Expanding the Boundaries of Drug Development
Cora N. Sternberg, MD, a leading international researcher and expert in the field of medical oncology, genitourinary cancers, and drug development, serves as Clinical Director of the Englander Institute for Precision Medicine at Weill Cornell Medicine and is a member of the Genitourinary Oncology Program at NewYork-Presbyterian/Weill Cornell Medical Center. A Professor of Medicine at Weill Cornell Medicine, Dr. Sternberg is well-known for her work in developing novel therapies and targeted agents for the treatment of prostate, renal, and bladder cancers.
A key opinion leader in genitourinary cancers, Dr. Sternberg helped develop the original M-VAC chemotherapy regimen, as well as the double-dose/high-dose/accelerated-dose M-VAC chemotherapy regimens in bladder and urothelial cancers – treatments that became the gold standard. Additionally, she served as Principal Investigator and has been involved in numerous practice-changing studies for prostate cancer leading to FDA approvals of abiraterone acetate and enzalutamide in advanced prostate cancer. Dr. Sternberg also was instrumental in the development of pazopanib, an antiangiogenic targeted therapy, for advanced clear cell renal cell carcinoma and served as lead investigator in the phase 3 international study that culminated in its FDA approval for patients with metastatic kidney cancer. She has also participated in the development of other antiangiogenic agents, such as sunitinib, cabozantinib, tivozanib, and dovitinib to treat renal cell cancer and immunotherapy for bladder cancer.
At Weill Cornell Medicine, Dr. Sternberg is facilitating the continued growth and development of clinical and translational research programs in genitourinary malignancies while continuing her influential research in the field. “Most recently, we published a study on immunotherapy for patients with advanced bladder cancer,” says Dr. Sternberg. “Because immunotherapy works by boosting the patient’s immune system, it is usually not given to patients with any kind of inflammatory disease. In this study, we lowered the entry criteria to include patients with inflammatory and renal disease who are never eligible for these clinical trials. The 1,000-patient trial showed that you could safely administer these drugs even to those patients who theoretically would be more at risk because of their autoimmune diseases or poor renal function.” The results were published in July 2019 in European Urology.
Dr. Sternberg’s research also focuses on nonmetastatic castration-resistant prostate cancer. Patients who have a rapidly rising prostate-specific antigen are at high risk for the development of metastasis. “We knew that enzalutamide prolongs overall survival among patients with metastatic castration-resistant prostate cancer, so our thinking was that this drug could also delay metastasis in men with nonmetastatic disease,” says Dr. Sternberg.
She served as a Principal Investigator and the results, published in the October 4, 2018 issue of The New England Journal of Medicine, demonstrated dramatic improvements in metastasis-free survival, leading to the approval of enzalutamide for treatment of this patient population. “This is a population for whom there were previously no approved therapeutics. When given early, the drug reduces the risk of metastasis or death by more than 70 percent.”
More recently, Dr. Sternberg served as a lead investigator in an international study of cabazitaxel versus an androgensignaling- targeted inhibitor (abiraterone or enzalutamide) in patients with metastatic castration-resistant prostate cancer that recurred after being treated with docetaxel and an androgen-signaling targeted inhibitor. The results, published in the September 30, 2019 issue of The New England Journal of Medicine, demonstrated that cabazitaxel significantly improved clinical outcomes, including progression free survival and overall survival.