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TEMPUS AND NORTHWESTERN’S LURIE CANCER CENTER ANNOUNCE PERSONALIZED MEDICINE PARTNERSHIP FOR CANCER PATIENTS

On September 29, 2016 Tempus, a health-tech company focused on helping doctors personalize cancer care, and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University reported a partnership to pursue their shared goal of providing precision medicine to cancer patients (Press release, Tempus, SEP 29, 2016, View Source [SID:SID1234515503]). Tempus will serve as a preferred partner to handle genomic sequencing and analysis as part of Lurie Cancer Center’s new OncoSET initiative.

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"We have built a platform to modernize cancer care by merging powerful analytics with cutting edge bioinformatics to empower physicians to make data-driven decisions tailored to each patient," said Eric Lefkofsky, Co-founder and CEO of Tempus. "With thousands of clinical trials opening all the time, and with advances in targeted therapies, including the emergence of immunotherapies, it is more important than ever to understand what is happening to a patient at a molecular level."

Lurie Cancer Center launched the OncoSET (Sequence, Evaluate, Treat) Program on Northwestern Medicine’s Chicago campus to provide personalized care and customized treatments for patients with cancer. OncoSET’s precision medicine approach to cancer care combines genomic sequencing and sophisticated molecular analysis with pathology to identify new, individually tailored treatments and clinical trials for patients whose cancers are resistant to traditional therapies.

"We are pleased to partner with Tempus to achieve our shared vision of taking precision medicine to the next level," said Leonidas Platanias, MD, PhD, Director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. "Lurie Cancer Center launched OncoSET to deliver personalized, effective cancer treatments to patients who currently have limited options. In the rapidly evolving landscape of precision medicine, our ability to leverage Tempus’ expertise in bioinformatics and technology infrastructure will be a major asset in OncoSET’s arsenal of targeted therapies and novel clinical trials."

"Oncologists and pathologists need modern and easy-to-use tools to keep up with the ever-increasing amount of data that is being generated during the course of a patient’s treatment," said Kevin White, President of Tempus. "We have built a technology infrastructure that can gather, store and analyze large amounts of molecular data that match clinical trials and new therapeutic options. This allows physicians to make use of the most information available when making treatment decisions for their patients."

Tempus, founded in 2015, has built a technology platform that can gather large amounts of molecular data, combine it with phenotypic and therapeutic data and analyze it, looking for clinically relevant patterns. Tempus has recruited a world-class team of accomplished geneticists, computational biologists, data scientists and software engineers who have developed software and analytic tools that work within a hospital’s existing infrastructure to analyze data and provide decision support for physicians whose patients are not responding to conventional therapies.

Data presented at ASTRO underscore the promise of Elekta’s high-field MR-adaptive linear accelerator as a transformative advance in radiation therapy

On september 29, 2016 Elekta (EKTA-B.ST) reported that its high-field MR-linac was the focus of multiple presentations at the American Society for Radiation Oncology (ASTRO) 2016 Annual Meeting, held September 25 – 28 in Boston (Press release, Elekta
, SEP 29, 2016, View Source [SID:SID1234515500]). Additional abstracts presented by members of Elekta’s MR-linac Consortium also highlight the need for adaptation of radiation therapy to address moving tumors and nearby organs during treatment sessions. Naturally occurring physiological movements limit our ability to conform the treatment to the target and increase exposure of radiation to healthy tissues.

Elekta’s MR-linac will integrate an advanced linear accelerator and a 1.5 Tesla magnetic resonance imaging (MRI) system. Combined, these systems will allow for simultaneous radiation therapy delivery and high-field MR tumor monitoring.

A joint session of ASTRO and the European Society for Radiation Oncology (ESTRO) highlighted the potential for adaptive imaging in radiation therapy during a session titled "In Room Adaptive Imaging with a Focus on MRI." (View Source;sp=-1) Elekta’s MR-linac was featured in two presentations during this session:

· "Linac-based MR Device"; Christopher Schultz, MD, FACR, Professor in the Department of Radiation Oncology at Froedert and Medical College of Wisconsin. This presentation discussed strategies for integrating MR-linac into current RT protocols and provided an overview of the development plan that the Elekta MR-linac Consortium is undertaking in order to generate the clinical, physics and quality control data that will be essential for developing and realizing the full clinical potential of MR-linac technology.

· "MRI Linac: Physics Perspective"; Bas Raaymakers, PhD, Professor in the Department of Radiotherapy at University Medical Center Utrecht. This presentation highlighted the potential to leverage the power of MR-linac technology to move from pre-treatment planning to online plan adaptation and, ultimately, to real-time plan adaptation. Dr. Raaymakers also discussed the need for novel quality assurance procedures for MR-linac devices, patients and workflow.

"Online treatment adaptation is the future of radiation therapy and it is essential for enabling surgical precision and accuracy," said John Christodouleas, MD, MPH, Vice President of Clinical Affairs, Elekta, and a practicing radiation oncologist at the Hospital of the University of Pennsylvania. "The Elekta MR-linac Consortium is advancing MR-linac technology toward the clinic. Data demonstrating the feasibility of MR-linac in breast, non-small cell lung cancer and other cancers also highlight required advances in the software and computer algorithms that are critical to transforming online imaging into actionable adaptive replanning."

Additional key findings related to the MR-linac Consortium’s development of MR-linac presented at the conference include:

· Abdominal organ motion is complex and can occur despite motion management strategies. Abstract #3708: "Complex Abdominal Organ Motion Assessed from MRI"; (View Source(16)32699-2/fulltext) Eenas Omari, PhD, Postdoctoral Fellow in the Department of Radiation Oncology at Medical College of Wisconsin.

· Substantially improves targeting and lowers radiation dose to normal breast tissue in patients undergoing pre-operative partial breast irradiation. Abstract #3695: "Dosimetric Feasibility of Pre-operative Partial Breast Irradiation in Prone Position Using MR-linac" (View Source(16)32685-2/fulltext); Phil Prior, PhD, Medical Physicist in the Department of Radiation Oncology at Medical College of Wisconsin.

· Clinically acceptable treatment plans for patients with locally advanced non-small cell lung cancer can be created. Abstract #3150: "Dosimetric Implications for Radical Radiotherapy on the MR-linac (MRL) in Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)"; (View Source(16)32129-0/fulltext) Dr. Hannah Bainbridge, Clinical Fellow Lung Team, The Institute of Cancer Research, Sutton, United Kingdom, The Royal Marsden NHS Foundation Trust, Sutton, United Kingdom.

· Online adaptive replanning is feasible for prostate cancer radiation therapy. Abstract #3639: "A Hybrid Adaptive Replanning Approach for Prostate SBRT"; (View Source(16)32627-X/fulltext) Ozgur Ates, PhD, Postdoctoral Fellow in the Department of Radiation Oncology at Medical College of Wisconsin.

· An automated QA tool can quickly identify contour errors from auto-segmentation and may have utility in online adaptive replanning. Abstract #3638 "Implementation of a Machine-learning Based Automatic Contour QA Tool for Online Adaptive Radiotherapy of Prostate Cancer" (View Source(16)32626-8/fulltext); Jing Qiao Zhang, PhD, Postdoctoral Fellow in the Department of Radiation Oncology at Medical College of Wisconsin.

Several additional presentations described the potential for MR-linac and adaptive therapy to enable dose painting – the precise delivery of varying doses of radiation to specific regions within a tumor in order to account for differences in cell type, location and density from one part of the tumor to another.

"The data presented at this conference support the potential of MR-linac as a key development in the future of radiation therapy and we are encouraged by the Consortium’s progress," said Kevin Brown, Elekta’s Global Vice President of Scientific Research. "The use of integrated, MR imaging to improve radiation therapy is a topic of widespread interest within the community, and Elekta’s MR-linac is poised to deliver an advanced and intuitive treatment experience with the potential to significantly improve patient outcomes and our clinical customer experience."

Elekta’s MR-linac is a work in progress and not available for sale or distribution.

Galena Biopharma to Present NeuVax™ (nelipepimut-S) Interim Safety Data at the European Society for Medical Oncology (ESMO) 2016 Congress

On September 29, 2016 Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, reported that interim safety data from the Company’s NeuVax (nelipepimut-S) Phase 2b combination study will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress in Copenhagen, Denmark (Press release, Galena Biopharma, SEP 29, 2016, View Source [SID:SID1234515498]). The clinical trial is a randomized, multicenter, investigator-sponsored, 300 patient Phase 2b study. It is currently enrolling HER2 1+ and 2+ node positive, and high-risk node negative patients to study NeuVax in combination with trastuzumab. Details of the poster presentation are as follows:

Poster #: 1069P
Abstract #: 3981 – the abstract can be found on the conference website here
Title: Interim safety analysis of a phase II trial combining trastuzumab and NeuVax, a HER2-targeted peptide vaccine, to prevent breast cancer recurrence in HER2 low expression
Date: Sunday, October 9, 2016
Time: 1:00 p.m. to 2:00 p.m. local time
Location: Hall E

About NeuVax (nelipepimut-S)

NeuVax (nelipepimut-S) is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. It is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to specific HLA molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. In clinical studies, NeuVax is combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF).

NeuVax is currently in two breast cancer studies in combination with trastuzumab (Herceptin; Genentech/Roche): a Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+ (clinicaltrials.gov identifier: NCT01570036); and, a Phase 2 trial in high risk, node positive or negative HER2 IHC 3+ patients (clinicaltrials.gov identifier: NCT02297698). Phase 2 clinical trials with NeuVax are also planned in patients with ductal carcinoma in situ (DCIS), and in patients with gastric cancer.

About HER2 1+/2+ Breast Cancer

According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, only about 25% are HER2 positive (IHC 3+). NeuVax targets approximately 50%-60% of these women who are HER2 low to intermediate (IHC 1+/2+ or FISH < 2.0) and achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.

OncoMed to Present Clinical Data for Wnt Inhibitors at the ESMO 2016 Congress

On September 29, 2016 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) reported it will present interim data from Phase 1b clinical trials of the company’s Wnt inhibitors, vantictumab and ipafricept, at the upcoming ESMO (Free ESMO Whitepaper) 2016 Congress being held October 7-11 in Copenhagen, Denmark (Press release, OncoMed, SEP 29, 2016, View Source [SID:SID1234515491]).

Vantictumab (anti-Fzd7, OMP-18R5) and ipafricept (FZD8-Fc, OMP-54F28) are each being tested in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in patients with previously untreated Stage IV pancreatic cancer. Dr. Colin Weekes of the University of Colorado, an investigator for both Phase 1b clinical trials, will present.

Data from the vantictumab Phase 1b clinical trial will be presented in a poster session on Saturday, October 8 at 1:00 pm CEST:

Abstract #3412; Phase 1b study of WNT inhibitor vantictumab (VAN, human monoclonal antibody) with nab-paclitaxel (Nab-P) and gemcitabine (G) in patients (pts) with previously untreated stage IV pancreatic cancer (PC)
Session: Gastrointestinal Tumors

A poster discussion of data from the ipafricept Phase 1b clinical trial will be presented on Sunday, October 9, 2016 at 3:00 pm CEST:

Abstract #3410 Phase 1b study of WNT inhibitor ipafricept (IPA, decoy receptor for WNT ligands) with nab-paclitaxel (Nab-P) and gemcitabine (G) in patients (pts) with previously untreated stage IV pancreatic cancer (PC)
Session: Developmental Therapeutics

US FDA Approves TAGRISSO® (osimertinib) Blood-Based T790M Companion Diagnostic Test

On September 29, 2016 AstraZeneca today reported that the US Food and Drug Administration (FDA) has approved a blood-based companion diagnostic for TAGRISSO (osimertinib) (Press release, AstraZeneca, SEP 29, 2016, View Source [SID:SID1234515502]). The companion diagnostic for TAGRISSO is the only FDA-approved and clinically validated companion diagnostic test that uses either tissue or a blood sample to confirm the presence of a T790M mutation in patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after an EGFR tyrosine kinase inhibitor (TKI) medicine.

"Blood-based testing has the potential to rapidly identify patients eligible for targeted therapy, who may not be eligible for biopsy. Availability of this blood-based test may help aid treatment decisions"

The approval provides a new, non-invasive option to identify patients with metastatic EGFR T790M mutation-positive NSCLC, ensuring that those patients who may not be suitable for biopsy procedures have an opportunity to be tested. Blood-based testing for the presence of the mutation is recommended only when a tumor biopsy cannot be obtained. Patients who test negative for the T790M mutation with the blood-based test, and their physicians, should re-evaluate the feasibility of tissue-based testing to confirm the presence of the EGFR T790M mutation.

The companion diagnostic, cobas EGFR Mutation Test v2, was developed by Roche Molecular Systems. The test enables identification of patients who have the T790M mutation at disease progression, and is initially available through Baystate Health, Carolinas HealthCare System, Laboratory Corporation of America Holdings (LabCorp), and PhenoPath.

"Blood-based testing has the potential to rapidly identify patients eligible for targeted therapy, who may not be eligible for biopsy. Availability of this blood-based test may help aid treatment decisions," said Balazs Halmos, MD, Montefiore Medical Park, Albert Einstein College of Medicine.

"The availability of an FDA-approved, blood-based companion diagnostic is a tremendous step forward for patients with lung cancer in need of a high-quality test that provides results with a rapid turnaround time. This development offers an important option for the identification of the T790M mutation in patients with metastatic EGFR mutation-positive NSCLC who have progressed on an EGFR TKI medicine, for whom a tissue biopsy may not be feasible," said Andrew Coop, Vice President, US Medical Affairs, Oncology, AstraZeneca. "Delivering targeted therapies, such as TAGRISSO, to the right patients at the right time demonstrates our commitment to testing and quality companion diagnostics."

Nearly two-thirds of cases of progression with first-generation EGFR TKIs are related to an acquired EGFR T790M mutation — for which there have been limited treatment options in the past. TAGRISSO is the only FDA-approved targeted medicine for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after an EGFR TKI medicine, and was approved by the FDA in November 2015. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

The TAGRISSO tolerability profile showed that no individual severe grade 3+ adverse events occurred at ≥ 3.5%. The most common adverse events were generally mild to moderate and included diarrhea (42% all grades; 1.0% grade 3/4), rash (41% all grades; 0.5% grade 3/4), dry skin (31% all grades; 0% grade 3/4), and nail toxicity (25% all grades; 0% grade 3/4).

Important Safety Information About TAGRISSO (osimertinib)

There are no contraindications for TAGRISSO.
Interstitial Lung Disease (ILD)/Pneumonitis occurred in 3.3% and were fatal in 0.5% of 813 TAGRISSO patients. Withhold TAGRISSO and promptly investigate for ILD in any patient presenting with worsening of respiratory symptoms indicative of ILD (e.g., dyspnea, cough and fever). Permanently discontinue TAGRISSO if ILD is confirmed
QTc interval prolongation occurred in TAGRISSO patients. Of the 411 patients in two Phase II studies, 0.2% were found to have a QTc greater than 500 msec, and 2.7% had an increase from baseline QTc greater than 60 msec. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life threatening arrhythmia
Cardiomyopathy occurred in 1.4% and were fatal in 0.2% of 813 TAGRISSO patients. Left Ventricular Ejection Fraction (LVEF) decline >10% and a drop to <50% occurred in 2.4% of (9/375) TAGRISSO patients. Assess LVEF before initiation and then at 3 month intervals of treatment. Withhold TAGRISSO if ejection fraction decreases by 10% from pretreatment values and is less than 50%. For symptomatic congestive heart failure or persistent asymptomatic LV dysfunction that does not resolve within 4 weeks, permanently discontinue TAGRISSO.
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during TAGRISSO treatment and for 6 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the final dose.
The most common adverse reactions (>20%) observed in TAGRISSO patients were diarrhea (42%), rash (41%), dry skin (31%) and nail toxicity (25%).
TAGRISSO is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor therapy.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Please see accompanying complete Prescribing Information including Patient Information.