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.

On October 2nd, 2018 Fierce Biotech disclosed the 15 selected companies for the Fierce 15 Award. This prestigious award has come to symbolize novelty and being at the forefront of biotechnology development among privately held businesses. The winners of this award are aiming at breakthroughs and big things, not at being ‘me-too’.

Since 2010 1stOncology has included the Fierce 15 award in a set of attractive benchmarking parameters to identify and analyze the pipeline of movers and shakers in cancer drug development. Year after year oncology keeps coming back as a dominating therapeutic area among the Fierce 15 awardees and 2018 is no different!
In fact, no less than eleven out of the fifteen 2018 Fierce 15 companies are active in cancer drug development. Three of the companies, Beam Therapeutics, Gossamer Bio and Quentis Therapeutics were all founded in 2018, with another three companies formed in 2017, see table below. Compass Therapeutics is this year oldest recipient founded in 2013.

Fierce pointed to the fact that this years winners have been notable in their success in already raising serious funding. In total they have raised $1.36 billion in funding rounds and capital commitments with four over $100 million and most others between $40 million and $60 million. Notable too was that all eleven of the oncology companies were based out of the US, whereas in previous years the field has been more global.

Our 1stOncology clients can review detailed pipeline analysis of each these Fierce 15 companies via our special analyst report available in the platform. For all others, we are happy to offer a free online demo here, so you can see the actionable information that 1stOncology provides.

List of Oncology Associated Companies Among this Year Recipients of the Fierce 15 Award:

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On October 8, 2018 Eli Lilly and Company (NYSE: LLY) reported that it will present new data from its clinical development program at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in Munich, Germany, October 19-23 (Press release, Eli Lilly, OCT 8, 2018, View Source [SID1234529809]). Data presented showcase how Lilly is taking a global, patient-centric research approach to drive advances in cancer care. Data include presentations on abemaciclib, pemetrexed and ramucirumab, as well as investigational compound pegilodecakin – used as a single agent and in combination with chemotherapy and with checkpoint inhibitor therapy – across multiple tumor types. Pegilodecakin joined the Lilly Oncology pipeline with the company’s acquisition of ARMO BioSciences earlier this year.

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Key abemaciclib data include findings from the Phase 3 MONARCH 2 trial evaluating abemaciclib plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Additionally, results will be presented from Lilly’s ongoing immuno-oncology clinical collaboration with Merck (known as MSD outside the U.S. and Canada) on the KEYNOTE-189 trial evaluating pemetrexed plus platinum chemotherapy in combination with pembrolizumab in the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC). Ramucirumab data include Phase 3 findings from several patient populations with aggressive disease such as the REACH-2 study of ramucirumab as a single agent in the second-line treatment of people with hepatocellular carcinoma (HCC), also known as liver cancer, and the RANGE study evaluating ramucirumab in combination with docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy. Pegilodecakin data include new results from an early-phase study in patients with renal cell, non-small cell lung, pancreatic, ovarian and breast cancers.

"The breadth and depth of our data being presented at ESMO (Free ESMO Whitepaper) underscores this year’s congress theme of ‘securing access to optimal cancer care’ by demonstrating how we are working to develop innovative new medicines that will make a difference to patients and doctors," said Maura Dickler, M.D., vice president, late phase development, Lilly Oncology. "We’re also excited to share data for the first time from our promising next generation clinical immunotherapy asset pegilodecakin, which examines its potential in several tumor types in combination with existing treatments and as a monotherapy. We are encouraged by the results and look forward to further investigating pegilodecakin in a wide range of settings."

Select studies, along with the dates, times and locations of their data sessions, are highlighted below.

Abemaciclib

Abstract #329P: Abemaciclib with fulvestrant in patients with HR+, HER2- advanced breast cancer (ABC) that exhibited primary or secondary resistance to prior endocrine therapy (ET)

Monday, October 22; 12:45-1:45 p.m. CEST; Exhibit Hall A3
Abstract #339P: Management of abemaciclib associated adverse events in patients with hormone receptor positive (HR+), HER2- advanced breast cancer: analysis of the MONARCH trials

Monday, October 22; 12:45-1:45 p.m. CEST; Exhibit Hall A3
Pegilodecakin

Abstract #1130O: Responses and Durability of Clinical Benefit in Renal Cell Carcinoma Treated with Pegilodecakin in Combination with Anti-PD-1 Inhibitors

Monday, October 22; 12:18-12:30 p.m. CEST; Exhibit Hall A2 ­– Room 18
Abstract #1145P: Responses and Durability of Cinical Benefit in Triple Negative Breast Cancer Patients Treated With Pegilodecakin Monotherapy or in Combination With Platinum Plus Taxane-Based Chemotherapy

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Abstract #1144P: Responses and Durability of Clinical Benefit in Non-Small Cell Lung Cancer Treated with Pegilodecakin in Combination With Anti-PD-1 Inhibitors

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Abstract #1143P: Responses and Durability of Clinical Benefit in Pancreatic Ductal Adenocarcinoma (PDAC) Patients Treated With Pegilodecakin (AM0010) in Combination With 5-FU/LV and Oxaliplatin (FOLFOX)

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Abstract #1146P: Durability of Clinical Benefit in Metastatic Epithelial Ovarian Cancer Patients Treated With Pegilodecakin Monotherapy or in Combination With Platinum Plus Taxane-Based Chemotherapy

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Abstract #1180P: Combination of Pegilodecakin and Docetaxel Shows Synergy in Tumor Rejection in Immune Resistant TNBC model

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Pemetrexed

Abstract #1464P: KEYNOTE-189 study of pembrolizumab (pembro) plus pemetrexed (pem) and platinum vs placebo plus pem and platinum for untreated, metastatic, nonsquamous NSCLC: does choice of platinum affect outcomes?

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Abstract #1381PD: Gefitinib With or Without Pemetrexed in Nonsquamous (NS) Non-Small Cell Lung Cancer (NSCLC) With EGFR Mutation (mut): Final Overall Survival (OS) Results From a Randomized Phase II Study

Friday, October 19; 2:00-4:00 p.m. CEST; ICM – Room 14b
Ramucirumab

Abstract #622PD: Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated alpha-fetoprotein (AFP) following first-line sorafenib: patient reported outcome results across two phase 3 studies (REACH-2 and REACH)

Friday, October 19; 3:45-5:25 p.m. CEST; ICM – Exhibit Hall B3 – Room 21
Abstract #708P: Relationship between change in α-fetoprotein (AFP) and patient (pt) survival in hepatocellular carcinoma (HCC): a real-world electronic medical records (EMR) database study

Sunday, October 21; 12:45-1:45 p.m. CEST; Exhibit Hall A3
Abstract #865PD: RANGE, a phase 3, randomized, placebo-controlled, double-blind trial of ramucirumab (RAM) and docetaxel (DOC) in platinum-refractory urothelial carcinoma (UC): overall survival results

Saturday, October 20; 2:45-4:05 p.m. CEST; ICM – Room 1
Abstract #616PD: Quality-of-life (QoL) results from RAINFALL: A randomized, double-blind, placebo (PL)-controlled phase 3 study of cisplatin (Cis) plus capecitabine (Cape) or 5FU with or without ramucirumab (RAM) as first-line therapy for metastatic gastric or gastroesophageal junction (G-GEJ) cancer

Friday, October 19; 3:45-5:30 p.m. CEST; Exhibit Hall B3 – Room 21

On October 8, 2018 Adaptimmune Therapeutics plc ("Adaptimmune") (Nasdaq: ADAP), a leader in T-cell therapy to treat cancer, reported further details about two poster presentations at the upcoming ESMO (Free ESMO Whitepaper) congress, as follows (Press release, Adaptimmune, OCT 8, 2018, View Source;p=RssLanding&cat=news&id=2370701 [SID1234530171]):

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MAGE-A10 poster for discussion presentation details:

A late-breaking abstract with data from the two ongoing MAGE-A10 studies ("triple tumor" and lung) was accepted for poster discussion, with the full abstract and data to be made available at the time of presentation.
Title: Safety and Anti-Tumor Effects of MAGE-A10c796TCR T-cells in Two Clinical Trials (Poster #LBA38)
Poster discussion session: Immuno 1 in ICM room 14b
Time: Saturday, October 20 from 16:45 to 17:45 CEST (10:45 to 11:45 EDT)
MAGE-A4 poster presentation details:

The full abstract for the MAGE-A4 poster is now available online (https://bit.ly/2NMBC3d) and is summarized below
Title: Initial Safety Assessment of MAGE-A4 SPEAR T-cells (Poster #1156P)
Poster display session (ID 259): Immunotherapy of cancer in Hall A3 poster networking Hub
Time: Saturday, October 20 from 12:30 to 13:30 CEST (06:30 to 07:30 EDT)
Brief summary of abstract (data cut-off 25 April 2018):
Background:

Ongoing study (NCT03132922) to evaluate safety and tolerability of SPEAR T-cells directed towards a MAGE-A4 peptide expressed on tumors in the context of HLA-A*02
Methods:

Modified 3+3 design
Patients have inoperable or metastatic (advanced) non-small cell lung cancer (NSCLC), urothelial ("bladder"), melanoma, synovial sarcoma, myxoid/round cell liposarcoma (MRCLS), head & neck, ovarian, gastric, or esophageal cancers expressing MAGE-A4
Lymphodepletion regimen:
Cohorts 1, 2: [fludarabine (Flu) 30 mg/m2/day and cyclophosphamide (Cy) 600 mg/m2/day] x 3 days
Cohort 3: [Flu 30 mg/m2/day] x 4 days + [Cy 600 mg/m2/day] x 3 days
Expansion Cohort: [Flu 30 mg/m2/day] x 4 days + [Cy 600 mg/m2/day] x 3 days
Dose:
Cohort 1: target 100 million (M) transduced cells; range 80 to 120 M transduced cells
Cohort 2: target 1 billion (B) transduced cells; range 0.5 to 1.2 B transduced cells
Cohort 3: target 5 B transduced cells; range 1.2 to 6.2 B transduced cells
Expansion Cohort: target 5 B transduced cells; range 1.2 to 10 B transduced cells
Results:

Three patients were treated with 100 M MAGE-A4 SPEAR T-cells, and transduced cells were detectable in peripheral blood
Adverse events (AEs) for the first 2 patients reported at grade (G) ≥3 included anemia, hypoglycemia, hyponatremia, lymphopenia, neutropenia, and thrombocytopenia
Serious AEs included G4 hyponatremia, G3 atrial fibrillation, G3 syncope (unrelated to T-cell therapy), G1 CRS and G2 encephalopathy syndrome (both related), and G2 generalized muscle weakness (possibly related)
None of the events were considered dose limiting toxicities (DLTs) by the Safety Review Committee
Conclusions:

MAGE-A4 SPEAR T-cells at the 100 M transduced cell dose appear to show no evidence of on‑target or off-target toxicity
Preliminary data support continued investigation of the T-cell receptor (TCR), and this trial is ongoing