Feb. 14, 2020:

Monika Joshi, MD, MRCP, associate professor of medicine at Penn State Hershey Cancer Institute, will present a poster that highlights early safety and efficacy data from the Big Ten Cancer Research Consortium’s BTCRC-GU15-023 study during the American Society of Clinical Oncology’s 2020 Genitourinary Cancers Symposium on Feb. 14 in San Francisco, Calif.

The poster, titled, “Concurrent durvalumab and radiation therapy followed by adjuvant durvalumab in patients with locally advanced urothelial cancer of the bladder (DUART),” will be presented during Poster Session B: Prostate Cancer; Urothelial Carcinoma; Penile, Urethral, Testicular, and Adrenal Cancers, from 12:15-1:45 p.m. PT in the Moscone West Building at Poster J14 (Abstract 513).

See abstract.

Study authors include:

• Monika Joshi, Penn State Cancer Institute, Hershey, Penn.
• Leonard Tuanquin, Penn State Cancer Institute, Hershey, Penn.
• Matthew Kaag, Penn State Health Milton S. Hershey Medical Center, Hershey, Penn.
• Deepak Kilari, Medical College of Wisconsin, Milwaukee, Wis.
• Sheldon L. Holder, Penn State Cancer Institute, Hershey, Penn.
• Hamid Emamekhoo, University of Wisconsin School of Medicine and Public Health, Madison, Wis.
• Alexander Sankin, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, N.Y.
• Suzanne B. Merrill, Penn State University College of Medicine, Hershey, Penn.
• David DeGraff, Penn State Cancer Institute, Hershey, Penn.
• Joshua Warrick, Penn State Hershey Medical Center, Hershey, Penn.
• Hong Zheng, Penn State Cancer Institute, Hershey, Penn.
• Ralph J. Hauke, Nebraska Cancer Specialists, Omaha, Neb.
• Benjamin Adam Gartrell, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, N.Y.
• Mark N. Stein, Columbia University Medical Center, New York, N.Y.
• Yousef Zakharia, Georgia Regents University, Augusta, Ga.
• Joseph J. Drabick, Penn State Hershey Medical Center, Hershey, Penn.

The purpose of the study is to evaluate the safety and efficacy of combining definitive radiation therapy (RT) with immunotherapy, using durvalumab, in a unique subset of bladder cancer patients with localized disease who are either unresectable or unable to have surgery or receive cisplatin-based chemotherapy.

“Our goal was to generate pilot data that could help advance future clinical studies in this area,” said Dr. Joshi, sponsor-investigator of the study. “We have short-term efficacy data showing promise that this therapy may be helpful in this particular subset of patients. Post completion of DurvaRT, clinical response was seen in 17 of 24 patients (70.8%) and disease control rate (DCR) was observed in about 95% of patients.”

About 31% of patients were node positive, with more aggressive disease than those with only muscle invasive bladder cancer.

“The intervention overall was quite tolerable,” Dr. Joshi said. “More than half of the patients (53.8%) experienced fatigue to some degree with this combination, but we did not observe any enhanced immune-related side effects in this population with DurvaRT, when compared to traditional immune-related AEs from durvalumab alone.”

Dr. Joshi noted the data presented pertains only to treatment-related adverse events and early efficacy end points. She anticipates data from primary and correlative endpoints will be presented in the near future.

“We are very fortunate to have an excellent team whose efforts made this study possible,” Dr. Joshi said. “The Big Ten Cancer Research Consortium GU team comprises researchers from various member institutions, who bring their expertise to the study and are driven by a common goal – to move compelling research ideas from bench to bedside. This trial focused on a unique patient population and would have been impossible to complete at a single institution.”

Learn more about BTCRC-GU15-023.

About the Big Ten Cancer Research Consortium: The Big Ten Cancer Research Consortium was created in 2013 to transform the conduct of cancer research through collaborative, hypothesis-driven, highly translational oncology trials that leverage the scientific and clinical expertise of Big Ten universities. The goal of the Big Ten Cancer Research Consortium is to create a unique team-research culture to drive science rapidly from ideas to new approaches to cancer treatment. Within this innovative environment, today’s research leaders collaborate with and mentor the research leaders of tomorrow with the unified goal of improving the lives of all patients with cancer.

About the Big Ten Conference: The Big Ten Conference is an association of world-class universities whose member institutions share a common mission of research, graduate, professional and undergraduate teaching and public service. Founded in 1896, the Big Ten has sustained a comprehensive set of shared practices and policies that enforce the priority of academics in the lives of students competing in intercollegiate athletics and emphasize the values of integrity, fairness and competitiveness. The broad-based programs of the 14 Big Ten institutions will provide over $200 million in direct financial support to more than 9,800 students for more than 11,000 participation opportunities on 350 teams in 42 different sports. The Big Ten sponsors 28 official conference sports, 14 for men and 14 for women, including the addition of men’s ice hockey and men’s and women’s lacrosse since 2013. For more information, visit www.bigten.org.