On December 10, 2018 Genomic Health, Inc. (NASDAQ: GHDX) reported results from multiple Oncotype DX Breast Recurrence Score (RS) presentations at the 2018 San Antonio Breast Cancer Symposium (SABCS), reinforcing the value of the Oncotype DX test in optimizing treatment and outcomes in patients with both node-negative and node-positive early-stage breast cancer (Press release, Genomic Health, DEC 10, 2018, View Source [SID1234532003]).

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Among the data presented at SABCS are two presentations from investigators involved in the landmark TAILORx (Trial Assigning IndividuaLized Options for Treatment (Rx)) trial, which provided independent analysis using the Oncotype DX test to gain further information about chemotherapy benefit across ethnic groups and chemotherapy effect on quality of life. Other presentations included the first report of long-term outcomes from the Surveillance, Epidemiology, and End Results (SEER) registry program of the National Cancer Institute (NCI) on early-stage patients with node-positive disease not treated with chemotherapy and the first study specifically focused on the Oncotype DX test in women less than 40 years of age.

"With the practice-changing results of TAILORx and new real-world evidence in more the 80,000 patients, the Oncotype DX test is being increasingly used in the United States and around the world to contribute to smarter cancer care and improved outcomes for breast cancer patients," said Steven Shak, M.D., chief scientific officer and chief medical officer, Genomic Health.

Independent Analyses Reinforce TAILORx Conclusions
As follow-up to the TAILORx results that were published by the ECOG-ACRIN Cancer Research Group in the New England Journal of Medicine in June 2018, Kathy S. Albain, M.D., FACP, professor of medicine, Loyola University Chicago Stritch School of Medicine, evaluated outcomes among patients of different races and/or ethnic backgrounds. These findings reported at SABCS reinforce the original TAILORx results, showing that chemotherapy in early-stage breast cancer can be safely avoided if the Recurrence Score result is less than 26 in women of all races/ethnicities, including Black, Hispanic and Asian women.

Results of a separate TAILORx sub-study, presented at SABCS by Lynne I. Wagner, Ph.D., professor, Social Sciences and Health Policy at Wake Forest School of Medicine, provide additional evidence regarding the negative impact of chemotherapy on patient quality of life. These results underscore the value of the Oncotype DX Breast Recurrence Score in avoiding unnecessary chemotherapy in the majority of patients with node-negative breast cancer.

Additionally, real-world evidence from a more than 80,000 patient study based on an analysis of data from the SEER registry program of the NCI reinforced findings from multiple clinical trials, including TAILORx, and confirmed that the Oncotype DX Breast Recurrence Score result is predictive of chemotherapy benefit in patients with node-negative disease (p=0.009), with no chemotherapy benefit with RS results less than 26. In patients with node-negative disease and RS results less than 26 not treated with chemotherapy, the Breast Cancer Specific Survival (BCSS) was greater than 96 percent at nine years. In patients with node-positive disease not treated with chemotherapy and RS results less than 18, BCSS was greater than 97 percent at nine years.

"The SEER nine-year real-world evidence supports the new TAILORx-defined paradigm for Recurrence Score-guided chemotherapy treatment using the cutoff of 26," said Gabriel N. Hortobagyi, M.D., FACP, program director, Department of Breast Medical Oncology, Division of Susan G. Komen Interdisciplinary Breast Fellowship Program, The University of Texas MD Anderson Cancer Center. "Importantly, these long-term SEER results also support the option of hormone therapy alone for patients with one to three positive nodes and an Oncotype DX Recurrence Score less than 18."

Finally, investigators at Dana-Farber led a multi-center study to prospectively analyze Oncotype DX test results in 500 young women with node-positive and node-negative breast cancer. The findings showed very good outcomes for those with a RS of 0 to 25 who were not treated with chemotherapy. These results provide further evidence of the unique value of the Oncotype DX test to guide chemotherapy treatment decision-making in early-stage breast cancer in patients age 40 or younger.

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 cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. 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.OncotypeDX.com or www.MyBreastCancerTreatment.org.

On December 10, 2018 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported an update of the ProSTAR study, its ongoing Phase 1b/2 clinical trial of CPI-1205 in patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Constellation Pharmaceuticals, DEC 10, 2018, View Source [SID1234532000]).

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The ProSTAR study is evaluating CPI-1205, Constellation’s potent and highly selective small-molecule EZH2 inhibitor, in combination with either enzalutamide or abiraterone / prednisone ("abiraterone"), in mCRPC patients who experienced disease progression while receiving the other ARS inhibitor. Based on encouraging results from the Phase 1b portion of ProSTAR, the Company has initiated dosing in the randomized Phase 2 portion studying CPI-1205 in combination with enzalutamide versus enzalutamide alone. Constellation has also decided to expand the Phase 2 portion of the study by adding an arm evaluating CPI-1205 in combination with abiraterone in the second-line setting.

"We are pleased that CPI-1205 achieved its Phase 1b endpoints in ProSTAR, demonstrating an encouraging safety profile and evidence of clinical activity in both arms," said Adrian Senderowicz, Chief Medical Officer of Constellation

Pharmaceuticals. "As we advance into the Phase 2 portion of the study, we believe combination therapy with CPI-1205 may provide a meaningful second-line treatment option to patients with metastatic castration-resistant prostate cancer, an area of significant unmet medical need. We are excited about expanding our opportunity to include an arm evaluating CPI-1205 in combination with abiraterone in the second-line setting, given that very few patients experience a 50% reduction in PSAs on second-line treatment with abiraterone and that time to progression in this setting is typically short."

Initiation and Expansion of Phase 2 Portion of ProSTAR

As planned, Constellation has already begun dosing patients in the Phase 2 portion of the study, evaluating CPI-1205 in combination with enzalutamide versus enzalutamide alone. The Company continues to expect enrollment of up to 35 patients in both the treatment and the control arms.

Additionally, Constellation is expanding the trial to include a separate Phase 2 arm evaluating CPI-1205 in combination with abiraterone in up to 30 mCRPC patients who progressed on prior enzalutamide therapy. This arm, which will soon begin dosing patients, will not be randomized against a control arm due to the low response rate and lack of durability seen with abiraterone in the second-line setting.

In a recent randomized cross-over trial, only 4% of patients taking abiraterone after disease progression on enzalutamide, and only 31% of patients taking enzalutamide after disease progression on abiraterone, achieved a 50% reduction in PSA levels. Time to PSA progression was only 1.3 months and 2.7 months, respectively. Time to disease progression was only 1.6 months and 2.7 months, respectively.1

Constellation continues to expect to determine proof of concept for CPI-1205 in mid-2019.

1 D. Khalaf et al, Phase 2 randomized cross-over trial of abiraterone + prednisone (ABI) vs enzalutamide (ENZ) for patients (pts) with metastatic castration resistant prostate cancer (mCRPC): results for 2nd-line therapy, poster presented at 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting.

About mCRPC

mCRPC is an advanced form of prostate cancer and is defined by disease progression despite treatment with androgen depletion therapy (ADT). mCRPC may present as one or any combination of the following: a continuous rise in serum levels of PSA, progression of known metastases, or appearance of new metastases. Prognosis is associated with several factors, including the

ability to perform certain daily activities and the presence of bone pain. Additional symptoms commonly include anemia (low healthy red blood cell levels), weight loss, fatigue, hypercoagulability (abnormal blood coagulation), and increased susceptibility to infection. mCRPC presents as a spectrum of disease ranging from patients without symptoms but rising PSA levels despite ADT, to patients with metastases and significant debilitation.

On December 10, 2018 Immix Biopharma, Inc reported positive interim results from its ongoing phase 1b/2a study testing IMX-110 in advanced solid tumors (Press release, Immix Biopharma, DEC 10, 2018, View Source [SID1234531999]). Immix observed Stable Disease at cohort (dose-level) 2 in a middle-aged male with stage IV colorectal cancer that was refractory to radiation therapy, chemotherapy and immunotherapy. The team observed no adverse events at this dose level.

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The study is a multiple-ascending dose, Phase 1b clinical trial of IMX-110 to evaluate the compound’s safety, pharmacokinetics, pharmacodynamics and preliminary efficacy in patients with advanced solid tumors and is led by Principal Investigator Prof. Paul de Souza of Western Sydney University, Sydney. Currently, the team is awaiting additional preliminary efficacy readouts from patients in cohorts (dose-levels) 3 and 4, with cohort 5 enrollees set to be recruited imminently. For information about participating in this study, please visit clinicaltrials.gov: View Source

The company is also announcing its plans to investigate IMX-109, a nanoformulation of curcumin, in neurodegenerative and age-related diseases, with preliminary human data scheduled to be shared publicly in early 2019.

About IMX-110
IMX-110 is a first-in-class combination therapy designed to inhibit cancer resistance and evolvability while inducing apoptosis. IMX-110 contains NF-kB/Stat3/pan-tyrosine kinase inhibitor curcumin combined with a small amount of doxorubicin encased in a nano-sized delivery system for optimal tumor penetration. The nanoparticle is tunable in that it can be bound to various targeting moieties, allowing it to deliver even more payload to tumors or other cell populations of interest, if needed. IMX-110 showed preclinical efficacy in glioblastoma, multiple myeloma, triple-negative breast, colorectal, ovarian, and pancreatic tumor models — with the mechanism of action being a 5x increase in cancer cell apoptosis compared to doxorubicin or curcumin alone, and a wholesale shift in the tumor-immune system microenvironment post administration.

About IMX-109
IMX-109 is a nanoformulation of curcumin, a substance with significant preclinical evidence of activity in inflammation-driven and age-related diseases, whose clinical use to-date has been hampered by the poor bioavailability of natural curcumin.

On December 10, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Sarah Cannon Research Institute reported a strategic oncology development collaboration (Press release, Daiichi Sankyo, DEC 10, 2018, View Source [SID1234531997]). This partnership brings together Daiichi Sankyo’s expertise in developing novel cancer agents with Sarah Cannon’s leadership in designing and optimizing clinical trials to expand treatment options for patients.

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"We look forward to partnering with Sarah Cannon to accelerate drug development globally for patients with cancer who need more innovative therapies," said Tom Held, Vice President, Head, Antibody Drug Conjugate Task Force, Oncology Research and Development, Daiichi Sankyo. "We believe that this collaboration will help to make an impact in the field of cancer research, as we combine our operational and scientific expertise to focus on the development of targeted therapies, such as antibody drug conjugates. We look forward to initiating with Sarah Cannon joint clinical activities in the U.S. and Japan as quickly as possible."

"Sarah Cannon’s expertise and focus on oncology drug development provides a solid platform to enable us to partner with Daiichi Sankyo on exploring these promising new agents," said Johanna Bendell, MD, Chief Development Officer, Sarah Cannon. "We greatly value the trust that Daiichi Sankyo has placed in our team and are excited to offer novel therapies for our cancer patients."

Through Sarah Cannon Development Innovations, its full-service, oncology-focused contract research organization (CRO), Sarah Cannon will provide comprehensive clinical development services and operational delivery to several of Daiichi Sankyo’s translational development programs. The collaboration will enable rapid patient enrollment to clinical trials through Sarah Cannon’s extensive research network across the U.S. and UK, which serves thousands of patients annually in clinical trials, as well as through Daiichi Sankyo’s clinical network in Japan.

On December 10, 2018 Varian (NYSE: VAR) reported that it will report results for the first quarter of fiscal year 2019 after market close on Wednesday, January 23, 2019 (Press release, Varian Medical Systems, DEC 10, 2018, View Source [SID1234531996]). The news release will be followed by a teleconference available to all interested at 1:30 p.m. Pacific Time. To access the teleconference call and replay:

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Teleconference: Access from within the U.S. by dialing 1-877-869-3847, and from outside the U.S. by dialing 1-201-689-8261.

Replay: Access from within the U.S. by dialing 1-877-660-6853 and from outside the U.S. by dialing 1-201-612-7415, and enter conference ID 13685671. The teleconference replay will be available until 5:00 p.m. Pacific Time, Friday, January 25, 2019.

Webcast: To access the live webcast and replay, visit the company website at: www.varian.com/investors and click on the link for First Quarter Earnings Results.

For automatic e-mail alerts regarding Varian news and events, investors can subscribe on the company website: View Source