On May 17, 2017 Halozyme Therapeutics (NASDAQ: HALO) reported that results from a Phase 2 randomized, multi-center clinical trial in pancreas cancer patients of its targeted investigational therapy, PEGPH20, will be presented in an oral presentation on June 4 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual conference (Press release, Halozyme, MAY 17, 2017, View Source [SID1234519199]).

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Principal Investigator Sunil R. Hingorani, M.D., Ph.D., a pancreas cancer expert at Fred Hutchinson Cancer Research Center and professor at University of Washington School of Medicine will present the HALO-202 results, which include the study meeting its primary and key secondary endpoints.

"The HALO-202 data confirm for the first time in a randomized Phase 2 trial using the current standard of care that a biopsy-based biomarker for hyaluronan content can potentially identify patients who will have a meaningfully greater response when PEGPH20 is added to their treatment," said Dr. Hingorani. "The analysis suggests statistically significant and clinically important progress in this very difficult to treat cancer. The median PFS is a notable increase over the current standard of care and supports ongoing exploration in the current Phase 3 study."

The study demonstrated that PEGPH20 plus standard chemotherapy of ABRAXANE (nab-paclitaxel) and gemcitabine improved median progression-free survival (mPFS) by 77 percent over chemotherapy alone in stage IV pancreas cancer patients with high levels of hyaluronan (HA-High). Halozyme is currently enrolling HA-High patients in a global Phase 3 clinical trial.

In a subanalysis of patients who received uninterrupted therapy with PEGPH20 plus chemotherapy (Stage 2 patients), a 91 percent improvement in mPFS and a 4-month benefit in overall survival were observed.

Dr. Helen Torley, president and chief executive officer of Halozyme said, "The results in the HA-High patient cohort are particularly encouraging given that we are using this biomarker and recruiting this specific patient population in our ongoing global Phase 3 study, HALO-301. We believe that HALO-301 is the first targeted or biomarker driven Phase 3 study to date in this highly lethal cancer type."

Pancreas cancer is the third-leading cause of cancer related death in the United States, and more than 65,000 people in the U.S. and top five European countries are diagnosed annually with advanced cases of the disease.

About HALO-301 and HALO-202
HALO-301 is a phase 3 global, randomized, double-blind placebo controlled clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer. The trial will be conducted at approximately 200 sites with two primary endpoints, progression free survival and overall survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and ABRAXANE (nab-paclitaxel) compared to gemcitabine and nab-paclitaxel alone. Secondary endpoints also include objective response rate and overall survival. More information may be found at clinicaltrials.gov (search HALO 301 or trial identifier NCT02715804) or www.HALO301.com.

HALO-202 (Halo 109-202) is a phase 2 multi-center, randomized clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer. The primary outcome of the trial is to measure improvement in progression-free survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel alone. A second primary endpoint assesses the thromboembolic event rate in the PEGPH20 treatment arm. Secondary endpoints also include objective response rate and overall survival.

About PEGPH20
PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan. PEGPH20 is an enzyme that temporarily degrades HA, a dense component of the tumor microenvironment that can accumulate in higher concentrations around certain cancer cells, potentially constricting blood vessels and impeding the access of other therapies.

FDA granted orphan drug designation to PEGPH20 for treatment of pancreas cancer and fast track designation for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreas cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreas cancer.

On May 17, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that study investigators will present larotrectinib (LOXO-101) interim clinical data across the RECIST-evaluable TRK fusion clinical trial database from all three ongoing clinical trials in a late breaking oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting being held on June 2 – 6, 2017 in Chicago, IL (Press release, Loxo Oncology, MAY 17, 2017, View Source [SID1234519197]). This presentation was also selected for inclusion in the ASCO (Free ASCO Whitepaper) Press Program. In addition, the larotrectinib interim pediatric Phase I clinical data will be highlighted in a separate oral presentation.

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The schedule for the presentations is as follows:

Late Breaking Presentation Date & Time: Saturday, June, 3, 2017, 1:15 – 4:15PM CT
Title: The efficacy of larotrectinib (LOXO-101), a selective tropomyosin receptor kinase (TRK) inhibitor, in adult and pediatric TRK fusion cancers.
Abstract Number: LBA2501
Session Title: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Location: E450ab
Presenter: David Michael Hyman, M.D.

Presentation Date & Time: Monday, June, 5, 2017, 8:00 – 11:00AM CT
Title: A pediatric phase I study of larotrectinib, a highly selective inhibitor of the tropomyosin receptor kinase (TRK) family.
Abstract Number: 10510
Session Title: Pediatric Oncology II
Location: S504
Presenter: Theodore Willis Laetsch, M.D.

Conference Call and Webcast Information
Loxo Oncology will host a conference call and live webcast with slides and Q&A on Sunday, June 4, 2017 at 5:30PM CT to discuss the larotrectinib data presented at ASCO (Free ASCO Whitepaper). To participate in the conference call, please dial (877) 930-8065 or (253) 336-8041 and refer to 14447513. 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 90 days following the call.

About Larotrectinib (LOXO-101)
Larotrectinib (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, larotrectinib has demonstrated encouraging preliminary efficacy. Larotrectinib is also being evaluated in the NAVIGATE global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions, and the SCOUT Phase 1/2 trial in pediatric patients, including patients with advanced cancer, TRK gene fusions and infantile fibrosarcoma. Larotrectinib has been granted Breakthrough Therapy Designation and Rare Pediatric Disease Designation by the U.S. FDA. For additional information about the larotrectinib 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 or visit www.loxooncologytrials.com.

On May 17, 2017 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") reported an update regarding the Company’s diverse oncology portfolio, including the acceptance of a wide selection of abstracts across a broad range of cancers for oral or poster presentation at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 2-6 in Chicago (Press release, Astellas, MAY 17, 2017, View Source [SID1234519195]).

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Astellas is presenting a record number of abstracts at ASCO (Free ASCO Whitepaper), including data for gilteritinib in acute myeloid leukemia, enfortumab vedotin in urothelial cancer, and IMAB362 from the recently acquired Ganymed. A number of XTANDI (enzalutamide) abstracts accepted for presentation also speak to the comprehensive clinical trial program in metastatic CRPC and other prostate cancer populations. In just over a decade, Astellas has built a leadership position and substantial Oncology pipeline through a thoughtful blend of investments in organic R&D, strategic business development and strong collaborative partnerships with some of the most renowned institutions around the world.

"We are thrilled to announce our largest presence to date at this year’s ASCO (Free ASCO Whitepaper) meeting," said Steven Benner, M.D., senior vice president and global therapeutic area head, oncology development, Astellas. "We believe these data reflect significant progress in our pursuit to create innovative treatment options for some of the most difficult-to-treat cancers and further underscore our ongoing commitment to becoming a world-class oncology company focusing on patients with cancer."

Additionally, the Company announced today the joint decision with Pfizer to discontinue the planned ENDEAR trial (A Phase III, Randomized, International Study Comparing the Efficacy and Safety of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer); no patients were ever enrolled in the trial. The companies have also decided that based on the enzalutamide data from the Phase 2 HER2+ and ER/PR+ breast cancer studies, there will not be follow-on Phase 3 studies at this time.

About XTANDI (enzalutamide) capsules
XTANDI (enzalutamide) is an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. In preclinical studies, enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors, and inhibit androgen receptor nuclear translocation and interaction with DNA. The clinical significance of this mechanism of action (MOA) is unknown.

XTANDI is approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). Enzalutamide is not approved for use in patients with breast cancer.

On May 17, 2017 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the fields of cancer metabolism and rare genetic diseases, reported that new data from its isocitrate dehydrogenase (IDH) programs will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 2-6, 2017 in Chicago (Press release, Agios Pharmaceuticals, MAY 17, 2017, View Source [SID1234519194]).

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In total, three abstracts led by Agios describing new data from the company’s IDH programs have been accepted for presentation at ASCO (Free ASCO Whitepaper), as well as two abstracts led by Celgene. IDHIFA (enasidenib) is being developed in collaboration with Celgene.

The accepted abstracts are listed below and are available online on the ASCO (Free ASCO Whitepaper) conference website: View Source

Oral presentation by Agios and Celgene:

Title: Enasidenib in mutant-IDH2 relapsed or refractory acute myeloid leukemia (R/R AML): Results of a phase 1 dose-escalation and expansion study
Date & Time: Tuesday, June 6, 2017 from 10:57-11:09 a.m. CT
Oral Abstract Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: 7004
Location: E450ab
Presenter: Eytan Stein, M.D., Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College
This abstract has been selected as part of the "Best of ASCO (Free ASCO Whitepaper)" program to be presented in cities across the country. "Best of ASCO (Free ASCO Whitepaper)" features the top abstracts, highlighting the most cutting-edge science and education from the annual meeting.

Poster discussions and poster presentations by Agios and/or Celgene:

Title: Phase 1 study of AG-120, an IDH1 mutant enzyme inhibitor: results from the cholangiocarcinoma dose escalation and expansion cohorts
Poster Session Date & Time: Saturday, June 3, 2017 from 8:00-11:30 a.m. CT
Poster Discussion Date & Time: Saturday, June 3, 2017 from 5:21-5:33 p.m. CT
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Abstract: 4015
Poster Board: 7
Poster Location: Hall A
Poster Discussion Location: Hall D2
Presenter: Maeve Aine Lowery, M.D., Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College

Title: Differentiation syndrome associated with enasidenib, a selective inhibitor of mutant isocitrate dehydrogenase 2 (mIDH2)
Poster Session Date & Time: Monday, June 5, 2017 from 8:00-11:30 a.m. CT
Poster Discussion Date & Time: Monday, June 5, 2017 from 12:06-12:18 p.m. CT
Poster Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract: 7015
Poster Board: 215
Poster Location: Hall A
Poster Discussion Location: E354b
Presenter: Amir Tahmasb Fathi, M.D., Massachusetts General Hospital and Harvard Medical School

Title: Pharmacokinetic/pharmacodynamic (PK/PD) profile of AG-120 in patients with IDH1-mutant cholangiocarcinoma from a phase 1 study of advanced solid tumors
Date & Time: Saturday, June 3, 2017 from 8:00-11:30 a.m. CT
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Abstract: 4082
Poster Board: 74
Location: Hall A
Author: Bin Fan, Ph.D., Agios Pharmaceuticals

Title: ClarIDHy: A phase 3, multicenter, randomized, double-blind study of AG-120 vs placebo in patients with an advanced cholangiocarcinoma with an IDH1 mutation
Date & Time: Saturday, June 3, 2017 from 8:00-11:30 a.m. CT
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Abstract: TPS4142
Poster Board: 128b
Location: Hall A
Author: Maeve Aine Lowery, M.D., Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College

On May 17, 2017 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported the release of an abstract on its drug candidate PB272 (neratinib) that will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held June 2–6, 2017, in Chicago (Press release, Puma Biotechnology, MAY 17, 2017, View Source [SID1234519193]). Abstracts are available to the public online on the ASCO (Free ASCO Whitepaper) website: www.abstract.asco.org.

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Abstract #1005, TBCRC 022: Phase II trial of neratinib + capecitabine for patients (Pts) with human epidermal growth factor receptor 2 (HER2+) breast cancer brain metastases (BCBM).

The abstract will be presented as an Oral Abstract Session: Breast Cancer–Metastatic; Saturday, June 3, 1:15–4:15 p.m. CDT, Hall D1.