On June 3, 2019 Genomic Health, Inc. (NASDAQ: GHDX) reported that its Oncotype DX Breast Recurrence Score test and the TAILORx results have been recommended to guide chemotherapy treatment use in patients with node-negative early-stage breast cancer by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in its 2019 Guidelines for Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy (Press release, Genomic Health, JUN 3, 2019, View Source [SID1234536824]). Using the strong and highest level of evidence from TAILORx, the updated ASCO (Free ASCO Whitepaper) guidelines increase the proportion of women who can be effectively treated without chemotherapy based on the Oncotype DX results, highlighting the importance of testing all medically eligible patients as standard of care.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased that the ASCO (Free ASCO Whitepaper) guidelines have been updated to reflect the findings from the landmark TAILORx trial, the practice-changing results of which demonstrated that the Oncotype DX Recurrence Score result can be used to guide chemotherapy decision-making for all medically eligible women with the most common form of early-stage, invasive breast cancer," said Steven Shak, M.D., chief scientific officer, Genomic Health. "The TAILORx results have influenced positive treatment guideline recommendations from ASCO (Free ASCO Whitepaper) and other organizations around the world, elevating the Oncotype DX test to a new global standard of care."

TAILORx, sponsored by the National Cancer Institute (NCI) and conducted by the ECOG-ACRIN Cancer Research Group, involved 10,273 women across 1,100 trial sites in six participating countries. The study results, which were presented during the Plenary Session at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting last June and simultaneously published in The New England Journal of Medicine, demonstrated that the Oncotype DX Breast Recurrence Score test definitively identifies the vast majority of women with early-stage breast cancer who receive no benefit from chemotherapy, and the important minority of women for whom chemotherapy benefit can be life-saving. Patients with an Oncotype DX Breast Recurrence Score result of 25 or less – up to about 80 percent of patients – may be safely spared chemotherapy and its well-known side effects, while those with scores of 26 to 100 may receive a life-saving benefit from chemotherapy.

"The updated ASCO (Free ASCO Whitepaper) breast cancer treatment guidelines based on the TAILORx results will provide physicians with clarity and confidence that they are selecting the right treatment for each of their breast cancer patients," said Harold A. Burstein, M.D., Ph.D., medical oncologist at the Dana-Farber Cancer Institute. "Having guidelines that reflect the latest ground-breaking research is critical in ensuring that physicians incorporate standard-of-care technology, such as the Oncotype DX test, when making clinical decisions about treatment for their patients with breast cancer."

New TAILORx Data Analysis at 2019 ASCO (Free ASCO Whitepaper) Annual Meeting
New analysis of a secondary endpoint of the TAILORx trial will be presented in the "Breast Cancer—Local/Regional/Adjuvant" oral abstract session at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting. The presentation, titled "Impact of clinical risk category on prognosis and prediction of chemotherapy benefit in early breast cancer (EBC) by age and the 21-gene recurrence score (RS) in TAILORx," will take place on Monday, June 3. The abstract (#503) can be accessed here.

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 androgen receptor (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 1 million 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.

On June 3, 2019 Brooklyn ImmunoTherapeutics, a biopharmaceutical company focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, reported the presentation of an ongoing trial poster at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 31 – June 4, 2019 at the McCormick Place in Chicago, IL (Press release, Brooklyn ImmunoTherapeutics, JUN 3, 2019, View Source [SID1234536842]). The poster describes a Phase 1b study to evaluate the safety, determine the recommended Phase 2 dose and investigate the biologic and clinical activity of IRX-2 in combination with nivolumab in solid tumor indications (NCT03758781).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

IRX-2 is an allogeneic, cell-derived biologic with multiple active cytokine components, including IL-2, that act on various parts of the immune system associated with activation of the entire tumor microenvironment.

"Anti-PD-1 therapy in oncology has been demonstrated to be a safe and effective therapeutic approach in treating certain cancers and increased lymphocyte infiltration has been associated with improved patient outcomes," said Rohit K Jain, M.D. M.P.H., principal investigator on the Phase 1b trial and Assistant Member in Moffitt Cancer Center Department of Genitourinary Oncology. "In data collected to date, IRX-2 has demonstrated an increase immune activation in the tumor microenvironment and was correlated with greater progression free survival and overall survival in a Phase 2 study in head and neck cancer. This clinically observed increased immune activation suggests the combination of IRX-2 therapy with PD-1 blockade with nivolumab could enhance outcomes compared to PD-1 blockade alone. This robust Phase 1b trial in up to five different indications will help us better understand the potential role of IRX-2 in oncology immunotherapy."

The Phase 1b clinical trial is taking place at Moffitt Cancer Center in Tampa, Florida and is currently recruiting patients.

"IRX-2 has been well-tolerated to date in clinical trials while demonstrating encouraging activity in squamous cell cancer of the head and neck," said Mark Leuchtenberger, interim President and CEO of Brooklyn ImmunoTherapeutics. "We believe the mechanism of action as well as the safety and clinical activity shown to date provides a strong rationale for combining IRX-2 with checkpoint inhibitors such as nivolumab for the treatment of solid tumor cancers. We look forward to the results of this important trial as well as the results of other ongoing studies, including the Phase 2B INSPIRE trial and an investigator-sponsored trial in squamous cervical intraepithelial neoplasia 3 or vulvar intraepithelial neoplasia 3."

About the Phase 1b Trial
Patients with recurrent or metastatic renal cell carcinoma, urothelial carcinoma, non-small cell lung cancer, HNSCC and melanoma are eligible. Patients who have received prior anti-PD-1/PD-L1 antibodies are eligible. The IRX-2 regimen consists of cyclophosphamide 300mg/m2 (Day 1) and subcutaneous IRX-2 injections for 10 days every 3 months. Nivolumab is administered at 240 mg once every two weeks. Planned total enrollment of approximately 100 patients. The study will include cohorts of the 5 different diseases. Each cohort will include two groups: 1) anti-PD-1/PD-L1 antibody naïve tumors, and 2) progressed during or after anti-PD-1/PD-L1 antibodies.

The primary study objective is to determine safety and tolerability of combination therapy. Secondary objectives are to evaluate the objective response rate, progression-free survival, and overall survival. The study is actively accruing patients.

On June 3, 2019 Bio-Techne Corporation (NASDAQ:TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the Goldman Sachs 40th Annual Global Healthcare Conference on Tuesday, June 11th, 2019, at 1:20 p.m. PDT. The conference will be held at the Terranea Resort in Rancho Palos Verdes, CA (Press release, Bio-Techne, JUN 3, 2019, View Sourcenews/detail/141/bio-techne-to-present-at-the-goldman-sachs-40th-annual-global-healthcare-conference" target="_blank" title="View Sourcenews/detail/141/bio-techne-to-present-at-the-goldman-sachs-40th-annual-global-healthcare-conference" rel="nofollow">View Source [SID1234536928]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation can be accessed via Bio-Techne’s Investor Relations website at View Source or through the following link https://protect-us.mimecast.com/s/fEXdCzpB7LFm8ZnoS4YhL5?domain=cc.talkpoint.com.

On June 3, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported results from a number of abstracts highlighting studies including the treatment of both PD-L1-positive triple-negative and HER2-positive breast cancer at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting, 31 May – 4 June, in Chicago, United States (Press release, Hoffmann-La Roche, JUN 3, 2019, View Source [SID1234536789]). Data include results from the second overall survival (OS) interim analysis from the phase III IMpassion130 study evaluating Tecentriq (atezolizumab) plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the initial (first-line) treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).1 In HER2-positive breast cancer, results of an end-of-study analysis of the phase III CLEOPATRA study will also be presented, evaluating the long-term efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and docetaxel chemotherapy (the Perjeta-based regimen) in patients with previously untreated HER2-positive metastatic breast cancer (mBC).2

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our science-driven approach has been transforming standards of care in breast cancer for more than 20 years, and we are excited to present data from a Perjeta study, that showed an unprecedented survival benefit for patients living with advanced HER2-positive disease," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We are continuing our transformative work in breast cancer, presenting updated interim overall survival results from our phase III Tecentriq combination, the first positive immunotherapy study in PD-L1-positive metastatic triple-negative breast cancer, a disease with high unmet need."

TNBC is a form of breast cancer representing approximately 15% of all cases.3,4 Metastatic TNBC is one of the most aggressive and difficult-to-treat forms of breast cancer.3,4 HER2-positive disease is another particularly aggressive form of breast cancer accounting for approximately 15-20% of all cases of breast cancer.5

IMpassion130 study results
Results presented at ASCO (Free ASCO Whitepaper) were consistent with the first interim analysis reported at the European Society for Medical Oncology congress in October 2018.1,6 At the second interim analysis, statistical significance was not met for overall survival (OS) in the intention-to-treat (ITT) population (median OS=21.0 vs 18.7 months; HR=0.86, 95% CI: 0.72-1.02, p=0.078).1 However, Tecentriq and nab-paclitaxel showed a clinically meaningful OS improvement of seven months vs placebo and nab-paclitaxel in patients who were tested positively for PD-L1 expression on tumour-infiltrating immune cells (median OS=25.0 vs 18.0 months; HR=0.71, 95% CI: 0.54-0.93) with more mature data.1 OS results in the PD-L1-positive population were not formally tested due to the prespecified hierarchical analysis plan of the study. Over half (51% (43-59%)) of PD-L1-positive metastatic TNBC patients in the Tecentriq arm were alive at two years, compared with 37% (29-45%) in the control arm. Follow-up will continue until the next planned analysis.1

Additional analyses of patient-reported outcomes from IMpassion130 showed that the combination was well-tolerated, similarly to nab-paclitaxel alone.7 Tecentriq plus nab-paclitaxel showed gains in clinical benefit without compromising patients health-related quality of life (HRQoL), day-to-day functioning and without increasing patients toxicity burden compared to nab-paclitaxel alone.7 HRQoL evaluates the overall impact of disease and treatment on patient’s quality of life in terms of disease related symptoms, treatment side effects and function/well-being. An expanded safety analysis showed that the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles from the primary data with no new safety signals observed.8

CLEOPATRA study results
After a follow-up of eight years, results from the phase III CLEOPATRA study, investigating patients with previously untreated HER2-positive mBC, showed a median OS benefit of 57.1 months in the Perjeta arm compared with 40.8 months in the control arm (placebo, Herceptin and chemotherapy), an absolute improvement of 16.3 months, with a 31% overall reduction in the risk of death (HR=0.69, 95% CI 0.58-0.82, p<0.0001).2

These new data are consistent with previously published results and confirm that the unprecedented OS benefit of the Perjeta-based regimen was maintained after an additional four years of follow-up.2 Significantly, over a third (37%) of HER2-positive mBC patients in the Perjeta arm were alive at eight years, compared with 23% in the control arm.2 Safety data from the long-term follow-up study were consistent, and showed that the cardiac and overall safety profiles of the Perjeta-based regimen were maintained.2

Additionally, data from the Chinese phase III PUFFIN study were presented at this year’s meeting further confirming the use of the Perjeta-based regimen in HER2-positive mBC, as results were consistent with those seen in the CLEOPATRA study.9

Roche’s breadth of expertise continues to advance breast cancer research with the goal of expanding treatment options to improve the lives of patients living with the disease worldwide.

About the IMpassion130 study
The IMpassion130 study is a phase III, multicentre, randomised, double-blind study evaluating the efficacy, safety and pharmacokinetics of Tecentriq plus nab-paclitaxel compared with placebo plus nab-paclitaxel in people with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for mBC. The study enrolled 902 people who were randomised equally (1:1). The co-primary endpoints are progression-free survival (PFS) per investigator assessment (RECIST 1.1) in the ITT population and in the PD-L1-positive population and OS in the ITT population. Secondary endpoints include objective response rate and duration of response.

About the CLEOPATRA Study
CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) was an international, phase III, randomised, double-blind, placebo-controlled study. The study compared the combination of Perjeta, Herceptin and docetaxel chemotherapy with placebo, Herceptin and chemotherapy in 808 people with previously untreated HER2-positive mBC, or with HER2-positive mBC that had come back after prior therapy in the adjuvant or neoadjuvant setting. The primary endpoint of the study was PFS as assessed by an independent review committee. Secondary endpoints included OS and safety profile.

About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough innovations in HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for all forms of early and advanced breast cancer, including triple-negative and hormone receptor-positive.

Our targeted medicines Herceptin, Perjeta and Kadcyla are continuing to transform the treatment of early and advanced HER2-positive breast cancer and, through our Tecentriq and ipatasertib clinical programmes, we are committed to bring new treatment combinations to people with triple-negative breast cancer, ultimately improving outcomes.

On June 3, 2019 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of novel cancer therapies reported clinical updates from the Company’s ongoing first- and second-line trials in patients with MGMT-unmethylated glioblastoma multiforme (GBM) at a key opinion leader (KOL) forum focused on brain tumors and the role of VAL-083 to address the unmet medical need in GBM during the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, IL (Press release, DelMar Pharmaceuticals, JUN 3, 2019, View Source;and-second-line-trials-in-patients-with-mgmt-unmethylated-glioblastoma-at-a-key-opinion-leader-forum-during-the-american-society-of-clinical-oncology-asco-annual-meeting [SID1234536806]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

At the KOL forum, the Company provided an update on the ongoing Phase 1/2 clinical study investigating the front line treatment of VAL-083 with radiation therapy in newly diagnosed MGMT-unmethylated GBM. This trial is being conducted at the Sun Yat-sen University Cancer Center (SYSUCC) in Guangzhou, China in collaboration with Guangxi Wuzhou Pharmaceutical Company. The trial is designed to enroll up to 30 patients to determine if first-line therapy with VAL-083 treatment, in lieu of first-line temozolomide, improves progression free survival (PFS).

As of May 17, 2019, eighteen patients have been enrolled in the trial. Of these patients, fifteen have received their post-cycle 3 MRI and investigator assessment, and ten have received their post-cycle 7 MRI and investigator assessment. Two patients have not been on the study long enough to reach their first assessment, and one patient died before their first assessment. Assessments are based on the trial investigator’s clinical and radiologic assessment, according to the Response Assessment in NeuroOncology (RANO) criteria. For the fifteen patients who have received at least one assessment, eight patients were assessed with a best response of "Complete Response" (8/15, 53.3% CR) and seven patients were assessed with a best response of "Stable Disease" (7/15, 46.7% SD). Fourteen of the eighteen patients were still alive at the data cut-off date.

The Company also provided an update on the ongoing second-line Phase 2 clinical study of VAL-083 in patients with MGMT-unmethylated, Bevacizumab-naïve recurrent GBM. This study is being conducted in collaboration with The University of Texas MD Anderson Cancer Center (MDACC). This biomarker-driven trial (testing for MGMT methylation status) has been amended to enroll up to 83 patients (35 with a starting dose of 40 mg/m2; 48 with a starting dose of 30 mg/m2) to determine the potential of VAL-083 treatment to improve overall survival compared to historical reference control of 7.2 months with lomustine.

As of May 5, 2019, 51 patients have been enrolled, 35 patients at a starting dose of 40 mg/m2, and 16 patients at a starting dose of 30 mg/m2.
For the 47 patients who have been on study long enough to be assessed at the post-cycle 2 MRI:
9/35 (25.7%) patients initially receiving 40 mg/m2 exhibited "Stable Disease" per investigator assessment at the end of cycle 2
4/12 (33.3%) patients initially receiving 30 mg/m2 exhibited "Stable Disease" per investigator assessment at the end of cycle 2
Additionally, the study protocol has been amended to include enrollment of up to 24 newly-diagnosed GBM patients who have completed chemoradiation treatment with TMZ and received no subsequent TMZ maintenance therapy but will receive VAL-083 instead (Group 2). This Group has been included to explore whether earlier intervention with VAL-083 instead of TMZ maintenance therapy offers clinical benefit and extends the time to recurrence as compared to TMZ maintenance therapy.

Consistent with prior studies, myelosuppression (primarily thrombocytopenia and neutropenia) is the most common adverse event in both ongoing clinical trials.

"We are pleased with the progress to date with our two Phase 2 programs for VAL-083. In our view, these results support the preclinical and prior clinical efficacy that was observed in the MGMT-unmethylated GBM population. Additionally, we continue to view the 2017 revised NCCN guidelines for MGMT-unmethylated GBM patients quite favorably for VAL-083, which cautions against the use of temozolomide (TMZ) for this particular patient population. The MGMT-unmethylated patients represent over 60% of the GBM cases and the revised NCCN guidelines expand the therapeutic opportunity for VAL-083 to all major lines of GBM treatment from front-line and maintenance as well as second line (recurrent) GBM," commented Saiid Zarrabian, DelMar’s Chief Executive Officer.

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:

View Source

VAL-083 has been granted orphan drug designations by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas. VAL-083 has been granted fast-track status for the treatment of recurrent GBM by the US FDA