February 15, 2021:

Researchers leading a Big Ten Cancer Research Consortium phase Ib/II study of concurrent durvalumab and radiation therapy (DUART) in adults with unresectable, cisplatin ineligible locally advanced bladder cancer, reported promising results during recent virtual scientific meetings.

Monika Joshi, MD, MRCP, sponsor-investigator of the BTCRC-GU15-023 study, presented a rapid abstract session during the 2021 Genitourinary Cancers Symposium on Friday, Feb. 12, that built upon data previously reported by study co-author Leonard C. Tuanquin, MD, during an oral scientific session at the ASTRO Annual Meeting, on Sunday, Oct. 25, 2020.

In his ASTRO presentation, Dr. Tuanquin, a radiation oncologist at Penn State Cancer Institute, reported the novel combination of durvalumab with radiotherapy followed by durvalumab demonstrated promising efficacy, with a 95.8% disease control rate and a 70.8% clinical complete response rate in unresectable, cisplatin ineligible locally advanced bladder cancer. Efficacy was also seen in node positive patients. Researchers continue to follow patients on study.

“Durvalumab and radiation therapy followed by adjuvant durvalumab was generally well tolerated with no grade 5 treatment-related adverse events,” said Dr. Tuanquin. “Four patients discontinued treatment with three of those due to treatment-related adverse events, including acute kidney injury, transaminitis, and scleritis.”

See abstract.

In her rapid abstract session, Dr. Joshi, a medical oncologist at Penn State Cancer Institute, presented progression-free survival (PFS), 1-year overall survival (OS), and disease control rate (DCR) data from the study. Study authors reported promising efficacy with 1-year PFS probability of 73%, 1-year OS probability of 83.8%, and DCR of 70% in muscle-invasive bladder cancer and locally advanced bladder cancer patients with comorbidities. Efficacy was also seen in node-positive patients, which led to the design of a prospective randomized NCTN study.

A follow-up ECOG-ACRIN/NRG study (EA8185; NCT04216290) for patients with node-positive bladder cancer, chaired by Dr. Joshi, is now underway.

See abstract.

The purpose of the BTCRC-GU15-023 study was to evaluate the safety and clinical outcomes of this combined therapy for a population that currently has limited treatment options. The study enrolled 26 subjects from six institutions.

Participating institutions and site principal investigators included: the University of Iowa Holden Comprehensive Cancer Center (Yousef Zakharia, MD), Penn State Cancer Institute (Dr. Joshi), University of Wisconsin Carbone Cancer Center (Hamid Emamekhoo, MD), Froedtert and The Medical College of Wisconsin (Deepak Kilari, MD), Montefiore Medical Center (Alexander I. Sankin, MD), and Nebraska Cancer Specialists (Ralph Hauke, MD).

“The Big Ten CRC collaboration expedited the successful accrual of patients to this clinical trial and provided the framework to bring the multi-disciplinary clinical and research team members together to develop, implement, and complete this valuable study aimed at defining better available therapies for bladder cancer patients,” Dr. Joshi said.

Dr. Zakharia, a medical oncologist at the University of Iowa Holden Comprehensive Cancer Center, noted the importance of multi-institutional collaboration to advance the field of oncology research.

“It is such an exciting time for cancer research! The field is moving so fast and we are on the right track to eventually cure cancer. Collaboration across multiple institutions and with pharma colleagues is the way to expedite this process,” Dr. Zahkaria said. “The Big Ten Cancer Research Consortium provides a great avenue for such successful collaborations, and this study is just one of many examples. I am privileged and honored to be part of such a great group of investigators and researchers across the Big Ten cancer centers who work tirelessly to fight cancer.”

Authors for the ASTRO 2020 oral scientific session included: Monika Joshi¹, Yousef Zakharia², Matthew Kaag³, Deepak Kilari⁴, Sheldon L. Holder¹, Hamid Emamekhoo⁵, Alexander Sankin⁶, Jiangang Liao¹, Suzanne B. Merrill³, David DeGraff⁷, Hong Zheng¹, Joshua Warrick⁷, Ralph Hauke⁸, Benjamin A. Gartrell⁶, Mark N. Stein⁹, Joseph J. Drabick¹, Leonard Tuanquin³.

Authors for the 2021 Genitourinary Cancers Symposium rapid abstract session included: Monika Joshi¹, Matthew Kaag³, Leonard Tuanquin³, Jason Liao¹, Deepak Kilari⁴, Hamid Emamekhoo⁵, Alexander Sankin⁶, Suzanne B. Merrill³, Hong Zheng¹, Sheldon L. Holder¹, Joshua Warrick⁷, Ralph J. Hauke⁸, Benjamin A. Gartrell⁶, Mark N. Stein⁹, Joseph J. Drabick¹, David DeGraff⁷, Yousef Zakharia².

¹Penn State Cancer Institute, Hershey, PA, ²University of Iowa Hospitals and Clinics, Holden Comprehensive Cancer Center, Iowa City, IA, ³Penn State Health Milton S. Hershey Medical Center, Hershey, PA, ⁴Medical College of Wisconsin, Milwaukee, WI, ⁵University of Wisconsin Carbone Cancer Center, Madison, WI, ⁶Montefiore Medical Center, Bronx, NY, ⁷Pennsylvania State University College of Medicine, Hershey, PA, ⁸Nebraska Cancer Specialists, Omaha, NE, ⁹Columbia University Irving Medical Center, New York, NY.

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.