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 17, 2019 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that Paul A. Meyers, M.D., Chief, Pediatric Sarcoma Service and Vice Chair for Clinical Affairs of Memorial Sloan Kettering Cancer Center, presented a case study of a patient with Ewing sarcoma who achieved a sustained response following treatment with Oncternal’s investigational product candidate, TK216, in an ongoing Phase 1, first-in-human clinical trial (Press release, Oncternal Therapeutics, SEP 17, 2019, View Source [SID1234539588]). The presentation entitled, "TK216 for the Treatment of Ewing Sarcoma," was given at the Fall Children’s Oncology Group (COG) Meeting.

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Dr. Meyers reported that the patient, who had a history of Ewing sarcoma with pulmonary metastases, had recurrent disease despite multiple courses of chemotherapy, radiation, bevacizumab, pazopanib and surgery. Following two cycles of TK216 therapy given as a single agent, the patient achieved a confirmed objective response, which included resolution of several pulmonary lesions. This response has been sustained and has continued at six months of treatment, with the patient receiving TK216 plus vincristine in subsequent treatment courses. The final remaining residual tumor nodule which was less than one centimeter in diameter was later surgically removed, leading to a surgical complete remission. Treatment with TK216 has been well-tolerated by this patient.

"I am encouraged that this patient has had a sustained, impressive response on the TK216 study," said Dr. Meyers. "There is a high unmet medical need for new options to treat Ewing sarcoma, which is a rare cancer that affects mostly pediatric patients and young adults and has been very challenging to treat effectively."

"We are pleased by the results reported by Dr. Meyers and look forward to examining what we believe could be a recommended dosing regimen of TK216 in a larger number of patients with Ewing sarcoma," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO.

About TK216

TK216 is an investigational, potentially first-in-class small molecule that is designed to inhibit the biological activity of E26 transformation-specific (ETS) transcription factor oncoproteins including fusion proteins. Tumorigenic gene fusions involving ETS factors are frequently found in tumors such as Ewing sarcoma and prostate cancer, and ETS factors are often overexpressed in other tumors such as prostate cancer, and acute myeloid leukemia (AML). TK216 was developed based on discoveries of Jeffrey Toretsky, M.D. and his team at Georgetown University, who found inhibitors of EWS-FLI1 using a novel chemical screening assay. In preclinical models, TK216 binds to EWS-FLI1 and blocks the interaction between ETS family members and RNA helicase A leading to tumor cell apoptosis.

About the Study

TK216 is being evaluated in a Phase 1 clinical study as a single agent and in combination with vincristine in patients with relapsed or refractory Ewing sarcoma, a rare pediatric cancer that has historically been very challenging to treat effectively, particularly for recurrent and metastatic disease. A dose-finding arm of this study is nearing completion, after which Oncternal intends to begin enrolling patients in an expansion cohort of the study to evaluate the clinical response of treatment with TK216 in combination with vincristine, an approved chemotherapy agent. This multi-center study is actively enrolling patients at six clinical trial centers across the U.S. Additional information about the TK216 study may be accessed at ClinicalTrials.gov (NCT02657005).

On September 17, 2019 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that its chief operating officer, Dr. Matthias Schroff, will give a company presentation titled, "Multitargeting Spherical Nucleic Acids: Advantages & Applications," on Wednesday, September 18, 2019 at 11:40 am GMT at the 2019 International Oligonucleotide and Peptide Conference (Press release, Exicure, SEP 17, 2019, View Source [SID1234539589]). The presentation will be made in the Caplus Room of the Ramada Plaza Hotel in Milan.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

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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