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Durvalumab with or without tremelimumab plus chemotherapy in HRR non-mutated, platinum-resistant ovarian cancer (KGOG 3045): A phase II umbrella trial.
Kim, Se Ik; Joung, Je-Gun; Kim, Yoo-Na; Park, Junsik; Park, Eunhyang; Kim, Jae-Weon; Lee, Sungyoung; Lee, Jung Bok; Kim, Sunghoon; Choi, Chel Hun; Kim, Hee Seung; Lim, Jinyeong; Chung, Jongsuk; Kim, Byoung-Gie; Lee, Jung-Yun.
Afiliación
  • Kim SI; Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.
  • Joung JG; Department of Biomedical Science, College of Life Science, CHA University, Seongnam, Republic of Korea.
  • Kim YN; Department of Obstetrics and Gynecology, Yonsei University College of Medicine, Seoul, Republic of Korea.
  • Park J; Department of Obstetrics and Gynecology, Yonsei University College of Medicine, Seoul, Republic of Korea.
  • Park E; Department of Pathology, Yonsei University College of Medicine, Seoul, Republic of Korea.
  • Kim JW; Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.
  • Lee S; Department of Genomic Medicine, Center for Precision Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
  • Lee JB; Department of Clinical Epidemiology & Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Ulsan, Republic of Korea.
  • Kim S; Department of Obstetrics and Gynecology, Yonsei University College of Medicine, Seoul, Republic of Korea.
  • Choi CH; Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
  • Kim HS; Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.
  • Lim J; Department of Health Sciences and Technology, Samsung Advanced Institute for Health Science and Technology, Sungkyunkwan University, Seoul, Republic of Korea; Samsung Genome Institute, Samsung Medical Center, Seoul, Republic of Korea.
  • Chung J; Geninus Inc., Seoul, Republic of Korea.
  • Kim BG; Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: bgkim@skku.edu.
  • Lee JY; Department of Obstetrics and Gynecology, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: jungyunlee@yuhs.ac.
Gynecol Oncol ; 182: 7-14, 2024 03.
Article en En | MEDLINE | ID: mdl-38246047
ABSTRACT

AIM:

We investigated the efficacy and safety of durvalumab (D) with or without tremelimumab (T) in addition to single-agent chemotherapy (CT) in patients with platinum-resistant recurrent ovarian cancer (PROC) lacking homologous recombination repair (HRR) gene mutations. PATIENTS AND

METHODS:

KGOG 3045 was an open-label, investigator-initiated phase II umbrella trial. Patients with PROC without HRR gene mutations who had received ≥2 prior lines of therapy were enrolled. Patients with high PD-L1 expression (TPS ≥25%) were assigned to arm A (D + CT), whereas those with low PD-L1 expression were assigned to arm B (D + T75 + CT). After completing arm B recruitment, patients were sequentially assigned to arms C (D + T300 + CT) and D (D + CT).

RESULTS:

Overall, 58 patients were enrolled (5, 18, 17, and 18 patients in arms A, B, C, and D, respectively). The objective response rates were 20.0, 33.3, 29.4, and 22.2%, respectively. Grade 3-4 treatment-related adverse events were observed in 20.0, 66.7, 47.1, and 66.7 of patients, respectively, but were effectively managed. Multivariable analysis demonstrated that adding T to D + CT improved progression-free survival (adjusted HR, 0.435; 95% CI, 0.229-0.824; P = 0.011). Favorable response to chemoimmunotherapy was associated with MUC16 mutation (P = 0.0214), high EPCAM expression (P = 0.020), high matrix remodeling gene signature score (P = 0.017), and low FOXP3 expression (P = 0.047). Patients showing favorable responses to D + T + CT exhibited significantly higher EPCAM expression levels (P = 0.008) and matrix remodeling gene signature scores (P = 0.031) than those receiving D + CT.

CONCLUSIONS:

Dual immunotherapy with chemotherapy showed acceptable response rates and tolerable safety in HRR non-mutated PROC, warranting continued clinical investigation.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Ováricas / Anticuerpos Monoclonales Humanizados / Antígeno B7-H1 / Anticuerpos Monoclonales Límite: Female / Humans Idioma: En Revista: Gynecol Oncol Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
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XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Ováricas / Anticuerpos Monoclonales Humanizados / Antígeno B7-H1 / Anticuerpos Monoclonales Límite: Female / Humans Idioma: En Revista: Gynecol Oncol Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos