EORTC abstracts selected at EBCC-12 Virtual Congress

On September 28, 2020 3 EORTC reported that abstracts were selected for the 12th European Breast Cancer Conference (EBCC-12) that will take place virtually on 2-3 October 2020 (Press release, EORTC, SEP 28, 2020, View Source [SID1234567660]).

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Plenary Session

Keynote Lecture, Best and Late Breaking Abstract Presentations

Clinical Utility of MammaPrint testing in Invasive Lobular Carcinoma: Results from the MINDACT phase III trial

Presentation number: ORAL-007
Date: 2 October 2020, 13:50-14:00
Speaker: Otto Metzger (USA)
Proffered Papers Session

Updated results of the MINDACT trial: 70-gene signature to guide de-escalation of chemotherapy in early breast cancer

Presentation number: ORAL-021
Date: 3 October 2020, 13:00-13:10
Speaker: Emiel Rutgers (The Netherlands)
Screen-detected breast cancers have different tumor biology and better prognosis compared to interval breast cancers

Presentation number: ORAL-011
Date: 3 October 2020, 12:50-13:00
Speaker: Josephine Lopez Cardozo (The Netherlands)
EBCC-12 is a breast cancer conference where the very latest practice-changing research is presented. It aims to provide a unique multidisciplinary setting for all professionals with a common interest in breast cancer to discuss, debate, inform and educate themselves about this evolving disease.

To view the full two day programme, visit the EBCC-12 searchable programme.

EORTC Melanoma Group changing daily practice for cancer patients

On September 28, 2020 EORTC Melanoma group reported that it has presented and published new data that has shown improved outcomes for cancer patients. First of all, EORTC 1325/Keynote 054 study (adjuvant pembrolizumab vs. placebo after complete resection of high-risk stage III melanoma) which was presented at ASCO (Free ASCO Whitepaper) 2020, showed new recurrence free survival (RFS) data with median 3-year follow-up, confirming that the positive effect of pembrolizumab is durable with longer follow-up (Press release, EORTC, SEP 28, 2020, View Source [SID1234567658]).

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In addition, EORTC 1325 study presented, at the ESMO (Free ESMO Whitepaper) virtual Congress, the reduced risk of Distant Metastasis Free Survival (DMFS) or death with adjuvant immunotherapy.

EORTC MG has, also, published a number of papers, Alexander van Akkooi, group chair, highlights the importance of these papers:

Evaluating the potential of relapse-free survival as a surrogate for overall survival in the adjuvant therapy of melanoma with checkpoint inhibitors (EJC)
This is an important paper, as it shows that RFS is a surrogate for OS in case of adjuvant immunotherapy for melanoma. This is an important methodological study, since RFS is not always a proxy for durable and meaningful benefit in OS.
Prognosis of Patients With Stage III Melanoma According to American Joint Committee on Cancer Version 8: A Reassessment on the Basis of 3 Independent Stage III Melanoma Cohorts (JCO)
This paper shows that the new AJCC 8th edition staging prognosis seems to be too positive, which does not seem realistic. In this independent European cohort ofall substages of melanoma, the prognosis seems slightly worse compared to AJCC, which is important information when counselling patients about their risks and the need for adjuvant treatment or participation into trials.
Adjuvant therapy with pegylated interferon-alfa2b vs observation in stage II B/C patients with ulcerated primary: Results of the European Organisation for Research and Treatment of Cancer 18081 randomised trial (EJC)
Although one might think that this prospective randomized trial with an ‘old’ therapy would not be worth reporting, it still confirms that patients with non-metastatic, but thick and ulcerated primary melanomas can benefit from PEG-IFN treatment. Might not be very relevant anymore in Europe, but certainly important findings for developing countries.
The EORTC-DeCOG nomogram adequately predicts outcomes of patients with sentinel node-positive melanoma without the need for completion lymph node dissection (EJC)
This study is relevant as it gives a prognostic risk assessment of melanoma patients with a positive Sentinel Node, without the need to perform extensive surgery (CLND). The latter clearly benefits patients’ Quality of life. This study was conducted by an early career investigator, who defended her PhD thesis in recent months.

Apollomics, Inc. Receives China Investigational New Drug Approval for APL-106 to Initiate a Phase 3 Bridging Study in Acute Myeloid Leukemia

On September 27, 2020 Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, reported APL-106 (uproleselan) has received Investigational New Drug (IND) approval from the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) (Press release, Apollomics, SEP 28, 2020, View Source [SID1234567657]). This approval enables the initiation of a Phase 1 pharmacokinetic (PK) and tolerability study and includes acceptance of a Phase 3 bridging study of APL-106 in combination with chemotherapy in relapsed/refractory acute myeloid leukemia (AML).

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"Our team has worked diligently since licensing APL-106 earlier this year, and receiving China IND approval for our Phase 3 bridging study is a major milestone for Apollomics," said Guo-Liang Yu, PhD, Co-Founder, Chairman and Chief Executive Officer. "AML is one of the most common leukemias in adults, and there is a strong demand for an effective breakthrough treatment for relapsed/refractory AML. We are pleased that the CDE recognized the need to improve treatment outcomes in this patient population and accepted our Phase 3 bridging study while the Global Phase 3 trial sponsored by GlycoMimetics, our partner, is ongoing. We look forward to initiating our clinical trials in China as we strive to offer a new and effective treatment option for AML patients."

A comprehensive Phase 3 development program in AML is currently ongoing with uproleselan in the United States by GlycoMimetics. Uproleselan has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as well as Breakthrough Therapy Designation for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan has also been granted Orphan Drug Designation in AML from the FDA and European Union.

About Uproleselan (APL-106)

Discovered and developed by GlycoMimetics, uproleselan (APL-106) is a late clinical stage, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an) is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. Apollomics licensed APL-106 from Glycomimetics in January 2020. Under the terms of the agreement, Apollomics has the rights and responsibility to develop and commercialize APL-106 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China.

About Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow. It is an aggressive disease that causes the bone marrow to produce immature cells that are unable to carry out their normal function and develop into leukemic white blood cells called myeloblasts. In the U.S., there are approximately 20,000 new cases of AML each year and a 5-year survival rate of 28.7%.1 The annual incidence of new cases of AML in China is 21,600, and relapsed/refractory AML has an extremely poor prognosis.2

Ona Therapeutics is named as one of Fierce Biotech’s “Fierce 15” Biotech Companies of 2020

On September 28, 2020 Ona Therapeutics, which is focused on the discovery and development of therapeutic biologics to treat metastatic cancer, reported that it has been named by Fierce Biotech as one of 2020’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry (Press release, Ona Therapeutics, SEP 28, 2020, View Source;utm_medium=rss&utm_campaign=ona-therapeutics-is-named-as-one-of-fierce-biotechs-fierce-15-biotech-companies-of-2020 [SID1234567656]).

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Valerie Vanhooren, CEO and co-founder of Ona Therapeutics, commented: "It is a great honor to be selected from hundreds of companies around the world as a Fierce 15 company. It has been a transformational year for Ona Therapeutics. Following one of the biggest Series A in Europe this year, this award validates our scientific approach and our commitment to developing first-in-class treatments for metastatic cancer patients. I would like to thank our team for their exceptional work, and we look forward to taking Ona Therapeutics to the next stage of development."

Ona Therapeutics was founded in 2019 by research scientists Salvador Aznar-Benitah and Valerie Vanhooren as an IRB Barcelona and ICREA spin-off. Its approach is based on pioneering work from Dr Aznar-Benitah published in Nature in 2017 that validates Metastasis-Initiating Cells as therapeutic targets in metastatic cancer. In June 2020, Ona Therapeutics raised €30 million in Series A financing to complete the pre-clinical development in a variety of tumor types and to move its lead candidate into first clinical studies in patients with metastatic cancer. The company’s investors include Asabys Partners, Alta Life Sciences, Bpifrance – InnoBio 2, Fund+ and Ysios Capital.

Now in its 18th edition, Fierce 15 celebrates the next generation of healthcare companies championing innovation and creativity in the face of intense competition. Every year Fierce Biotech evaluates hundreds of private companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.

TYVYT® (Sintilimab Injection) in Combination with BYVASDA® (Bevacizumab Injection) ORIENT-32 Study Met Its Primary Endpoints of Progression-Free Survival and Overall Survival in the First-Line Treatment of Patients with Advanced Hepatocellular Carcinoma (HCC)

On September 27, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported the results of a Phase 3, open label, randomized study in China (Press release, Innovent Biologics, SEP 27, 2020, View Source [SID1234567638]). The ORIENT-32 trial evaluating TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection, or IBI305) as a first-line treatment in advanced hepatocellular carcinoma (HCC) met the predefined primary endpoints of progression-free survival (PFS) and overall survival (OS) in an interim analysis. This is the first Phase 3 clinical trial using PD-1 inhibitor-based combination therapy that has met the primary endpoint in the first-line treatment of advanced HCC.

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Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) demonstrated a statistically significant improvement in PFS and OS compared with sorafenib. The safety profile of TYVYT (sintilimab injection) and BYVASDA (bevacizumab biosimilar injection) in this trial was consistent with previously reported studies, and no new safety signals were identified. These data will be presented at an upcoming medical conference. Based on the IDMC recommendation, Innovent will review these results with the Drug Evaluation Center (CDE) of the National Medical Products Administration (NMPA) in China.

The principal investigator of the ORIENT-32 study, Professor Fan Jia from Zhongshan Hospital of Fudan University, stated: "In China, HCC is the fourth most common malignancy with the second highest mortality rate. More than half of new and fatal cases of HCC in the world occur in China every year. At present, sorafenib, lenvatinib and chemotherapy are the main treatments for HCC in the first-line treatment setting in China, with very limited efficacy. About 85% of HCC patients in China have the history of HBV infection, which is a quite different feature from HCC in the European and American countries. Therefore, continued clinical research in treating HCC is of great importance in China. The ORIENT-32 study confirmed that TYVYT (sintilimab injection), in combination with BYVASDA (bevacizumab biosimilar injection), can prolong PFS and OS in the first-line treatment of HCC. Despite the COVID-19 pandemic, all study investigators worked to overcome many challenges to continue this trial with the goal of bringing new hope to HCC patients."

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent stated: "TYVYT is the only anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List in China. It was officially approved by the NMPA on December 24, 2018 for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy. BYVASDA (bevacizumab biosimilar injection) was officially approved by the NMPA for patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China. The results of the ORIENT-32 study demonstrate the potential of TYVYT in combination with BYVASDA to treat patients with advanced HCC in the first-line setting. We hope this clinical trial can potentially provide a more effective treatment option for clinicians and HCC patients. We would like to express our sincere gratitude to all the patients and investigators who participated in the ORIENT-32 study. Outstanding contributions were made through the joint efforts of investigators and the study team, despite the challenges and impact from the COVID-19 pandemic.

About ORIENT-32 Trial

ORIENT-32 is a Phase 3 randomized, open-label, multi-center study to evaluate the efficacy and safety of TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) compared to sorafenib in the first-line treatment of patients with advanced hepatocellular carcinoma (ClinicalTrials.gov, NCT 03794440). The primary endpoints are progression-free survival (PFS) and overall survival (OS) assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1.

Enrolled patients were randomly assigned 2:1 to receive TYVYT (sintilimab injection) combination with BYVASDA (bevacizumab biosimilar injection) or sorafenib, until disease progression, unacceptable toxicity, withdrawal of consent, death, or other reasons stated in the protocol, whichever occurs first.

About Hepatocellular Carcinoma (HCC)

Primary liver cancer (PLC) is a common malignancy of the digestive system worldwide, among which about half new cases and deaths occur in China. The main pathological types of liver cancer are hepatocellular carcinoma (HCC), accounting for 85 to 90 percent, and a small number of cases of intrahepatic cholangiocarcinoma (ICC) and HCC-ICC mixed liver cancer. In China, HCC is primarily caused by hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection) is an innovative drug with global quality standards jointly developed by Innovent and Lilly in China. TYVYT has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy and was included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT is the only PD-1 inhibitor that has been included in the new Catalogue of the NRDL in November 2019.

In April 2020, the NMPA accepted the supplemental new drug application for TYVYT in combination with ALIMTA (pemetrexed) and platinum chemotherapy as first-line therapy in nonsquamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT combined with GEMZAR (gemcitabine for injection) and platinum chemotherapy met the predefined primary endpoint in the Phase 3 ORIENT-12 study as first-line therapy in patients with locally advanced or metastatic squamous NSCLC. TYVYT monotherapy met the primary endpoint in the ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma as well. In August 2020, the NMPA accepted the sNDA for TYVYT in combination with GEMZAR (gemcitabine for injection) and platinum chemotherapy as first-line therapy in patients with locally advanced or metastatic squamous NSCLC.

TYVYT is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT to evaluate its safety and efficacy in a wide variety of cancer indications globally, including more than 10 registrational or pivotal clinical trials.

About BYVASDA (Bevacizumab Biosimilar Injection)

BYVASDA (IBI305) is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. BYVASDA produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. Since the launch of bevacizumab, it has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of bevacizumab have been well recognized worldwide.