Astellas Announces Record Number of Abstracts Highlighting Breadth and Depth of Oncology Portfolio Data to be Presented at 2017 ASCO Annual Meeting

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May 17, 2017, 20:01 ET

NORTHBROOK, Ill., May 17, 2017 /PRNewswire/ -- Astellas announced today that a wide selection of abstracts highlighting the Company's diverse oncology portfolio across a broad range of cancers have been accepted for oral or poster presentation at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, June 2-6 in Chicago.

The number of high-profile abstracts selected for presentation at ASCO, including new data for gilteritinib in acute myeloid leukemia and IMAB362 from the recently acquired Ganymed, is a record for the company. 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 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 enabling patients with cancer to focus on living."

The following data will be shared during oral presentations:

Title: (Abstract 5004) A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study of Continued Enzalutamide Post Prostate-Specific Antigen Progression in Men with Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer.

Presenter: Gerhardt Attard, MD, PhD

Session Date/Time: Saturday, June 3, 2:27-2:39 p.m. CDT
Location: Hall B1

Title: (Abstract 106) A Phase 1 Study of Enfortumab Vedotin (ASG-22CE; ASG-22ME): Updated Analysis of Patients with Metastatic Urothelial Cancer.

Presenter: Daniel Peter Petrylak

Session Date/Time: Monday, June 5, 10:00-10:11 a.m. CDT
Location: Hall D1

Title: (Abstract 7003) Deep Molecular Response to Gilteritinib Improves Survival in FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia.

Presenter: Jessica K. Altman, MD

Session Date/Time: Tuesday, June 6, 10:45-10:57 a.m. CDT
Location: E450ab

Additionally, the following data will be shared during poster presentations:

Title: (Abstract 4028) Expression of Claudin 18.2 and HER2 in Gastric, Gastroesophageal Junction, and Esophageal Cancers: Results from the FAST Study.

Presenter: Martin H. Schuler, MD

Session Date/Time: Saturday, June 3, 8:00-11:30 a.m. CDT
Location: Hall A

Title: (Abstract 9037) Tolerability and Antitumor Activity of ASP8273 in TKI-Naïve Japanese Subjects with EGFR Mutation Positive Non-Small Cell Lung Cancer.

Presenter: Shunichi Sugawara, MD, PhD

Session Date/Time: Saturday, June 3, 8:00-11:30 a.m. CDT
Location: Hall A

Title: (Abstract 1089) Overall Survival in Patients with Diagnostic Positive Breast Cancer: Subgroup Analysis from a Phase 2 Study of Enzalutamide, an Androgen Receptor (AR) Inhibitor, in AR+ Triple-negative Breast Cancer Treated with 0-1 Prior Lines of Therapy.

Presenter: Tiffany A. Traina, MD

Session Date/Time: Sunday, June 4, 8:00-11:30 a.m. CDT
Location: Hall A

Title: (Abstract TPS7068) A Phase 2/3, Multicenter, Open-Label, 3-Arm Study of Gilteritinib, Gilteritinib Plus Azacitidine, or Azacitidine Alone in the Treatment of Newly Diagnosed FLT3 Mutation-Positive Acute Myeloid Leukemia Patients Ineligible for Intensive Induction Chemotherapy.

Presenter: Jorge E. Cortes, MD

Session Date/Time: Monday, June 5, 8:00-11:30 a.m. CDT
Location: Hall A

Title: (Abstract TPS7067) An Open-Label, Randomized Phase 3 Study of Gilteritinib versus Salvage Chemotherapy in Relapsed or Refractory FLT3 Mutation-Positive Acute Myeloid Leukemia

Presenter: Alexander E. Perl, MD

Session Date/Time: Monday, June 5, 8:00-11:30 a.m. CDT
Location: Hall A

Title: (Abstract TPS5097) A Randomized Study of Enzalutamide in Patients with Localized Prostate Cancer Undergoing Active Surveillance (ENACT).

Presenter: Neal D. Shore

Session Date/Time: Monday, June 5, 1:15-4:45 p.m. CDT
Location: Hall A

Title: (Abstract 5022) Development and Validation of a Prognostic Model for Overall Survival in Chemotherapy-Naïve Men with Metastatic Castration-Resistant Prostate Cancer from the Phase 3 PREVAIL Clinical Trial.

Presenter: Andrew J. Armstrong, MD, MSc

Session Date/Time: Monday, June 5, 1:15-4:45 p.m. CDT
Location: Hall A

Enzalutamide is jointly developed by Astellas and Pfizer. Enfortumab vedotin is jointly developed by Astellas and Seattle Genetics.

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.

Important Safety Information

Contraindications
XTANDI is not indicated for women. XTANDI can cause fetal harm and potential loss of pregnancy.

Warnings and Precautions
Seizure occurred in 0.5% of patients receiving XTANDI in clinical studies. In placebo-controlled studies, 8 of 1671 (0.5%) patients treated with XTANDI and 1 of 1243 (0.1%) patients treated with placebo experienced a seizure. In patients who previously received docetaxel, 7 of 800 (0.9%) patients treated with XTANDI experienced a seizure and no patients treated with placebo experienced a seizure. In a placebo-controlled study in chemotherapy-naïve patients, 1 of 871 (0.1%) treated with XTANDI and 1 of 844 (0.1%) patients treated with placebo experienced a seizure. In bicalutamide-controlled studies conducted in chemotherapy-naïve patients, 3 of 380 (0.8%) patients treated with XTANDI and 1 of 387 (0.3%) patients treated with bicalutamide experienced a seizure. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES)
In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Adverse Reactions
The most common adverse reactions (≥ 10%) that occurred more commonly (≥ 2% over placebo) in the XTANDI patients from the two placebo-controlled clinical trials were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo. In the bicalutamide-controlled study of chemotherapy naïve patients, the most common adverse reactions (≥ 10%) reported in XTANDI patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, upper respiratory tract infection, diarrhea, and weight loss.

In the study of patients taking XTANDI who previously received docetaxel, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In the placebo-controlled study of chemotherapy-naïve patients, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups. In the bicalutamide-controlled study of chemotherapy naïve patients, Grade 3-4 adverse reactions were reported in 38.8% of XTANDI patients and 37.6% of bicalutamide patients.

Discontinuations due to adverse events were reported for 7.6% of XTANDI patients and 6.3% of bicalutamide patients.

Lab Abnormalities: In the two placebo-controlled trials Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). Grade 1-4 thrombocytopenia occurred in 6% of XTANDI patients (0.3% Grade 3-4) and 5% of placebo patients (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of XTANDI patients (0.2% Grade 3-4) and 16% of placebo patients (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients (0.1% Grade 3-4) and 2% of placebo patients (no Grade 3-4).

Infections: In a study of patients taking XTANDI who previously received docetaxel, 1% of XTANDI patients compared to 0.3% of placebo patients died from infections or sepsis. In the placebo-controlled study of chemotherapy-naïve patients, 1 patient in each treatment group (0.1%) had an infection resulting in death.

Falls (including fall-related injuries) occurred in 9% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients, and included non-pathologic fractures, joint injuries, and hematomas.

Hypertension occurred in 11% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of all patients in each arm.

Drug Interactions
Effect of Other Drugs on XTANDI
Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI.

Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If co-administration is necessary, increase the dose of XTANDI.

Effect of XTANDI on Other Drugs
Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.

Please see Full Prescribing Information at for additional safety information.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About Astellas
Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information on Astellas, please visit our website at www.astellas.us. You can also follow us on Twitter at @AstellasUS, Facebook at www.facebook.com/AstellasUS or LinkedIn at www.linkedin.com/company/astellas-pharma.

SOURCE Astellas Pharma Inc.