On March 28, 2019 -Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported positive topline results from the first cohort of patients in a pivotal phase 2 single-arm clinical trial known as EV-201 (Press release, Seattle Genetics, MAR 28, 2019, View Source [SID1234534679]). The cohort is evaluating enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received previous treatment with both platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. Results showed a 44 percent objective response rate (ORR) per blinded independent central review. The duration of response was consistent with that recently reported in the previous phase 1 study (EV-101). The most common treatment-related adverse events included fatigue, alopecia, decreased appetite, rash and peripheral neuropathy. The data will be presented at an upcoming medical meeting.

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Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) that targets Nectin-4, a therapeutic target that is highly expressed in multiple solid tumors including urothelial cancers. Based on preliminary results from a phase 1 trial (EV-101), enfortumab vedotin was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for patients with locally advanced or metastatic urothelial cancer whose disease has progressed during or following treatment with a PD-1 or PD-L1 inhibitor.

The companies plan to submit a Biologics License Application (BLA) to the FDA later this year based on the results from the EV-201 trial (cohort 1). A global, randomized phase 3 clinical trial (EV-301) is ongoing and intended to support global registration as well as to serve as the confirmatory randomized trial for enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.

"Despite recent approvals of multiple checkpoint inhibitors for previously treated locally advanced or metastatic urothelial cancer, there remains a high unmet need for effective treatments upon progression after initial chemotherapy and immunotherapy," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "These results for enfortumab vedotin indicate it may be able to help patients whose urothelial cancer progresses following treatment with standard chemotherapy and a PD-1 or PD-L1 inhibitor."

"After progression on platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor, patients with locally advanced or metastatic urothelial cancer are left with no approved standard of care treatment options," said Steven Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas. "These data are very encouraging, and we look forward to discussing the data with relevant health authorities."

Urothelial cancer is the most common type of bladder cancer (90 percent of cases).1 In 2018, more than 82,000 people were diagnosed with bladder cancer in the United States.2 Globally, approximately 549,000 people were diagnosed with bladder cancer last year, and there were approximately 200,000 deaths worldwide.3 Approximately 80 percent of people do not respond to PD-1 or PD-L1 inhibitors after a platinum-containing therapy has failed as an initial treatment for advanced disease.4 There are currently no approved therapies for metastatic urothelial cancer once it has progressed after chemotherapy and a PD-1 or PD-L1 inhibitor.5

In addition to the ongoing confirmatory phase 3 study intended to also support global registration, development of enfortumab vedotin is underway in earlier lines of treatment for locally advanced or metastatic urothelial cancer, including in newly diagnosed patients in combination with pembrolizumab and/or platinum chemotherapy.

About The EV-201 Trial

EV-201 is an ongoing single-arm, pivotal phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1 or PD-L1 inhibitor, including those who have also been treated with a platinum-containing chemotherapy (cohort 1) and those who have not received a platinum-containing chemotherapy and who are ineligible for cisplatin (cohort 2). The EV-201 phase 2 trial continues to enroll patients in cohort 2. In cohort 1, 128 patients were enrolled at multiple centers internationally.6 The primary endpoint is confirmed objective response rate per blinded independent central review. Secondary endpoints include assessments of duration of response, disease control rate, progression-free survival, overall survival, safety and tolerability. More information about enfortumab vedotin clinical trials can be found at clinical trials.gov.

About Enfortumab Vedotin

Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent (MMAE) using Seattle Genetics’ proprietary linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule identified as an ADC target by Astellas, which is expressed on many solid tumors.

The safety and efficacy of enfortumab vedotin are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval and become commercially available for the uses being investigated.

Seattle Genetics Conference Call Details

Seattle Genetics’ management will host a conference call and webcast to discuss the announcement of enfortumab vedotin topline data. The event will be held today at 6:00 a.m. Pacific Time (PT); 9:00 a.m. Eastern Time (ET). The live event will be available from the Seattle Genetics website at www.seattlegenetics.com, under the Investors section, or by calling 866-288-0540 (domestic) or 786-460-7199 (international). The conference ID is 3807860. A replay of the live event will be available starting on March 28, 2019 on the Seattle Genetics website or by calling 888-203-1112 (domestic) or 719-457-0820 (international), using conference ID 3807860. The telephone replay will be available until 5:00 p.m. PT on April 1, 2019.

On March 28, 2019 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported financial results for its fourth quarter ended December 31, 2018 (Press release, NantHealth, MAR 28, 2019, View Source [SID1234534721]).

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"Our financial results over 2018 reflect continued overall progress to our business," said Bob Petrou, Interim Chief Financial Officer of NantHealth. "On a sequential quarterly basis, we grew revenue, significantly lowered total operating expenses and reduced our cash burn. We are particularly pleased with the growth of our entire SaaS business. Looking ahead, our well-developed sales pipeline bodes well for the company’s topline, and our entire team is focused on further growing the business, managing costs and driving meaningful improvement in our financial performance."

Software and Services Highlights:

Clinical Decision Support (Eviti):
In Q4, deployed release 7.5, with new features that include:
A new configuration, known as the Treatment Warning and Deviation Configuration, that enables payers to display custom drug deviation messages, enhancing value-based care and compliance with payer guidelines
A new analyzer deviation that supports the Febrile Neutropenia (FN) risk factor associated with white blood cell (WBC) growth factors, a key driver of regimen costs
Updated the Medical Policy QA report that assists partners/resellers with their internal quality assurance process
Enhanced the Precision Insights Portal, features include:
All treatment plans that are presented to a user are saved and stored, enabling analytics for the understanding of treatment plan trends and improvement in the presentation of the plans to users
Enhanced drug mapping management feature in the portal enables a comparison of the Precision Insights portal recommended drugs to the evidence based Eviti drug recommendation to help align to the standard of care library
Payer Engagement (NaviNet):
Completed 12 client service implementation projects in Q4, for a total of 57 in 2018
In Q4, introduced two key features for NaviNet Open
Routing Attributes for Document Exchange were enhanced to provide health plans more control over document routing to users
NaviNet Open subscribers are now provided a detailed view of user activity for all Authorization Appeals in a monthly report delivered to the health plan
In December 2018, at the Healthcare Payers Transformation Assembly hosted by the Millennium Alliance, the company met with Payer groups and led a roundtable discussion entitled, "Looking at the Challenges Health Plans Face with the Convergence of Precision Medicine and Value Based Care." As a result, the company is engaged in a number of ongoing sales conversations based on discussions initiated at this event
Connected Care (DeviceConX):
In Q4, completed a DeviceConX implementation in Sweden, which included our first deployment with physiological waveform capabilities
In Q4, as previously announced, collaborated with B. Braun Australia, GE Healthcare and iProcedures to demonstrate the exchange of data between patient devices and medical records at the Interoperability Showcase as part of the Healthcare Information and Management Systems Society (HIMSS) Asia Pacific Conference
Significantly increased connectivity license sales in Q1, driving improved recurring maintenance revenue on a go forward basis
In Q1, deployed DeviceConX Version 5.15 upgrade, with the ability to push OS security patches directly to HBox Connected Care hardware devices
Sequencing and Molecular Analysis – Highlights

In Q4, total orders (GPS Cancer and Liquid GPS) increased 10% to 1,021 from 930 in Q3
In Q4, the company expanded the molecular analysis reporting of GPS Cancer to provide information on a patient’s pharmacogenomic profile. These results, now available in the GPS Cancer test report, provide insights into potential drug toxicity and/or interactions
In December 2018, at the San Antonio Breast Cancer Symposium, the company and NantOmics presented the findings of three investigations, which examine the theme of providing oncologists with insights that enable cancer treatment tailored to the individual characteristics of each patient
In Q4, expanded existing employer reimbursement contract with Northwest Firefighters Benefits Trust to include Liquid GPS coverage and signed a net new reimbursement contract for both GPS Cancer and Liquid GPS with an additional city fire/police employee trust
Business and Financial Highlights

The company adopted a new revenue recognition standard on January 1, 2018. Please note that the financial results presented below include only new revenue standard values. For additional information and reconciliations of the company’s financial results between the new and previous revenue recognition standard, see the additional tables included in this press release and in the company’s Form 10-K to be filed with the Securities and Exchange Commission.

For the 2018 full year, total net revenue increased 3.2% to $89.5 million from $86.7 million in 2017. Gross profit was $45.2 million, or 51% of total net revenue, compared with $45.2 million, or 52% of total net revenue, for the prior year. Selling, general and administrative (SG&A) expenses decreased to $70.8 million from $75.0 million in 2017. Research and development (R&D) expenses decreased to $20.9 million from $33.9 million in 2017.

Financial results for 2018 included a non-cash charge for loss from related party equity method investment, including impairment, of $108.4 million, and an unrealized loss from change in fair value of the Bookings Commitment liability of $16.9 million. Net loss from continuing operations, net of tax, was $190.4 million, or $1.74 per share, compared with $131.4 million, or $1.12 per share, for the 2017 full year. Loss from discontinued operations, net of tax, was $1.7 million, or $0.02 per share, compared with $43.8 million, or $0.37 per share. Net loss was $192.2 million, or $1.76 per share, compared with $175.2 million, or $1.49 per share, for 2017.

For the 2018 full year, on a non-GAAP basis, adjusted net loss from continuing operations was $44.5 million, or $0.41 per share, compared with $55.5 million, or $0.47 per share, for 2017.

For the 2018 fourth quarter, total net revenue was $22.9 million, compared with $22.3 million in 2017 fourth quarter. Gross profit was $11.5 million, or 50% of total net revenue, compared with $13.4 million, or 60% of total net revenue, for the prior year. SG&A expenses declined to $14.6 million, from $20.8 million in 2017 fourth quarter. R&D expenses decreased to $5.0 million from $8.8 million.

Financial results for the fourth quarter of 2018 included a non-cash charge for loss from related party equity method investment, including impairment, of $18.9 million, and an unrealized loss from change in fair value of the Bookings Commitment liability of $16.9 million. Net loss from continuing operations, net of tax, was $49.2 million, or $0.45 per share, compared with $22.6 million, or $0.21 per share, for the 2017 fourth quarter. Net loss was $49.1 million, or $0.45 per share, compared with $21.6 million, or $0.20 per share, for 2017 fourth quarter.

For the 2018 fourth quarter, on a non-GAAP basis, adjusted net loss from continuing operations was $9.0 million, or $0.08 per share, compared with $7.8 million, or $0.07 per share, for the 2017 fourth quarter.

In August 2017, NantHealth sold its provider/patient engagement assets to Allscripts to focus on core competencies and accelerate the plan to achieve profitability. As a result, the company has classified the current and prior period operating results of its provider/patient engagement business as discontinued operations. All results presented above represent the company’s continuing operations.

Conference Call Information and Forward-Looking Statements

Later today, the company will host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to review its results of operations for the fourth quarter ended December 31, 2018. The conference call will be available to interested parties by dialing 844-309-3709 from the U.S. or Canada, or 281-962-4864 from international locations, passcode 1059708. The call will be broadcast via the Internet at www.nanthealth.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding topics such as the company’s financial status and performance, regulatory and operational developments, and other comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including adjusted net loss and adjusted net loss per share, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. Other companies may define these measures in different ways. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP. Non-GAAP per share numbers are calculated based on one class of common stock and do not incorporate the effects, if any, of using the two-class method.

On March 28, 2019 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the launch of new solutions designed to advance cancer research as part of its highlights at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting from March 29 to April 3, 2019, in Atlanta, Georgia (Press release, Qiagen, MAR 28, 2019, View Source [SID1234534722]). More than 30 studies being presented at AACR (Free AACR Whitepaper) 2019 cite molecular testing tools from QIAGEN’s Sample to Insight portfolio.

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These products involve:

New solution bundles for all QIAseq and QIAact DNA panels for next-generation sequencing (NGS), integrating its market-leading CLC Genomics Workbench and QIAGEN Clinical Insight-Interpret software with these assays for seamless secondary analysis and tertiary interpretation of complex genomic data. The proprietary technology driving the superior performance of QIAGEN’s NGS panels was described in a recent Nature article: View Source
QIAGEN is introducing its exoRNeasy Midi and Maxi Kits for isolation of exosomes and other extracellular vesicles from urine and other samples, as well as the miRNeasy 96 Advanced QIAcube HT Kit for automated purification of total RNA, including miRNA, from serum and plasma samples. These are two novel liquid biopsy workflows for cancer research designed to enable non-invasive extraction and purification of ribonucleic acid (RNA).

On March 28, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it will share further data on the savolitinib development programs in lung cancer at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, Georgia, USA, March 31 to April 3, 2019 (Press release, Hutchison China MediTech, MAR 28, 2019, http://www.chi-med.com/pres-on-savo-at-aacr19/ [SID1234534753]).

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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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Preliminary efficacy and safety results will be presented from the China Phase II study of savolitinib monotherapy in non-small cell lung cancer ("NSCLC") patients with MET Exon 14 skipping mutations who have failed prior systemic therapy, or are unable to receive chemotherapy (abstract #CT031, clinicaltrials.gov identifier NCT02897479).

In addition, several abstracts will be presented from the TATTON Phase Ib/II trial of savolitinib in combination with Tagrisso (osimertinib) in patients with epidermal growth factor receptor ("EGFR") mutation-positive NSCLC and MET-amplification who have progressed following treatment with an EGFR tyrosine kinase inhibitor ("EGFR-TKI") (clinicaltrials.gov identifier NCT02143466). One presentation will focus on patients who had progressed on a first- or second-generation EGFR-TKI and had not previously received a third-generation EGFR-TKI (abstract #CT032). Another presentation will focus on patients whose disease further progressed despite prior treatment with a third-generation EGFR-TKI (abstract #CT033). These presentations are complemented by a poster presentation on detection methods for identifying MET-driven EGFR-TKI resistance in the TATTON trial (abstract #4897/20).

TATTON preliminary results were presented at the World Conference on Lung Cancer (WCLC) in Yokohama, Japan, in October 2017.[1] The TATTON trial supports SAVANNAH, an ongoing Phase II clinical trial exploring the combination of savolitinib and Tagrisso to overcome MET-driven EGFR-TKI resistance following treatment with Tagrisso (clinicaltrials.gov identifier NCT03778229).

Further details of the presentations are as follows:

Session: Can the Challenge of NSCLC Resistance Be MET or Will We Not MEK It?
Session Type: Clinical Trials Plenary Session
Session # & Link: CTPL02
Date & Time: Sunday, March 31: 3:00 PM-5:15 PM
Location: Marcus Auditorium, Building A, Georgia World Congress Center
1st Presentation Title: Preliminary efficacy and safety results of savolitinib treating patients with pulmonary sarcomatoid carcinoma (PSC) and other types of non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations
Lead Author: Shun Lu, Professor at Shanghai Chest Hospital, Jiao Tong University
Abstract # & Link: CT031 – abstract available after 3:00 PM EST on Friday, March 29, 2019
Time: 3:05 PM-3:30 PM
2nd Presentation Title: TATTON Phase Ib expansion cohort: Osimertinib plus savolitinib for patients (pts) with EGFR-mutant, MET-amplified NSCLC after progression on prior first/second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)
Lead Author: Helena A. Yu, Medical Oncologist at Memorial Sloan Kettering Cancer Center
Abstract # & Link: CT032 – abstract only available at time of presentation
Time: 3:40 PM-3:55 PM
3rd Presentation Title: TATTON Phase Ib expansion cohort: Osimertinib plus savolitinib for patients (pts) with EGFR-mutant, MET-amplified NSCLC after progression on prior third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)
Lead Author: Lecia V. Sequist, Associate Professor of Medicine at Harvard Medical School and the Director of the Center for Innovation in Early Cancer Detection at Massachusetts General Hospital
Abstract # & Link: CT033 – abstract only available at time of presentation
Time: 3:55 PM-4:15 PM

Session: Novel Strategies for Biomarker Identification and Use in Cancer 3
Poster Title: Detection of MET-mediated EGFR tyrosine kinase inhibitor (TKI) resistance in advanced non-small cell lung cancer (NSCLC): biomarker analysis of the TATTON study
Lead Author: Ryan J. Hartmaier, AstraZeneca
Abstract # & Link: 4897 / 20 – abstract now available
Date & Time: April 3, 2019, 8:00 AM – 12:00 PM
Location: Section 19, Building B, Georgia World Congress Center

About Savolitinib
Savolitinib is a potential first-in-class inhibitor of c-MET, an enzyme which has been shown to function abnormally in many types of solid tumors. Chi-Med designed savolitinib to be a potent and highly selective oral inhibitor, which, through chemical structure modification, addresses human metabolite-related renal toxicity, the primary issue that halted development of several other selective c-MET inhibitors. In clinical studies to date, involving over 900 patients, savolitinib has shown promising signs of clinical efficacy in patients with c-MET gene alterations in multiple tumor types with an acceptable safety profile. Chi-Med is currently testing savolitinib in partnership with AstraZeneca in Phase Ib/II studies, in multiple solid tumor indications, both as a monotherapy and in combinations.

On March 28, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported publication of abstracts on neratinib for the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 (Press release, Puma Biotechnology, MAR 28, 2019, View Source [SID1234534707]). The AACR (Free AACR Whitepaper) Annual Meeting will be held at the Georgia World Congress Center in Atlanta, Georgia from March 29 to April 3. Posters will be available on Puma’s website following presentation.

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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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Full abstracts of the following presentations are available online at www.aacr.org :

March 31, 2019, 3:35 – 3:50 p.m. EDT – Abstract 1724 (Oral): Natural history and clinical characteristics of ERBB2 mutant hormone receptor-positive breast cancers: Results from the AACR (Free AACR Whitepaper) Project GENIE Registry.
Michele LeNoue-Newton et al, Vanderbilt-Ingram Cancer Center, TN.

March 31, 2019, 3:50 – 4:05 p.m. EDT – Abstract 929 (Oral): Paired tumor and cfDNA in patients with HER2-mutant solid tumors treated with neratinib reveals convergence of multiple ontarget resistance mechanisms: Results from the SUMMIT ‘Basket’ Trial.
Helen H. Won et al, Memorial Sloan Kettering Cancer Center, New York.

April 2, 2019, 3:20 – 3:35 p.m. EDT – Abstract 4459 (Oral): Morphologic and genomic characterization of circulating tumor cells in patients with ERBB2 mutant HER2 non-amplified metastatic breast cancer treated with neratinib.
Stephanie Nicole Shishido et al, USC, Los Angeles.

April 2, 2019, 4:35 – 4:50 p.m. EDT – Abstract 4527 (Oral): Patient-derived organoids and xenografts identify neratinib plus HER2 antibody drug conjugate as a synergistic drug combination for HER2 mutated, non-amplified metastatic breast cancer.
Shunqiang Li et al, Washington University School of Medicine, Saint Louis, MO.

March 31, 2019, 1:00 – 5:00 p.m. EDT – Abstract 328 (Poster): ADAM17-induced activation of HER receptors mediate resistance to trastuzumab in a subset of moderate HER2-expressing breast cancer cells.
Katharina Feldinger et al, University of Birmingham, UK.

March 31, 2019, 1:00 – 5:00 p.m. EDT – Abstract 329 (Poster): Hyperactivation of mTORC1 drives acquired resistance to the pan-HER tyrosine kinase inhibitor neratinib in HER2-mutant cancers.
Dhivya R. Sudhan et al, UT Southwestern Medical Center, Dallas, TX.

March 31, 2019, 1:00 – 5:00 p.m. EDT – Abstract 389 (Poster): Role of HER3 signaling pathways in ER+ and HER2+ breast cancers.
Rosalin Mishra et al, University of Cincinnati College of Pharmacy, Cincinnati, OH.

March 31, 2019, 1:00 – 5:00 p.m. EDT – Abstract 395 (Poster): Aberrant HER2 signaling is a therapeutic target in a subset of castration-resistant prostate cancer.
Joshua W. Russo et al, Beth Israel Deaconess Medical Center, Boston, MA.

April 1, 2019, 1:00 – 5:00 p.m. EDT – Abstract 1923 (Poster): KRAS-mutant (mt) colorectal cancer (CRC) organoid models generated from patient-derived xenografts (PDX) show response to combination of trametinib (Tm), neratinib (N), and trastuzumab (Tz).
Rekha Pal et al, NSABP Foundation, Inc., Pittsburgh, PA.

April 2, 2019, 1:00 – 5:00 p.m. EDT – Abstract 3705 (Poster): Identification of frequent HER2 activating mutations in canine primary pulmonary adenocarcinoma.
Gwendolen Lorch et al, Ohio State University College of Veterinary Med., Columbus, OH.

April 3, 2019, 8:00 a.m. – 12:00 p.m. EDT – Abstract 4827 (Poster): The therapeutic superiority of neratinib in combination with trastuzumab compared to pertuzumab plus trastuzumab in HER2-positive in vivo breast cancer models.
Jamunarani Veeraraghavan et al, Baylor College of Medicine, Houston, TX.

April 3, 2019, 8:00 a.m. – 12:00 p.m. EDT – Abstract 4832 (Poster): Preclinical evaluation of neratinib plus T-DM1 in orthotopic PDX models of HER2-positive breast cancer brain metastases.
Jing Ni et al, Dana Farber Cancer Institute, Boston, MA.