On June 7, 2019 ArQule, Inc. (Nasdaq: ARQL), reported that it will present clinical data from the company-sponsored phase 1 dose escalation study on its BTK inhibitor, ARQ 531, for the treatment of relapsed or refractory B-cell lymphoid malignancies in a poster presentation at the 24thCongress of European Hematology Association (EHA) (Free EHA Whitepaper), held from June 13-16, 2019 in Amsterdam (Press release, ArQule, JUN 7, 2019, View Source [SID1234536955]).

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Presentation Details

Title:A Phase 1 Dose Escalation Study Of ARQ 531 In Patients with Relapsed or Refractory B-Cell Lymphoid Malignancies
Abstract #: PS1150
Session: 6. Chronic lymphocytic leukemia and related disorders – Clinical
Date:Saturday, June 15, 2019
Time:5:30-7:00 p.m. CEST
Location: RAI Amsterdam; Poster area

ArQule will host a conference call and webcast for investors on Friday, June 14, 2019 at 8:00 a.m. EDT to discuss the ARQ 531 clinical data. The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events & Presentations" or by visiting View Source You may also listen to the call by dialing 1-800-239-9838 within the U.S. or 1-323-794-2551 outside the U.S. and providing conference ID 3110780. A replay will be available two hours after the completion of the call and can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events and Presentations."

ArQule Management will also be hosting an Investor event to answer questions and discuss these data on Friday, June 14th from 5:30 – 8:00 p.m. CEST. Investors, sell side analysts and industry representatives are welcome to attend. To register to attend, please click on the link here.

About BTK and ARQ 531
Bruton’s tyrosine kinase, BTK, is a therapeutic target that has been clinically proven to inhibit B-cell receptor signaling in blood cancers. ARQ 531 is an orally bioavailable, potent and reversible dual inhibitor of both wild type and C481S-mutant BTK. The C481S-mutation is a known resistance mechanism for first generation irreversible BTK inhibitors. ARQ 531 has demonstrated a good safety profile, predictable PK, profound pharmacodynamic effects and emerging signs of dose-proportional clinical activity in phase 1 clinical testing.

On June 7, 2019 LabCorp (NYSE: LH), a leading global life sciences company that is deeply integrated in guiding patient care, reported a new companion diagnostic called therascreen PIK3CA PCR mutation analysis, which is now available through LabCorp and its Integrated Oncology specialty laboratory (Press release, LabCorp, JUN 7, 2019, View Source;p=RssLanding&cat=news&id=2400961 [SID1234536953]).

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This press release features multimedia. View the full release here: View Source

The test, developed by QIAGEN (NYSE: QGEN, Frankfurt Stock Exchange: QIA), a world leader in Sample to Insight solutions for molecular testing, identifies whether a patient has the specific gene mutation that is a prerequisite for treatment with Piqray (aplelisib), a new therapy from Novartis for the treatment of postmenopausal women and all men with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after an endocrine-based regimen. Piqray, in combination with fulvestrant, and therascreen PIK3CA PCR mutation analysis assay received approval from the U.S. Food and Drug Administration (FDA) on May 24, 2019. LabCorp is able to make the test available quickly after FDA approval through its participation in QIAGEN’s Day-One Lab Readiness program, under which LabCorp began test validation and development of operating protocols while the test was under regulatory review and is therefore able to make the test available to patients just two weeks after approval.

"Piqray (aplelisib), from Novartis, is the first and only therapy for HR+/HER2- advanced breast cancer with a PIK3CA mutation," said Marcia Eisenberg, PhD, chief scientific officer, LabCorp Diagnostics. "Through our collaboration with QIAGEN and participation in their Day-One Lab Readiness Program, LabCorp is able to quickly make new companion diagnostics available to help identify patients who are eligible for the most innovative treatments, individualized to their disease. Enabling patients to gain access to new treatments faster, furthering LabCorp’s mission to improve health and improve lives."

The American Cancer Society estimates that in 2019, there will be 268,600 new cases of breast cancer and approximately 70% will be HR+/HER2-. For patients with HR+/HER2-advanced breast cancer, approximately 40% have the PIK3CA mutation, which is associated with tumor growth, resistance to endocrine treatment and a poor overall prognosis.

The availability of this new companion diagnostic demonstrates LabCorp’s continued leadership in companion diagnostics and precision medicine, with the industry’s leading portfolio of tests that identify personalized characteristics for each patient, and help guide more specific treatment choices. For more than 20 years, long before they joined forces, LabCorp Diagnostics and Covance Drug Development have been involved in the development, commercialization and launch of companion and complementary diagnostics, and together they have supported more FDA-approved companion diagnostics than any other company. Since 2018, the Company has collaborated with more than 75 clients on over 150 projects targeted at the development of new companion diagnostics.

LabCorp joined QIAGEN’s Day-One Lab Readiness program in early 2019. In addition to the therascreen PIK3CA PCR mutation analysis assay announced today, LabCorp also recently launched the therascreen FGFR mutation assay by RGQ RT-PCR for bladder cancer through the Day-One program. Multiple other assays, including novel companion diagnostics for lung, colorectal, bladder and other cancers, and eventually pan-tumor disease areas, are currently in LabCorp’s Day-One Lab Readiness pipeline.

"The promise of precision medicine is delivering the right drug to the right patient at the right time, and it can be an absolute game-changer for cancer patients," said Dr. Dot Adcock, chief medical officer, LabCorp Diagnostics. "LabCorp’s close relationships with numerous hospitals, health systems, cancer clinics and oncologists across the U.S. enables us to provide genetic testing for an increasing number of patients, helping them to more quickly access the targeted therapy that is right for them. We’re seeing extraordinary breakthroughs in precision medicine in oncology patients, and it’s exciting to be a part of these advances in patient care."

For more information about LabCorp’s leadership role in precision medicine, visit View Source

Piqray is a registered trademark of Novartis AG.

therascreen is a registered trademark of QIAGEN N.V.

On June 7, 2019 Amgen (NASDAQ:AMGN) reported that it will present at the Goldman Sachs 40th Annual Global Healthcare Conference at 11:20 a.m. PT on Wednesday, June 12, 2019, in Rancho Palos Verdes, Calif. David M. Reese, M.D., executive vice president of Research and Development at Amgen, will present at the conference (Press release, Amgen, JUN 7, 2019, View Source;p=RssLanding&cat=news&id=2400957 [SID1234536952]). Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for at least 90 days following the event.

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On June 7, 2019 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that Jeff Goater, chief executive officer, will participate in the Goldman Sachs 40th Annual Global Healthcare Conference on Wednesday, June 12, 2019 at the Terranea Resort in Rancho Palos Verdes, CA (Press release, Surface Oncology, JUN 7, 2019, View Source [SID1234536951]).

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The corporate presentation will be accessible by visiting the Events and Presentations page of the website at View Source

On June 7, 2019 Astex Pharmaceuticals reported A new set of statistically significant overall survival (OS) data unveiled at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract# LBA1008), and published in The New England Journal of Medicine, are being heralded as a major breakthrough forpre- and perimenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancerpremenopausal women with advanced breast cancer (Press release, Astex Pharmaceuticals, JUN 7, 2019, View Source [SID1234536950]).

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Kisqali was discovered and developed by the Novartis Institutes for Biomedical Research (NIBR) under a research collaboration entered into with Astex in 2005. Kisqali is a CDK4/6 inhibitor that slows the progression of cancer by inhibiting two proteins (CDK4 & CDK6) which, when over-activated, can enable cancer cells to grow and divide quickly.

Successful results from the phase III MONALEESA-7 clinical trial resulted in Kisqali receiving marketing approval in the US and EU in 2018 in combination with an endocrine-based therapy for pre- and perimenopausal women with (HR+/HER2-) locally advanced or metastatic breast cancer in combination with an aromatase inhibitor.

The UK’s National Institute for Health and Care Excellence (NICE) recommended Kisqali as a cost-effective treatment option for postmenopausal women within England and Wales with advanced breast cancer in November 2017. Advanced breast cancer in premenopausal women is the leading cause of cancer death in women 20-59 years old [1],[2].

Kisqali is the only CDK4/6 inhibitor to show superior overall survival in a clinical trial (alt. "v. placebo") in advanced breast cancer (HR=0.712; p=0.00973)[3]. In its announcement at ASCO (Free ASCO Whitepaper), Novartis noted that the new data from its MONALEESA-7 trial showed that after a median of 42 months follow-up, survival rate for women was 70.2% for women who received Kisqali combination therapy compared to 46.0% for women who received endocrine therapy alone. The breakthrough data has been widely reported in the world’s press.

Harren Jhoti Ph.D., President and CEO of Astex, UK, said, "It’s fantastic to see such a significant advance in cancer treatment. Ultimately as life science entrepreneurs, our goal is to improve lives through the discovery of new therapies. Kisqali was the first new cancer drug discovered and developed from our collaboration with Novartis to reach marketing approval and was a milestone for the company in 2017. These new data are a real milestone for patients."
The paper,Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer, was a published in The New England Journal of Medicinetoday and is available online.

See the discovery journey for Kisqali, here: View Source