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

On October 8, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported it will present data on its investigational BTK inhibitor zanubrutinib and its investigational PARP inhibitor pamiparib at two upcoming medical meetings (Press release, BeiGene, OCT 8, 2018, View Source;p=irol-newsArticle&ID=2370698 [SID1234529823]).

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Zanubrutinib clinical data will be included in an oral presentation at the 10th International Workshop on Waldenström’s Macroglobulinemia (IWWM). The IWWM meeting is taking place in New York City from October 11th to 13th, 2018.

Pamiparib clinical data will be included in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, which will take place October 19th to 23rd in Munich, Germany.

IWWM Oral Presentation:

Title: Improved Depth of Response With Increased Follow-up in Phase 1 Trial of Patients with Waldenström Macroglobulinemia (WM) Treated With Oral Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib (BGB-3111)
Session ID: Session X
Location: Main Area
Date: October 12, 2018
Time: 12:45 pm ET
Presenter: Constantine Tam, M.D., Director of Hematology, St. Vincent’s Hospital and Consultant Hematologist, Peter MacCallum Cancer Center

ESMO Poster Presentation:

Title: Preliminary Results of Pamiparib (BGB-290), a PARP1/2 Inhibitor, in Combination with Temozolomide (TMZ) in Patients With Locally Advanced or Metastatic Solid Tumors
Presentation #: 421P
Session ID: Poster display session (ID 258)
Location: Hall A3 – Poster Area Networking Hub
Date: October 22, 2018
Time: 13:15 to 14:15 CEST
Presenter: Melissa Johnson, M.D., Associate Director, Lung Cancer Research Program, Sarah Cannon Research Institute
About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that is currently being evaluated in a broad pivotal clinical program globally and in China as a monotherapy and in combination with other therapies to treat various lymphomas.

About Pamiparib
Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP-DNA complex trapping in preclinical models. Discovered by BeiGene scientists in Beijing, pamiparib is currently in global clinical development as a monotherapy and in combination with other agents for a variety of solid tumor malignancies.

On October 8, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported the successful animal testing of DNA-encoded monoclonal antibodies targeting the immune checkpoint molecule CTLA-4 as published in Cancer Research (Press release, Inovio, OCT 8, 2018, View Source;Monoclonal-Antibody-dMAb-Checkpoint-Inhibitor–and-Demonstrates-Tumor-Shrinkage-in-Preclinical-Studies/default.aspx [SID1234530270]). The breakthrough preclinical study demonstrated that highly optimized dMAbs targeting mouse CTLA-4 protein can be robustly expressed in vivo, and shrank tumors in mice. More importantly, Inovio’s dMAb constructs for anti-human CTLA-4 antibodies ipilimumab (YERVOY) and tremelimumab, achieved high expression levels in mice (approximately 85µg/ml and 58µg/ml, respectively). These dMAbs exhibited long-term expression with maintenance of serum levels >15µg/ml for over a year.

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This research publication is significant because it is the first to report on the use of Inovio dMAb technology to develop novel monoclonal antibody-based therapies targeting checkpoint inhibitors. Inovio is developing additional dMAbs targeting other checkpoint molecules including PD-1. When delivered directly into the body, the genetic instructions provided from the dMAb construct enable the patient’s own cells to become the factory which manufactures the therapeutic monoclonal antibody products. Inovio has previously published several papers demonstrating its dMAb product candidate’s ability to treat multiple virus targets such as flu, dengue, chikungunya, and HIV.

Laurent Humeau, Ph.D., Inovio’s Senior Vice President, Research & Development, said, "Even though conventional monoclonal antibodies represent one of the most successful segments of the biotechnology market, accounting for over $50 billion in sales today, manufacturing complexity and repeated dosing may limit a broader use of this technology. Inovio’s dMAb products may improve upon this class using our synthetic design and in vivo production. This newly published study further support that Inovio’s potent dMAb platform can be expanded to target cancer. We plan on advancing the first clinical dMAb candidate into the first-in-human study in 2019. Moreover, we expect to form partnerships to advance several dMAb products targeting cancers and infectious diseases."

David B. Weiner, Ph.D., the paper’s senior author and the W.W. Smith Charitable Trust Professor in Cancer Research at The Wistar Institute, said, "Our work provides the first demonstration that we can use synthetic DNA technology to produce checkpoint inhibitor molecules in vivo to impact tumor growth in a preclinical setting. We showed that dMAbs may represent a valuable addition to the cancer immunotherapy toolbox: In our preclinical studies, dMAbs achieved antitumor activity comparable to that of traditional monoclonal antibodies, while being delivered through a simpler formulation that may provide a bridge to expand target populations for checkpoint inhibitors."

The study highlights that delivery of a synthetic, sequence-optimized DNA plasmid designed to encode anti-mouse CTLA-4 monoclonal antibodies, with the aid of an electroporation device to enhance uptake, resulted in significant and prolonged antibody expression with even a single dose. Importantly, this approach stimulated robust CD8+ T cell infiltration, achieving tumor clearance across multiple mouse tumor models. The researchers then went on to develop human checkpoint inhibitor molecules and demonstrated their production in mice and their ability to stimulate human T cell responses associated with antitumor activity. The study clearly demonstrates how optimized dMAbs encoding the human CPI’s ipilimumab and tremelimumab are potently expressed in vivo and enhance the activation of human effector T cells with the potential to destroy tumors. This strategy provides a novel approach to immune checkpoint therapy, with the potential to expand patient access to this breakthrough immunotherapy to treat cancer.

Funded with over $60 million in R&D support from top agencies like DARPA, NIH, and the Gates Foundation, Inovio dMAb products could extend the medical benefits that marketed monoclonal antibodies have already achieved, and even potentially address diseases that conventional monoclonal antibodies cannot.

About Inovio’s DNA-based Monoclonal Antibody Platform

Traditional monoclonal antibodies are manufactured outside the body in bioreactors, typically requiring costly large-scale manufacturing facility development and laborious production. Inovio’s disruptive dMAb technology has the potential to overcome these limitations by virtue of their simplified design, rapidity of development, product stability, ease of manufacturing and deplorability, and cost effectiveness, thereby providing potential new avenues for treating a range of diseases. Another significant advancement seen in Inovio dMAb technologies is that the optimized genes for a desired monoclonal antibody is encoded in a DNA plasmid, which is produced using very cost effective and highly scalable fermentation techniques. These plasmids are delivered directly into cells of the body using electroporation and the encoded monoclonal antibody is then directly produced by these cells. Previously published studies show that a single administration of a highly optimized DNA-based monoclonal antibody targeting HIV virus produced a high level of expression of the antibody in the bloodstream of mice; Inovio similarly reported data showing that dMAb products against flu, Ebola, chikungunya and dengue protected animals against lethal challenge. Inovio Ebola dMAb product is being developed under a grant from the Defense Advanced Research Projects Agency (DARPA).

On October 6, 2018 Veracyte, Inc. (Nasdaq: VCYT) reported that new findings from six studies reinforcing the "real world" performance of the next-generation Afirma Genomic Sequencing Classifier (GSC) and the Afirma Xpression Atlas in thyroid cancer diagnosis were presented at the 88th Annual Meeting of the American Thyroid Association (ATA) (Press release, Veracyte, OCT 6, 2018, View Source [SID1234529797]). The meeting is being held October 3-7 in Washington, D.C.

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Researchers from leading institutions presented posters showing that use of the Afirma GSC at their respective centers significantly increased the identification of benign thyroid nodules among those deemed indeterminate – not clearly benign or malignant – following cytopathology review, compared to the original Afirma test.

The Ohio State University – Researchers compared results of 113 indeterminate samples that were tested with the Afirma GSC to those of 403 samples using the earlier version of the test (the Afirma Gene Expression Classifier, or GEC). The Afirma GSC identified 74.1 percent of the nodules as benign, compared to 48.4 percent with the GEC, an increase of 53 percent. The overall surgery rate among all patients who underwent genomic testing decreased by more than half – from 42.2 percent with the GEC to 20.2 percent with the GSC.
Cleveland Clinic – Comparing results of 46 samples tested with the Afirma GSC between July 2017 and December 2017 with 182 samples tested with the original test between December 2011 and July 2017, researchers found that the GSC identified 67.4 percent as benign, compared to 41.8 percent with the GEC – an increase of 61 percent. The overall surgery rate for nodules tested with the GSC was 32.6 percent, compared to 47.3 percent with the original test, a decrease of 31 percent.
Brigham and Women’s Hospital – Researchers evaluated results for 583 thyroid nodules tested with either the Afirma GSC (n=97) or GEC (n=486) between 2011 and 2018. They found that the Afirma GSC identified 64.9 percent of nodules as benign, compared to 47.9 percent with the GEC, an increase of 35 percent.
"Our results show that with the improved testing, we sent significantly fewer patients to surgery," said Dr. Christian Nasr, medical director of the Thyroid Center in the Endocrinology & Metabolism Institute at Cleveland Clinic in Cleveland, Ohio. "Additionally, when patients went to surgery following ‘suspicious’ results, we were more likely to find cancer. Our findings suggest that the next-generation test can help more patients avoid unnecessary thyroid surgery, while focusing healthcare resources on the patients who are more likely to need them."

Additionally, in two oral presentations, researchers shared the first "real world" Afirma Xpression Atlas data, providing insights into the distribution of a wide range of gene variants and fusions across key categories of indeterminate thyroid nodules and Afirma GSC results. For example, among 13,549 indeterminate thyroid nodules evaluated using the Afirma GSC and Xpression Atlas, more than a quarter (25.9 percent) of GSC-suspicious nodules (in primary risk categories known as Bethesda III/IV) contained RAS variants. Additionally, RET, NTRK, BRAF and ALK fusions were only found in GSC-suspicious, versus GSC-benign, cases (in all Bethesda categories).

"Having detailed genomic information about thyroid nodules that are malignant or suspicious for cancer may in some cases help inform surgical decision-making for these patients," said Dr. Allan C. Golding of Memorial Healthcare System in Hollywood, Fla. "Additionally, the wide range of gene alterations detected by the Xpression Atlas may provide further insights into pathway activation and potential cancer treatment targets for patients with thyroid cancer."

The field of precision medicine is progressing rapidly, and multiple targeted therapies are in clinical trials or have been approved for treatment of advanced cancers that harbor specific genomic alterations. In the new data presented at the ATA conference, genomic changes (or alterations) targeted by these new therapies were identified in Afirma GSC-suspicious cases by the Xpression Atlas.

"The new data shared at the ATA annual meeting add to the growing library of real-world evidence demonstrating the Afirma GSC’s performance across multiple institutions in reducing unnecessary surgeries in thyroid cancer diagnosis," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "Additionally, these new study data for the Afirma Xpression Atlas demonstrate the ability of our robust RNA sequencing platform to provide rich genomic content that may help inform surgery decisions and treatment options for patients with suspected or confirmed thyroid cancer. The extensive gene alteration data that it provides becomes increasingly important in the era of targeted therapies."

For more information, please visit the Veracyte Booth #201 or www.afirma.com/ATA2018.

About Afirma

Veracyte’s Afirma solution provides a comprehensive offering in thyroid cancer diagnosis for physicians evaluating patients with thyroid nodules. The Afirma Genomic Sequencing Classifier combines RNA sequencing data with machine learning to identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to avoid unnecessary surgery and preserve the thyroid. Since the commercial introduction of Afirma in 2011, Veracyte has performed over 100,000 genomic tests, and estimates it has saved more than 40,000 patients from unnecessary thyroid surgery and removed an estimated $800 million in surgery costs from the healthcare system. The Afirma classifier is proven in over 20 published clinical studies, is included in most leading clinical guidelines and is covered as medically necessary by Medicare and all major U.S. health plans. The company’s Afirma Xpression Atlas platform, introduced in May 2018, provides extensive genomic data that may inform surgery strategy and treatment options for patients with thyroid nodules that are suspicious for cancer or cancerous. The RNA sequencing-based platform measures 761 DNA variants and 130 RNA fusions in over 500 genes shown to be associated with thyroid cancer on thyroid nodule fine needle aspiration samples.