Dr. Cora Sternberg is an American medical oncologist at Weill Cornell Medicine and NewYork-Presbyterian Hospital, serving as a member of the Genitourinary (GU) Oncology Program. Dr. Sternberg facilitates the continued growth and development of clinical and translational research programs in GU malignancies. Dr. Sternberg is an internationally respected leader in the field of medical oncology and urological malignancies and a recognized expert in the area of new drug development. She is known for her seminal contributions in bladder cancer, her strong track record of sustained genito-urinary (GU) oncology leadership and collaboration in multiple practice-changing clinical trials, including novel medicines, and her current role applying her expertise in oncology and GU cancers to precision medicine to further improve outcomes for patients. Dr. Sternberg has been decidedly influential in the development of novel hormonal therapies and checkpoint inhibitors across the landscape of GU oncology as evidenced in her curriculum vitae. She is a globally respected researcher who has lectured extensively at universities and cancer symposia worldwide (>800). As Clinical Director of the Englander Institute for Precision Medicine (EIPM), Dr. Sternberg develops strategies to incorporate genomic sequencing and precision medicine throughout the Weill Cornell Medicine and NewYork-Presbyterian healthcare network, including Lower Manhattan, Brooklyn and Queens.

Dr. Sternberg previously served as chief of the medical oncology department at San Camillo-Forlanini Hospital in Rome, Italy, and adjunct professor at Sapienza University of Rome.^[1][2] Sternberg is an elected board member of the European Organisation for Research and Treatment of Cancer (EORTC).^[3]

She has been awarded the title ‘Grande Ufficiale al Merito della Repubblica Italiana’ and has received the Premio Minerva for Scientific Achievement, XVIII Edition for Achievements in Science.^[4] Sternberg has received the Premio ROSA “Risultati Ottenuti Senza Aiuti", award for special achievement from the Canova Club in 2011.

Biography

Born in Philadelphia, Sternberg earned her undergraduate degree at the College of Women at the University of Pennsylvania and her medical degree at the University of Pennsylvania in Philadelphia. She also obtained a second medical degree at the University of Rome La Sapienza.^[5]

Upon transferring to Italy, Sternberg became a Consultant Physician at the Regina Elena Cancer Institute for Cancer Research, 1st Division of Medical Oncology in Rome, Italy. She then went on to become a Consultant Oncologist at the C.T.O. Hospital in Rome, Italy and subsequently Chief of the Department of Medical Oncology at the San Raffaele Scientific Institute in Rome, Italy and Consultant in Medical Oncology at the Regional General Hospital F. Miulli in Acquaviva delle Fonti, in Bari, Italy. From Fall 2002 - 2018 she was the Chief of the Department of Medical Oncology at the San Camillo-Forlanini Hospital in Rome, Italy.^[6] Since 2018, Dr. Cora Sternberg has been the Clinical Director of the Englander Institute for Precision Medicine and a full Professor at Weill Cornell in New York.

Prostate Cancer

Dr. Cora Sternberg has been intimately involved in developing studies that have led to the registration of abiraterone acetate and enzalutamide, as well as other novel therapies for prostate cancer. Abiraterone was approved in the USA the day after the FDA inspection at Dr. Sternberg's department in Italy. She is a Principal Investigator (PI) and senior author of the PROSPER phase III study of enzalutamide in patients with non-metastatic castration-resistant prostate cancer (M0 CRPC), published in the NEJM and approved by the FDA and EMA due to its decrease of > 70% in metastases-free survival. This study was associated with a statistically significant 27% reduction in the risk of death, an evident improvement in overall survival, enhanced quality of life, and reduced time for the need of other antineoplastic therapy1,2. This study has proven to be an important practice-changing milestone.

Dr. Sternberg was the PI of the Satraplatin study in prostate cancer3 and the Oblimersen Sodium4 study in prostate cancer. She was also the PI of the phase III study with tasquinimod (an experimental immunotherapy and antiangiogenic agent)5 and the PI of a phase II study of varying doses of alpharadin. She led the REASSURE study, evaluating the sequence of novel hormonal therapies and alpharadin, as well as a study investigating three dosing regimens of radium-223 dichloride6. She was part of the steering committee for the COMIT I cabozantanib study (a small molecule inhibitor of the tyrosine kinases c-Met and VEGFR2). Dr. Sternberg is a member of the steering committee of a study of the combination of abiraterone and an AKT inhibitor, ipatasertib, which was published in the Lancet7. She also played a role in the steering committee for the CARD study, which established sequencing in metastatic castration-resistant prostate cancer (mCRPC). Dr. Sternberg was instrumental in developing darolutamide, a novel androgen receptor inhibitor in prostate cancer, a study that changed practice and was published in NEJM and presented at ASCO GU 2022. She has collaborated with investigators at Johns Hopkins University to validate a test for ARV-7 splice variants in circulating tumor cells (CTCs) in patients with CRPC and has worked closely with them on several academic studies. She serves as the PI on a study she has written for her institution on the Molecular Basis of Lineage Plasticity and AR-Independent Prostate Cancer. Dr. Sternberg has been involved in developing PCWG2, PCWG3, and now PCWG4, which are guidelines for academicians in evaluating prostate cancer patients in clinical trials. She has recently obtained grant support to study the genomics of African American men with prostate cancer. She also collaborates on genomic studies with the NCI.

• Hussain, M., Fizazi, K., Saad, F., Rathenborg, P., Shore, N., Ferreira, U., Ivashchenko, P., Demirhan, E., Modelska, K., Phung, D., Krivoshik, A., and Sternberg, C.N. (2018) Enzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med, 378(26), 2465-2474.
• Sternberg CN, Fizazi K, Saad F, Shore ND, De Giorgi U, Penson DF, Ferreira U, Efstathiou E, Madziarska K, Kolinsky MP, Cubero DIG, Noerby B, Zohren F, Lin X, Modelska K, Sugg J, Steinberg J, and Hussain M. (2020) Enzalutamide and Survival in Nonmetastatic Castration-Resistant Prostate Cancer. N Engl J Med, May 29 [Epub ahead of print]
• Sternberg, C., Armstrong, A., Pili, R., Ng, S., Huddart, R., Agarwal, N., Khvorostenko, D., Lyulko, O., Brize, A., Vogelzang, N., Delva, R., Harza, M.,Thanos, A., James, N., Werbrouck, P., Bögemann, M., Hutson, T., Milecki, P., Chowdhury, S., Gallardo, E., Schwartsmann, G., Pouget, J.C., Baton, F., Nederman, T., Tuvesson, H., & Carducci, M. (2016). Randomized, Double-Blind, Placebo-Controlled Phase III Study of Tasquinimod in Men with Metastatic Castrate Resistant Prostate Cancer. J Clin Oncol, 34(22), 2636-2643.
• Sternberg, C.N., Saad, F., Graff, J.N., Peer, A., Vaishampayan, U.N., Leung, E., Rosenbaum, E., Gurney, H., Epstein, R., Davis, I.D., Wu, B., Trandafir, L., Wagner, V.J., Hussain, M. (2018). A Randomized Phase 2 Study Investigating 3 Dosing Regimens of Radium-223 Dichloride (Ra-223) in Bone Metastatic Castration-Resistant Prostate Cancer (mCRPC). Journal of Clinical Oncology, 36(15), 5008-5008.
• Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, Kopyltsov E, Park CH, Alekseev B, Montesa-Pino Á, Ye D, Parnis F, Cruz F, Tammela TLJ, Suzuki H, Utriainen T, Fu C, Uemura M, Méndez-Vidal MJ, Maughan BL, Joensuu H, Thiele S, Li R, Kuss I, Tombal B; ARASENS Trial Investigators. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med 2022 Mar 24;386(12):1132-1142. doi: 10.1056/NEJMoa2119115. Epub 2022 Feb 17.

Urothelial Cancer

Dr. Cora Sternberg has been responsible for developing chemotherapy regimens in bladder cancer that are today considered the standard of care worldwide, such as M-VAC and High dose or dose dense M-VAC (HD-MVAC, DD-MVAC)1-2. HD-M-VAC is primarily used in the neoadjuvant setting and is currently the subject of a SWOG ongoing study and was presented as superior to GC therapy at ESMO in 2021.

She has published on behalf of the EORTC and several large cooperative groups the largest randomized adjuvant chemotherapy bladder cancer trial to date, "Immediate Versus Deferred Chemotherapy after Radical Cystectomy in Patients with pT3-pT4 or N+ M0 Urothelial Carcinoma of the Bladder (EORTC 30994): An Intergroup, Open-Label, Randomised Phase 3 Trial"3. This trial demonstrated the value of adjuvant chemotherapy after cystectomy. A meta-analysis showed that overall there is an OS benefit of immediate adjuvant chemotherapy, especially with cisplatin-based combination therapy. Dr. Sternberg has recently published a collaborative update of the individual patient meta-analysis in collaboration with the MRC. She has collaborated with the RISC (Retrospective International Study of Cancers of the Urothelial Tract) investigators to create a large database (n=3024). Several publications have already emerged, including work from her department using this database on neoadjuvant vs. adjuvant chemotherapy. With knowledge from the TCGA, a new classification of urothelial cancer by molecular markers has become a reality. Inhibition of Fibroblast Growth Factor Receptor (FGFR), a frequent driver in bladder cancer, is an area where Dr. Sternberg has made significant contributions. She is the co-PI of a study with Rogaratinib, a potent and selective inhibitor of FGFR subtypes. This study involves a comparison of Rogaratinib vs. Chemotherapy in Patients with FGFR Positive Locally Advanced or Metastatic Urothelial Carcinoma (FORT-1) (NCT03410693). Tumor FGFR mRNA levels predict Rogaratinib activity independent of FGFR subtype and cancer type. She is also actively involved on the steering committee and treating patients on another study with another FGFR inhibitor, a Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects with Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations.

Dr. Sternberg is the PI and the highest contributor to the SAUL study4, an extended access program of atezolizumab, a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1) in patients who have received prior chemotherapy and who were ineligible for the prior registration studies (due to factors like poor renal function, inflammatory disease, etc.), demonstrating that this regimen can be safely administered to these patients. She is an author on the practice-changing phase III study of Pembrolizumab as 2nd-line therapy after failure of platinum-based therapy vs. chemotherapy (investigator’s choice). Dr. Sternberg is a PI on the Javelin Bladder 100 trial with avelumab maintenance therapy that has changed clinical practice guidelines worldwide in patients who have responded to first-line platinum-based combination therapy. She is on the steering committee and recently published the STRONG study with durvalumab, a monoclonal antibody that targets programmed cell death-1 ligand 1 (PD-L1), in pre-treated bladder cancer patients. She is on the steering committee of a study with Sacituzumab govitecan (anti-Trop-2-SN-38 ADC), a first-in-class antibody-drug conjugate. Their findings have recently been published in the JCO. She has written a Phase 1 trial of naptumomab estafenatox (NAP) in combination with pembrolizumab in patients with UC. NAP is a recombinant protein with a Fab moiety targeting the 5T4 antigen fused with a genetically engineered superantigen moiety. The 5T4 antigen is an oncofetal glycoprotein that is upregulated in UC. Additionally, Dr. Sternberg has established a collaboration with BCAN and the Hoosier Cancer Oncology Group to perform Whole Genome Sequencing (WGS) on their large cohort of bladder cancer patients.

• Sternberg, C.N., Yagoda, A., Scher, H.I., Watson, R.C., Geller, N., Herr, H.W., Morse, M.J., Sogani, P.C., Vaughan, E.D., Bander, N., Weiselberg, L., Rosado, K., Smart-Curly, T., Lin, S., Penenberg, D., Fair, W., Whitmore, W.F. Jr. (1989). M-VAC for Advanced Transitional Cell Carcinoma of the Urothelium: Efficacy and Patterns of Response. Cancer, 64, 2448-2458.
• Sternberg, C.N., de Mulder, P., Schnornagel, J.H., Theodore, C., Fossa, S.D., van Oosterom, A.T., Witjes, J.A., Spina, M., van Groeningen, C.J., Duclos, B., Roberts, J.T., de Balincourt, C., Collette, L., EORTC Genito-Urinary Cancer Group. (2006). Seven Year Update of an EORTC Phase III Trial of High-Dose Intensity M-VAC Chemotherapy and G-CSF Versus Classic M-VAC in Advanced Urothelial Tract Tumours. Eur J Cancer, 42(1), 50-54.
• Sternberg, C.N., Skoneczna, I., Kerst, J.M., Albers, P., Fossa, S.D., Agerbaek, M., Dumez, H., de Santis, M., Théodore, C., Leahy, M.G., Chester, J.D., Verbaeys, A., Daugaard, G., Wood, L., Witjes, J.A., de Wit, R., Geoffrois, L., Sengelov, L., Thalmann, G., Charpentier, D., Rolland, F., Mignot, L., Sundar, S., Symonds, P., Graham, J., Joly, F., Marreaud, S., Collette, L., Sylvester, R., European Organisation for Research and Treatment of Cancer Genito-Urinary Cancers Group, Groupe d'Etude des Tumeurs Urogénitales, National Cancer Research Institute Bladder Cancer Study Group, National Cancer Institute of Canada Clinical Trials Group, German Association of Urologic Oncology (AUO). (2015). Immediate Versus Deferred Chemotherapy after Radical Cystectomy in Patients with pT3-pT4 or N+ M0 Urothelial Carcinoma of the Bladder (EORTC 30994): An Intergroup, Open-Label, Randomised Phase 3 Trial. Lancet Oncol,16(1), 76-86.
• Sternberg CN, Loriot Y, James N, Choy E, Castellano D, Lopez-Rios F, Bann GL, De Giorgi U, Masini C, Bamias A, Garcia del Muro X, Duran I, Powles T, Gamulin M, Zengerling F, Geczi L, Gedye C, de Ducla S, Fear S, Merseburger A. Primary Results from SAUL, a Multinational Single-arm Safety Study of Atezolizumab Therapy for Locally Advanced or Metastatic Urothelial or Non-urothelial Carcinoma of the Urinary Tract. Eur Urol. 2019 Jul;76(1):73-81.
• Sternberg, C.N., Petrylak DP, Bellmunt J, Nishiyama H, Necchi A, Gurney H, Lee JL, van der Heijden MS, Rosenbaum E, Penel N, Pang ST, Li JR, García Del Muro X, Joly F, Pápai Z, Bao W, Carrasco-Alfonso MJ, Aimone P, Voi M, Doehn C, Russo P, Sternberg CN, Shin N, Chernyshov K, Calabro F, Cerbone L, Procopio G, Miheecheva N, Sagaradze G, Zaichikova A, Samarina N, Boyko A, Brown JH, Yunusova L, Guevara D, Manohar J, Sigouros M, Al Assaad M, Elemento O, Mosquera JM. Case report: Metastatic urothelial cancer with an exceptional response to immunotherapy and comprehensive understanding of the tumor and the tumor microenvironment. Front Oncol. 2022 Oct 31;12:1006017. doi: 10.3389/fonc.2022.1006017. eCollection 2022. PMID: 36387205

Renal Cancer

Dr. Cora Sternberg has participated in the majority of important registration renal cancer studies in first, second, and third-line therapy as a principal investigator or steering committee member. Her research in this area began at MSKCC when she was responsible for the IL-2 LAK program. Dr. Sternberg has played a central role as the PI in the development and registration of the drug pazopanib, an antiangiogenic molecule, for advanced clear cell carcinoma.1,2 She has also completed an adjuvant trial where she was the lead investigator in Europe with pazopanib.3 Her contributions include published work that demonstrates adjuvant pazopanib can significantly extend DFS after nephrectomy in patients with high-risk RCC, with adequate exposure being critical in both the adjuvant and metastatic settings. She was also the first to present collaborative work at ASCO on a SNP signature for response and survival, as well as a cytokine signature. Dr. Sternberg's recent work includes the evaluation of IL 8 polymorphisms and overall survival in pazopanib or sunitinib-treated patients with RCC. She has also been involved in developing a nomogram to predict outcome in renal cancer.

Dr. Sternberg has been intimately involved in comparative studies with pazopanib and sunitinib in terms of efficacy and patient preferences (COMPARZ and PISCES studies). She has collaborated with RCC international experts to investigate treatment patterns, patient preferences, and proper sequencing utilizing various methodologies. Additionally, she has participated in the development of other antiangiogenic agents such as sunitinib, tivozanib, cabozantinib, lenvatinib, and dovitinib. Her research extends to studies involving the combination of checkpoint inhibitors and immunotherapy in advanced RCC.

• Sternberg, C.N., Davis, I.D., Mardiak, J., Szczylik, C., Lee, E.S., Wagstaff, J., Barrios, C.H., Salman, P., Gladkov, O.A., Kavina, A., Zarbá, J.J., Chen, M., McCann, L., Pandite, L., Roychowdhury, D.F., & Hawkins, R.E. (2010). Pazopanib in Locally Advanced and/or Metastatic Renal Cell Carcinoma: Results of a Randomized Phase III Trial. J Clin Oncol. 28(6), 1061-1068.
• Sternberg, C.N., de Mulder, P., Schnornagel, J.H., Theodore, C., Fossa, S.D., van Oosterom, A.T., Witjes, J.A., Spina, M., van Groeningen, C.J., Duclos, B., Roberts, J.T., de Balincourt, C., Collette, L., EORTC Genito-Urinary Cancer Group. (2006). Seven Year Update of an EORTC Phase III Trial of High-Dose Intensity M-VAC Chemotherapy and G-CSF Versus Classic M-VAC in Advanced Urothelial Tract Tumours. Eur J Cancer, 42(1), 50-54.
• Sternberg, C.N., Skoneczna, I., Kerst, J.M., Albers, P., Fossa, S.D., Agerbaek, M., Dumez, H., de Santis, M., Théodore, C., Leahy, M.G., Chester, J.D., Verbaeys, A., Daugaard, G., Wood, L., Witjes, J.A., de Wit, R., Geoffrois, L., Sengelov, L., Thalmann, G., Charpentier, D., Rolland, F., Mignot, L., Sundar, S., Symonds, P., Graham, J., Joly, F., Marreaud, S., Collette, L., Sylvester, R., European Organisation for Research and Treatment of Cancer Genito-Urinary Cancers Group, Groupe d'Etude des Tumeurs Urogénitales, National Cancer Research Institute Bladder Cancer Study Group, National Cancer Institute of Canada Clinical Trials Group, German Association of Urologic Oncology (AUO). (2015). Immediate Versus Deferred Chemotherapy after Radical Cystectomy in Patients with pT3-pT4 or N+ M0 Urothelial Carcinoma of the Bladder (EORTC 30994): An Intergroup, Open-Label, Randomised Phase 3 Trial. Lancet Oncol,16(1), 76-86.

Works

Dr. Cora Sternberg has published over 500 peer-reviewed scientific works throughout her illustrious career. For a selection of these, visit PubMed

Honors and awards

• Order of Merit of the Italian Republic^[7] (2004)
  • Awarded by: Italian Government

• Premio Minerva for Scientific Achievement, XVIII Edition for Achievements in Science (2007)
  • Awarded by: Premio Minerva

• Premio Rosa "Risultati Ottenuti Senza Aiuti", Award for Special Achievement (2011)
  • Awarded by: Canova Club, Rome, Italy

• ESMO Award for Outstanding Contribution to the Development of Medical Oncology (2013)
  • Awarded by: European Society of Medical Oncology

• Pieter De Mulder award (2017)
  • Awarded by: European International Kidney Cancer Symposium (EIKCS)

• Oncology Times 2020 Excellence in Oncology Award (2020)
  • Awarded by: Oncology Times

References