On July 3, 2019 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it was selected to be a specialty pharmacy network partner for Karyopharm’s new product XPOVIO (selinexor) a nuclear export inhibitor indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (Press release, Onco360, JUL 3, 2019, View Source [SID1234537380]).

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"Onco360 is excited to be selected as a specialty pharmacy provider for XPOVIO patients," said Paul Jardina, President and CEO, Onco360. "The recent approval of XPOVIO unlocks a new treatment option for relapsed or refractory multiple myeloma patients who have failed previous lines of treatment. As a provider of this key treatment, Onco360 can support the highly specialized needs of relapsed or refractory multiple myeloma and their physicians across the states."

Multiple myeloma is an incurable hematological malignancy involving plasma cells. Only 50 percent of patients diagnosed with multiple myeloma survive past five years following initial diagnosis. The National Cancer Institute estimates that in 2018, approximately 30,770 new patients were diagnosed with multiple myeloma in the U.S.1 Unfortunately, most multiple myeloma patients will relapse following the first complete remission and often require continuous treatment to prevent disease progression. Previously, there were no U.S. Food and Drug Administration (FDA)-approved products or regimens for patients with relapsed or refractory multiple myeloma who failed treatment with lenalidomide, pomalidomide, bortezomib, carfilzomib, and/or daratumumab.

XPOVIO is manufactured by Karyopharm Therapeutics, and was approved by the U.S. FDA on July 3, 2019 based on positive clinical trial results from the Phase IIb STORM Trial which demonstrated a 21% overall response rate in heavily-pretreated multiple myelmoma patients.2 XPOVIO is the first and only nuclear export inhibitor that blocks XPO1. For full prescribing information, visit XPOVIO.com.

On July 3, 2019 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that it will report its second quarter 2019 financial results on Tuesday, July 16, 2019 after the close of financial markets (Press release, Seattle Genetics, JUL 3, 2019, View Source [SID1234537368]). Following the announcement, management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

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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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LIVE access on Tuesday, July 16, 2019

1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 800-458-4121 (domestic) or +1 323-794-2093 (international); conference ID 3271918
Webcast with slides available at www.seattlegenetics.com in the Investors section
REPLAY access

Telephone replay will be available beginning at approximately 4:30 p.m. PT on Tuesday, July 16, 2019 through 5:00 p.m. PT on Friday, July 19, 2019 by calling 888-203-1112 (domestic) or +1 719-457-0820 (international); conference ID 3271918
Webcast replay will be available on the Seattle Genetics website at www.seattlegenetics.com in the Investors section

On July 3, 2019, Jacobio reported that JAB-3312, an oral small-molecule anti-tumor drug has obtained FDA’s approval for clinical study (Press release, Jacobio Pharmaceuticals, JUL 3, 2019, View Source [SID1234538526]). JAB-3312 was independently designed and developed by Jacobio which owns its intellectual property right worldwide. This is the second small-molecule anti-tumor drug approved for clinical research after JAB-3068 ,which has been in phase IIa clinical study.

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JAB-3312 can block the KRAS-MAPK signaling pathway and can be used for the treatment of multiple solid tumors, including non-small-cell lung cancer, colorectal cancer and pancreatic cancer. Meanwhile, it can also attenuate the tumor immunosuppressive microenvironment and enhance the efficacy of existing tumor immunotherapies.

On July 2, 2019 Sandoz reported the launch of the generic oncology medicine gefitinib indicated for adult patients with locally advanced or metastatic non-small cell lung cancer with activating mutations of EGFR-TK[1], which is recommended by ESMO (Free ESMO Whitepaper) as first-line treatment[4] (Press release, Novartis, JUL 2, 2019, View Source [SID1234537355]). The medicine will become available immediately in 13 countries across Europe on the day the reference medicine loses market exclusivity. Sandoz will continue to expand to other countries through a phased rollout.

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"Generics help expand access to medicine, sometimes as much as doubling the amount of patients treated without any increase in cost[5]," said Francesco Balestrieri, ad interim CEO, Sandoz. "At Sandoz, we recognize that oncology still lags behind seven other therapeutic areas that already benefit from considerable generic competition. The day one launch of generic gefitinib, seen by oncology experts as an essential treatment[8], is part of a wider Sandoz effort to change that equation."

In Europe lung cancer is the fourth most common cancer in both women and men, only exceeded by breast, prostate and colorectal cancer. Each year approximately 312,000 patients are diagnosed with lung cancer[2]. Non-small-cell lung carcinoma (NSCLC) is any type of epithelial lung cancer other than small cell lung carcinoma (SCLC) and accounts for approximately 80% to 85% of all lung cancers cases[6].

Sandoz is the #1 provider of generic oncology medicines worldwide[7] with a broad portfolio of more than 50 products, ranging from chemotherapy, hormones and supportive care to biologics[3]. Its growing oncology portfolio covers an industry-leading 75% of molecules on the WHO’s global Oncology Essential Medicines List[8],[9]. It invests in research and development to improve the lives of cancer patients and liberate healthcare resources through increased access to high-quality, affordable medicines.

About Gefitinib
Gefitinib is a once-daily, oral, non-chemotherapy medicine indicated for monotherapy treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations of EGFR-TK[1]. It has been shown to potently inhibit EGFR, a protein involved in the growth and development of this type of cancer[1]. The ESMO (Free ESMO Whitepaper) guidelines recommend gefitinib as a first-line treatment option for patients with EGFR-activating mutation metastatic NSCLC[4]. Gefitinib is part of the national essential medicines list for cancer[8]. European regulatory approval was received for the generic molecule in July 2018, but generic products can only be made available at loss of market exclusivity of the reference product, provided that the patent protection has already expired.

On July 2, 2019 GNS Healthcare (GNS), a leading precision medicine company, together with the Alliance for Clinical Trials in Oncology (Alliance), is reported discoveries of predictive biomarkers for metastatic colorectal cancer (mCRC) patient response to receiving different treatments of cetuximab, bevacizumab, and panitumumab this week at the ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer 2019 conference held in Barcelona, Spain (Press release, GNS Healthcare, JUL 2, 2019, View Source [SID1234537371]). Patient subpopulation-specific prognostic factors of overall survival (OS) were also discovered. The in silico patient models identified AST level, primary side of tumor, intra-abdominal metastasis status as ubiquitous predictors of OS. KRAS status and hemoglobin levels were found to be predictors specific to the side of tumor location.

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The study titled "Bayesian machine learning on CALGB/SWOG 80405 (Alliance) and PEAK data identifies heterogeneous landscape of clinical predictors of overall survival (OS) in different populations of metastatic colorectal cancer (mCRC)" was selected to be presented in a poster discussion session, Friday July 5 from 10 am–5:15 pm local time.

Identification of prognostic factors of OS for subpopulations of patients with colorectal cancer is the key to better risk stratification at treatment initiation and identifying predictive factors for treatment response is crucial for making personalized treatment decisions.

In this study, one of several conducted by GNS and the Alliance, Bayesian machine learning approach was applied to the CALGB/SWOG 80405 (Alliance) and PEAK clinical trials datasets to discover gender and primary side specific predictors of OS in mCRC and patient subpopulations with better response to a given treatment.

Using clinical data from more than 2,000 patients with mCRC and GNS’ powerful causal AI platform, Reverse Engineering & Forward Simulation (REFS), nine independent predictive model ensembles were built to understand predictive biomarkers for patient response to receiving different treatments (cetuximab, bevacizumab, or panitumumab) and to identify patient subpopulation-specific prognostic factors of OS.

The study also identified gender-specific predictors, specifically creatinine level, intra-abdominal metastasis status, and the interaction of albumin and neutrophil levels. Urine protein levels were shown to be predictive of better efficacy from cetuximab treatment in patients with mCRC and left-sided tumors.

"We have never been in a better position to unravel drivers of disease and patient response to specific drugs. We built an in silico patient model of colorectal cancer and were able to uncover biomarkers that tell us which patients will respond to which treatment, and most importantly, why. This is what will get us to the point of delivering personalized medicine and eradicating disease," said Colin Hill, GNS Chairman, CEO, and Co-Founder.

"There is no such thing as a one-size-fits-all approach," said Alan P. Venook, MD, Study Chair for the CALGB/SWOG 80405 (Alliance) study, Madden Family Distinguished Professor of Medical Oncology and Translational Research at the University of California-San Francisco, and Shorenstein Associate Director for Program Development at the Helen Diller Family Comprehensive Cancer Center. "The better we understand how this disease progresses and which biomarkers predict treatment response, the closer we will get to curing it. We are committed to leveraging the best tools at hand – GNS’ powerful AI, comprehensive data, and the best minds in research – to cure cancer."

Previous results from these collaborations were presented in June 2018 at the ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois and at ESMO (Free ESMO Whitepaper) 2018 in Munich, Germany.

As one of the most common cancers in the U.S., there are an estimated 140,000 new cases of colorectal cancer diagnosed each year. There is still much to learn about the factors that drive progression and for patients with mCRC, the optimal treatment is still unknown.

About the Alliance for Clinical Trials in Oncology
The Alliance for Clinical Trials in Oncology develops and conducts clinical trials with promising new cancer therapies, and utilizes the best science to develop optimal treatment and prevention strategies for cancer, as well as research methods to alleviate side effects of cancer and cancer treatments. The Alliance is part of the National Clinical Trials Network (NCTN) sponsored by the National Cancer Institute (NCI) and serves as a research base for the NCI Community Research Oncology Program (NCORP).
To learn more about the Alliance, visit www.AllianceforClinicalTrialsinOncology.org.