A plain language summary of the TROPHY-U-01 study (Cohort 2): use of sacituzumab govitecan after immunotherapy in people with metastatic urothelial cancer who cannot take cisplatin-based chemotherapy

Plain Language SummaryWhat is this summary about?People with locally advanced or metastatic cancer of the bladder and upper urinary tract (also called urothelial cancer) are often treated with a type of platinum-based chemotherapy called cisplatin and/or immunotherapy. Not all patients can be treated with cisplatin. Cancer can also get worse after prior therapies including immunotherapy.Sacituzumab govitecan (brand name: TRODELVY®) is a type of cancer medicine called an antibody-drug conjugate. Antibody-drug conjugates are made of an antibody to find the cancer cells in your body and a drug to kill the cancer cells. The TROPHY-U-01 study looked at how well this treatment works in people with locally advanced or metastatic urothelial cancer who have already been treated with 1 or 2 other types of cancer treatments. The study included more than 1 group ('cohort') of participants. This paper reports results in participants who could not take cisplatin and whose cancer got worse after immunotherapy (Cohort 2). All participants got sacituzumab govitecan.What were the results?There were 38 participants in Cohort 2. Before treatment, most participants had cancer that had spread to their internal organs. After sacituzumab govitecan treatment, the tumors in 12 of 38 participants (32%) shrank by a degree that was substantial enoughfor doctors to consider a 'response' to treatment. This response started at a median of 1.4 months of treatment and lasted for a median of 5.6 months. In 13 of 38 participants (34%), the cancer remained stable for some time. In 16 of 38 participants (42%), the cancer was controlled (not worsened) for at least 6 months. All participants had adverse events regardless of the cause. The most common severe adverse events were low levels of certain blood cells, tiredness, and diarrhea.What do the results of the study mean?The study showed that sacituzumab govitecan treatment worked well on its own, with response noted in about one-third of participants with locally advanced or metastatic urothelial cancer who could not take cisplatin and whose cancer got worse after immunotherapy alone.This is an abstract of the Plain Language Summary of Publication article.View the full Plain Language Summary PDF of this article to read the full-textThis article is related to: AcknowledgmentsWe extend our thanks to the study participants and their caregivers and families for their participation and commitment to clinical research. We also thank the dedicated clinical trial investigators and their devoted team members who participated in the TROPHY-U-01 study.Disclosure statementPetros Grivas has received consultancy/advisory fees from AbbVie, AstraZeneca, Asieris Pharmaceuticals, Astellas Pharma, Bicycle Therapeutics, Bristol Myers Squibb, Daiichi Sankyo, Fresenius Kabi, Gilead, ImmunityBio, Janssen, Merck KGaA, MSD, Pfizer, Roche, Strata Oncology, Replimune, and Foundation Medicine; and research funding to the institution by Acrivon Therapeutics, ALX Oncology, Bristol Myers Squibb, Merck KGaA, MSD, Genentech, Gilead, and QED Therapeutics. Scott T. Tagawa has stock and other ownership interests in Convergent Therapeutics; has received consultancy/advisory fees from Medivation, Astellas Pharma, Dendreon, Janssen, Genentech, Endocyte, Immunomedics, Karyopharm Therapeutics, AbbVie, Tolmar, QED Therapeutics, Amgen, Sanofi, Pfizer, Clovis Oncology, Novartis, Genomic Health, POINT Biopharma, Blue Earth Diagnostics, Seagen, AIkido Pharma, 4D Pharma, Clarity Pharmaceuticals, Gilead Sciences, Telix Pharmaceuticals, Bayer, Myovant Sciences, Convergent Therapeutics, Hookipa Pharma, Merck, Daiichi Sankyo, Regeneron, TransThera Biosciences, Bicycle Therapeutics, Ambrx, Exelixis, and Boston Scientific; research funding from Lilly (Inst), Sanofi (Inst), Janssen (Inst), Astellas Pharma (Inst), Progenics (Inst), Millennium (Inst), Amgen (Inst), Bristol Myers Squibb (Inst), Dendreon (Inst), Rexahn Pharmaceuticals (Inst), Bayer (Inst), Genentech (Inst), Newlink Genetics (Inst), Inovio Pharmaceuticals (Inst), AstraZeneca (Inst), Immunomedics (Inst), Novartis (Inst), AVEO (Inst), Boehringer Ingelheim (Inst), Merck (Inst), Stem CentRx (Inst), Karyopharm Therapeutics (Inst), AbbVie (Inst), Medivation (Inst), Endocyte (Inst), Exelixis (Inst), Clovis Oncology (Inst), POINT Biopharma (Inst), Ambrx (Inst), and Clarity Pharmaceuticals (Inst); has patents, royalties, and other intellectual property from Immunomedics/Gilead (patent royalty), and travel, accommodations, expenses from Sanofi, Immunomedics, Amgen, Merck, and Astellas Pharma; and has uncompensated relationships with ATLAB Pharma and Phosplatin Therapeutics. Rohit K. Jain has received honoraria from DAVA Oncology, Curio Science, FLASCO, and MJH Life Sciences; consultancy/advisory fees from Gilead Sciences, EMD Serono, Bristol Myers Squibb, AVEO, and Sanofi; speakers' bureau fees from Seattle Genetics/Astellas; research funding from Bristol Myers Squibb, Gilead Sciences, and NCI; and travel, accommodations, and expenses from DAVA Oncology, FLASCO, and Sanofi. Manojkumar Bupathi has received consulting fees from Xencor, Merck, Johnson & Johnson, Bayer, Eisai, and Exelixis. Arjun Balar is employed by Loxo/Lilly; has a leadership role with Volastra Therapeutics; and has stock and other ownership Interests in Lilly. Arash Rezazadeh Kalebasty has received grants from Immunomedics, Bristol Myers Squibb, Pfizer, AstraZeneca, Exelixis, Genentech, Gilead Sciences, Novartis, EMD Serono, Immunomedics, Seattle Genetics/Astellas, Amgen, Astellas Medivation, AVEO, Eisai, Genentech/Roche, Janssen, Merck, Myovant Sciences, Sanofi, Bayer, Arvinas, Mirati Therapeutics, and POINT Biopharma; honoraria from Pfizer, Seattle Genetics/Astellas, AstraZeneca, AVEO, Bristol Myers Squibb, Eisai, EMD Serono, Genentech/Roche, Exelixis, Janssen, Gilead Sciences, Merck, Immunomedics, Myovant Sciences, Sanofi, and Bayer; and has stock ownership in ECOM Medical. Saby George has received consultancy/advisory fees from Eisai, Bristol Myers Squibb, Novartis, Merck Sharp & Dohme, Aveo, GSK, AstraZeneca, Bayer, Seattle Genetics, Sanofi/Genzyme, Johnson & Johnson, and QED Therapeutics; and research funding from Gilead/Immunomedics, Bayer, Bristol Myers Squibb, Exelixis, Seattle Genetics, Eisai, Novartis, Merck Sharp & Dohme, Aveo, and Surface Oncology. Phillip Palmbos has received research funding from NCI and Genentech and honoraria from University of Washington. Luke Nordquist has nothing to disclose. Daniel P. Petrylak has received consultancy/advisory fees from Advanced Accelerator Applications, Amgen, Astellas Pharma, AstraZeneca, Bayer, Bicycle Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Clovis Oncology, Exelixis, Gilead Sciences, Incyte, Janssen, Lilly, Mirati Therapeutics, Monopteros Therapeutics, Pfizer, Pharmacyclics, Regeneron, Roche, Seagen, and Urogen Pharma; research funding from Advanced Accelerator Applications, Agensys, Astellas Medivation, AstraZeneca, Bayer, BioXCel Therapeutics, Bristol Myers Squibb, Clovis Oncology, Eisai, Endocyte, Genentech, Gilead Sciences, Innocrin Pharma, Lilly, MedImmune, Medivation, Merck, Mirati Therapeutics, Novartis, Pfizer, Progenics, Replimune, Roche, Sanofi, and Seagen; and has given expert testimony for Celgene and Sanofi. Nancy Davis is employed by Merck, Sharp & Dohme, Inc; has received consultancy/advisory fees from Janssen Biotech; and has received research funding from AstraZeneca (Inst), Roche (Inst), Pfizer (Inst), Merck (Inst), Incyte (Inst), Mirati Therapeutics (Inst), Seattle Genetics/Astellas (Inst), Calithera Biosciences (Inst), Immunomedics (Inst), Bristol Myers Squibb (Inst), Exelixis (Inst), and Gilead Sciences (Inst). Cora N. Sternberg has received consultancy/advisory fees from Bayer, MSD, Pfizer, Roche, AstraZeneca, Merck, Medscape, UroToday, Astellas Pharma, Genzyme, Foundation Medicine, Bristol Myers Squibb/Medarex, Gilead Sciences, and Janssen Oncology; and honoraria from Merck and Pfizer. Neeraj Agarwal has received research funding from Arvinas, Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb, Calithera Biosciences, Celldex, Clovis Oncology, CRISPR Therapeutics, Eisai, EMD Serono, Exelixis, Genentech, Gilead Sciences, GlaxoSmithKline, Immunomedics, Janssen, Lava, Lilly, Merck, Nektar, Neoleukin, Novartis, ORIC Pharmaceuticals, Pfizer, Rexahn, Roche, Sanofi, Seagen, Takeda, and TRACON; and grants from NIH/NCI. Chandler Park has received consultancy/advisory fees from Janssen Oncology; honoraria from Merck, Pfizer, and Ono Pharmaceutical; and research funding from Merck Sharp & Dohme (Inst). Julia Tonelli is employed by Gilead Sciences and has stock and other ownership interests in Gilead Sciences. Huafeng Zhou is employed by Gilead Sciences and has stock and other ownership interests in Gilead Sciences. Rick Bangs has received consultancy fees from CPRIT, NCI, and The Hope Foundation for Cancer Research; honoraria from Gilead, NCCN, and Bladder Cancer Advocacy Network; and travel support from The Hope Foundation for Cancer Research, IBCG, AUC3, Bladder Cancer Advocacy Network, Van Andel Institute, and AUA. Yohann Loriot has received honoraria from Janssen, Bristol Myers Squibb, Roche, Gilead, MSD, and Pfizer; research funding from Amgen (Inst), Janssen Oncology (Inst), MSD Oncology (Inst), Lilly (Inst), AstraZeneca (Inst), Orion (Inst), Exelixis (Inst), Incyte (Inst), Pfizer (Inst), Sanofi (Inst), Astellas Pharma (Inst), Gilead Sciences (Inst), Merck KGaA (Inst), Taiho Pharmaceutical (Inst), Bristol Myers Squibb (Inst), Roche (Inst), and Tyra Biosciences (Inst); and travel, accommodations, and expenses from Astellas Pharma, Pfizer, MSD Oncology, and AstraZeneca. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.Medical writing support was provided by Priya Talluri, MSc, from Parexel and was funded by Gilead Sciences, Inc.Patient reviewers on this PLSP have received honorarium from Future Oncology for their review work but have no other relevant financial relationships to disclose.Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.Ethical declarationThe study was approved by the institutional review board at each study site. All participants provided their written informed consent to join the study. Informed consent ensures that participants are made aware of what participating would mean for them.FundingThe TROPHY-U-01 study was sponsored by Gilead Sciences, Inc. The funder reviewed and approved this PLSP.