Montefiore News Releases

Studies Reveal Benefits of Immunotherapy for Prostate Cancer and Assess Its Safety and Efficacy for Neuroendocrine Tumors, Squamous Cell Carcinoma and Advanced Solid Tumors

NEW YORK (June 1, 2016) – Investigators from the Montefiore Einstein Center for Cancer Care (MECCC) and the NCI-designated Albert Einstein Cancer Center (AECC) in New York, will present several abstracts at the 52^nd Annual Meeting of the American Society of Clinical Oncology (ASCO). Presentations evaluate biomarkers for neuroendocrine therapies, reveal benefits of an immunotherapy for African American men with prostate cancer, speak to phase II trial results of a combined modality therapy for squamous cell carcinoma of the anal canal, and evaluate therapies for patients with advanced solid tumors. ASCO is being held June 3 – June 7 in Chicago.

Edward M. Wolin M.D., a leading authority on neuroendocrine tumors (NET), which arise from certain cells of the endocrine system, co-authored five ASCO abstracts on NET. Neuroendocrine cancer is one of the most rapidly increasing cancers in the United States, with a 500 percent increase in incidence in the last 30 years. In one abstract, Dr. Wolin reports on findings from the multicenter CLARINET study, in which levels of a serotonin metabolite correlated with cancer control. Dr. Wolin was also author of the large international study, NETTER-1, demonstrating effectiveness of Lu-177-DOTATATE in controlling intestinal carcinoid tumors.

Montefiore-Einstein investigators are available to speak with media about their studies as well as topics related to the ASCO meeting.

Highlights from Selected Presentations

1. Characteristics and Anticancer Interventions (ACIs) in African Americans (AA) and Caucasian (CAU) Patients (pts) Treated with Sipuleucel-T (sipT): Real World Experience from the PROCEED Registry. Compared with Caucasian men, African-American men are more likely to develop prostate cancer and die from it, possibly due to genetic or socioeconomic factors. Researchers recently analyzed results from A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer (PROCEED), which used the immunotherapy sipuleucel-T (sip-T) to treat advanced prostate cancer patients. African-American men enrolled in PROCEED responded to the drug similarly to Caucasian men even though the higher baseline PSA of the African-American men would have predicted less clinical benefit for them following sip-T treatment. Presented by Sanjay Goel, M.B.B.S., medical oncologist, MECCC and associate professor of medicine (oncology), Albert Einstein College of Medicine. Session: Genitourinary (Prostate) Cancer – Location: Hall A, Abstract #5025. Saturday, June 4 at 1:00PM.

2. Phase II Trials of Cetuximab Plus Combined Modality Therapy (CMT) in Squamous Cell Carcinoma of the Anal Canal (SCCAC) With and Without Human Immunodeficiency Virus (HIV) Infection. Squamous cell carcinoma of the anal canal (SCCAC) caused by the human papillomavirus (HPV), and commonly associated with HIV infection, is potentially curable with combined modality therapy (CMT), but is also characterized by high local regional failure (LRF) rates. Since the monoclonal antibody cetuximab is known to enhance radiation’s effectiveness in treating HPV-associated oropharyngeal SCC, researchers evaluated the efficacy and toxicity of cetuximab plus CMT in phase II trials involving stage I-III SCCAC patients with and without HIV infection.  The findings suggest that therapy combining cetuximab with CMT can be safely used in efforts to cure stage I-III SCCAC patients with or without HIV infection. Presented by Madhur Garg, M.D., clinical director of radiation oncology, MECCC and professor of clinical radiation oncology at Einstein and Joseph A. Sparano, M.D., F.A.C.P., vice chair of medical oncology, MECCC and associate director for clinical research, AECC. Session: Gastrointestinal (Colorectal) Cancer – Location: Hall A, Abstract #3522. Saturday, June 4 at 1:15PM.

3. A First in Human Phase I Study of Receptor Tyrosine Kinase (RTK) Inhibitor MGCD516 in Patients with Advanced Solid Tumors. Several types of cancer (including non-small cell lung cancer, breast cancer and chronic myeloid leukemia) can occur when enzymes called receptor tyrosine kinases (RTKs) are overactive, often because of mutations. Several anti-cancer RTK inhibitors are now on the market. A first-in-human phase 1 study of the RTK inhibitor MGCD516 was recently conducted on patients with advanced solid tumors. Eligible patients received a single oral dose for pharmacokinetic profiling followed by continuous daily dosing in 21 day cycles. MGCD516 showed favorable pharmacokinetic characteristics, on-target pharmacodynamic effects and adverse effects limited mainly to gastrointestinal-related and general (e.g., fever) symptoms. Presented by Sanjay Goel, M.B.B.S., medical oncologist, MECCC and associate professor of medicine (oncology), Einstein and leader of the AECC Phase I program. Session: Developmental Therapeutics-Clinical Pharmacology and Experimental Therapeutics – Location: Hall A, Abstract #2575. Sunday, June 5 at 8:00AM.

4. Results from a phase 1b/2 study of RX0201, a novel AKT1 antisense, combined with everolimus to treat metastatic clear cell renal carcinoma. The novel oligonucleotide RX-0201 binds RNA that codes for the enzyme AKT-1, preventing AKT-1 from inactivating the apoptotic (programmed cell death) machinery in cancer cells. Stage 1 of a phase 1b/2 proof-of-concept, multicenter, open label study was recently conducted using RX-0201 in combination with the drug everolimus to treat 10 patients with metastatic clear-cell renal carcinoma. Subjects were treated with three different doses of RX-0201 given as a continuous intravenous infusion for 14 days followed by seven days of rest, in combination with 10 mg everolimus. The treatment combination appears safe and well tolerated, with most adverse events (81 percent) mild or moderate in severity. The target dose of RX-0201 identified in Stage 1 is being further evaluated in Stage 2, a randomized two-arm study of RX-0201 in combination with everolimus versus everolimus alone. Presented by Sanjay Goel, M.B.B.S., medical oncologist, MECCC and associate professor of medicine (oncology), Einstein and leader of the AECC Phase I program.., Session: Developmental Therapeutics-Clinical Pharmacology and Experimental Therapeutics – Location: Hall A, Abstract #2559. Sunday, June 5 at 8:00AM.

In addition to data presentations, Kartik Mani, M.D. chief resident, Department of Radiation Oncology, Montefiore and Einstein, will receive a 2016 Conquer Cancer Foundation of ASCO Young Investigator Grant to research a novel combination of radiation and targeted agents for pancreatic cancer, under the mentorship of Chandan Guha, M.B.B.S., Ph.D., vice chair, radiation oncology, MECCC and Einstein professor of medicine (oncology), Einstein.