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New Analysis of NSABP Randomized B-20 Study Confirms Patients with Oncotype DX Breast Recurrence Score® Results Greater Than 25 Have Life-saving Benefit from Chemotherapy, Reinforcing the Conclusions of the Landmark TAILORx Study

On November 29, 2018 Genomic Health, Inc. (NASDAQ: GHDX) and the NSABP Foundation reported the publication of positive results from a new analysis of the NSABP-led B-20 study reconfirming that the Oncotype DX Breast Recurrence Score test predicts which patients with early-stage, HER2-negative breast cancer will benefit from chemotherapy (Press release, Genomic Health, NOV 29, 2018, View Source [SID1234531720]).

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Applying the patient criteria from the TAILORx study, the largest ever breast cancer treatment trial, sponsored by the National Cancer Institute (NCI), and led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), NSABP conducted a new analysis in 569 patients from its previously completed B-20 study. The results show that Oncotype DX provides definitive information about which patients will derive life-saving benefit from chemotherapy treatment.

"We previously had an unprecedented amount of data on patients with Oncotype DX Breast Recurrence Score results of 25 or lower, and now with the results from TAILORx and the new B-20 analysis, we have critical confirmation for patients with scores over 25 that they should be treated with chemotherapy," said Norman Wolmark, M.D., chairman of the NSABP Foundation in Pittsburgh, Pennsylvania. "Our publication underscores the important clinical value of the Oncotype DX test in guiding treatment decision in every early-stage, HER2-negative breast cancer patient."

The new results, published in November in the Nature Partner Journals (NPJ) Breast Cancer, show a statistically significant (p < 0.001) benefit from the addition of chemotherapy to hormonal therapy in patients with Breast Recurrence Score results greater than 25.

About 50 percent of all breast cancer patients diagnosed worldwide each year have hormone-receptor positive, HER2-negative, node-negative cancer. The TAILORx study, published in The New England Journal of Medicine, definitively established that chemotherapy may be spared in the majority of these patients. Importantly, some early-stage breast cancer patients – as reinforced by the new NSABP publication – will derive life-saving benefit from chemotherapy, including women with Breast Recurrence Score results of 26 to 100. TAILORx participants with Breast Recurrence Score results from 26 to 100 were treated with chemotherapy plus endocrine therapy.

"The new B-20 study analysis, combined with the published results from TAILORx, provide unparalleled evidence from randomized patients that Oncotype DX can predict which patients will benefit from chemotherapy," said Steven Shak, M.D., chief scientific officer and chief medical officer, Genomic Health. "Also recognized by the National Comprehensive Cancer Network (NCCN) as the only multi-gene test to predict chemotherapy benefit, physicians can now tell every patient more confidently, based on Oncotype DX, whether they should receive chemotherapy or not."

About Oncotype DX

The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX Breast Recurrence Score test, is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to AR-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Genomic Health. With more than 950,000 patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

ArQule to Host Analyst Call Highlighting Clinical Progress from Ongoing Phase 1 Study of Reversible BTK Inhibitor, ARQ 531, in Patients with Relapsed/Refractory Hematologic Malignancies

On November 29, 2018 ArQule, Inc. (Nasdaq: ARQL) reported that it will host a call to discuss the updated safety, PK, biomarker and anti-tumor activity data from the company’s Phase 1 dose escalation study in patients with relapsed or refractory hematologic malignancies (ARQ 531-101) that are being presented in a poster presentation at the 60thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition on December 3, 2018 in San Diego (Press release, ArQule, NOV 29, 2018, View Source [SID1234531719]).

Call Details

Date: Monday, December 3, 2018
Time:6:00 a.m. PT/9:00 a.m. ET

The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events & Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. 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."

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 BTK inhibitor. Biochemical and cellular studies have shown that ARQ 531 inhibits both the wild type and C481S-mutant forms of BTK. The C481S-mutation is a known resistance mechanism for first generation irreversible BTK inhibitors. In preclinical studies, ARQ 531 has demonstrated good oral bioavailability as well as favorable pharmacokinetic, pharmacodynamic and metabolic properties

OncoSec Presents New Data During Oral Presentation At Melanoma Bridge Demonstrating Intratumoral Monotherapy TAVO™ Induces Abscopal Responses In Metastatic Melanoma Patients

On November 29, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, reported the presentation of new data from the company’s Phase 2 study of TAVO (tavokinogene telseplasmid) for the treatment of metastatic melanoma (Press release, OncoSec Medical, NOV 29, 2018, View Source [SID1234531716]). The newly presented data reports abscopal responses with TAVO monotherapy, finding that treatment with TAVO monotherapy resulted in 47 percent of patients experiencing tumor regression in at least one untreated lesion. These data were selected for an oral presentation at Melanoma Bridge 2018, taking place November 30 to December 1, Naples, Italy.

"These findings are significant because they clearly demonstrate that intratumoral treatment with TAVO is having a systemic effect that goes beyond the treated tumor, and to see that effect in nearly half of treated patients is remarkable, particularly with such a well-tolerated therapy," said Alain Algazi, M.D., Lead Trial Investigator, Associate Professor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center and Strategic Clinical Advisor to OncoSec. "These findings build upon our previous report from this study showing an approximate 30 percent overall response rate with monotherapy TAVO and further support the potential value of TAVO therapy for this patient population."

OMS-100 is a Phase 2 study of monotherapy TAVO for the treatment of patients with metastatic melanoma. In all, 51 subjects were enrolled in three treatment arms. Reponses data from the study were previously reported, with approximately 30 percent of subjects achieving a best overall response based on RECIST criteria. In addition, 47 percent of patients had stable disease, resulting in a DCR (Disease Control Rate) of 77 percent. Among patients who responded to monotherapy, investigators noted upregulation of innate immune mediators in the periphery of responding patients after treatment. TAVO was well tolerated, with predominantly grade 1 procedural related adverse events.

Slides from the Melanoma Bridge will be available following the conference on www.oncosec.com

Bristol-Myers Squibb to Take Part in Citi 2018 Global Healthcare Conference

On November 29, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported that it will take part in the Citi 2018 Global Healthcare Conference on Thursday, December 6, 2018 in New York (Press release, Bristol-Myers Squibb, NOV 29, 2018, View Source [SID1234531711]). Tom Lynch, chief scientific officer, will answer questions about the company at 2:10 p.m. ET.

Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.

Clinical Genomics partners with the Colorectal Cancer Alliance in the Life After Cancer Mission

On November 29, 2018 Clinical Genomics, a leading provider of cancer diagnostic solutions including liquid biopsy tests, reported its partnership with the Colorectal Cancer Alliance in a yearlong collaboration for the Life After Cancer mission (Press release, Clinical Genomics, NOV 29, 2018, View Source [SID1234531709]). The Alliance is the largest US-based nonprofit patient advocacy group for colorectal cancer patients, providing resources and education to patients in their fight against this disease. The Life After Cancer initiative focuses on helping patients navigate their survivorship path by creating awareness about recurrence monitoring as part of their follow up care, allowing those who have overcome the disease to become an advocate of their long-term health and well-being. This expanded partnership between Clinical Genomics and the Colorectal Cancer Alliance builds upon an existing relationship to continue the mission to support this patient community.

Clinical Genomics is the sole provider of COLVERA, a unique blood test for patients who have been diagnosed with colorectal cancer (CRC) that identifies circulating tumor DNA (ctDNA) for early detection of residual and recurrent disease, at a stage when more treatment options are available for these patients. COLVERA is currently marketed in the USA and available through our CLIA-certified laboratory in Bridgewater, NJ.

"Early detection has been shown to improve overall survival from this deadly disease. Colorectal cancer affects a wide range of ages with increasing incidence in younger patients. Partnerships like this with Clinical Genomics are critical in order to make an impact on this devasting disease and provide patients with cutting edge tools and resources they need in order to navigate their choices," stated Michael Sapienza, CEO of the Colorectal Cancer Alliance.

"We had the great pleasure to meet patients and their circle of support at the Alliance’s National Conference in Houston this year. Working with the Alliance on Life After Cancer, we can contribute to providing important education and awareness resources to this community. Colorectal cancer screening is an important focus in the US and now we must emphasize the importance of follow-up care surveillance monitoring of CRC with tests like COLVERA, for patients who have been diagnosed with the disease," said Betsy Hanna, Chief Commercial Officer of Clinical Genomics.

About Colorectal Cancer
Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer related deaths in the United States, with more than 140,000 people per year expected to be diagnosed with CRC and as many as 50,000 succumbing to the disease. For patients who survive, 30-50% will experience a recurrence, most within the first two to three years of primary treatment. On average, the lifetime risk of developing colorectal cancer is about one in 23 for men and women combined, however, this varies widely according to individual risk factors.