On September 18, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported multiple data presentations from its solid tumour portfolio, including key prostate cancer data, will be featured at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress, taking place 27th September to 1st October in Barcelona, Spain (Press release, Janssen Pharmaceuticals, SEP 18, 2019, View Source [SID1234539622]). Among Janssen’s 12 accepted abstracts is an oral presentation reporting overall survival from the Phase 3 SPARTAN study investigating the use of apalutamide in patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC); patient-reported outcomes from the Phase 3 TITAN study in patients with metastatic hormone-sensitive prostate cancer (mHSPC) demonstrating maintenance of overall health-related quality of life with apalutamide; and a late-breaking interim analysis from the Phase 2 GALAHAD study evaluating niraparib in the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects (DRD).

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"We are delighted to share key data from our solid tumour portfolio at this year’s ESMO (Free ESMO Whitepaper) Congress, including new findings for apalutamide and niraparib in the treatment of prostate cancer," said Dr Joaquín Casariego, Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A.. "We continue to pursue areas of oncology where there is the greatest unmet need, and the data being presented in Barcelona reflects our ongoing passion and commitment to improving patient outcomes."

Company-sponsored abstracts to be presented at the meeting include:

Abstract No.

Title

Date/Time

Apalutamide

Oral Presentation

Abstract #843O

Apalutamide and Overall Survival in Patients with Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC): Updated Results from the Phase 3 SPARTAN Study

Friday 27th September

14:00 – 14:15 CET

Poster Presentations

Abstract #851PD

Patient-Reported Outcomes (PROs) From TITAN: A Phase 3, Randomized, Double-Blind Study of Apalutamide Versus Placebo

Added to Androgen Deprivation Therapy in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Sunday 29th September

09:20 CET

Abstract #883P

Androgen Receptor Aberrations in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) Treated with Apalutamide Plus Androgen Deprivation Therapy in TITAN

Monday 30th September

12:00 – 13:00 CET

Abstract #900TiP

A Phase 2 randomized, open-label study comparing salvage radiotherapy in combination with 6 months of androgen-deprivation therapy with LHRH agonist or antagonist versus anti-androgen therapy with apalutamide in patients with biochemical progression after radical prostatectomy

Monday 30th September

12:00 – 13:00CET

Abiraterone acetate

Poster Presentation

Abstract #95P

Evaluation of markers associated with efficacy of abiraterone acetate plus prednisone in patients with castration-sensitive prostate cancer (mCSPC) from the LATITUDE study

Monday 30th September

12:00 – 13:00 CET

Niraparib

Poster Presentations

Abstract #LBA50

Pre-specified interim analysis of GALAHAD: A Phase 2 study of niraparib in patients with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects

Sunday, 29th September

08:30 CET

Abstract #897TiP

A Phase 3 randomized, placebo-controlled, double-blind study of niraparib plus abiraterone acetate and prednisone versus abiraterone acetate

and prednisone in patients with metastatic prostate cancer (NCT03748641)

Monday 30th September

12:00 – 13:00 CET

Abstract #1412P

Analytical performance of the Resolution-HRD plasma assay used to identify mCRPC patients with biallelic disruption of DNA repair genes for

treatment with niraparib

Monday 30th September

12:00 – 13:00 CET

Erdafitinib

Poster Presentations

Abstract #925P

Analysis of response to prior therapies and therapies after treatment with erdafitinib in fibroblast growth factor receptor (FGFR)-positive patients with metastatic urothelial carcinoma

Monday 30th September

12:00 CET

Abstract #926P

Erdafitinib versus available therapies in advanced urothelial cancer: A matching adjusted indirect comparison

Monday 30th September 30

12:00 CET

Abstract #932P

Hyperphosphatemia due to Erdafitinib (a Pan-FGFR Inhibitor) and Antitumor Activity Among Patients with Advanced Urothelial Carcinoma

Monday 30th September

12:00 CET

Solid Tumor Portfolio

Poster Presentation

Abstract #488P

Correlation of Progression Free Survival-2 and Overall Survival in Solid Tumors

Saturday 28th September

12:00 CET

About ERLEADA (apalutamide)

ERLEADA (apalutamide) is an androgen receptor (AR) inhibitor indicated for use in Europe for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).1 In the U.S. apalutamide is indicated for the treatment of nmCRPC.2

About ZYTIGA (abiraterone acetate)

ZYTIGA (abiraterone acetate) in combination with prednisone is indicated in Europe and the U.S. for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC).3,4

About BALVERSATM (erdafitinib)

BALVERSA (erdafitinib) is a once-daily, oral fibroblast growth factor receptor (FGFR) kinase inhibitor that is currently being studied for the treatment of patients with advanced or metastatic urothelial cancer.5 In the U.S. it is indicated for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) that has susceptible FGFR3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.6

About niraparib

Niraparib is an orally-administered selective poly ADP ribose polymerase (PARP) inhibitor that is currently being studied by Janssen for the treatment of patients with prostate cancer.7 In April 2016, Janssen entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc., for exclusive rights to niraparib in prostate cancer.8 In the U.S., niraparib is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.9 Niraparib is currently marketed by TESARO, an oncology-focused business within GSK, devoted to providing transformative therapies to people facing cancer.10

On September 18, 2019 EORTC reported will be presenting 3 abstracts (2 oral presentations and 1 poster) at the ESMO (Free ESMO Whitepaper) Congress 2019 from 27 September until 1 October in Barcelona, Spain (Press release, EORTC, SEP 18, 2019, View Source [SID1234539604]).

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Andrew Bottomley, Head of the Quality of Life at EORTC, will chair a session about "Surviving a cancer diagnosis with a good QoL" on 30 September from 8:30 to 10:00 and give a lecture on "Can value frameworks (such as ESMO (Free ESMO Whitepaper)-MCBS) contribute to a higher QoL?"

During the same session, Madeline Pe, EORTC Specialist in QoL, will talk about EORTC’s work on survivorship.

Meet us at our booth located in the society village n°20.

Oral presentations

A phase II study of Monalizumab in patients with recurrent/metastatic (RM) squamous cell carcinoma of the head and neck (SCCHN): results of the I1 cohort of the EORTC-HNCG-1559 trial (UPSTREAM)

R Galot, C Le Tourneau, E Saada-Bouzid, A Daste, C Even, P Debruyne, S Henry, S Zanetta, A Rutten, L Licitra, JL Canon, MC Kaminsky, P Specenier, S Rottey, L Dirix, T Raveloarivahy, C Fortpied, M Vanlancker, A Govaerts, JP Machiels

Presentation number: 1109O

Speaker: Rachel Galot

Date: 30.09.2019 – Lecture time: 10:15 – 11:45 – Location: Cordoba Auditorium (Hall 7)

Redefining the IGCCCG Classification in advanced Non-Seminoma

Gillessen S, Collette L, Daugaard G, De Wit R, Tryakin A, Albany C, Stahl O, Fizazi K, Gietema J, De Giorgi U, Hansen AR, Feldman D, Cafferty FH, Tandstad T, Garcia del Muro X, Huddart R, Sweeney C, Heng DY, Sauvé N and Beyer J for the IGCCCG Update Consortium

Presentation number: 903O

Speaker: Silke Gillessen

Date: 28.09.2019 – Lecture time: 15:30 – 15:45 – Location: Sevilla Auditorium (Hall 2)

Poster

There is a lack of clinical research for patients with cancer in palliative care

M. Vinches, A. Neven, L. Fenwarth, M. Terada, G. Rossi, S. Kelly, J. Peron, M. Thomaso, M. Groenvold, T. De Rojas

Poster number: 1610P

Poster presenter: Marie Vinches

Date: 28.09.2019 – Lecture time: 12:20 – Location: Poster Area (Hall 4)

On September 18, 2019 Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company, reported that it will present at the Singular Research Midwestern Values Conference on September 19, 2019 via webcast (Press release, Genprex, SEP 18, 2019, View Source [SID1234539623]).

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Genprex’s Chairman and Chief Executive Officer, Rodney Varner, will lead the company’s webcast presentation.

Genprex will present at the Singular Research Midwestern Values Conference as follows:

Date: Thursday, September 19, 2019

Time: 4:00-4:30 p.m. CDT

Webcast Link: http://bit.ly/2kpgxlu

Registration for the webcast can be completed on the Singular Research website at www.SingularResearch.com.

On September 18, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported additional analyses from three completed and ongoing clinical studies of fruquintinib and savolitinib at the 22nd Annual Meeting of the Chinese Society of Clinical Oncology ("CSCO") on September 18 to 22, 2019 in Xiamen, China (Press release, Hutchison China MediTech, SEP 18, 2019, View Source [SID1234539605]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Fruquintinib (Elunate): Two subgroup analyses will be presented from the FRESCO study, a randomized, double-blind, placebo-controlled, multi-center, Phase III study of fruquintinib efficacy and safety in third-line or above colorectal cancer ("CRC") patients.

Presentation Title 1:

Subgroup Analysis of Patients With Metastatic Colorectal Cancer Treated With Fruquintinib in the FRESCO Trial Who Had Liver Metastasis

Presenting Author:

Shukui Qin, Nanjing Chinese Medicine University Affiliated Bayi Hospital

Other Authors:

Jin Li, Rui-Hua Xu, Lin Shen, Jianming Xu, Yuxian Bai, Yanhong Deng, Lei Yang, Zhen-dong Chen, Haijun Zhong, Hongming Pan, Weijian Guo, Yongqian Shu, Ying Yuan, Jianfeng Zhou, Nong Xu, Tianshu Liu, Dong Ma, Changping Wu, Ying Cheng, Donghui Chen, Wei Li, Sanyuan Sun, Zhuang Yu, Peiguo Cao, Haihui Chen, Jiejun Wang, Shubin Wang, Hongbing Wang, Xia Qin, Ning Wang, Bin Zhang, Songhua Fan, Xiaojun Guo, Mengye Peng

Abstract #:

5278

Session:

Plenary session

Date:

Thursday, September 19, 2019

Time:

10:45 AM

The development of metastases is the main cause of death in patients with CRC, and about 70% of patients with CRC develop liver metastases during the course of their disease1,2. Abstract 5278 is a subgroup analysis to determine the benefit of fruquintinib to patients with liver metastases on study entry. Liver metastases were present in 69% of the patients recruited into the study.

Fruquintinib demonstrated a statistically significant increase in overall survival ("OS"; 8.61 vs. 5.98 months; hazard ratio = 0.59, 95% CI: 0.45-0.77, p<0.001) and progression-free survival ("PFS"; 3.71 vs 1.84 months; hazard ratio = 0.22, 95% CI: 0.17-0.30, p<0.001) as compared with placebo in CRC patients with liver metastasis, while the hepatotoxicity of fruquintinib was comparable with placebo in CRC patients with liver metastasis.

1 van de Velde CJH. Treatment of liver metastases of colorectal cancer. Annals of Oncology, Volume 16 (Supplement 2): ii144 – ii149, June 2005. doi:10.1093/annonc/mdi702.

2 Welch JP & Donaldson GA. The clinical correlation of an autopsy study of recurrent colorectal cancer. Annals of Surgery, 189(4), 496–502, 1979. doi:10.1097/00000658-197904000-00027.

Presentation Title 2:

Association Between Hand-Foot Skin Reaction and Survival Benefit of Fruquintinib in FRESCO Trial

Presenting Author:

Yuxian Bai, Harbin Medical University Cancer Hospital

Other Authors:

Jin Li, Shukui Qin, Yanhong Deng, Lei Yang, Rui-hua Xu, Zhendong Chen, Haijun Zhong, Hongming Pan, Weijian Guo, Yongqian Shu, Ying Yuan, Jianming Xu, Lin Shen, Ning Wang, Chao Zhu, Songhua Fan, Wei Gong, Wei Wang

Abstract #:

5517

Session:

CSCO CRC Expert Committee, CRC standardized treatment and MDT

Date:

Saturday, September 21, 2019

Time:

11:17 AM

Abstract 5517 is a subgroup analysis of the FRESCO results to explore whether patients in the fruquintinib group of the study experiencing hand-foot skin reaction ("HFSR") saw a greater survival benefit. These reactions of any grade developed in 52% of patients who completed at least one cycle of fruquintinib treatment.

The analysis indicated that patients who reported HFSR had a greater survival benefit from fruquintinib, showing statistically significant benefit in both median OS (11.24 vs. 7.54 months; hazard ratio = 0.57, 95% CI: 0.42-0.78; p<0.001) and median PFS (5.49 vs 3.48 months; hazard ratio = 0.70, 95% CI: 0.54-0.91; p=0.008) compared to those that did not report HFSR.

Results of the FRESCO study were initially presented in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 5, 2017 and published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).

Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor ("VEGFR") 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor-related angiogenesis, cutting off the blood supply that a tumor needs to grow rapidly. Fruquintinib has been designed to be a global best-in-class VEGFR inhibitor for many types of solid tumors. It was designed to improve kinase selectivity in comparison to other approved small molecule tyrosine kinase inhibitors, to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. Chi-Med retains all rights to fruquintinib outside of China and is partnered with Eli Lilly and Company in China.

Savolitinib:

Presentation Title:

Phase II Study of Savolitinib in Patients with NSCLC Harboring MET Exon 14 Skipping Mutations: Preliminary Efficacy and Safety Results

Presenting Author:

Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University

Other Authors:

Jian Fang, Xingya Li, Jianying Zhou, Lejie Cao, Ying Cheng, Liyan Jiang, Qisen Guo, Zongan Liang, Yuan Chen, Helong Zhang, Nong Yang, Hua Xu, Xin Zhang, Biao Wu, Jianhua Shi, Zhigang Han, Jianjin Huang, Zhixiong Yang, Xiaodong Zhang, Gongyan Chen, Yanping Hu, Jingxun Wu, Shan Zeng, Sanyuan Sun, Longzhen Zhang, Rui Ma, Xiaorong Dong, Di Zhang, Jing Li, Linfang Wang, Yongxin Ren, Weiguo Su

Abstract #:

5707

Session:

CSCO NSCLC Expert Committee, SCLC Expert Committee, MDT for liver cancer with ALK and other rare mutations

Date:

Friday, September 20, 2019

Time:

4:40 PM

Abstract 5707 highlights updated preliminary efficacy and safety results from the ongoing China Phase II study of savolitinib monotherapy in NSCLC patients with mesenchymal epithelial transition receptor ("MET") Exon 14 skipping mutations who have failed prior systemic therapy or are unable to receive chemotherapy.

Savolitinib showed promising antitumor activity in this population with rapid and durable tumor response and disease control, anti-tumor activity in brain metastasis, and a generally tolerable safety profile with mostly grade 1 or 2 related treatment emergent adverse events. The study continues to enroll patients. Earlier results of this study were first presented on March 31, 2019 at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 (clinicaltrials.gov identifier: NCT02897479).

Savolitinib is a potent and selective inhibitor of MET, an enzyme which has been shown to function abnormally in many types of solid tumors. In clinical studies to date in over 1,000 patients globally, savolitinib has shown promising signs of clinical efficacy in patients with MET gene alterations in lung cancer, kidney cancer, and gastric cancer with an acceptable safety profile. Chi-Med is currently testing savolitinib in global partnership with AstraZeneca, both as a monotherapy and in combinations.

On September 18, 2019 Biodesix, Inc. reported findings from multiple studies demonstrating the significance and clinical utility of its VeriStrat blood-based proteomic test as a predictive biomarker for patient survival outcomes and as a diagnostic tool to improve the clinical management of patients with non-small cell lung cancer (NSCLC) (Press release, Biodesix, SEP 18, 2019, View Source [SID1234539624]). This information is vital to implementing optimal treatment strategies for patients and supports disease state monitoring. To date, VeriStrat testing has helped more than 50,000 patients in determining the best treatment for their lung cancer.

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Biomarker Identification for Immunotherapy

Data from a clinical study that examined the impact of VeriStrat testing on patients receiving immune checkpoint inhibitors (ICIs) as part of their NSCLC treatment strategy, showed that the VeriStrat MS-based proteomic signature has potential as a biomarker for survival outcomes in NSCLC patients receiving immunotherapy. Among NSCLC patients treated with ICIs, VeriStrat-Good classification was associated with significantly increased PFS in comparison to VeriStrat-Poor classification (median PFS of 6.2 vs. 3.0 months, p=0.012), while the differences in OS trended towards significance (median OS, not reached vs. 16.5 months p=0.076). These results were presented by Northwestern University Feinberg School of Medicine Professor Young Kwang Chae, MD, MPH, MBA at the International Association for the Study of Lung Cancer (IASLC) 2019 World Conference on Lung Cancer.

"As an oncologist, my goal is to identify the treatment course that will give each of my patients the best possible outcome," Dr. Chae stated. "By using VeriStrat, I am able to get a more complete clinical picture of my patient’s state of health, which allows me to work with that individual to determine the path forward that is best for them."

Improved Clinical Management of Advanced NSCLC Patients Unsuited for Chemotherapy

A recent University College London (UCL) study published in the European Journal of Cancer found that the VeriStrat test improved prognosis accuracy for patients with advanced NSCLC who were considered to be unsuitable candidates for chemotherapy. NSCLC accounts for 80-85 percent of all lung cancers and many patients are not diagnosed until their cancer has advanced to a late stage. Siow Ming Lee, PhD, UCL Professor of Medical Oncology and Chief Investigator of the TOPICAL trial, reported a strong correlation between the results of the VeriStrat test and patient outcomes. This VeriStrat correlation held even when the patients were split into the good and poor ECOG performance status subgroups; VeriStrat Good versus VeriStrat Poor in ECOG 0-1; HR 0.25, p=0.006 and ECOG 2-3; HR 0.60, p=0.002.

"The relationship between the VeriStrat test and survival is a major finding within this patient population, who have generally poor health and are difficult to treat," Dr. Lee commented. "The VeriStrat test seems to distinguish patients who have a shorter or longer survival. This has never been reported before in this particular patient group."

The VeriStrat test is a multivariate, mass-spectrometry based test that measures circulating proteins in the blood serum or plasma of patients with NSCLC. Test results assign a good (VS Good) or poor (VS Poor) classification to patient samples. Multiple studies support that patients with a VS Good result have a better prognosis than patients with a VS Poor result, independent of current clinical prognostic indicators and treatment choice. VeriStrat testing has been validated in more than 85 studies with more than 6,600 patients and is covered by Medicare and many private health insurers.

"VeriStrat blood testing continues to help guide treatment decisions as evidenced through these studies and many others," said Scott Hutton, Biodesix COO. "The potential for VeriStrat continues to expand as studies demonstrate relevancy in lung cancer with the latest therapies in development."

Veristrat is part of the Biodesix Lung Reflex Strategy (BLR), which integrates the GeneStrat genomic test. The BLR strategy has been widely adopted across oncology clinics due primarily to its ability to provide a more comprehensive understanding of patients’ health. Through a series of case studies, physicians detail the value offered through GeneStrat and VeriStrat testing, highlighting their ability to optimize treatment strategies, and to inform conversations on prognoses and treatment options with patients.