Summary
What is this summary about?
Sacituzumab govitecan (brand name: TRODELVY®) is a new treatment being studied for people with a type of bladder cancer, called urothelial cancer, that has progressed to a locally advanced or metastatic stage. Locally advanced and metastatic urothelial cancer are usually treated with platinum-based chemotherapy. Metastatic urothelial cancer is also treated with immune checkpoint inhibitors. There are few treatment options for people whose cancer gets worse after receiving these treatments. Sacituzumab govitecan is a suitable treatment option for most people with urothelial cancer because it aims to deliver an anti-cancer drug directly to the cancer in an attempt to limit the potential harmful side effects on healthy cells. This is a summary of a clinical study called TROPHY-U-01, focusing on the first group of participants, referred to as Cohort 1. All participants in Cohort 1 received sacituzumab govitecan.
What are the key takeaways?
All participants received previous treatments for their metastatic urothelial cancer, including a platinum-based chemotherapy and a checkpoint inhibitor. The tumor in 31 of 113 participants became significantly smaller or could not be seen on scans after sacituzumab govitecan treatment; an effect that lasted for a median of 7.2 months. Half of the participants were still alive 5.4 months after starting treatment, without their tumor getting bigger or spreading further. Half of them were still alive 10.9 months after starting treatment regardless of tumor size changes. Most participants experienced side effects. These side effects included lower levels of certain types of blood cells, sometimes with a fever, and loose or watery stools (diarrhea). Side effects led 7 of 113 participants to stop taking sacituzumab govitecan.
What were the main conclusions reported by the researchers?
The study showed that sacituzumab govitecan had significant anti-cancer activity. Though most participants who received sacituzumab govitecan experienced side effects, these did not usually stop participants from continuing sacituzumab govitecan. Doctors can help control these side effects using treatment guidelines, but these side effects can be serious.
Clinical Trial Registration: NCT03547973 (ClinicalTrials.gov) (TROPHY-U-1)
Keywords: : bladder, chemotherapy, clinical trials, immunotherapy, metastasis, molecular oncology, sacituzumab govitecan, targeted therapy, urologic, urothelial carcinoma
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Acknowledgments
The authors thank the participants and their caregivers for their participation and commitment to clinical research. The authors also thank the dedicated study investigators and their devoted team members who participated in the TROPHY-U-01 study.
Financial disclosure
The TROPHY-U-01 study was sponsored by Gilead Sciences, Inc. The study was approved by the institutional review board at each study site. All participants provided written informed consent. 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.
Competing interests disclosure
Y Loriot: Honoraria: Sanofi, Pfizer. Consulting or Advisory Role: Janssen, Astellas Pharma, Roche, AstraZeneca, MSD Oncology, MSD Oncology, Seattle Genetics, Bristol Myers Squibb, Immunomedics, Taiho Pharmaceutical. Research Funding: Sanofi, Janssen Oncology, MSD Oncology, AstraZeneca, Clovis Oncology, Exelixis, Boehringer Ingelheim, Incyte, Pfizer, Oncogenex, Medivation, CureVac, Nektar. Travel, Accommodations, Expenses: Astellas Pharma, Janssen Oncology, Roche, MSD Oncology, AstraZeneca, Seattle Genetics. A Rezazadeh: Stock and Other Ownership Interests: ECOM Medical. Consulting or Advisory Role: Exelixis, AstraZeneca, Bayer, Pfizer, Novartis, Genentech, Bristol Myers Squibb, EMD Serono, Immunomedics, Gilead Sciences. Speakers' Bureau: Janssen, Astellas Medivation, Pfizer, Novartis, Sanofi, Genentech/Roche, Eisai, AstraZeneca, Bristol Myers Squibb, Amgen, Exelixis, EMD Serono, Merck, Seattle Genetics/Astellas, Myovant Sciences, Gilead Sciences, AVEO. Research Funding: Genentech, Exelixis, Janssen, AstraZeneca, Bayer, Bristol Myers Squibb, Eisai, Macrogenics, Astellas Pharma, BeyondSpring Pharmaceuticals, BioClin Therapeutics, Clovis Oncology, Bavarian Nordic, Seattle Genetics, Immunomedics, Epizyme. Travel, Accommodations, Expenses: Genentech, Prometheus, Astellas Medivation, Janssen, Eisai, Bayer, Pfizer, Novartis, Exelixis, AstraZeneca. A Flechon: Honoraria: MSD Oncology, AstraZeneca, Bristol Myers Squibb, Janssen-Cilag, Astellas Pharma, Pfizer, Sanofi/Aventis, Roche/Genentech, Bayer, Ipsen, AAA HealthCare. Travel, Accommodations, Expenses: Astellas Pharma, Sanofi/Aventis, Janssen-Cilag, Bayer, Pfizer, Ipsen, Bristol Myers Squibb, AstraZeneca, MSD Oncology, Roche/Genentech, AAA HealthCare. R Jain: Honoraria: DAVA Oncology, Curio Science, FLASCO. Consulting or Advisory Role: BMS, EMD Serono, Gilead, Seattle Genetics, AVEO, Sanofi. Speakers' Bureau: Seattle Genetics. Research Funding: BMS, Gilead, CTEP. S Gupta: Stock and Other Ownership Interests: Salarius Pharmaceuticals (family member). Research Funding: Mirati Therapeutics, Novartis, Pfizer, Viralytics, Hoosier Cancer Research Network, Rexahn Pharmaceuticals, Five Prime Therapeutics, Incyte, MedImmune, Merck, Bristol Myers Squibb, Clovis Oncology, LSK BioPharma, QED Therapeutics, Daiichi Sankyo/Lilly, Immunocore, Seattle Genetics, Acrotech, Astra Zeneca. Travel: QED Therapeutics. M Bupathi: Honoraria: Bristol Myers Squibb, Exelixis, AstraZeneca, Pfizer, Astellas Pharma. Consulting or Advisory Role: Bristol Myers Squibb, AstraZeneca, Exelixis. Speakers' Bureau: AstraZeneca, Bristol Myers Squibb, Pfizer, Exelixis, Astellas Pharma. P Beuzeboc: Honoraria: MSD, Astellas, Zeneca, Bayer, Janssen. Travel: MSD, Pfizer, Gilead. P Palmbos: Research Funding: Roche, Immunomedics. A Balar: Honoraria: Merck, Genentech/Roche, AstraZeneca/MedImmune. Consulting or Advisory Role: Immunomedics, Bristol Myers Squibb, Genentech/Roche, Merck, Cerulean Pharma, AstraZeneca/MedImmune, Pfizer/EMD, Serono, Incyte, Seattle Genetics/Astellas, Nektar, Dragonfly Therapeutics, GlaxoSmithKline. Research Funding: Immunomedics, Merck, Genentech/Roche, AstraZeneca/MedImmune, Seattle Genetics. C Kyriakopoulos: Consulting or Advisory Role: Exelixis, Sanofi, AVEO, EMD Serono, Janssen Oncology. Research Funding: Sanofi. D Pouessel: Honoraria: Ipsen, Janssen Oncology, Bristol Myers Squibb, AstraZeneca, Merck, Astellas Pharma. Consulting or Advisory Role: Astellas Pharma, AstraZeneca, Janssen Oncology, Pfizer, Sanofi. Research Funding: Incyte, Merck Sharp & Dohme, Roche, Bristol Myers Squibb, AstraZeneca, Janssen Oncology, Seattle Genetics. Travel, Accommodations, Expenses: Janssen Oncology, AstraZeneca, Pfizer. C Sternberg: Consulting or Advisory Role: BMS, MSD, Pfizer, Roche-Genentech, Incyte, AstraZeneca, Merck, Medscape, UroToday, Astellas Pharma, Sanofi-Genzyme, Immunomedics (now Gilead), Foundation Medicine, CCO Clinical, Janssen, NCI. Research Funding: Pfizer, MSD, Astellas, BMS, Immunomedics (now Gilead), Arvinas, Mirati. J Tonelli: Employment: Gilead Sciences. M Sierecki: Stock and Other Ownership Interests: Gilead Sciences, Bayer HealthCare Pharmaceuticals. Employment: Gilead Sciences. H Zhou: Stock and Other Ownership Interests: Gilead Sciences. Employment: Gilead Sciences. P Grivas: Consulting or Advisory Role: 4D Pharma, Aadi Bioscience, Asieris Pharmaceuticals, Astellas, AstraZeneca, BostonGene, Bristol Myers Squibb, CG Oncology, Dyania Health, Exelixis, Fresenius Kabi, G1 Therapeutics, Genentech, Gilead Sciences, Guardant Health, ImmunityBio, Infinity Pharmaceuticals, Janssen, Lucence, Merck KGaA, Mirati Therapeutics, MSD, Pfizer, PureTech, QED Therapeutics, Regeneron, Roche, Seattle Genetics, Silverback Therapeutics, Strata Oncology, UroGen Pharma. Research Funding: ALX Oncology, Acrivon Therapeutics, Bavarian Nordic, Bristol Myers Squibb, Clovis Oncology, Debiopharm Group, G1 Therapeutics, Gilead Sciences, GSK, Merck KGaA, Mirati Therapeutics, MSD, Pfizer, QED Therapeutics. P Barthélémy: Honoraria: Ipsen, Bristol Myers Squibb, MSD, Astellas Pharma, Janssen-Cilag, Pfizer, Merck KGaA. Consulting or Advisory Role: Ipsen, Bristol Myers Squibb, MSD Oncology, Pfizer, Janssen-Cilag, AstraZeneca, Amgen. Travel, Accommodations, Expenses: Bristol Myers Squibb, Pfizer, Janssen-Cilag, Astellas Pharma, MSD, Ipsen. R Bangs: Consulting or Advisory Role: Bladder Cancer Advocacy Network. Honoraria: The Hope Foundation for Cancer Research. S Tagawa: Consulting or Advisory Role: Medivation, Astellas Pharma, Dendreon, Janssen, Bayer, Genentech, Immunomedics, Karyopharm Therapeutics, AbbVie, Tolmar, QED Therapeutics, Amgen, Sanofi, Pfizer, Clovis Oncology, Novartis, Genomic Health, POINT Biopharma, Blue Earth Diagnostics, Seattle Genetics, AIkido Pharma, Teliz, Convergent Therapeutics, EMD Serono, Myovant, Merck, Daiichi Sankyo, TransThera, Regeneron. Research Funding: Lilly, Sanofi, Janssen, Astellas Pharma, Progenics, Millennium, Amgen, Bristol Myers Squibb, Dendreon, Rexahn Pharmaceuticals, Bayer, Genentech, Newlink Genetics, Inovio Pharmaceuticals, AstraZeneca, Immunomedics, Novartis, AVEO, Boehringer Ingelheim, Merck, Stem CentRx, Karyopharm Therapeutics, AbbVie, Medivation, Endocyte, Exelixis, Clovis Oncology, Seagen, Novartis, Gilead, POINT Biopharma, Ambrx, Clarity. Travel, Accommodations, Expenses: Sanofi, Immunomedics, Amgen. Uncompensated Relationships: ATLAB Pharma, Phosplatin Therapeutics. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.
Writing disclosure
Catherine Bowe, PhD, of Parexel provided medical writing support, which was funded by Gilead Sciences, Inc., in accordance with Good Publication Practice (GPP 2022) guidelines.