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Stemline Therapeutics to Participate in Panel on Myeloid Tumors at the 31st Annual ROTH Conference

On March 18, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that Ivan Bergstein, M.D., Stemline’s CEO, was selected to participate as a panelist on "The Brave New World of Myeloid Tumors (Press release, Stemline Therapeutics, MAR 18, 2019, View Source [SID1234534420])." The panel will take place on Monday, March 18 at 3 PM PT during the 31st Annual ROTH conference at the Ritz-Carlton Laguna Niguel, CA.

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About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.

About ELZONRIS
ELZONRIS (tagraxofusp), a CD123-directed cytotoxin, was approved by the Food and Drug Administration (FDA) on December 21, 2018 for the treatment of adult and pediatric patients, two years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In November 2018, the European Medicines Agency (EMA) granted ELZONRIS accelerated assessment to the marketing authorization application (MAA), which was submitted to, and validated by, the EMA in January 2019. ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, and other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

Veracyte Announces New Afirma Xpression Atlas Data on Medullary Thyroid Cancer to Be Presented at ENDO 2019

On March 18, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported that new data derived from the Afirma Xpression Atlas, which help characterize the genomic underpinning of medullary thyroid cancer (MTC), will be presented at ENDO 2019, the Endocrine Society’s annual meeting (Press release, Veracyte, MAR 18, 2019, View Source [SID1234534419]). The findings on this rare–but aggressive–form of thyroid cancer will be presented in a guided poster presentation during the conference, which is taking place March 23-26 in New Orleans, La.

"The Afirma Xpression Atlas is enabling us to shed new light on the scope and scale of gene alterations found in medullary thyroid cancer," said Giulia C. Kennedy, Ph.D., chief medical and scientific officer of Veracyte. "We believe that, in the emerging era of precision medicine, such information will be vital to advancing the diagnosis and treatment of this aggressive cancer and we look forward to sharing our findings at ENDO 2019."

The following guided poster will be presented during the meeting:

Title: The Genomic Landscape of Preoperative FNAs Positive for the Afirma GSC Medullary Thyroid Cancer Classifier

Presenter: S.G. Waguespack, M.D., University of Texas MD Anderson Cancer Center, Houston, Texas

Date: Monday, March 25, 1:00 – 3:00 PM CT

Location: ENDOExpo, Ernest N. Morial Convention Center

About Afirma

The Afirma Genomic Sequencing Classifier (GSC) and Xpression Atlas provide physicians with a comprehensive solution for a complex landscape in thyroid nodule diagnosis. The Afirma GSC was developed with RNA whole-transcriptome sequencing and machine learning and helps identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to help patients avoid unnecessary diagnostic thyroid surgery. The Afirma Xpression Atlas provides physicians with genomic alteration content from the same fine needle aspiration samples that are used in Afirma GSC testing and may help physicians decide with greater confidence on the surgical or therapeutic pathway for their patients. The Afirma Xpression Atlas includes 761 DNA variants and 130 RNA fusion partners in over 500 genes that are associated with thyroid cancer.

corporate presentation of Vaccinex, Inc.

On March 18, 2019, Vaccinex, Inc. presented the corporate presentation (Presentation, Vaccinex, MAR 18, 2019, View Source [SID1234534418]).

Corcept Therapeutics Appoints Former Amgen Development Executive, Andreas Grauer, M.D., as Chief Medical Officer

On March 18, 2019 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported the appointment of Andreas Grauer, M.D., as Chief Medical Officer (Press release, Corcept Therapeutics, MAR 18, 2019, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-appoints-former-amgen-development-executive [SID1234534417]). Dr. Grauer most recently served as Vice President of Global Development at Amgen.

"We are delighted Andreas will be joining us," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. "His extensive experience advancing novel compounds through every stage of development and regulatory approval will be invaluable as Corcept’s pipeline progresses."

"There is much to do," said Dr. Belanoff. "Relacorilant is in the midst of its Phase 3 trial as a treatment for patients with hypercortisolism and in Phase 2 as a treatment for patients with advanced ovarian cancer. More indications for relacorilant, including metastatic pancreatic cancer, are under consideration. We expect to select a dose this year of CORT125281 as a treatment for patients with castration-resistant prostate cancer. And CORT118335 will enter the clinic soon as a treatment for antipsychotic induced weight gain and, later this year, non-alcoholic steatohepatitis."

"I am excited to join Corcept at this key moment," said Dr. Grauer. "Cortisol modulation has the potential to improve the lives of many seriously ill patients. I look forward to bringing my experience and expertise to bear to develop truly novel, beneficial medications."

Prior to joining Corcept, Dr. Grauer spent more than ten years at Amgen in a variety of leadership roles, most recently as Vice President of Global Development, where he led or oversaw programs in therapeutic areas including bone, nephrology, and inflammation throughout all phases of development. Dr. Grauer also brings significant experience in regulatory filings across the world that culminated in multiple new drug application and biologic license application approvals. Before Amgen, he held senior executive positions at Procter & Gamble Pharmaceuticals. Dr. Grauer holds an M.D. from the University of Heidelberg Medical School, where he graduated magna cum laude. He is Board Certified in both internal medicine and endocrinology in Germany.

Puma Biotechnology Presents Interim Results from the Phase II SUMMIT Trial of Neratinib for HER2 (ERBB2) Mutant, Metastatic Cervical Cancer at the Society of Gynecologic Oncology (SGO) 2019 Annual Meeting

On March 18, 2019 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that updated results from the cervical cancer cohort of SUMMIT, an ongoing Phase II basket trial examining the efficacy of neratinib in HER2-mutated cancers, were reported at the Society of Gynecologic Oncology (SGO) 2019 Annual Meeting in Honolulu, Hawaii (Press release, Puma Biotechnology, MAR 18, 2019, View Source [SID1234534416]). "Neratinib in patients with HER2-mutant, metastatic cervical cancer: findings from the phase II SUMMIT ‘basket’ trial," was presented during the Scientific Plenary Session by Anishka D’Souza, M.D., Assistant Professor of Clinical Medicine, Keck School of Medicine of University of Southern California (USC). SGO selected this abstract as the recipient of the 2019 SGO Presidential Award. Slides from the presentation are available on the Puma Biotechnology website.

The Phase II SUMMIT ‘basket’ trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating, somatic HER2 mutations. The cervical cancer cohort was comprised of 11 patients with advanced and/or metastatic disease treated with neratinib monotherapy. Patients received a median of 2 (range 1–4) prior regimens in the recurrent or metastatic setting before entering this trial. Six patients (54.5%) had been previously treated with bevacizumab prior to entering the study; 7 patients (63.6%) had received prior surgery; and 9 patients (81.8%) received prior radiation therapy. The objective response rate was 27.3% (95% CI: 6.0%–61.0%). The clinical benefit rate was 54.5% (95% CI: 23.4%–83.3%) and included 3 patients with confirmed partial responses and 3 patients with stable disease that lasted greater than 16 weeks. The median progression free survival was 7.0 months (95% CI: 0.7–20.1 months).

The safety profile observed in neratinib-treated cervical cancer patients in SUMMIT was consistent with that reported for HER2-amplified metastatic breast cancer. The most frequently observed adverse event was diarrhea, any grade (n=9, 81.8%) including 1 (9%) grade 3 diarrhea event. The duration of grade 3 diarrhea was 1 day. None of the diarrhea events resulted in dose reduction, dose discontinuation or hospitalization.

"Somatic HER2 mutations represent a distinct class of oncogenic driver mutations that appear to be clinically actionable for metastatic cervical cancers. Treatment with neratinib led to durable responses and disease control in metastatic patients with HER2-mutant cervical cancer," said Dr. D’Souza, who practices oncology at the USC Norris Comprehensive Cancer Center.

Alan H. Auerbach, CEO and President of Puma Biotechnology, added, "We are very pleased with the activity seen with neratinib in this cohort of patients with HER2-mutated cervical cancer. We look forward to the further development of neratinib in this patient population."