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Extending overall survival is less important than quality of life and disease stability for the majority of physicians treating patients with advanced lung cancer following first-line chemotherapy

On September 24, 2015 Boehringer Ingelheim reported results of a new European survey investigating therapy goals, prescribing habits and decision-making criteria of physicians treating patients with advanced lung cancer with adenocarcinoma histology after first-line chemotherapy (Press release, Boehringer Ingelheim, SEP 24, 2015, View Source [SID:1234507545]). These data show that, when administering treatment after first-line chemotherapy, only 40% of physicians considered extending overall survival as a priority goal for those patients with a good performance status; 55% of physicians stated that their priority therapy goal was either related to maintaining quality of life (36%) or achieving disease stability (19%).1

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Professor Nicolas Girard, University Hospital of Lyon, France, commented, "Effectively balancing efficacy and tolerability is at the core of achieving the best outcomes for patients with advanced lung cancer and both factors always need to be considered in tandem. These data have highlighted that whilst a significant number of physicians treating patients with advanced adenocarcinoma, who have a good performance status after first-line chemotherapy, are ‘survival orientated’, the primary intention of therapy for over a third of physicians remains quality of life. This is despite the fact that extension of life, whilst maintaining quality of life, is now a realistic therapy goal for these patients against a backdrop of a rapidly evolving treatment landscape."

The European survey questioned 500 physicians treating patients with advanced/ metastatic (stage IIIb/IB) non-small cell lung cancer (NSCLC) of adenocarcinoma histology with anti-cancer medications. The aim of the survey was to better understand the perspective of physicians when prescribing a treatment in order to stimulate discussion on the provision of optimal care for all lung cancer patients. Following a screening process, 100 physicians from each country (France, Germany, Italy, Spain and the UK) were asked to consider their approach to treatment of advanced adenocarcinoma after first-line chemotherapy. They were asked to consider their most important therapy goal, prescribing behaviour, based on perceived patient outcomes; product features of their preferred treatment choices and clinical parameters that influence treatment choice.1

With regards to product criteria, only 36% of physicians considered the most important product feature to be that it ‘offers a clinically relevant increase in overall survival’; 54% of physicians prioritised either ‘offers a clinically relevant increase in progression-free survival’ (27%) or ‘maintaining quality of life’ (27%), as the most important.1

These data also highlighted that physician therapy goals changed depending on the line of therapy and performance status, with tolerability becoming more important in later lines of therapy and as performance status declined. The most important patient characteristics considered, when deciding on a treatment for advanced adenocarcinoma after first-line chemotherapy, were the patient’s comorbidities.1

Dr Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented, "In the last few years huge strides have been made in the treatment of advanced adenocarcinoma of the lung after first-line chemotherapy. Following an absence of clinically meaningful developments in the previous decade for the biggest lung cancer patient population, extending patient survival is now a realistic therapy goal. We are committed to improving the lives of lung cancer patients and we hope to share the results of this survey across the lung cancer community to help increase understanding and communicate learnings of the different prescribing approaches of physicians in Europe."

The full results of the survey will be published in a peer-reviewed journal in 2016.

CTI BioPharma Announces $15.7 Million Registered Direct Offering

On September 24, 2015 CTI BioPharma Corp. (NASDAQ and MTA: CTIC) reported that it has entered into an agreement with institutional investors to purchase 10 million shares of the Company’s common stock in a registered direct offering conducted without an underwriter or placement agent for gross proceeds to the Company of approximately $15.7 million at a purchase price per share of $1.57 (the "Offering"), equal to the consolidated closing bid price on The NASDAQ Global MarketSM on September 23, 2015 (Press release, CTI BioPharma, SEP 24, 2015, View Source;p=RssLanding&cat=news&id=2090328 [SID:1234507541]). The net proceeds from the Offering, after deducting estimated offering expenses, will be approximately $15.1 million.

CTI BioPharma plans to use the net proceeds from the Offering to support the continued clinical development of its lead product candidate, pacritinib, as a potential new treatment for patients with myelofibrosis, and additional research into new indications outside of myelofibrosis, and for general corporate purposes. The Offering is expected to close on or about September 29, 2015.

The shares of common stock are being offered by CTI BioPharma pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC"), which the SEC declared effective on December 8, 2014. A prospectus supplement related to the Offering will be filed with the SEC and will be available on the SEC’s website located at View Source Alternatively, CTI BioPharma will arrange to send you the prospectus supplement and the accompanying prospectus upon request to CTI BioPharma Investor Relations by calling (206) 272-4345 or writing [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy shares of common stock, nor shall there be any sale of common stock in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The shares of common stock will not be offered, sold or distributed, directly or indirectly, in Italy in an offer to the public of financial products under the meaning of Article 1, paragraph 1, letter t) of Legislative Decree No. 58 of February 24, 1998, as amended (the "Financial Services Act"), unless an express exemption from compliance with the restrictions on offers to the public, including, without limitation, as provided under Article 100 of the Financial Services Act and Article 34-ter of CONSOB Regulation No. 11971 of May 14, 1999, as amended, applies.

NewLink Genetics Corporation Announces Presentation of Clinical Data in Melanoma at Upcoming European Cancer Congress 2015 (ECC)

On September 24, 2015 NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company at the forefront of developing and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer, reported that it will present early stage clinical data from its indoximod program in melanoma at the European Cancer Congress 2015 (ECC) being held September 25-29 in Vienna, Austria (Press release, NewLink Genetics, SEP 24, 2015, View Source [SID:1234507536]).

NewLink Genetics Presentation
Abstract Title: Results of Phase 1b trial of the indoleamine 2,3-dioxygenase (IDO) pathway inhibitor indoximod plus ipilimumab for the treatment of unresectable stage III or IV melanoma
Abstract Number: 514
Time: 4:45 – 6:45 p.m. CET
Date: Saturday, Sept. 26
Location: Hall C, Posterboard #248
Session Title: Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Session Type: Poster session

Exelixis Announces Key Senior Leadership Hires in Medical Affairs, Sales, and Marketing to Support Commercialization of Cabozantinib and Cobimetinib

On September 24, 2015 Exelixis, Inc. (NASDAQ:EXEL) reported three high-level appointments as the company prepares for the potential commercialization of its lead compound, cabozantinib, for the treatment of advanced renal cell carcinoma (RCC) following positive results from the METEOR pivotal phase 3 trial. William Berg, M.D. has joined the company as Senior Vice President of Medical Affairs, Jonathan Berndt as Vice President of Sales, and Gregg Bernier as Vice President of Marketing (Press release, Exelixis, SEP 24, 2015, View Source;p=RssLanding&cat=news&id=2090105 [SID:1234507535]).

"Exelixis is moving rapidly to thoughtfully expand our medical affairs and commercial capabilities in advance of our planned U.S. and EU regulatory filings for cabozantinib in advanced renal cell carcinoma in late 2015 and early 2016, respectively," said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. "Will, Jon, and Gregg bring a wealth of oncology experience and successful track records gained at some of the biopharmaceutical industry’s most prestigious companies. Their new roles on the Exelixis team will help to ensure we are well-positioned to execute on our many critical milestones in the months to come."

As Senior Vice President of Medical Affairs, William Berg, M.D. will oversee medical affairs in the United States. He joins Exelixis after spending more than 12 years at Novartis, where he served in roles of increasing responsibility, including vice president and franchise head within Global Medical Affairs. Notably, Dr. Berg led the Afinitor Medical Affairs program which was instrumental in the development of Afinitor in advanced RCC. Prior to Novartis, he was a director of U.S. medical affairs at Aventis Oncology. Before entering the pharmaceutical industry, Dr. Berg served on the faculty of the Memorial Sloan Kettering Cancer Center (MSKCC), where he saw patients as part of the Genitourinary Oncology Service, contributed to the MSKCC risk model for advanced RCC, and researched novel therapies for the disease. Dr. Berg completed his fellowship in medical oncology at MSKCC, training under Robert J. Motzer, M.D. He earned his medical degree from Cornell University Medical College and his Bachelor of Science from Duke University.

Vice President of Sales Jonathan Berndt will lead all sales activities for cabozantinib and also direct U.S. co-promotion efforts for cobimetinib, including Exelixis’ plans to field up to 25 percent of the cobimetinib U.S. sales force in the event of a potential regulatory approval later this year. Mr. Berndt joins Exelixis with two decades of commercial sales experience in the biopharmaceutical industry, including multiple oncology product and line extension launches. Most recently, he served as senior director, oncology sales at Gilead Sciences, where he assembled and led the company’s oncology sales team supporting Zydelig. Prior to Gilead, Mr. Berndt served at Genentech for 13 years. While there, he served in a variety of roles, including directing national and regional sales for products including Rituxan and Avastin, and managing sales operations for Herceptin and Tarceva. He received his Bachelor of Science in management from Virginia Tech.

Exelixis’ new Vice President of Marketing Gregg Bernier will lead the marketing group in its commercialization of cabozantinib for RCC. Mr. Bernier has more than 20 years of experience in biotech and pharmaceutical sales and marketing, primarily in oncology. Prior to joining Exelixis, he served as senior director of marketing at Medivation, where he led the launch of Xtandi for a new indication in metastatic castration-resistant prostate cancer. Mr. Bernier joined Medivation from Genentech, where he worked on a variety of product launches including Tarceva, Kadcyla, Erivedge and Avastin, among other products. He has also held positions at Pharmacia and Sanofi. Mr. Bernier received his Bachelor of Arts in advertising at Michigan State University.

The new appointments come as Exelixis prepares U.S. and EU regulatory filings for cabozantinib in advanced RCC, and awaits a U.S. regulatory decision on its partner Genentech’s application for cobimetinib. In July, Exelixis announced top-line results from METEOR, its phase 3 pivotal trial comparing cabozantinib to everolimus in 658 patients with metastatic RCC who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. Cobimetinib, the Exelixis-discovered selective inhibitor of MEK, was recently approved in Switzerland for use in combination with vemurafenib as a treatment for patients with advanced melanoma, and has a Prescription Drug User Free Act action date of November 11, 2015 in the United States. If cobimetinib is approved in the United States, Exelixis is entitled to an initial equal share of U.S. profits and losses, which will decrease as sales increase, and will share in U.S. marketing and commercialization costs. Having exercised its option to co-promote the compound in the United States, Exelixis is prepared to field up to 25 percent of the U.S. sales force.

Myriad Genetics Presents New Data on Its Companion Diagnostic and Prostate Cancer Tests at the European Society for Medical Oncology Annual Meeting

On September 24, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported three poster presentations that will be featured at the 40th European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting being held Sept. 25 to 29, 2015 in Vienna, Austria (Press release, Myriad Genetics, SEP 24, 2015, View Source [SID:1234507533]). The presentations include new studies on the myChoice HRD and Tumor BRACAnalysis CDx companion diagnostic tests and final results from the EMPATHY-P clinical utility study on Prolaris.

"Myriad continues to place a strong emphasis on molecular diagnostic research with the goal of enabling personalized medicine and improving patient outcomes. We are presenting exciting new data on the unique ability of our companion diagnostics to identify the highest number of patients who may benefit from drugs that target the DNA-repair pathway, such as PARP inhibitors," said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad. "We’re also presenting the final results for the EMPATHY-P study that show the Prolaris test provides essential clinical information to help physicians select men with prostate cancer who are good candidates for active surveillance versus those who need more medical treatment based on a genetic evaluation of their tumor."

The list of key Myriad presentations at ESMO (Free ESMO Whitepaper) (#ECC2O15) follows.

myChoice HRD

Title: DNA Repair Deficiencies in Ovarian Cancer: Genomic Analysis of High Grade Serous Ovarian Tumors from the NOVA Study.

Date: Saturday, Sept. 26, 2015: 4:45 to 6:45 p.m. CEST.

Location: Hall C, Poster P108.

Homologous recombination deficiency was assessed on tumors obtained from 318 patients enrolled in the NOVA study, a Phase 3 clinical trial evaluating the PARP inhibitor niraparib as a treatment in patients with platinum-sensitive ovarian cancer. The results show that 100 percent of patients with a germline BRCA mutation and 55 percent of patients without a BRCA mutation were HRD positive as determined by the myChoice HRD test. Importantly, the myChoice HRD test, which uses three novel algorithms of DNA damage (LOH, LST, TAI), more clearly defined the HRD positive population in ovarian cancer than did LOH alone. These findings support the use of the myChoice HRD test to more effectively identify patients who may benefit from therapy with DNA-damaging agents, such as platinum drugs and PARP inhibitors.

Tumor BRACAnalysis CDx

Title: Next Generation Sequencing of BRAC1 and BRCA2 Genes in Ovarian Tumors Captures Germline Mutations and Expands the Potential Treatment Group for the PARP Inhibitor Olaparib.

Date: Saturday, Sept. 26, 2015: 4:45 to 6:45 p.m. CEST.

Location: Hall C, Poster P116.

This study assessed the ability of Tumor BRACAnalysis CDx, a tumor-based next generation sequencing (NGS) test, to detect germline BRAC1/2 mutations in patients with high-grade serous ovarian cancer versus germline testing using Sanger sequencing in a reference laboratory. Tumor tissue was available from 54 patients to evaluate the Tumor BRACAnalysis CDx test. In all 54 cases, Tumor BRACAnalysis CDx correctly identified the deleterious BRAC1/2 mutations, demonstrating 100 percent sensitivity. The study also showed that tumor cells have de novo somatic mutations not identifiable via germline testing alone. For example, Tumor BRACAnalysis CDx found 12 somatic BRCA1/2 mutations, which represents an increase of 22 percent over germline testing in a sample set that had been specifically enriched for germline mutations. Importantly, patients with germline and tumor BRAC1/2 mutations showed similar treatment response to olaparib, suggesting that tumor testing effectively identifies patients appropriate for treatment with PARP inhibitors.

Prolaris

Title: Potential Reduction of Overtreatment of Localized Prostate Cancer Using a Cell Cycle Gene Expression Assay (Prolaris) in Biopsy Specimens: Results from the European Multi-Center EMPATHY-P Study.

Date: Monday, Sept. 28, 2015: 4:45 to 6:45 p.m. CEST.

Location: Hall C, Poster P072.

The EMPATHY-P study evaluated the Prolaris test in 502 patient biopsy samples to determine the aggressiveness of prostate cancer in these newly diagnosed patients from five European countries including: Italy, Germany, Spain, Switzerland and the UK. The patients’ biopsy samples also were evaluated using standard clinical pathology methods (D’Amico/AUA risk stratification) that were then compared to the Prolaris test results. The EMPATHY-P data show that overall the Prolaris test identified 54 percent of the European men with a risk profile that was different than would be expected using standard clinical pathology. Specifically, the EMPATHY-P study demonstrated that the Prolaris test score found 24 percent of European men had less aggressive prostate cancer and 30 percent of patients had more aggressive disease compared to standard clinical pathology measurements. These data demonstrate that the Prolaris test score can be used to personalize risk assessment for men with localized prostate cancer and identify good candidates for active surveillance.

About myChoice HRD

Myriad’s myChoice HRD is the first homologous recombination deficiency test that can detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. High myChoice HRD scores reflective of DNA repair deficiencies are prevalent in all breast cancer subtypes, ovarian and most other major cancers. In previously published data, Myriad showed that the myChoice HRD test predicted drug response to platinum therapy in certain patients with triple-negative breast and ovarian cancers. It is estimated that 1.8 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents.

About Tumor BRACAnalysis CDx

Myriad’s Tumor BRACAnalysis CDx is a companion diagnostic test for identifying both germline (hereditary) and somatic (tumor) cancer-causing mutations in the BRCA1 and BRCA2 genes. Tumor BRACAnalysis CDx has undergone significant analytic validation and has been shown to identify 44 percent more patients with cancer-causing BRCA1/2 mutations compared to germline testing alone. Myriad is actively collaborating with leading pharmaceutical companies to develop Tumor BRACAnalysis CDx as a companion diagnostic for use with certain PARP inhibitors, platinum-based drugs and other chemotherapeutic agents. The test is currently available in Europe and will be performed at the Company’s Munich laboratory. Prescribing physicians will receive Tumor BRACAnalysis CDx test results in approximately two weeks.

About Prolaris

Prolaris is a prognostic test that measures the expression level of genes involved with tumor proliferation to predict disease outcome. Prolaris is the only test that provides insight into meaningful oncologic endpoints by predicting 10-year prostate cancer-specific mortality, thereby guiding medical management.