PMID- 38028143 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240130 IS - 1758-8340 (Print) IS - 1758-8359 (Electronic) IS - 1758-8340 (Linking) VI - 15 DP - 2023 TI - CF33-hNIS-anti-PD-L1 oncolytic virus followed by trastuzumab-deruxtecan in a patient with metastatic triple negative breast cancer: a case study. PG - 17588359231210675 LID - 10.1177/17588359231210675 [doi] LID - 17588359231210675 AB - Prognosis of metastatic triple negative breast cancer (mTNBC) remains poor despite recent advances in therapeutic options. Trastuzumab deruxtecan (T-DXd) has shown promising efficacy in patients with human epidermal growth factor receptor 2 (HER2)-low breast cancer, which is defined by immunohistochemistry (IHC) 1+ or 2+ and lack of HER2 amplification by fluorescence in situ hybridization (FISH) testing. The purpose of the study is to evaluate the safety and initial evidence of efficacy of intratumoral administration of CF33-hNIS-anti-PD-L1 (CHECKvacc) against mTNBC. Oncolytic virus CHECKvacc intratumoral injection is currently undergoing investigation in patients with mTNBC as a single agent (NCT05081492). The patient was enrolled on the clinical trial CHECKvacc for the Treatment of Metastatic Triple Negative Breast Cancer, received a single dose of CHECKvacc, and discontinued the study due to lack of immediate response. We report a case of a patient with mTNBC who was heavily pretreated and presented with extensive dermal metastasis. Two dermal metastasis biopsies in 2021 showed HER2 0 by IHC. The patient received a single dose of CHECKvacc and discontinued the study due to lack of immediate response. Twenty-five days later, the patient received treatment with T-DXd, and her tumor regressed significantly. The patient's disease-free survival was 10 months (December 2021-October 2022). The sequential treatment with intratumoral injection of CHECKvacc followed by T-DXd may have significant clinical activity in select patients with heavily pretreated mTNBC. ClinicalTrials.gov NCT05081492. CI - (c) The Author(s), 2023. FAU - Yuan, Yuan AU - Yuan Y AD - Cedars-Sinai Medical Center, 127 S San Vicente Blvd, Los Angeles, CA 90048, USA. FAU - Egelston, Colt AU - Egelston C AD - Department of Immune-Oncology, City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte, CA, USA. FAU - Colunga Flores, Oscar AU - Colunga Flores O AD - Department of Immune-Oncology, City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte, CA, USA. FAU - Chaurasiya, Shyambabu AU - Chaurasiya S AD - Department of Surgery, City of Hope Comprehensive Cancer, Duarte, CA, USA. FAU - Lin, David AU - Lin D AD - Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA. FAU - Chang, Helen AU - Chang H AD - Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA. FAU - Chong, Leslie Mi Ok AU - Chong LMO AD - Imugene Limited, Sydney, NSW, Australia. FAU - Seiz, Amanda AU - Seiz A AD - Imugene Limited, Sydney, NSW, Australia. FAU - Shah, Monil AU - Shah M AD - Imugene Limited, Sydney, NSW, Australia. FAU - Meisen, W Hans AU - Meisen WH AD - Department of Translational Development, City of Hope Comprehensive Cancer Center, Duarte, CA, USA. FAU - Tang, Aileen AU - Tang A AD - Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA. FAU - Martinez, Norma AU - Martinez N AD - Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA. FAU - Pickett, Wichanee AU - Pickett W AD - Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA. FAU - Murga, Mireya AU - Murga M AD - Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA. FAU - Yost, Susan E AU - Yost SE AUID- ORCID: 0000-0002-9422-0316 AD - Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA. FAU - Stewart, Daphne AU - Stewart D AD - Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA. FAU - Zhang, Jianying AU - Zhang J AD - Department of Statistics, City of Hope Comprehensive Cancer Center, Duarte, CA, USA. FAU - Ede, Nicholas AU - Ede N AD - Imugene Limited, Sydney, NSW, Australia. FAU - Modi, Badri AU - Modi B AD - Department of Surgery, City of Hope Comprehensive Cancer, Duarte, CA, USA. FAU - Kessler, Jonathan AU - Kessler J AD - Department of Radiology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA. FAU - Rand, Jamie AU - Rand J AD - Department of Surgery, City of Hope Comprehensive Cancer, Duarte, CA, USA. FAU - Fong, Yuman AU - Fong Y AUID- ORCID: 0000-0002-8934-9959 AD - Department of Surgery, City of Hope Comprehensive Cancer, Duarte, CA, USA. LA - eng SI - ClinicalTrials.gov/NCT05081492 GR - P30 CA033572/CA/NCI NIH HHS/United States PT - Case Reports DEP - 20231110 PL - England TA - Ther Adv Med Oncol JT - Therapeutic advances in medical oncology JID - 101510808 PMC - PMC10640805 OTO - NOTNLM OT - CF33-hNIS-anti-PD-L1 OT - CHECKvacc OT - T-DXd OT - triple negative breast cancer COIS- YY has contracted research sponsored by Merck, Genentech, and Pfizer; is a consultant for Pfizer, and Immunomedics; and is on the Speakers Bureau for Genentech, AstraZeneca, Daiichi Sankyo, Pfizer, Merck, and Gilead. YF is co-founder and has equity interest in XDemics Corporation; is a consultant for Covidien; is on the advisory board and has common stock options for Theromics, Vergent Biosciences, and Eureka Biologics; is on the advisory board and receives compensation from Imugene; is a consultant and receives compensation from Iovance Biotherapeutics; and is on the Data Safety Board for Sangamo Therapeutics and the University of Alabama, Birmingham. The other authors declare that they have no commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2023/11/29 18:41 MHDA- 2023/11/29 18:42 PMCR- 2023/11/10 CRDT- 2023/11/29 17:10 PHST- 2023/06/05 00:00 [received] PHST- 2023/10/12 00:00 [accepted] PHST- 2023/11/29 18:42 [medline] PHST- 2023/11/29 18:41 [pubmed] PHST- 2023/11/29 17:10 [entrez] PHST- 2023/11/10 00:00 [pmc-release] AID - 10.1177_17588359231210675 [pii] AID - 10.1177/17588359231210675 [doi] PST - epublish SO - Ther Adv Med Oncol. 2023 Nov 10;15:17588359231210675. doi: 10.1177/17588359231210675. eCollection 2023.