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BeiGene Initiates Pivotal Trial of PARP inhibitor Pamiparib (BGB-290) in China in Patients with Ovarian Cancer

On December 18, 2017 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported that the first patient was dosed in a pivotal Phase 2 clinical trial of pamiparib (BGB-290), an investigational PARP inhibitor, in Chinese patients with advanced ovarian cancer (Press release, BeiGene, DEC 18, 2017, View Source;p=RssLanding&cat=news&id=2323078 [SID1234522679]).

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"We are pleased to announce the initiation of the first pivotal trial of pamiparib in China. Clinical development began in Australia in July 2014 and in China in December 2016. Pamiparib is being evaluated in several global clinical trials in a broad range of indications, both as monotherapy and in combination with tislelizumab (BGB-A317), our anti-PD-1 antibody, with chemotherapy or with radiotherapy. We look forward to advancing pamiparib in China, where no PARP inhibitor has been approved," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

"Patients with advanced ovarian cancer who harbor a germline BRCA mutation will be recruited to this study. Patients in China have limited treatment options, especially following platinum-based therapy, despite the multiple approvals of PARP inhibitors in other regions of the world," commented Amy Peterson, M.D., Chief Medical Officer for Immuno-Oncology of BeiGene.

The pivotal Phase 2 single-arm, open-label, multi-center trial is designed to evaluate the efficacy, safety, tolerability, and pharmacokinetic profile of pamiparib in patients with high-grade ovarian cancer, including fallopian cancer or primary peritoneal cancer, harboring a known or suspected deleterious germline BRCA1/2 mutation. This trial plans to enroll approximately 100 patients who have received at least two previous lines of therapy in the advanced or metastatic setting, and will be divided into two cohorts according to their platinum-sensitivity status. The trial’s primary endpoint is objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1), as assessed by independent radiology review. Secondary endpoints include ORR as assessed by investigators, progression-free survival, duration of response, overall survival, disease control rate, best overall response, clinical benefit rate, safety, tolerability, and pharmacokinetic profile. Professor Xiaohua Wu of the Fudan University Cancer Center is the lead principal investigator of the trial.

About Pamiparib

Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2 which demonstrated pharmacological properties such as brain penetration and PARP–DNA complex trapping in preclinical models. Pamiparib is currently in global clinical development as a monotherapy and in combination with other agents for a variety of solid tumor malignancies.

Launch of the Photodynamic Diagnostic Agent "ALAGLIO® Divided Granules 1.5g"

On December 18, 2017 Chugai Pharmaceutical Co., Ltd. (Head office: Tokyo; Chairman & CEO: Osamu Nagayama; "Chugai") reported that it will launch the photodynamic diagnostic agent, "ALAGLIO Divided Granules 1.5g" ("this Agent") on December 19th (Press release, Chugai, DEC 18, 2017, View Source [SID1234522677]). This Agent was developed by SBI Pharmaceuticals Co., Ltd., (Head office: Tokyo; Representative Director & President: Yoshitaka Kitao; "SBI Pharma"), a subsidiary of SBI Holdings, Inc., engaged in the research and development of medicines using 5-ALA (5-Aminolevulinic acid) and received a manufacturing and marketing approval on September 27th, 2017 for the indication of "visualization of non-muscle invasive bladder cancer during transurethral resection" and was listed on the National Health Insurance reimbursement price list on November 22nd.

This Agent for photodynamic diagnosis (PDD) works because the site of the tumor lesion emits red fluorescence when the metabolite of the Agent, protoporphyrin IX, is irradiated with blue light. ALAGLIO is an orphan drug and the first in the world to be approved for this indication. Combining PDD to the transurethral resection of bladder tumors (TURBT) is expected to facilitate the detection of non-muscle invasive bladder cancer and be clinically useful in preventing post-TURBT progression and recurrence.

Chugai and SBI Pharma are dedicated to providing information to ensure that "ALAGLIO Divided Granules 1.5g" is used appropriately and can make an even greater contribution to the treatment of patients with bladder cancer.

5-Aminolevulinic acid (5-ALA):
An amino acid produced in mitochondria. It is an important substance that serves as a functional molecule related to energy production in the form of heme and cytochromes, and its productivity is known to decrease with age. 5-ALA is contained in food such as shochu lees, red wine and Asian ginseng. It is also known as a material forming chloroplasts in plants.

Transurethral resection of the bladder tumor (TURBT):
A method to insert a surgical endoscope (cystoscope) from the urethra without laparotomy, and resect the tumor while preserving the bladder function.

Non-muscle invasive bladder cancer:
The bladder cancer of a relatively early stage, without invading muscular layer of urinary bladder. It accounts for about 70% of all types of the bladder cancer*. The initial treatment for this type of cancer is primarily TURBT, aiming at the preservation of the bladder function. However, TURBT with a conventional white light source only results in the recurrence with the ratio of 31-78% within 5 years after the operation**.
* Edited by The Japanese Urological Association; Guideline for the Diagnosis and Treatment of the Bladder Cancer 2015 (Igakutosho-shuppan Ltd.); 25
** Sylvester RJ, et al. (2006) Eur Urol; 49: 466-77

Drug Information

Brand name: ALAGLIO Divided Granules 1.5g

Generic name: Aminolevulinic acid hydrochloride

Indications:
Diagnostic agent to visualize non-muscle invasive bladder cancer at the operation of its transurethral resection

Dosage and administration:
The recommended dose for adult patients is 20mg of 5-aminolevulinic acid hydrochloride per kg body weight, dissolved in water and orally administered to the patient 3 hours (range: 2-4 hours) before the insertion of a cystoscope to the bladder

Storage: Protection from light, Store at room temperature

Date of approval: September 27, 2017

Date of NHI reimbursement price listing: November 22, 2017

Date of launch: December 19, 2017

Drug price: JPY 74,873.70/ one 1.5g packet
Trademarks used or mentioned in this release are protected by law.

US FDA accepts regulatory submission for Tagrisso in 1st-line EGFR-mutated non-small cell lung cancer

On December 18, 2017 AstraZeneca reported that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations) (Press release, AstraZeneca, DEC 18, 2017, View Source [SID1234522676]). The FDA has granted Tagrisso Priority Review status and previously granted Breakthrough Therapy Designation in the 1st-line treatment of patients with metastatic EGFR mutation-positive (EGFRm) NSCLC.

The submission acceptance is based on data from the Phase III FLAURA trial, in which Tagrisso significantly improved progression-free survival (PFS) compared to current 1st-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC.

On 28 September 2017, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology were updated to include the use of Tagrisso in the 1st-line treatment of patients with metastatic EGFRm NSCLC. The use of Tagrisso in this indication is not yet approved by the FDA.

NOTES TO EDITORS

About NSCLC

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-quarter of all cancer deaths, more than breast, prostate and colorectal cancers combined. Approximately 10-15% of patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC. These patients are particularly sensitive to treatment with currently-available EGFR-TKIs, which block the cell-signalling pathways that drive the growth of tumour cells. However, tumours almost always develop resistance to EGFR-TKI treatment leading to disease progression. Approximately half of patients develop resistance to approved EGFR-TKIs such as gefitinib and erlotinib due to the resistance mutation, EGFR T790M.Tagrisso also targets this secondary mutation that leads to disease progression. There is also a need for medicines with improved CNS efficacy, since approximately 25% of patients with EGFR-mutated NSCLC have brain metastases at diagnosis, increasing to approximately 40% within two years of diagnosis.

About Tagrisso

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against CNS metastases. Tagrisso 40mg and 80mg once-daily oral tablets have been approved in more than 60 countries, including the US, EU, Japan and China, for patients with EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being investigated in the adjuvant setting and in combination with other treatments.

About the FLAURA trial

The FLAURA trial assessed the efficacy and safety of Tagrisso 80mg once daily vs standard-of-care EGFR-TKIs (either erlotinib [150mg orally, once daily] or gefitinib [250mg orally, once daily]) in previously-untreated patients with locally-advanced or metastatic EGFR-mutated NSCLC. The trial was a double-blinded, randomised trial, with 556 patients across 29 countries.

About AstraZeneca in Lung Cancer

AstraZeneca is committed to developing medicines to help every patient with lung cancer. We have two approved medicines and a growing pipeline that targets genetic changes in tumour cells and boosts the power of the immune response against cancer. Our unrelenting pursuit of science aims to deliver more breakthrough therapies with the goal of extending and improving the lives of patients across all stages of disease and lines of therapy.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

Transgene Announces Upcoming Investor Meetings

On December 18, 2017 Transgene (Paris:TNG) (Euronext Paris: TNG) reported that Management will participate in the upcoming investor events set out below (Press release, Transgene, DEC 18, 2017, View Source [SID1234522690]).

Transgene will meet institutional investors from January 7 to 11, 2018, in San Francisco, USA, concurrent with the J.P. Morgan Healthcare conference.

The Company will also attend:

Oddo Forum: January 11 & 12, 2018 – Lyon, France
Portzamparc MidCap Conference: April 4, 2018 – Paris, France
Small Cap Event: April 16 & 17, 2018 – Paris, France
Kempen Life Sciences Conference: April 18 & 19, 2018 – Amsterdam, Netherlands

Abbott Hosts Conference Call for Fourth-Quarter Earnings

On December 18, 2017Abbott (NYSE: ABT) reported that it will present its fourth-quarter 2017 financial results on Wednesday, Jan. 24, 2018, before the market opens (Press release, Abbott, DEC 18, 2017, View Source [SID1234522685]).

The announcement will be followed by a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.