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Astellas (ALPMY) To Present New Data For Enzalutamide And IMAB362 At 2017 European Society Of Medical Oncology (ESMO) Annual Meeting



8/31/2017 7:39:30 AM

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NORTHBROOK, Ill., Aug. 31, 2017 /PRNewswire/ -- Astellas announced today that a wide selection of abstracts highlighting the Company's diverse oncology portfolio across a broad range of cancers will be presented at the 2017 European Society of Medical Oncology (ESMO) Annual Congress, September 8-12 in Madrid, Spain.

Astellas is a pharmaceutical company dedicated to improving the health of people around the world. (PRNewsFoto/Astellas Pharma Inc.)

Key highlights from the Astellas Oncology portfolio include new analysis of  enzalutamide data in men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) and preclinical and clinical data for IMAB362, a compound from the recently acquired Ganymed,  in gastric and pancreatic cancer.

"We continue to investigate new agents in our broad oncology portfolio targeting cancers where unmet medical needs remain the most profound," said Steven Benner, M.D., senior vice president and global therapeutic area head, oncology development, Astellas. "We believe these data will continue to enhance the scientific knowledge of both our investigational agents and on-market therapies across our growing oncology portfolio."

The following data will be shared during several poster presentations:

Title: Prognostic Associations of Prostate-Specific Antigen (PSA) Decline With Survival, Radiographic Response and Progression in Chemotherapy-Naïve Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated With Enzalutamide

Lead Author:Andrew Armstrong

  • Session Date/Time: Saturday, September 10, 9:15 -10:15 a.m. UTC
  • Location: Bilbao Auditorium

Enzalutamide is jointly developed by Astellas and Pfizer.

Title:First-in-Human Study of IMAB362, an Anti-Claudin 18.2 Monoclonal Antibody, in Patients with Advanced Gastroesophageal Cancer

Lead Author: Ugur Sahin

  • Session Date/Time: Saturday, September 9, 13:15 -14:15 p.m. UTC
  • Location: Hall 8

Title:Phase 1 Study of IMAB362 with Immunomodulation in Patients with Advanced Gastric Cancer

Lead Author: Salah-Eddin Al-Bratran.

  • Session Date/Time: Saturday, September 9, 13:15 -14:15 p.m. UTC
  • Location: Hall 8

Title:Preclinical Characterization of IMAB362 for the Treatment of Gastric Carcinoma

Lead Author: Rita Mittnacht-Kraus

  • Session Date/Time: Monday, September 11, 13:15 -14:15 p.m. UTC
  • Location: Hall 8

Title:Preclinical Evaluation of the Anti-CLDN18.2 Antibody, IMAB362, in Pancreatic Carcinoma

Lead Author:Corina Heinz

  • Session Date/Time: Monday, September 11, 13:15 -14:15 p.m. UTC
  • Location: Hall 8

Title:Preclinical Characterization of IMAB362-vcMMAE, an Anti-CLDN18.2 AntibodyDrug Conjugate

Lead Author:Maria M. Kreuzberg

  • Session Date/Time: Monday, September 11, 13:15 -14:15 p.m. UTC
  • Location: Hall 8

The safety and efficacy of the investigational agent IMAB362 are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval and become commercially available for the uses being investigated. Information about pharmaceutical products (including products currently in development) which is included in this press release are not intended to constitute an advertisement or medical advice.

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. Additional ongoing studies, such as the ARCHES trial in metastatic hormone-sensitive prostate cancer and the EMBARK trial in non-metastatic hormone-sensitive prostate cancer, are continuing to the potential of enzalutamide to help patients in need.

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 a study of patients with predisposing factors, seizures were reported in 2.2% of patients. See section 5.1 of the Prescribing Information for the list of predisposing factors. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. 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 placebo-controlled 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 the 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 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 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 for additional safety information.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatchor 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.

 

 

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SOURCE Astellas


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