On January 14, 2020 Caris Life Sciences, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, reported that The Preston Robert Tisch Brain Tumor Center at Duke University Hospital has become the 32nd member of its Precision Oncology Alliance (Press release, Caris Life Sciences, JAN 14, 2020, View Source [SID1234553203]). The Alliance is a collaborative network of leading cancer centers that demonstrates a commitment to precision medicine. These centers work together toward a common goal to advance tumor profiling and establish standards of care for molecular testing in oncology.

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The Preston Robert Tisch Brain Tumor Center was one of the first brain tumor research and clinical programs in the United States. Since then, it has advanced to become one of the best pediatric and adult neuro-oncology programs in the world—leading the way in comprehensive care that combines research breakthroughs, clinical trials and the newest therapies. The National Cancer Institute (NCI) has given the center the highest rating of "exceptional" for each of the last 15 years.

The mission of the Center is to provide hope and empower brain tumor patients with unparalleled care, research and education. The Center sees up to 900 new adult brain tumor patients and up to 75 new pediatric brain tumor patients per year from across the country and around the world.

"We are excited to welcome Preston Robert Tisch Brain Tumor Center into the Precision Oncology Alliance," said Brian J. Brille, Vice Chairman of Caris Life Sciences. "The Preston Robert Tisch Brain Tumor Center is globally recognized for its collaborative spirit and commitment to its patients and we expect this partnership with the Alliance members to help further progress the potential of molecular profiling."

Through the Precision Oncology Alliance – powered by Caris – The Preston Robert Tisch Brain Tumor Center will partner with other notable cancer centers and academic institutions to broaden patient access to precision cancer care, have early access to Caris’ Next Generation Profiling offerings, and establish evidence-based standards for tumor profiling and molecular testing in oncology. By leveraging the comprehensive genomic and proteomic tumor profiling services available through the Caris Molecular Intelligence platform, oncologists from the Center will be able to prioritize therapeutic options and determine which clinical trial opportunities may benefit their patients. Additionally, the Center’s researchers will partner with other Alliance members to contribute to and publish data and advance collaborative clinical trials.

"We are well known for pioneering cancer research that results in optimal, individualized treatment," said David Ashley, Ph.D., a Neuro-oncologist and Pediatric Neuro-oncologist at Duke Cancer Center. "We look forward to collaborating with Caris Life Sciences and the members of the Precision Oncology Alliance to fuel the next great discoveries in precision medicine."

The Precision Oncology Alliance comprises 32 academic, hospital and community-based cancer institutions, including ten NCI-designated Comprehensive Cancer Centers. The Alliance now includes over 1,350 physicians, spanning more than 400 locations, who provide services for over 280,000 people with cancer each year. Precision Oncology Alliance members also have access to Caris Pharmatech’s oncology trial network, which can help reduce the time it takes to identify and connect appropriate patients with novel targeted cancer therapies in clinical development.

On January 14, 2020 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported its preliminary unaudited revenue for the fourth quarter and year ended December 31, 2019 (Press release, Nevro, JAN 14, 2020, View Source [SID1234553202]). In addition, the Company is providing its worldwide revenue guidance for the full year 2020.

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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

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Fourth Quarter 2019
Preliminary unaudited fourth quarter 2019 worldwide revenue is expected to be $114.4 million, compared to $107.9 million in the fourth quarter in the prior year period. Preliminary unaudited fourth quarter 2019 U.S. revenue is expected to be $97.9 million, compared to $91.6 million in the prior year period. Preliminary unaudited fourth quarter 2019 international revenue is expected to be $16.5 million, compared to $16.3 million in the prior year period. Fourth quarter U.S. trial procedure growth was 17% and permanent implant procedure growth was 20%.

Full Year 2019
Nevro’s preliminary unaudited full year 2019 worldwide revenue is expected to be $390.3 million, compared to $387.3 million in the prior year period. Preliminary unaudited full year U.S. revenue is expected to be $326.0 million, compared to $321.8 million in the prior year period. Preliminary unaudited full year international revenue is expected to be $64.3 million, compared to $65.5 million in the prior year period.

Worldwide Revenue Guidance for Full Year 2020
Nevro currently expects full year 2020 worldwide revenue to be in the range of $435 to $440 million. The Company plans to provide additional guidance metrics for 2020 when it reports its fourth quarter and full year 2019 results in February.

On January 14, 2020 Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, reported that its Target Selector assays are now available to physicians in order to evaluate the cerebrospinal fluid (CSF) of their patients for the presence of circulating tumor cells (CTCs) and biomarkers for patients with breast or lung cancer suspected of brain or central nervous system (CNS) metastases (Press release, Biocept, JAN 14, 2020, View Source [SID1234553201]). The presence of tumor cells in CSF may be an indicator of brain metastases, which occurs when cancer has spread into the CNS. Up to 30% and 36% of patients diagnosed with breast and lung cancer, respectively, will develop brain metastases.

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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

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"Testing the CSF for cancer biomarkers in patients suspected to have brain metastases can be important, as the rapid confirmation and characterization of CNS involvement enables appropriate treatment selection in a timely manner," stated Santosh Kesari, MD, PhD, Chair and Professor, Department of Translational Neurosciences and Neurotherapeutics, Director of Neuro-oncology at the Pacific Neuroscience Institute and John Wayne Cancer Institute. "Liquid biopsy tests offer the ability to analyze an additional specimen type, beyond blood, to help physicians identify biomarkers and hence inform clinical decision making."

"We are very pleased to make our Target Selector platform available for testing CSF, as a more rapid identification of molecular alterations in brain metastases can aid physicians in choosing the best treatment options for their patients with breast or lung cancer," said Michael W. Nall, Biocept’s President and CEO. "Among the significant capabilities of our technology is its versatility, which enables applications in a variety of clinical situations and for use with multiple types of biofluids."

About CSF Testing

A medical procedure known as a spinal tap or lumbar puncture is typically done to collect CSF when cancer patients present with CNS symptoms, for example confusion or dementia. Over 200,000 of these procedures are performed annually in the U.S. Biocept’s Target Selector testing provides an alternative and potentially more accurate means compared to cytology to evaluate CSF. For more information about Biocept’s Target Selector testing, please contact Biocept Customer Services at 888.332.7729.

On January 14, 2020 AMN Healthcare Services, Inc. (NYSE: AMN), healthcare’s leader and innovator in workforce solutions and staffing services, has reported a conference call to discuss its fourth quarter and full year 2019 financial results on Thursday, February 13, 2020 at 5:00 p.m. Eastern Time (Press release, AMN Healthcare Services, JAN 14, 2020, View Source [SID1234553200]). The same day, the Company also expects to issue an earnings news release after market close at approximately 4:15 p.m. Eastern Time.

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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

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A live webcast of the call can be accessed through AMN Healthcare’s website at View Source Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software. Interested parties may participate live via telephone by dialing (844) 721-7241 in the U.S. or (409) 207-6955 for international callers. Following the conclusion of the call, a replay of the webcast will be available at the Company’s website. Alternatively, a telephonic replay of the call will be available beginning at 6:30 p.m. Eastern Time on February 13, 2020, and can be accessed until 11:59 p.m. Eastern Time on February 27, 2020 by calling (866) 207-1041 in the U.S. or (402) 970-0847 internationally, with access code 2857669.

On January 14, 2020 Quantum Leap Healthcare Collaborative and G1 Therapeutics, Inc. (Nasdaq: GTHX) reported a collaboration to evaluate trilaciclib, an investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy, in a new randomized, investigational treatment arm for the ongoing I-SPY 2 TRIAL for neoadjuvant treatment of locally advanced breast cancer (Press release, QuantumLeap, JAN 14, 2020, View Source [SID1234553199]).

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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

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The I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2) is squarely focused on early stage breast cancers that have a high risk of recurrence. (PRNewsfoto/Quantum Leap Healthcare Collabo)
The I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2) is squarely focused on early stage breast cancers that have a high risk of recurrence. (PRNewsfoto/Quantum Leap Healthcare Collabo)
"The I-SPY 2 TRIAL is designed to evaluate agents with the goal of accelerating the pace of promising effective and potentially less toxic treatments to patients who are most likely to benefit quickly. We are excited to include trilaciclib in I-SPY 2, with the goal of determining whether adding trilaciclib to neoadjuvant chemotherapy-based treatment, either with or without an immune checkpoint inhibitor, increases the probability that the tumor will disappear prior to surgery, signaling a much better outcome and survival. The study will also measure how much chemotherapy lowers red and white blood cell levels (myelosuppression) to assess whether trilaciclib reduces any of these negative side effects, which have a significant impact on patient care and quality of life," stated Dr. Laura J. Esserman, MD, MBA, Principal Investigator of I-SPY 2 and Director of the Carol Franc Buck Breast Care Center at the UCSF Helen Diller Family Comprehensive Cancer Center. "As with other arms, the I-SPY 2 TRIAL, has the ability to evaluate the drug across an array of biomarker signatures to learn the chance of how it will benefit patients and predict success in a confirmatory phase 3 trial."

"The I-SPY 2 program is recognized as a leading breast cancer research initiative, and we are excited about the opportunity to evaluate the potential of trilaciclib to improve outcomes for a range of breast cancer subtypes. In our Phase 2 trial of women with triple negative breast cancer, patients who received trilaciclib plus chemotherapy showed significant improvement in overall survival, and reductions in the rate of red blood cell transfusions versus patients treated with chemotherapy alone," said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D at G1. "The I-SPY 2 study will allow us to evaluate trilaciclib for the first time in combination with several broadly-used chemotherapy classes. It will provide important data regarding which patients may benefit from treatment with trilaciclib and inform our future development plans."

The I-SPY 2 TRIAL, sponsored by Quantum Leap, is a standing Phase 2 randomized, controlled, multicenter platform with an innovative Bayesian adaptive randomization design aimed to rapidly screen and identify promising new treatments in specific subgroups of adults with newly-diagnosed, high-risk (high likelihood of recurrence), locally-advanced breast cancer (Stage II/III). G1 Therapeutics will provide funding and trilaciclib and Quantum Leap will be responsible for running the trial.

Trilaciclib will be evaluated across all high-risk, early stage breast cancer subtypes (including HR+, HER2+ and triple negative breast cancer). All patients will receive standard neoadjuvant treatment, including chemotherapy (and anti-HER2 Mab for HER2+ disease) prior to surgical resection of breast tissue. Patients in two arms of the study will also receive an anti-PD-1 immunotherapy in combination with paclitaxel prior to surgery. Biomarker data to evaluate the impact of trilaciclib on the tumor immune microenvironment, as well as pre-specified endpoints to evaluate anti-tumor efficacy and myelopreservation will be collected.

About Trilaciclib

Trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. Based on results from three randomized trials in patients with small cell lung cancer, trilaciclib has received Breakthrough Therapy Designation, and G1 Therapeutics expects to submit marketing applications in the U.S. and Europe for myelopreservation in small cell lung cancer in 2020. In a randomized trial of women with metastatic triple-negative breast cancer, trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone. In 2020, the company plans to initiate a Phase 3 clinical trial in colorectal cancer and begin a neoadjuvant trial in breast cancer as part of the I-SPY 2 TRIAL.

About the I-SPY TRIALs

The I-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from more than 20 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.ispytrials.org.