1stOncology™: Cancer Intelligence Service – Page 15983 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

PharmaMar to Present New Studies for YONDELIS® and PM1183 in Ovarian Cancer during ESGO 2015

On October 26th, 2015 PharmaMar reported that for the next few days, thousands of oncology experts in gynecologic cancers are gathering during the 19th Biennial Meeting of the European Society of Gynecological Oncology (ESGO 2015), which is taken place from October 24-27, 2015 in Nice, France. ESGO is the European leading organization that aims to advance gynecologic cancer care and is strongly committed to help women in Europe with this disease. This forum is an excellent opportunity for clinicians, researchers, patient associations and drug developers to learn about the most exciting developments in the field of gynecologic cancers, which include ovarian, cervical, uterine, vaginal and vulvar cancers.

Schedule your 30 min Free 1stOncology Demo!
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

Schedule Your 30 min Free Demo!

The initial standard treatment for ovarian cancer implies a platinum-based combination therapy. However, after recurrence, leading oncologists in the field recommend evaluating patients on a case-by-case basis to identify the best therapeutic option for each patient. In this scenario, platinum-free therapies keep gaining traction among clinicians.

"Making the most of every option in the treatment of ovarian cancer. Choosing the optimal sequency" is the title of the satellite symposium organized by PharmaMar, which gathered more than 600 oncologists, during ESGO 2015 to bring together
national and international oncologists and discuss the different aspects that need to be considered from a clinical standpoint to treat women with recurrent ovarian cancer. Among the most crucial topics to be discussed are the best approaches to
manage and overcome platinum hypersensitivity and the clinical benefit of platinum-free therapies after recurrence.

One of the participants, Nicoletta Colombo, MD, European Oncology Institute, University of Milan-Bicocca, Milan, has pointed how certain platinum sensitive tumors can also respond to other therapies and said "among the benefits of switching from a platinum-based therapy to a non-platinum treatment you can find two important aspects of the management of these patients; the probable recovery from neurotoxicity that is associated to platinum, and the potential to reduce and even prevent the hipersensitivity often found during treatment of these women with platinum".

When a patient is partially sensitive to platinum, that is the patient relapses within 6 to 12 months after treatment with platinum, among the recommended therapeutic options, oncologists and the most recent ESMO (Free ESMO Whitepaper) Clinical Practice Guidelines suggest a treatment combining YONDELIS (trabectedin) with pegylated liposomal doxorubicin followed by a platinum-based therapy. Dr. Colombo explained that with this sequential treatment, an overall survival of 6 months and a 41 percent reduction in the risk of death can be obtained. Also, the treated patient can recover from the toxicity caused by platinum-based therapiesi". The hypothesis to explain the benefit of this sequential treatment is that such approach could enhance the sensitivity of the tumor to a next platinum therapy, thus increasing the survival of the patient.

Studies highlighted at ESGO 2015
PharmaMar introduces several posters to show clinical data about the treatment combining YONDELIS with PLD in different patient profiles.

YONDELIS (trabectedin)

 Complete response to trabectedin in combination with pegylated liposomal doxorubicin (PLD) in heavily pre-treated BRCA-2 mutated platinum-sensitive intermediate epithelial ovarian cancer (EOC)
Poster: Saturday 24th, October, e-poster station
Lead author: P. Biondani, Hôpital Tenon 4 Rue de la chine 75020 Paris

 BRCA mutated ovarian cancer complete remission following second line treatment with trabectedin and lposomal Adriamycin
Poster: Saturday 24th, October, e-poster station
Lead author: Dr. Raffaella Bracci, Clinica di Oncologia Medica
Centro Regionale Genetica Oncologica, Azienda Ospedaliero-Universitaria
Ospedali Riuniti, Italy

 Extending the platinum-free interval (PFI) with trabectedin plus pegylated liposomal doxorubicin (PLD) in a patient with partially
platinum-sensitive (PPS) recurrent ovarian cancer (ROC)
Poster: Saturday 24th, October, e-poster station
Lead autor: Dr.ssa Sara Giovannoni, U.O.C.Oncologia B, Policlinico Umberto
I Roma

 Long-lasting complete response with trabectedin plus pegylated liposomal doxorubicin (PLD) in a young BRCA-mutated woman with platinum-sensitive relapsed ovarian cancer (ROC): a case report
Poster: Saturday 24th, October, e-poster station
Lead autor: Dr.ssa Sara Giovannoni, U.O.C.Oncologia B, Policlinico Umberto
I Roma

 Prolonged treatment with trabectin plus pegylated liposomal doxorubicin (PLD) combination in a heavily pretreated patient with
metastatic relapsed ovarian cancer (ROC)
Poster: Saturday 24th, October, e-poster station
Lead author: Dr Pierre Guillet, Centre Hospitalier Sainte Musse, Toulon

 Trabectedin in combination with pegylated liposomal doxorubicin to treat heavily-treated patient with relapsed ovarian cancer
Poster: Saturday 24th, October, e-poster station
Lead author: Professor Dr Saad Tahir. Broomfield Hospital. Chelmsford

 Trabectedin in monoteraphy, a therapeutic option
Poster: Saturday 24th, October, e-poster station
Lead autor: Dr S. Rego, Hospital da Arrábida, Portugal

 METASTATIC OVARIAN CANCER – CHRONIC DISEASE?
Poster: Saturday 24th, October, e-poster station
Lead autor: Dr S. Rego, Hospital da Arrábida, Portugal

 Multicenter retrospective study to analyze the effectiveness and safety of trabectedin (T) + PLD in recurrent ovarian cancer (ROC)
patients according to SMPC. GEICO-1402r study
Poster: Saturday 24th, October, e-poster station
Lead author: Dr L. Vidal, Hospital Universitari Clinic de Barcelona

 Trabectedin in advanced gynaecological carcinosarcomas – a single institution series (abstract #57)
Poster: Sunday 25th, October, poster area (endometrial cancer)
Laed author: Dr. J. Gounaris, Department of Oncology, Addenbrooke´s
Hospital, Cambridge, UK

PM1183 (lurbinectedina)
The Company also shows another poster about PM1183, a novel transcription inhibitor and DNA repair, to treat relapsed platinum-sensitive ovarian cancer

 LURBINECTEDIN (PM01183) EFFICACY IN PLATINUMRESISTANT/REFRACTORY OVARIAN CANCER (PRROC) PATIENTS CORRELATES WITH DRUG EXPOSURE USING
PHARMACOKINETIC/PHARMACODYNAMIC (PK/PD) MODELLING
(abstract #157)
Poster: Monday 26th, October, poster area
Lead author: C. Fernandez-Teruel

Loxo Oncology Announces Broad Pipeline Update at AACR-NCI-EORTC, Including New LOXO-101 Phase 1 Data

On October 26, 2015 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that it will present clinical and preclinical data from its pipeline of targeted, investigational oncology medicines at the 27th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics taking place in Boston on November 5-9, 2015 (Press release, Loxo Oncology, OCT 26, 2015, View Source [SID:1234507794]). New results from the Phase 1 study of Loxo Oncology’s tropomyosin receptor kinase (TRK) inhibitor, LOXO-101, will be reported in a late-breaking oral presentation. This presentation was selected for inclusion in the press program, and as a result, only the abstract title will appear in the October 26, 2015 online data release. The study data will remain embargoed until November 8, 2015 at 10:30 a.m. Eastern Time.

Loxo Oncology will also present two preclinical posters containing the first publicly disclosed data for its Rearranged during Transfection (RET) and Fibroblast Growth Factor Receptor (FGFR) programs. The posters will include in vitro and in vivo data on chemistry series showing potential best-in-class selectivity and target coverage profiles for these exciting emerging targets. Like TRK, RET and FGFR are known to participate in gene fusion events, and thus, activate cancers as single-gene alterations. In addition, RET and FGFR are also known to harbor activating gene mutations which are also likely to confer drug sensitivity. Loxo Oncology plans to use genetically driven patient enrollment strategies to demonstrate proof of efficacy early in clinical development for the RET and FGFR programs.

Loxo Oncology recently announced enrollment of the first patient in its Phase 2 basket trial of LOXO-101. A basket trial is a new clinical trial design that enrolls patients based on a common, defining genetic feature of their cancer rather than based on an anatomic definition. General information about basket trial designs will be discussed in a plenary presentation on November 8, 2015 at 8:50 a.m. Eastern Time in the Veterans Memorial Auditorium by David Hyman, M.D. of Memorial Sloan Kettering Cancer Center, LOXO-101 global principal investigator.

The details of the LOXO-101 oral presentation is as follows:

Press Program Date & Time: November 8, 2015, 10:30 a.m. Eastern Time
Oral Presentation Date & Time: November 8, 2015, 3:45 p.m. to 4:25 p.m. Eastern Time
Title: Clinical Safety and Activity from a Phase 1 Study of LOXO-101, a Selective TRKA/B/C Inhibitor, in Solid Tumor Patients with NTRK Gene Fusions
Session: Spotlight on Proffered Papers Session 3
Presenter: David Hong, M.D., deputy chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
Location: Veteran’s Memorial Auditorium

The details of the Loxo Oncology poster presentations are as follows:

Poster Session Data & Time: November 7, 2015, 12:30 p.m. to 3:30 p.m. Eastern Time
Title: Identification and Characterization of Highly Potent and Selective Kinase Inhibitors for the Treatment of RET-Driven Cancers
Session: Poster Session B, Therapeutic Agents: Small Molecule Kinase Inhibitors
Abstract Number: B192
Location: Exhibit Hall C-D

Poster Session Date & Time: November 8, 2015, 12:30 p.m. to 3:30 p.m. Eastern Time
Title: Identification of First-in-Class, Highly Potent FGFR Kinase Inhibitors that Spare FGFR1
Session: Poster Session C, Therapeutic Agents: Small Molecule Kinase Inhibitors
Abstract Number: C196
Location: Exhibit Hall C-D

Conference Call and Webcast Information

Loxo Oncology will host a conference call, live webcast with slides and Q&A on Monday, November 9, 2015 at 8:00 a.m. Eastern Time to discuss the LOXO-101 data and pipeline program updates. To participate in the conference call, please dial (877) 930-8065 (domestic) or (253) 336-8041 (international) and refer to conference ID 66690460. A live webcast of the presentation will be available at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the company’s website for 30 days following the call.

About LOXO-101

LOXO-101 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, LOXO-101 has demonstrated encouraging preliminary efficacy. LOXO-101 is also being evaluated in a global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions. For additional information about both the LOXO-101 clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123.

Data to be Presented on CYC065, Cyclacel’s CDK2/9 Inhibitor, at AACR-NCI-EORTC International Conference

On October 26, 2015 Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company"), reported an upcoming presentation of preclinical data from a study with the Company’s second generation cyclin dependent kinase (CDK) 2/9 inhibitor, CYC065, at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), November 5-9, 2015, in Boston (Press release, Cyclacel, OCT 26, 2015, View Source [SID:1234507793]).

The study evaluated the molecular rationale and dosing schedule of CYC065 for targeting tumors that are either dependent on sustained expression of CDK9 transcription targets, including Mcl-1 and MYC, or on activation of CDK2 by overexpression of cyclin E.

Details of the presentation are as follows:

Abstract Number: B182
Presentation Title: Molecular Basis for Clinical Development of the Novel CDK2/9 Inhibitor CYC065 in Oncology
Presentation Time: Saturday, November 7, 2015, 12:30 PM – 3:30 PM
Location: Exhibit Hall C-D
Poster Board Number: Poster Session B
Authors: Craig MacKay, Sheelagh Frame, Chiara Saladino, Elizabeth Pohler, Daniella Zheleva, David Blake. Cyclacel Ltd, Dundee, United Kingdom

The abstract can be accessed through the conference website, View Source

BIND Therapeutics’ Presentations at Upcoming AACR-NCI-EORTC Conference Reinforce Potential of Accurin Platform to Develop Best-in-Class Therapeutics

On October 26, 2015 BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called Accurins, reported that four abstracts have been accepted for presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held in Boston, November 5-9, 2015 (Press release, BIND Therapeutics, OCT 26, 2015, View Source [SID:1234507792]). The abstracts were published today on the AACR (Free AACR Whitepaper) website at www.AACR.org.

"These posters highlight compelling data across multiple payloads and therapeutic pathways that reinforce what we believe is a powerful platform with the potential to create best-in-class therapeutics," said Andrew Hirsch, president and chief executive officer at BIND. "These data add to a growing body of evidence that further validate the ability of our Accurins to control the biodistribution of therapeutic payloads to target diseased cells while limiting exposure to healthy tissues and minimizing on-target but off-tissue toxicities. We are committed to creating innovative medicines, both through internal discovery and collaborations with leading biopharmaceutical companies, that fully leverage the benefits of our proprietary nanomedicine platform."

The posters will include preclinical and clinical pharmacokinetic data from BIND’s clinical stage Accurin compound, BIND-014, data from BIND’s preclinical stage Accurin, BIND-510, and new data from a previously unannounced feasibility study with Merck, demonstrating the potential value of an Accurin formulation of Merck’s proprietary AKT inhibitor, MK-2206.

Poster presentations at AACR (Free AACR Whitepaper) include the following:

BIND-014

1. Poster title: Cardiovascular safety profile of BIND-014 (docetaxel nanoparticles for injectable suspension) evaluated in phase 1 and 2 studies (Abstract/poster board #A161)

Date/time: November 6, 2015; 12:15 – 3:15 pm ET
Poster session category: Therapeutic Agents: Other
Location: Poster Session A; Exhibit hall C-D
2. Poster title: Evaluation of total and encapsulated drug pharmacokinetics for BIND-014 (docetaxel nanoparticles for injectable suspension) in a phase 1 study (Abstract/poster board #B144)

Date/time: November 7, 2015; 12:30 – 3:30 pm ET
Poster session category: Pharmacokinetics and Pharmacodynamics
Location: Poster Session B; Exhibit hall C-D
BIND-510

1. Poster Title: BIND-510 improves the pharmacokinetics, tolerability, tumor accumulation and tumor growth inhibition in preclinical models of cancer compared to vincristine sulfate (Abstract/poster board #C184)

Date/time: November 8, 2015; 12:30 – 3:15 pm ET
Poster session category: Therapeutic Agents: Other
Location: Poster Session C; Exhibit Hall C-D
MK-2206 Accurin

1. Poster Title: Accurins improve the pharmacokinetics, pharmacodynamics, tolerability and anti-tumor activity of the AKT inhibitor MK-2206 (Abstract/poster board #C197)

Collaborator: Merck
Date/time: November 8, 2015; 12:30 – 3:30 pm ET
Poster session category: Therapeutic Agents: Small Molecule Kinase Inhibitors
Location: Poster Session C

Agios to Present Clinical Data from Ongoing AG-120 Phase 1 Trial in Advanced Solid Tumors at AACR-NCI-EORTC

On October 26, 2015 Agios Pharmaceuticals (NASDAQ:AGIO), a leader in the fields of cancer metabolism and rare genetic metabolic disorders, reported that the first results from the Phase 1 study of AG-120 in patients with IDH1-mutant positive advanced solid tumors will be presented in an oral presentation and featured in the press program at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) taking place November 5-9, 2015, in Boston (Press release, Agios Pharmaceuticals, OCT 26, 2015, View Source;p=RssLanding&cat=news&id=2102387 [SID:1234507791]).

"We look forward to sharing the first clinical data for AG-120 in patients with advanced solid tumors as we continue to understand the potential of this investigational medicine," said Chris Bowden M.D., chief medical officer at Agios. "This is an important step toward our long-term vision of making a difference for people with a broad range of hematologic and solid tumor cancers that harbor IDH mutations."

Title: The First Reported Results of AG-120, a First-in-class, Potent Inhibitor of the IDH1 Mutant Protein, in a Phase 1 Study of Patients with Advanced IDH1-Mutant Solid Tumors, Including Gliomas

Plenary Session Date & Time: Sunday, November 8, 2015, at 8:00 a.m. ET

Session: Advances in Targeted Therapy

Press Program Date & Time: Sunday, November 8, 2015, at 10:30 a.m. ET

Presenter: Howard A. Burris, III, M.D., Sarah Cannon Cancer Center, Nashville, Tennessee

Location: Hynes Convention Center

Investor Lunch and Webcast Information

Agios will host an investor lunch on Sunday, November 8, 2015 in Boston to review data presented at the conference, additional event details to come. The event will be webcast live and can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.agios.com. A replay of the webcast will be archived on the Agios website for approximately 30 days following the presentation.