Sheraton San Diego Hotel and Marina
Title: Anti-CDCP1 antibodies for drug conjugate

➢ World ADC San Diego 2022 Website

View Source
World ADC is one of the most comprehensive conferences in ADC fields from early discovery to clinical and manufacturing. It is held annually, and researchers and pharma companies around the world will participate. This year it is held for the first time in-person since 2019 with 600+ participants at the forefront of ADC R&D.

PCDC is the project on humanized monoclonal antibody that targets CDCP1, highly expresses in broad range of solid tumors, including lung, breast, colorectal, pancreas, prostate, ovarian cancers. Chiome has been studying PCDC as one of our therapeutic pipelines. Patent applications for this antibody has already been submitted.

Information
Chiome is granted access to the ATACⓇ platform, antibody targeted amanitin conjugate technology, developed by Heidelberg Pharma GmbH (Ladenburg, Germany). Amanitin is a toxin found in several species of mushrooms. With ATAC platform, amanitin is conjugated to our anti-CDCP1 antibody. In the preclinical study, the amanitin conjugated anti-CDCP1 antibody has shown significant anti-tumor activities in vitro and in vivo. Chiome is actively working to find a partner.