TAR-200 for Bacillus Calmette-Guérin–Unresponsive High-Risk Non–Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study
Abstract
PURPOSE TAR-200 is a first-in-class intravesical drug-releasing system designed to provide sustained delivery of gemcitabine in the bladder. TAR-200 alone or in combination with cetrelimab (PD-1 inhibitor) could improve outcomes in patients with bacillus Calmette-Guérin (BCG)–unresponsive high-risk non–muscle-invasive bladder cancer (NMIBC) ineligible for or refusing radical cystectomy. METHODS In this phase IIb parallel cohort study, patients with BCG-unresponsive carcinoma in situ (CIS) with/without papillary disease received TAR-200 monotherapy (Cohort 2 [C2]), TAR-200 plus cetrelimab (C1), or cetrelimab monotherapy (C3). Patients with BCG-unresponsive high-risk papillary disease–only NMIBC received TAR-200 monotherapy (C4). TAR-200 was dosed through month 24 and cetrelimab through month 18. Primary end points were centrally confirmed overall complete response (CR) rate (C1-3) or disease-free survival (DFS) rate (C4) (ClinicalTrials.gov number: NCT04640623 ). RESULTS At data cutoff (March 31, 2025), 53, 85, 28, and 52 patients were treated in C1-4, respectively. In C2, CR rate and median duration of response were 82.4% (95% CI, 72.6 to 89.8) and 25.8 months (95% CI, 8.3 to not estimable), respectively. In C4, 6-, 9-, and 12-month DFS rates were 85.3% (95% CI, 71.6 to 92.7), 81.1% (95% CI, 66.7 to 89.7), and 70.2% (95% CI, 51.6 to 82.8), respectively. In C1 and C3, CR rates were 67.9% (95% CI, 53.7 to 80.1) and 46.4% (95% CI, 27.5 to 66.1), respectively. Rates of grade ≥3 treatment-related adverse events (AEs) were 12.9%, 13.5%, 37.7%, and 7.1% in C2, C4, C1, and C3, respectively, and of serious treatment-related AEs, 5.9%, 5.8%, 15.1%, and 3.6%. No treatment-related deaths occurred. CONCLUSION TAR-200 monotherapy was well tolerated, with a high CR rate, durable responses, and prolonged DFS in patients with BCG-unresponsive high-risk NMIBC. TAR-200 monotherapy offered a more favorable risk-benefit profile versus TAR-200 plus cetrelimab or cetrelimab alone in BCG-unresponsive CIS.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (91)
Michiel S. Van Der Heijden
Department of Medical Oncology Netherlands Cancer Institute Amsterdam Netherlands
Joseph M. Jacob
Department of Urology, SUNY Upstate Medical University, Syracuse, NY
Félix Guerrero-Ramos
Christopher M. Pieczonka
Clinical Research, U.S. Urology Partners and Associated Medical Professionals of New York, Syracuse
Philipp Spiegelhalder
Urologie Neandertal, Gemeinschaftspraxis für Urologie, Mettmann, Germany
Katie S. Murray
Department of Urology, NYU Grossman School of Medicine, New York, NY
Katharine Stromberg
Johnson & Johnson, Raritan, NJ
Jason Martin
Abhijit Shukla
Johnson & Johnson, Lexington, MA
Christopher J. Cutie
Johnson & Johnson, Lexington, MA
Kristi Bertzos
Johnson & Johnson, Horsham, PA
Shalaka Hampras
Johnson & Johnson, Raritan, NJ
Hussein Sweiti
Johnson & Johnson, Spring House, PA
Manish Patel
Thierry Roumeguere
Charles Van Praet
Harm Arentsen
Bart De Troyer
Department of Urology, VITAZ, Sint-Niklaas, Belgium
Frederic Baekelandt
Karel Decaestecker
Girish Kulkarni
Wassim Kassouf
George Vrabec
Sabrina Falkowski
Clinique François Chénieux, Limoges, France
Geraldine Pignot
Institut Paoli-Calmettes, Department of Surgical Oncology, Marseille, France
Evanguelos Xylinas
Department of Urology, Bichat-Claude Bernard Hospital, Assistance Publique-Hôpitaux de Paris, Université de Paris Cité, Paris, France
Morgan Roupret
Sorbonne Université, Pitié-Salpêtrière Hospital, AP-HP, Paris, France
Marc Colombel
Romain Mathieu
University of Rennes Hospital Centre, Department of Urology, Rennes, France
Benoit Wolff
Marc-Olivier Timsit
Xavier Artignan
Hôpital Saint Grégoire, Rennes, France
Stephane Droupy
Herve Lang
Mathieu Roumiguié
Institut Universitaire du Cancer Toulouse Oncopole CHU, Toulouse, France
Frank Bladou
Catherine Becht
Martin Bögemann
Department of Urology, Münster University Hospital, Münster, Germany
Phillipp Spiegelhalder
Jorg Klier
Tilman Toderhofer
Eva Hellmis
Petros Sountoulides
Konstantinos Hatzimouratidis
Giuseppe Simone
Department of Urology, 'Regina Elena' National Cancer Institute, Rome, Italy
Luca Galli
Frederico Deho
Andrea Minervini
Andrea Necchi
Department of Medical Oncology Fondazione IRCCS Istituto Nazionale dei Tumori University of Milan Milan Italy
Takashi Kawahara
Shuya Kandori
Masao Tsujihata
Shinji Urakami
Taek Won Kang
Department of Urology, Chonnam National University Medical School, Gwangju, Republic of Korea
Ja Hyeon Ku
Seoul National University Hospital, Seoul, South Korea
Kang Su Cho
Department of Urology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
Wonho Jung
C1 Gas Refinery Research and Development Center, Sogang University
Ho Kyung Seo
Center for Urologic Cancer, National Cancer Center, Goyang, Korea, Republic of
Jong Kil Nam
Department of Urology, Pusan National University Yangan Hospital, Pusan National University School of Medicine, Yangsan, South Korea
Diederik Somford
Michiel Van der Heijden
Antonio Morais
Vania Grenha
Jorge Rebola
Sandra Custodio
Vagif Atduev
Volga District Medical Center, Federal Medical-Biological Agency, Nizhny Novgorod, Russian Federation
Denis Kholtdobin
Jose Luis Alvarez-Ossorio Fernandez
Javier Romero Otero
Felix Guerrero Ramos
Bernardo Herrera Imbroda
Urology Department, Hospital Universitario Virgen de la Victoria, IBIMA-Plataforma Bionand, Málaga, Malaga, Spain
Pol Servian Vives
Nelson Canales Casco
Hospital de Jerez de la Frontera y Punta Europa, Cádiz, Spain
Mario Eduardo Alvarez Maestro
David Morris
Dayton Children’s Hospital, Dayton, OH
Siamak Daneshmand
Department of Urology, Keck School of Medicine of University of Southern California, Norris Comprehensive Cancer Center
Curtis Dunshee
Daniel Zainfeld
Urology San Antonio, San Antonio, TX
Katie Murray
Laurence Belkoff
Midlantic Urology, Bala Cynwyd, PA
Peter Earl Clark
Yair Lotan
Department of Urology, UT Southwestern Medical Center, Dallas, TX
Joseph Jacob
David Cahn
Colorado Urology, Lakewood, CO
Christopher Pieczonka
Amy Luckenbaugh
Vanderbilt University Medical Center, Nashville, TN
Marc Pliskin
Jason Hafron
Corewell Health William Beaumont University Hospital, Royal Oak, MI
Eugene Cone
Urology of Indiana, Greenwood, IN
Brian Mazzarella
Urology Austin, Austin, TX
Richard David