YONSA (abiraterone acetate) In Metastatic Castration-Resistant Prostate Cancer

MedicalResearch.com Interview with:

https://www.churchillpharma.com/

Paul Nemeth, Ph.D.
Sr. Vice President, Regulatory Affairs, Clinical Development & Quality Assurance
Churchill Pharmaceuticals LLC
King of Prussia, PA 19406


MedicalResearch.com: What is the background for this study?

Response: In the STAAR study, 53 patients with metastatic castration-resistant prostate cancer (mCRPC) were randomized to receive YONSA, an abiraterone acetate fine particle formulation 500 mg once daily in combination with 4 mg of methylpresnisolone twice daily or 1,000 mg daily of the originator abiraterone acetate (OAA) in combination with 5 mg of prednisone twice daily for a period of 84 days.  Previous studies in healthy volunteers under fasted conditions had shown that single oral doses of 500 mg of YONSA are bioequivalent to single oral doses of 1,000 mg OAA and that a background of 4 mg of methylprednisolone twice daily on a single oral dose of 500 mg of YONSA results in the same extent of absorption as a background of 5 mg of prednisone twice daily on a single oral dose of 1,000 mg of OAA.  Continue reading

Combination Axitinib + Pembrolizumab Active Against Renal Cell Carcinoma

MedicalResearch.com Interview with:

Prof. Michael B. Atkins, MD Deputy Director, Georgetown-Lombardi Comprehensive Cancer Center William M. Scholl Professor and Vice-Chair Department of Oncology and  Professor of Medicine Georgetown University Medical Cente

Prof. Atkins

Prof. Michael B. Atkins, MD
Deputy Director, Georgetown-Lombardi Comprehensive Cancer Center
William M. Scholl Professor and Vice-Chair Department of Oncology and
Professor of Medicine
Georgetown University Medical Center 

MedicalResearch.com: What is the background for this study?

Response: Prior studies combining programmed death-1 (PD-1) checkpoint inhibitors with tyrosine kinase inhibitors of the vascular endothelial growth factor (VEGF)-pathway have been characterized by excess toxicity precluding further development. We hypothesized that axitinib, a more selective VEGF inhibitor would combine safely with pembrolizumab (anti-PD-1) and yield antitumour activity in treatment-naïve patients with advanced renal cell carcinoma.

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Liquid Biopsy Results for Cancer Mutations May Differ – Study Compares Idylla platform vs to OncoBEAM RAS CRC assay

MedicalResearch.com Interview with:

Dr. Ana Vivancos, Principal Investigator Cancer Genomics Group Vall d'Hebron Institute of Oncology (VHIO Barcelona 

Dr. Ana Vivancos

Dr. Ana Vivancos PhD, Principal Investigator
Cancer Genomics Group
Vall d’Hebron Institute of Oncology (VHIO
Barcelona 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Our study was designed to address a key issue in liquid biopsy testing: analytical sensitivity. We know that mutations in plasma of mCRC patients show a wide range in their allelic frequencies (0.01-90%), the biological basis for which remains unclear. We also know that around 35% of cases show very low mutant allele fractions (MAFs), < 1%, therefore highlighting the need of using high sensitivity techniques in the routine lab in order to properly detect mutations.

We have compared two different testing methods that are being used in liquid biopsy:

Digital PCR (OncoBEAM RAS test, BEAMing) with a limit of detection of 0.02% vs qPCR (Idylla ctKRAS test, Biocartis) with an analytical sensitivity of 1%.

Our findings indicate that detection sensitivity decreases for the qPCR based method in cases with low MAF (<1%) and more so when MAF values are very low (<0.01%).

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BEACON Triplet Therapy for BRAF Mutant Metastatic Colorectal Cancer Shows Promise

MedicalResearch.com Interview with:

Scott Kopetz, M.D., Ph.D., FACP Associate Professor Department of Gastrointestinal Medical Oncology Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston, TX

Dr. Kopetz

Scott Kopetz, M.D., Ph.D., FACP
Associate Professor Department of Gastrointestinal Medical Oncology
Division of Cancer Medicine
The University of Texas MD Anderson Cancer Center
Houston, TX

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The BRAF mutation carries a very poor prognosis for patients with advanced colo-rectal cancer (CRC), and is particularly unresponsive after first-line therapy, so additional treatment options for these patients are needed. While treatment with a BRAF inhibitor alone has not been effective in treating this disease, combination therapies have shown promise and lead to the initiation of the BEACON study. The safety lead-in phase of the BEACON CRC trial was designed to assess the safety and tolerability of encorafenib, binimetinib  and cetuximab triplet combination prior to the Phase 3 randomized portion of the study. Thirty patients were treated in the safety lead-in and received the triplet combination (encorafenib 300 mg daily, binimetinib 45 mg twice daily, and cetuximab per label). Out of the 30 patients, 29 had a BRAFV600E mutation. Microsatellite instability-high (MSI-H) (resulting from defective DNA mismatch repair) was detected in only 1 patient. The triplet demonstrated good tolerability, supporting initiation of the randomized portion of the study. In addition, promising initial clinical activity was observed.

In patients with the BRAFV600E mutation, the estimated median progression-free survival (mPFS) at the time of analysis was 8 months. The confirmed overall response rate (ORR) in patients with the BRAFV600E mutation was 48%, and 3 patients achieved complete responses (CR). Further, the ORR was 62% in the 16 patients (10/16) who received only one prior line of therapy.

Additionally, the triplet combination was generally well-tolerated. Two patients discontinued treatment due to AEs with only one of these considered related to treatment. The most common grade 3 or 4 AEs seen in at least 10% of patients were fatigue (4/30), urinary tract infection (3/30), increased aspartate aminotransferase (AST; 3/30) and increased blood creatine kinase (CK; 3/30).

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Regional Variation in Chemotherapy Prescriptions For Metastatic Prostate Cancer

MedicalResearch.com Interview with:

Megan Elizabeth Veresh Caram MD Clinical Lecturer Internal Medicine, Hematology & Oncology University of Michigan

Dr. Caram

Megan Elizabeth Veresh Caram MD
Clinical Lecturer
Internal Medicine, Hematology & Oncology
University of Michigan

 

MedicalResearch.com: What is the background for this study?

Response: Abiraterone and enzalutamide are oral medications that were approved by the Food & Drug Administration in 2011 and 2012 to treat men with metastatic castration-resistant prostate cancer. Most men with advanced prostate cancer are over age 65 and thus eligible for Medicare Part D. We conducted a study to better understand the early dissemination of these drugs across the United States using national Medicare Part D and Dartmouth Atlas data.

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Using a Spacer During Prostate Radiation May Help Preserve Sexual Function

MedicalResearch.com Interview with:

Daniel A. Hamstra, MD PhD The Texas Center for Proton Therapy Irving, TX

Dr. Hamstra

Daniel A. Hamstra, MD PhD
Radiation Oncologist
Beaumont Hospital
Dearborn Michigan

MedicalResearch.com: What is the background for the The SpaceOAR phase 3 trial study and the hydrogel spacer?

Response: External beam radiation therapy is commonly used to treat men with prostate cancer. As part of this treatment, side effects can occur involving bowel, urinary, and sexual symptoms.

This study was performed to test if an absorbable hydrogel placed between the prostate and rectum (using a simple outpatient procedure) could move the rectum away from the prostate and thus result in sparing of the rectum and decreased bowel toxicity. The study randomized 222 men and the three-year data were just published (The International Journal of Radiation Oncology Biology and Physics). With three years of follow-up, we saw that the spacer did improve the radiation plans and decreased both rectal toxicity and urinary toxicity.

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Losing Some Weight May Reduce Risk of Endometrial Cancer

MedicalResearch.com Interview with:

Juhua Luo, PhD Associate professor of epidemiology and biostatistics Indiana University School of Public Health

Dr. Juhua Luo

Juhua Luo, PhD
Associate professor of epidemiology and biostatistics
Indiana University School of Public Health

MedicalResearch.com: What is the background for this study?

Response: We already know obesity increases risk of endometrial cancer. However, information on whether weight loss reduces risk of endometrial cancer is limited.

MedicalResearch.com: What are the main findings?

Response: Women losing 5% or more weight reduced risk of getting endometrial cancer by 29%. This was observed for any weight loss but risk was even lower for obese women with intentional weight loss. Obese women intentionally losing their weights by 5% or more reduced risk of getting endometrial cancer by 56%.

MedicalResearch.com: What should readers take away from your report?

Response: Among post-menopausal women, intentional weight loss reduces risk of getting endometrial cancer, especially for obese women. Our findings suggest that weight loss in postmenopausal women may not be too late for potential health benefit.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Additional research on intentional weight loss in relation to risk for other obesity-related cancer types and for mortality from cancer or other diseases are needed.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Intentional Weight Loss and Endometrial Cancer Risk

Juhua LuoRowan T. ChlebowskiMichael HendryxThomas RohanJean Wactawski-WendeJ, Cynthia A. ThomsonAshley S. FelixChu Chen, …

JCO Jan 2017

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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Physical Activity Linked to Improved Survival from Metastatic Colon Cancer

MedicalResearch.com Interview with:

Brendan John Guercio, M.D. Clinical Fellow in Medicine (EXT) Brigham and Women's Hospital

Dr. Brendan Guercio

Brendan John Guercio, M.D.
Clinical Fellow in Medicine (EXT)
Brigham and Women’s Hospital

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Sedentary lifestyle is a known risk factor for the development of colon cancer and has been associated with increased disease recurrence and mortality in patients with early stage colorectal cancer. This is the first study to our knowledge to show an association between increased physical activity (i.e. non-sedentary lifestyle) and improved survival and progression-free survival in patients with metastatic colorectal cancer.

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Genetic Determinants of Cisplatin Resistance in Patients With Advanced Germ Cell Tumors

MedicalResearch.com Interview with:

Darren R. Feldman, MD Medical Oncologist Memorial Sloan Kettering Cancer Center

Dr. Darren Feldman

Darren R. Feldman, MD
Medical Oncologist
Memorial Sloan Kettering Cancer Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There is limited knowledge as to why a minority of patients with advanced germ cell tumors are resistant to chemotherapy while the majority achieve complete responses. Patients with cisplatin-resistant disease require intensive salvage treatment and are at high risk of dying from their disease. We sought to determine whether certain genomic alterations within tumors might be associated with cisplatin-resistance in GCT. We also wanted to identify the spectrum of genomic alterations in this population which might represent novel targets for existing or new drug development in this disease.

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Nivolumab Has Potential Activity Against Platinum Resistant Ovarian Cancer

Junzo Hamanishi M.D., Ph.D. Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine Assistant Professor Kyoto Japan

Dr. Hamanishi

MedicalResearch.com Interview with:
Junzo Hamanishi  M.D., Ph.D.
Department of Gynecology and Obstetrics,
Kyoto University Graduate School of Medicine
Assistant Professor
Kyoto Japan

Medical Research: What is the background for this study?

Dr. Hamanishi: More than 70% of patients with advanced ovarian cancer who achieve remission ultimately relapse and there are few effective treatments for these patients. Because the development of new treatment strategies for these patients is urgently required, we have focused on and studied the potential of cancer cells to escape from host immunity with PD-1/PD-L1 immunosuppressive signal in the tumor microenvironment to find new treatment strategies to overcome this phenomenon, collaborating with Professor Honjo who discovered PD-1 since 2006. Therefore, we conducted a phase II clinical trial in 20 platinum-resistant, recurrent ovarian cancer patients to evaluate the safety and anti-tumor efficacy of anti-PD-1 antibody (nivolumab) with 2 cohort at a dose of 1 or 3 mg/kg (constituting two 10-patient cohorts).

Medical Research: What are the main findings?

Dr. Hamanishi: This study is the first investigator-initiated phase II clinical trial testing the safety and efficacy of nivolumab against platinum-resistant ovarian cancer. In the 20 patients in whom responses could be evaluated, the best overall response was 15%, including two patients with a durable complete response (3mg/kg cohort). The disease control rate in all 20 patients was 45%. The median progression-free survival was 3.5 months, with a median overall survival of 20.0 months. Especially in the 3 mg/kg cohort, two patients achieved a complete response, and disease stabilized in another two patients. The objective response rate in 3mg/kg cohort cohort was 20% and disease was controlled in 40% of the higher-dose group. In the four patients who demonstrated an antitumor response, responses were durable and evident. Grade 3 or 4 treatment-related adverse events (AE) occurred in eight out of 20 patients or 40% overall. However, the frequency of AEs were not different in 2 cohorts.

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