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argenx announces efficacy and expanded safety data from Phase 1 trial of ARGX-111

On June 2, 2016 Argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies to treat cancer and severe autoimmune diseases, reported data published in conjunction with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting (Chicago, USA) presenting efficacy and safety data from its ARGX-111 Phase 1 expansion study in patients with MET amplified tumors (Press release, arGEN-X, JUN 2, 2016, View Source [SID:1234512983]). The data confirm ARGX-111 to have a favorable safety profile and to continue to show signs of anti-tumor activity. The abstract can be accessed here.

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In addition, data from preclinical studies demonstrate depletion of MET-positive myeloid-derived suppressor cells (MDSCs) by ARGX-111. These data provide an exciting new perspective for therapeutic intervention in MET cancer biology in targeting both the tumor cells and the tumor microenvironment.

About ARGX-111

ARGX-111 is a Met-targeting human monoclonal SIMPLE Antibody that modulates all known mechanisms of action of the receptor. ARGX-111 benefits from POTELLIGENT-enhanced Antibody Dependent Cellular Cytotoxicity (ADCC), which drives the immune system to destroy
c-MET positive cells of the primary tumor and the circulating tumor cells that are responsible for metastasis; and from NHance, which is thought to drive tissue penetration. This unique combination results in a potentially best-in-class drug candidate for c-Met therapies. ARGX-111 is tested in a Phase 1 safety expansion cohort in MET-amplified patients.

ASTELLAS AND MEDIVATION INITIATE PHASE III TRIAL OF ENZALUTAMIDE IN PATIENTS WITH TRIPLE-NEGATIVE BREAST CANCER

On JUNE 2, 2016 Astellas Pharma Inc. (TSE: 4503) and Medivation, Inc. (NASDAQ: MDVN) reported plans to commence a Phase III clinical trial to investigate the use of enzalutamide for the treatment of triple-negative breast cancer (TNBC) (Press release, Astellas, JUN 2, 2016, View Source [SID:1234512971]). The ENDEAR (A Phase III, Randomized, International Study Comparing the Efficacy and Safety of ENzalutamiDe in Combination With PaclitaxEl Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative BReast Cancer) trial will evaluate the efficacy and safety of enzalutamide in combination with paclitaxel chemotherapy or as monotherapy versus placebo with paclitaxel in patients with locally advanced or metastatic TNBC whose tumors test positive for a novel gene expression profile, which is referred to as diagnostic-positive TNBC. The trial, which will be led by Medivation, is expected to begin patient enrollment in the fourth quarter of 2016.

In the United States, breast cancer is one of the most commonly diagnosed cancers and the second leading cause of cancer deaths in women. According to the American Cancer Society, approximately 246,000 new cases of breast cancer will be diagnosed in women and 40,000 women will die of breast cancer in 2016.1 Approximately 15-20 percent of breast cancers are triple negative or basal-like, the subtype that the ENDEAR trial will study.2 Patients with TNBC have a poor prognosis3 and there are currently no therapies specifically approved to treat this patient population.

"Our initiation of this trial represents our commitment to explore the potential of enzalutamide in patients with advanced TNBC," said Mohammad Hirmand, M.D., interim chief medical officer, Medivation.

"The initiation of the ENDEAR trial reflects our ongoing commitment to investigate the full clinical utility of enzalutamide," said Claire Thom, Pharm D., senior vice president and oncology therapeutic area head, Astellas. 2

Enzalutamide, which is known by the brand name XTANDI, is not approved for use in patients with TNBC.

About ENDEAR
ENDEAR will be a Phase III, randomized, international trial, enrolling approximately 780 patients with advanced diagnostic-positive TNBC who have received either no or one prior line of systemic therapy for advanced disease. The primary efficacy endpoint is progression-free survival (PFS), defined as the time from randomization to the first evidence of disease progression or death, whichever occurs first. The trial will evaluate enzalutamide at a dose of 160 mg per day taken orally, either with paclitaxel (90 mg/m2 ) administered intravenously once weekly for 16 weeks (or longer at investigator discretion), or as monotherapy compared to placebo with paclitaxel.
About XTANDI
(enzalutamide) capsules XTANDI (enzalutamide) capsules are an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. In preclinical studies, enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors as well as inhibit androgen receptor nuclear translocation and interaction with DNA. The clinical significance of this MOA is unknown.

XTANDI is approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

Important Safety Information

Contraindications XTANDI is not indicated for women and is contraindicated in women who are or may become pregnant. XTANDI can cause fetal harm when administered to a pregnant woman.
Warnings and Precautions
Seizure In Study 1, conducted in patients with metastatic castration-resistant prostate cancer (CRPC) who previously received docetaxel, seizure occurred in 0.9% of XTANDI patients and 0% of placebo patients. In Study 2, conducted in patients with chemotherapy-naive metastatic CRPC, seizure occurred in 0.1% of XTANDI patients and 0.1% of placebo patients. There is no clinical trial experience re-administering XTANDI to patients who experienced a seizure, and limited safety data are available in patients with predisposing factors for seizure. Study 1 excluded the use of concomitant medications that may lower threshold; Study 2 permitted the use of these medications. Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity during which sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES. 3

Adverse Reactions The most common adverse reactions (≥ 10%) reported from two combined clinical studies that occurred more commonly (≥ 2% over placebo) in XTANDI patients were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo.

In Study 1, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In Study 2, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups.

• Lab Abnormalities: Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). Grade 1-4 thrombocytopenia occurred in 6% of XTANDI patients (0.3% Grade 3-4) and 5% of placebo patients (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of XTANDI patients (0.2% Grade 3-4) and 16% of placebo patients (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients (0.1% Grade 3-4) and 2% of placebo patients (no Grade 3-4).

• Infections: In Study 1, 1% of XTANDI patients compared to 0.3% of placebo patients died from infections or sepsis. In Study 2, 1 patient in each treatment group (0.1%) had an infection resulting in death.

• Falls (including fall-related injuries), occurred in 9% of XTANDI patients and 4% of placebo patients. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients, and included non-pathologic fractures, joint injuries, and hematomas.

• Hypertension occurred in 11% of XTANDI patients and 4% of placebo patients. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of all patients.

Drug Interactions

Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI. Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If coadministration is necessary, increase the dose of XTANDI.

Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.

For Full Prescribing Information for XTANDI (enzalutamide) capsules, please visit View Source

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088.

TG Therapeutics, Inc. Recaps Schedule of Clinical Data Presentations at the 52nd Annual Meeting of the American Society of Clinical Oncology

On June 02, 2016TG Therapeutics, Inc. (Nasdaq:TGTX) today recapped the schedule of data presentations at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held from June 3 – 7, 2016, at McCormick Place in Chicago, Illinois (Press release, TG Therapeutics, JUN 2, 2016, View Source [SID:1234512960]).

Poster Presentation & Discussion Session:

Title: Long-term follow-up of the PI3Kδ inhibitor TGR-1202 demonstrates a differentiated safety profile and high response rates in CLL and NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: 7512 (Poster Board # 68)
Presentation Date & Time: Monday, June 6, 2016 8:00 AM – 11:30 AM CT
Track: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Howard A. Burris MD, Sarah Cannon Research Institute/Tennessee Oncology
Discussion Session:
1:15 PM – 2:45 PM CT, at Room E354b

A copy of the above referenced abstract can be viewed online through the ASCO (Free ASCO Whitepaper) meeting website at www.asco.org. Following the presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.

TG Therapeutics will also host a reception on Monday, June 6, 2016 beginning at 7:00pm CT, with featured presentations beginning promptly at 7:10pm CT. The event will take place at the Peninsula Chicago Hotel in the Avenues Ballroom. This event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com, as well as archived for future review. This event will also be broadcast via conference call. In order to access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics June 2016 Investor & Analyst Event.

Navidea Announces Data Presentations at 2016 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI)

On June 2, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), reported that results from investigator studies using Lymphoseek (technetium Tc 99m tilmanocept) injection are being presented at the 2016 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) to be held June 11-15, 2016 in San Diego, CA (Press release, Navidea Biopharmaceuticals, JUN 2, 2016, View Source;p=RssLanding&cat=news&id=2174435 [SID:1234512958]). The oral and poster presentations highlight the comparative performance of Lymphoseek against commonly-used non-receptor targeted colloidal materials as well as other performance characteristics in breast cancer and melanoma.

Results being presented at SNMMI 2016 include:

Presentation Title: Use of lymphoscintigraphy with Tc-99m tilmanocept does not affect the number of nodes removed during sentinel node biopsy in breast cancer
Author: Jonathan Unkart, Anne Wallace, Surgery, University of California San Diego, San Diego, CA
Date: June 15, 2016
Session Breast, Clinical Applications

Presentation Title: Performance of Tc-99m tilmanocept when used alone is as or more effective in localizing sentinel nodes than sulfur colloid plus blue dye
Author: J. Unkart,1 D. W. King,2 L. A. Christman,2 A. M. Wallace1; 1UCSD, San Diego, CA, 2Statking Consulting, Inc, Fairfield, OH
Date: June 15, 2016
Session Breast, Clinical Applications

Presentation Title: Comparative analysis of 99mTc-Tilmanocept (Lymphoseek) vs. 99mTc-Sulfur Colloid Sentinel Node Lymphoscintigraphy and Biopsy
Author: J. H. Pollard, B. Zaidi, M. Graham; University of Iowa Hospital, Iowa City, IA
Date: June 14, 2016
Session: Sarcoma/Melanoma

Poster Title: Rate of sentinel lymph node visualization in fatty breasts: Tc-99m Tilmanocept versus Tc-99m filtered sulfur colloid
Author: Maryam Shahrzad, Valeria Moncayo, John Malko, and Raghuveer Halkar; Emory University School of Medicine, Atlanta, GA
Date: June 13, 2016
Session Oncology, Clinical Science Track – MTA I: Breast Cancer Posters

About Lymphoseek

Lymphoseek (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

Accurate diagnostic evaluation of cancer is critical, as results guide therapy decisions and determine patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 600,000 new cases of breast cancer, 160,000 new cases of melanoma and 100,000 new cases of head and neck/oral cancer diagnosed annually.

Lymphoseek Indication and Important Safety Information

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

• Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.

• Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

Important Safety Information

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers. In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT:
WWW.LYMPHOSEEK.COM

NanoString Technologies Highlights Advances in Precision Oncology and Immunotherapy at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO)

On June 02, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported the highlights of numerous advances in precision oncology and immunotherapy using the nCounter platform that will be presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, NanoString Technologies, JUN 2, 2016, View Source [SID:1234512957]).

"For more than 50 years the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) has been pioneering cancer research and advancing the care of patients with cancer around the world," said Brad Gray, president and chief executive officer of NanoString Technologies. "We are proud to participate in the ASCO (Free ASCO Whitepaper) Annual Meeting and to have the opportunity to highlight the groundbreaking cancer research and diagnostic assays that are being enabled through the nCounter platform and our expanding portfolio of 3D Biology products."

More than 30 abstracts will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting, which is being held June 3rd through June 7th, 2016 in Chicago, Illinois, that demonstrate the value of the nCounter Platform. In particular, several abstracts provide additional insights on the development and performance of NanoString’s investigational assays in development for immuno-oncology and lymphoma.

In immuno-oncology, NanoString and collaborators will present new details on nCounter-based assays under development for prediction of response to the checkpoint inhibitor pembrolizumab, including:

An interferon-gamma gene signature was shown to predict response more accurately than PD-L1 IHC in squamous cell carcinoma of the head and neck. This research further demonstrates the power of gene expression profiling on the nCounter Analysis System as a biomarker in immuno-oncology. (Abstract #6010)
An interferon-gamma gene signature and an expanded immune gene signature predicted response in five tumor types from the basket trial KEYNOTE-28, underscoring the potentially broad applicability of gene signatures in assessing patient response (Abstract #1536).
Data on the development and analytical performance of an nCounter-based assay incorporating an immune-related gene signature to predict response to checkpoint inhibition in eleven different tumor types. The data show that this assay is robust and may be well-suited to clinical applications. The signature is being evaluated as a predictive biomarker in multiple indications in several studies (Abstract #3034).
In lymphoma, NanoString and collaborators are presenting results generated using nCounter-based assays, including:

An update on the ongoing ROBUST trial, a global pivotal phase 3 trial evaluating the addition of lenalidomide to R-CHOP therapy in untreated ABC-type Diffuse Large B-cell Lymphoma (DLBCL) selected by NanoString’s investigational Cell-of-Origin assay. The results show that real-time testing of Cell-of-Origin using nCounter is feasible in a multi-center, global study with turnaround time of less than 3 days, demonstrating that a decentralized gene expression test can be used to select patients for a clinical trial where rapid results are critical for enrollment (Abstract #7538).
Independent validation of the nCounter-based Cell-of-Origin assay through comparison to subtyping using DNA microarrays. The assay proved to be highly efficient and reliable in an independent series of samples evaluated by a team of researchers not involved in the development of the assay. This research highlights the high concordance between the NanoString assay and the conventional microarray method as well as the robustness and ease of use of the assay, which can be successfully deployed in laboratories around the world (Abstract #7547).
The 2016 ASCO (Free ASCO Whitepaper) abstracts describe research and clinical applications that underscore the diverse capabilities and robust performance of the nCounter platform. The studies cover a wide range of cancers, tissue types (FFPE, peripheral blood and urine), and treatment modalities.

At the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting, NanoString will showcase its nCounter platform and 3D Biology capabilities at booth #8151.

Abstract # Summary Hyperlink
4525 Subclassification and outcome prediction of patients with muscle invasive urothelial carcinoma (MIUC) treated by radical cystectomy (RC) with a NanoString based molecular screening. View Source

3034 Development and analytical performance of a molecular diagnostic for anti-PD1 response on the nCounter Dx Analysis System. View Source

3008 Epigenetic control of CD4/CD8 lineage commitment and resistance to tumor infiltrating lymphocyte adoptive cell therapy for metastatic melanoma. View Source

6056 Immune-related gene expression signatures as predictive biomarkers for outcome after concurrent chemoradiation in patients with locally advanced oropharyngeal carcinomas. View Source

11522 Derivation of gene expression classifiers for the non-invasive detection of bladder cancer in the hematuria and recurrence surveillance populations. View Source

e16014 Multiplatform comprehensive kinase analysis of muscle-invasive bladder cancer (MIBC) to identify potentially actionable therapeutic targets. View Source

10561 Patterns of PD-1, PD-L1 and PD-L2 expression in pediatric solid tumors. View Source

TPS3636 The FUNNEL: A molecular multiplex triage for precision medicine in metastatic colorectal cancer. View Source

3038 Association of response to programmed death 1 receptor or ligand (PD1/PDL1) blockade with immune-related gene expression profiling across three cancer-types. View Source

7045 Up-regulation of BAALC/MN1/MLLT11/EVI1 gene cluster in relation to MYC / BCL2 protein co-expression and poor overall survival in acute myeloid leukemia (AML). View Source

e20089 Preliminary analysis of genomic profiling of small cell lung cancer in Chinese population revealed frequent PIK3CA hotspot mutations. View Source

e23235 Analysis of RSPO gene expression in solid tumors. View Source

e14565 Safety and immunologic activity of anakinra in HER2-negative metastatic breast cancer (MBC). View Source

10509 Relationship of BRAF V600E and associated secondary mutations on survival rate and response to conventional therapies in childhood low-grade glioma. View Source

e17103 Genomic profiling of high-intermediate risk endometrial cancer to differentiate recurrence risk. View Source

3570 Influence of mRNA expression of fibroblast growth factor 2 (FGF2) in colorectal cancer (CRC) cell lines and in patients with metastatic colorectal cancer (mCRC) treated with FUFIRI or mIrOx (FIRE1). View Source

7510 Prognostic significance of the proliferation signature in mantle cell lymphoma measured using digital gene expression in formalin-fixed paraffin-embedded tissue biopsies. View Source

TPS7575 Rituximab, lenalidomide, and ibrutinib alone and combined with dose adjusted chemotherapy for patients with high risk diffuse large B-cell lymphoma. View Source

7538 Feasibility of real-time cell-of-origin subtype identification by gene expression profile in the phase 3 trial of lenalidomide plus R-CHOP vs placebo plus R-CHOP in patients with untreated ABC-type diffuse large B-cell lymphoma (ROBUST). View Source

TPS7577 A phase 2 study of PNT2258 in patients with relapsed or refractory (r/r) diffuse large b-cell lymphoma (DLBCL): An initial report from the Wolverine study. View Source

6010 Biomarkers and response to pembrolizumab (pembro) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). View Source

e20014 The upregulation of FOXA2 transcription factor in RET rearranged lung adenocarcinoma. View Source

e16023 PD1, PDL1, PDL2 tumor tissue (TT) expression as predictors of response to neoadjuvant chemotherapy (NAC) and outcome in bladder cancer (BC). View Source

543 Prospective multicenter study of the impact of the Prosigna assay on adjuvant clinical decision-making in women with early stage breast cancer: which patients are the best candidates? View Source

7547 Classification of diffuse large b-cell lymphoma (DLBCL) FFPE samples of the GELA LNH2003 program, using Lymph2Cx assay on the nCounter analysis system. View Source

1536 T-cell inflamed phenotype gene expression signatures to predict clinical benefit from pembrolizumab across multiple tumor types. View Source

3510 Clinical outcome and benefit of oxaliplatin in colon cancer according to intrinsic subtypes: Results from NRG Oncology/NSABP C-07. View Source

1585 Male breast cancer: correlation between immunohistochemical subtyping and PAM50 intrinsic subtypes. View Source

575 A retrospective study of SPAG5 expression and its clinical implications in > 8,000 patients of ER positive (ER+) breast cancer (BC): Genomic, transcriptomic and protein analysis. View Source

569 Outcomes of single versus double hormone receptor positive breast cancer. View Source

TPS623 OPTIMA (Optimal Personalised Treatment of early breast cancer usIng Multi-parameter Analysis): A prospective trial to validate the predictive utility and cost-effectiveness of gene expression test-directed chemotherapy decisions. View Source

e23143 The genomic profile (GP) of early breast cancer (EBC): Daily practice analysis. View Source

555 A test utilizing diagnostic and on-treatment biomarkers to improve prediction of response to endocrine therapy in breast cancer. View Source