On October 9, 2018 NuCana plc (NASDAQ:NCNA), a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer, reported that investigators will present new data from the Acelarin (NUC-1031) and NUC-3373 programs at the ESMO (Free ESMO Whitepaper) 2018 Congress to be held October 19-23, 2018, in Munich, Germany (Press release, Nucana BioPharmaceuticals, OCT 9, 2018, View Source [SID1234529859]). These data include the latest results from the ABC-08 Phase Ib front-line study of Acelarin plus cisplatin in advanced biliary tract cancer, as well as a recruitment update from the Acelarate Phase III front-line study of Acelarin in pancreatic cancer. In addition, results from the NuTide:301 Phase I study of NUC-3373 in advanced solid tumors will be presented.

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Hugh S. Griffith, NuCana’s Chief Executive Officer, said: "We are excited about sharing these latest data at ESMO (Free ESMO Whitepaper) and the potential of our pipeline of innovative ProTides to transform the treatment of patients with cancer."

Details of NuCana’s poster presentations are as follows:

Poster Presentation Session Date & Time: October 21, 2018, 12:45pm CEST

Title: A new ProTide, NUC-1031, combined with cisplatin for the first-line treatment of advanced biliary tract cancer (ABC-08)

Presentation Number: 758P

Session Title: Basic science, Endocrine tumours, Gastrointestinal tumours – colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Location: Hall A3, Poster Area Networking Hub

Presenter: Dr. Mairead McNamara

Poster Presentation Session Date & Time: October 21, 2018, 12:45pm CEST

Title: ACELARATE – A randomised Phase III, open label, clinical study comparing NUC-1031 with gemcitabine in patients with metastatic pancreatic carcinoma

Presentation Number: 788TiP

Session Title: Basic science, Endocrine tumours, Gastrointestinal tumours – colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Location: Hall A3 – Poster Area Networking Hub

Presenter: Professor Daniel Palmer

Poster Presentation Session Date & Time: October 22, 2018, 12:45pm CEST

Title: A Phase I first-in-human, dose-escalation and expansion study to evaluate the safety and tolerability of NUC-3373 in patients with locally advanced, unresectable or metastatic solid malignancies

Presentation Number: 442TiP

Session Title: Breast cancer – early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours—prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Location: Hall A3 – Poster Area Networking Hub

Presenter: Professor Sarah Blagden

On October 9, 2018 AVEO Oncology (NASDAQ:AVEO) reported that updated interim data from the Phase 2 portion of the TiNivo trial of tivozanib and nivolumab (OPDIVO) in advanced renal cell carcinoma will be presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Annual Congress being held October 19-23, 2018 in Munich, Germany (Press release, AVEO, OCT 9, 2018, View Source [SID1234529825]). The TiNivo study is a Phase 1b/2 multicenter trial of oral tivozanib (FOTIVDA) in combination with intravenous nivolumab (OPDIVO, Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor, for the treatment of metastatic renal cell carcinoma (mRCC).

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The accepted abstract, which includes results from a poster presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January, is available via the ESMO (Free ESMO Whitepaper) 2018 Annual Congress website. Updated data will be presented at the ESMO (Free ESMO Whitepaper) conference.

Presentation Details

Title: TiNivo: Tivozanib combined with nivolumab: safety and efficacy in patients with metastatic renal cell carcinoma (mRCC)
Presenter: Philippe Barthelemy, Medical Oncology Department, Hôpitaux Universitaires de Strasbourg, Strasbourg, FR
Presentation Number: 878P
Date and Time: October 22, 2018, 1:05 p.m. CEST
Location: Hall A3 – Poster Area

On October 9, 2018 REVOLUTION Medicines, Inc. reported dosing of the first patient in a Phase 1, open-label, monotherapy dose-escalation and expansion study of RMC-4630, the company’s lead investigational drug candidate targeting the enzyme SHP2 (Press release, Revolution Medicines, OCT 9, 2018, View Source [SID1234529826]). REVOLUTION Medicines holds the IND for RMC-4630, and this trial is being conducted under the recently announced global partnership on SHP2 between REVOLUTION Medicines and Sanofi. Initiation of this clinical trial represents an important step in the company’s mission to translate frontier oncology targets on behalf of cancer patients.

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"REVOLUTION Medicines is proud to advance RMC-4630 into clinical development on behalf of patients with advanced cancers who have limited treatment options," said Stephen Kelsey, M.D., FRCP, FRCPath, president of R&D of REVOLUTION Medicines. "Our discovery of optimal inhibitors of SHP2 and elucidation of the critical role of SHP2 in the growth of certain cancers has, for the first time, suggested the potential to render these drivers of cancer clinically actionable. We are eager to advance this program by working with patients, experienced clinical investigators and our development partners at Sanofi."

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of RMC-4630 in people with relapsed, refractory solid tumors including non-small cell lung cancer and other tumor types carrying certain mutations that cause hyperactivation of the RAS-MAP kinase cell growth signaling cascade. Despite notable recent therapeutic advances in the management of lung cancer and melanoma, there remain large unmet medical needs as no targeted therapies have been approved for treating patients with solid tumors carrying these specific mutations. The study will comprise two parallel components: (1) a dose escalation study for patients with solid tumors, and (2) an expansion study for patients with tumors harboring specific mutations.

Original research led by scientists at REVOLUTION Medicines, and conducted in collaboration with researchers at the University of California, San Francisco School of Medicine, discovered that cancers caused by these oncogenic signaling proteins rely on the normal biochemical actions of SHP2. These data were first disclosed in preliminary form in 2017 via BioRxiv, and have now been published in a full peer-reviewed paper in Nature Cell Biology. They demonstrated that cancers with such "semi-autonomous" mutations may be susceptible to treatment with an inhibitor of SHP2. The trial of RMC-4630 will explore precision oncology hypotheses based on these findings at several clinical centers, including the University of California, Irvine, Chao Family Comprehensive Cancer Center.

The Role of SHP2 in Cancer

SHP2 (PTPN11), a cellular enzyme in the protein tyrosine phosphatase family, plays an important role in multiple forms of cancer and in anticancer immunity. Recently REVOLUTION Medicines reported discoveries about the regulation by SHP2 of a cell growth signaling pathway, known as the RAS-MAP kinase pathway, that frequently is hyperactive in human cancers. The research showed that some mutated forms of proteins in the RAS-MAP kinase pathway depend on SHP2 for their oncogenic activity, and that small molecule inhibitors of SHP2 designed by the company may reduce their tumorigenic effects.

About RMC-4630

RMC-4630 is a potent, selective and orally administered small molecule inhibitor of SHP2. RMC-4630 acts by stabilizing the SHP2 protein in an inactive conformation that is unable to transmit cell growth signals. RMC-4630 as a single agent was found to attenuate signal transduction through the RAS-MAP kinase cascade, reduce tumor growth and cause tumor cell death in preclinical xenograft studies of human tumors carrying select mutations in the RAS-MAP kinase pathway.

On October 9, 2018 Genomic Health, Inc. (NASDAQ: GHDX) reported that its Oncotype DX Breast Recurrence Score test has been categorized as the only "preferred" test for chemotherapy treatment decision-making for patients with node-negative early-stage breast cancer by the National Comprehensive Cancer Network (NCCN) in its 2018 guidelines for invasive breast cancer chemotherapy treatment (Press release, Genomic Health, OCT 9, 2018, View Source [SID1234529844]). The only test elevated to "strongly consider" guideline inclusion with level 1 evidence, Oncotype DX continues to be distinguished as the only genomic test predictive of chemotherapy benefit.

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NCCN’s guidelines update follows the recent publication of results of Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, led by ECOG-ACRIN Research Group. The largest adjuvant treatment breast cancer trial to date, TAILORx involved 10,273 women across 1,100 trial sites in six participating countries. The study results, published in The New England Journal of Medicine, demonstrated that the Oncotype DX Breast Recurrence Score test definitively identifies the vast majority of women with early-stage breast cancer who receive no benefit from chemotherapy, and the important minority of women for whom chemotherapy benefit can be life-saving.

Additionally, the NCCN guidelines elevated Oncotype DX into the algorithm for chemotherapy treatment of patients with micrometastases and one to three positive lymph nodes.

"We are pleased NCCN continues to clearly distinguish Oncotype DX from other genomic tests based on clinical evidence and the critical importance of predicting chemotherapy benefit," said Steven Shak, M.D., chief scientific and medical officer, Genomic Health. "This new strengthened NCCN guidelines, combined with the recent inclusion of Oncotype DX in international guidelines, demonstrates global support for Oncotype DX as the only ‘preferred’ test to guide optimal treatment based on its unique ability to predict chemotherapy benefit."

NCCN is an alliance of 21 world-leading cancer centers dedicated to improving the quality and effectiveness of care provided to patients with cancer. The 2018 guidelines were published online this week.

About Oncotype DX

The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX Breast Recurrence Score test, is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention. With more than 900,000 patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatement.org.

On October 9, 2018 Pfizer Inc. (NYSE:PFE) reported its executive team that will report to Albert Bourla, incoming Chief Executive Officer, coincident with the commencement of his new role effective January 1, 2019 (Press release, Pfizer, OCT 9, 2018, View Source [SID1234529943]).

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"We are at a pivotal moment in Pfizer’s history, with Ian Read having positioned the company with a strong portfolio of marketed products, a deep pipeline and the clear potential to accelerate our revenue growth,"
said Bourla. "Given this opportunity to realize this accelerated growth potential, we are creating an executive team that has a proven record of success, an unwavering commitment to the patients we serve, and a clear
value creation initiative. I look forward to working with these outstanding leaders to achieve the full potential of our pipeline and deliver our next stage of growth."

Frank D’Amelio – Chief Financial Officer and Executive Vice President, Global Supply and Business Operations, will also assume the leadership for our manufacturing operations, Pfizer Global Supply (PGS).

Mikael Dolsten – Global President, Worldwide Research and Development, and Medical, will also assume oversight of the Chief Medical Officer’s role.

Michael Goettler – Global President, Established Medicines. As previously announced Michael will lead the Established Medicines business that will operate as an autonomous, stand-alone unit within Pfizer.

Angela Hwang – Group President, Pfizer Innovative Medicines, will become the Group President of Pfizer’s science-based Innovative business responsible for the entire portfolio of innovative medicines.

Rady Johnson – Executive Vice President, Chief Compliance, Quality and Risk Officer, will continue in his role as the Company’s Chief Compliance Officer.

Doug Lankler – Executive Vice President, General Counsel, will continue in his role as the company’s General Counsel.

Freda Lewis-Hall – Executive Vice President, Chief Patient Officer, will assume a new role as Pfizer’s Chief Patient Officer, deploying the resources of the company to advocate on behalf of all patients who rely on Pfizer to deliver new therapies and vaccines.

Rod MacKenzie – Executive Vice President, Chief Development Officer, will expand his responsibilities to include Pfizer’s regulatory affairs function in addition to all late stage development activities.

Dawn Rogers – Executive Vice President, Chief Human Resources Officer, will continue to lead the Human Resources team.

Sally Susman – Executive Vice President, Chief Corporate Affairs Officer, will continue to lead the Corporate Affairs function.

John Young – Group President, Chief Business Officer, will assume a new role, responsible for strategy, business development, portfolio management and valuation activities; business analytics; global commercial operations; and Patient and Health Impact, among others. Pfizer’s Consumer Healthcare business will also report to John.

Given the growing strategic importance of deploying digital technologies in research, discovery and business processes, Pfizer is appointing a Chief Digital Officer responsible for creating and implementing a strategy that accelerates and improves our digital capabilities so we can deliver more value to patients. Lidia Fonseca will join Pfizer’s
Executive Leadership Team in January 2019, as Executive Vice President, Chief Digital and Technology Officer. She is currently the Chief Information Officer and Senior Vice President at Quest Diagnostics.
Previously, she served as SVP at Laboratory Corporation of America, Executive Vice President of Global Operations and Technology at Synarc Incorporated, and held several positions of increasing responsibility at Philips Healthcare.

Executive Vice President and President, PGS, Dr. Kirsten Lund-Jurgensen, will retire at the end of the year after 19 years at Pfizer, and Executive Vice President, Strategy & Commercial Operations, Laurie Olson, will retire effective January 1, 2019, after 32 years at Pfizer.