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2. A Phase 2 Study of Sitravatinib in Combination with Nivolumab in Patients with Advanced or Metastatic Urothelial Carcinoma

Author

Msaouel, Pavlos, Sweis, Randy F., Bupathi, Manojkumar, Heath, Elisabeth, Goodman, Oscar B., Jr, Hoimes, Christopher J., Milowsky, Matthew I., Davis, Nancy, Kalebasty, Arash Rezazadeh, Picus, Joel, Shaffer, David, Mao, Shifeng, Adra, Nabil, Yorio, Jeffrey, Gandhi, Sunil, Grivas, Petros, Siefker-Radtke, Arlene, Yang, Rui, Latven, Lisa, Olson, Peter, Chin, Curtis D., Der-Torossian, Hirak, Mortazavi, Amir, and Iyer, Gopa

Published
2024
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3. Association of the Time to Immune Checkpoint Inhibitor (ICI) Initiation and Outcomes With Second Line ICI in Patients With Advanced Urothelial Carcinoma

Author

Talukder, Rafee, Makrakis, Dimitrios, Lin, Genevieve Ihsiu, Diamantopoulos, Leonidas N., Dawsey, Scott, Gupta, Shilpa, Carril-Ajuria, Lucia, Castellano, Daniel, de Kouchkovsky, Ivan, Jindal, Tanya, Koshkin, Vadim S., Park, Joseph J., Alva, Ajjai, Bilen, Mehmet A., Stewart, Tyler F., McKay, Rana R., Tripathi, Nishita, Agarwal, Neeraj, Vather-Wu, Naomi, Zakharia, Yousef, Morales-Barrera, Rafael, Devitt, Michael E., Cortellini, Alessio, Fulgenzi, Claudia Angela Maria, Pinato, David J., Nelson, Ariel, Hoimes, Christopher J., Gupta, Kavita, Gartrell, Benjamin A., Sankin, Alex, Tripathi, Abhishek, Zakopoulou, Roubini, Bamias, Aristotelis, Murgic, Jure, Fröbe, Ana, Rodriguez-Vida, Alejo, Drakaki, Alexandra, Liu, Sandy, Lu, Eric, Kumar, Vivek, Lorenzo, Giuseppe Di, Joshi, Monika, Isaacsson-Velho, Pedro, Buznego, Lucia Alonso, Duran, Ignacio, Moses, Marcus, Barata, Pedro, Sonpavde, Guru, Wright, Jonathan L., Yu, Evan Y., Montgomery, Robert Bruce, Hsieh, Andrew C., Grivas, Petros, and Khaki, Ali Raza

Published
2022
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4. Association Between Sites of Metastasis and Outcomes With Immune Checkpoint Inhibitors in Advanced Urothelial Carcinoma

Author

Makrakis, Dimitrios, Talukder, Rafee, Lin, Genevieve Ihsiu, Diamantopoulos, Leonidas N., Dawsey, Scott, Gupta, Shilpa, Carril-Ajuria, Lucia, Castellano, Daniel, de Kouchkovsky, Ivan, Koshkin, Vadim S., Park, Joseph J., Alva, Ajjai, Bilen, Mehmet A., Stewart, Tyler F., McKay, Rana R., Tripathi, Nishita, Agarwal, Neeraj, Vather-Wu, Naomi, Zakharia, Yousef, Morales-Barrera, Rafael, Devitt, Michael E., Cortellini, Alessio, Fulgenzi, Claudia Angela Maria, Pinato, David J., Nelson, Ariel, Hoimes, Christopher J., Gupta, Kavita, Gartrell, Benjamin A., Sankin, Alex, Tripathi, Abhishek, Zakopoulou, Roubini, Bamias, Aristotelis, Murgic, Jure, Fröbe, Ana, Rodriguez-Vida, Alejo, Drakaki, Alexandra, Liu, Sandy, Lu, Eric, Kumar, Vivek, Lorenzo, Giuseppe Di, Joshi, Monika, Isaacsson-Velho, Pedro, Buznego, Lucia Alonso, Duran, Ignacio, Moses, Marcus, Jang, Albert, Barata, Pedro, Sonpavde, Guru, Yu, Evan Y., Montgomery, Robert Bruce, Grivas, Petros, and Khaki, Ali Raza

Published
2022
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5. Response and Outcomes to Immune Checkpoint Inhibitors in Advanced Urothelial Cancer Based on Prior Intravesical Bacillus Calmette-Guerin

Author

Talukder, Rafee, Makrakis, Dimitrios, Diamantopoulos, Leonidas N., Carril-Ajuria, Lucia, Castellano, Daniel, De Kouchkovsky, Ivan, Koshkin, Vadim S., Park, Joseph J., Alva, Ajjai, Bilen, Mehmet A., Stewart, Tyler F., McKay, Rana R., Santos, Victor S., Agarwal, Neeraj, Jain, Jayanshu, Zakharia, Yousef, Morales-Barrera, Rafael, Devitt, Michael E., Grant, Michael, Lythgoe, Mark P., Pinato, David J., Nelson, Ariel, Hoimes, Christopher J., Shreck, Evan, Gartrell, Benjamin A., Sankin, Alex, Tripathi, Abhishek, Zakopoulou, Roubini, Bamias, Aristotelis, Murgic, Jure, Fröbe, Ana, Rodriguez-Vida, Alejo, Drakaki, Alexandra, Liu, Sandy, Kumar, Vivek, Lorenzo, Giuseppe Di, Joshi, Monika, Velho, Pedro Isaacsson, Buznego, Lucia Alonso, Duran, Ignacio, Moses, Marcus, Barata, Pedro, Sonpavde, Guru, Yu, Evan Y., Wright, Jonathan L., Grivas, Petros, and Khaki, Ali Raza

Published
2022
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8. Patient-Reported Outcomes in Patients With Advanced Urothelial Cancer Who Are Ineligible for Cisplatin and Treated With First-Line Enfortumab Vedotin Alone or With Pembrolizumab.

Author

Milowsky, Matthew I., O'Donnell, Peter H., Hoimes, Christopher J., Petrylak, Daniel P., Flaig, Thomas W., Moon, Helen H., Friedlander, Terence W., Mar, Nataliya, McKay, Rana R., Srinivas, Sandy, Gravis, Gwenaelle, Ramamurthy, Chethan, Bupathi, Manojkumar, Bracarda, Sergio, Wright, Phoebe, Hepp, Zsolt, Carret, Anne-Sophie, Yu, Yao, Dillon, Ryan, and Kataria, Ritesh

Published
2024
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9. Myeloid-derived suppressors cells (MDSC) correlate with clinicopathologic factors and pathologic complete response (pCR) in patients with urothelial carcinoma (UC) undergoing cystectomy

Author

Ornstein, Moshe C., Diaz-Montero, Claudia Marcela, Rayman, Patricia, Elson, Paul, Haywood, Samuel, Finke, James H., Kim, Jin S., Pavicic, Paul G., Jr, Lamenza, Marcelo, Devonshire, Sarah, Dann, Priscilla, Schach, Kim, Stephenson, Andrew, Campbell, Steven, Emamekhoo, Hamid, Ernstoff, Marc S., Hoimes, Christopher J., Gilligan, Timothy D., Rini, Brian I., Garcia, Jorge A., and Grivas, Petros

Published
2018
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10. New phase 1 SURPASS trial cohort: Early-line ADP-A2M4CD8 T-cell receptor T-cell therapy plus pembrolizumab in urothelial carcinoma.

Author

Aggen, David H, Garcia, Alejandro, Saro Suarez, Jose M, Sauer, Amy, Cristiani, Sebastiano, Brophy, Francine Elizabeth, Streets, Sharon, Norry, Elliot, Nelson, Ariel Ann, Kilari, Deepak, Garmezy, Benjamin, Charlson, John A., Zugazagoitia, Jon, Calvo, Emiliano, Moreno, Irene, Moreno, Victor, Hoimes, Christopher J., Hong, David S., and Cervantes, Andres

Published
2024
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11. Outcomes with enfortumab vedotin in patients with advanced urothelial carcinoma and histology variants: Analysis of the UNITE study.

Author

Jindal, Tanya, Jiang, Cindy Y., Alhalabi, Omar, Nguyen, Charles B, Nizam, Amanda, Basu, Arnab, Bilen, Mehmet Asim, Zakharia, Yousef, Milowsky, Matthew I., Brown, Jason R, Kilari, Deepak, Emamekhoo, Hamid, Hoimes, Christopher J., Khaki, Ali Raza, Gupta, Shilpa, Grivas, Petros, Bellmunt, Joaquim, Campbell, Matthew T, Alva, Ajjai Shivaram, and Koshkin, Vadim S

Published
2024
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12. Impact of squamous histology on outcomes with enfortumab vedotin in patients with advanced urothelial carcinoma: Analysis of the UNITE study.

Author

Jindal, Tanya, Alhalabi, Omar, Nguyen, Charles B, Bakaloudi, Dimitra Rafailia, Nizam, Amanda, Bilen, Mehmet Asim, Basu, Arnab, Zakharia, Yousef, Milowsky, Matthew I., Brown, Jason R, Kilari, Deepak, Shah, Sumit, Emamekhoo, Hamid, Grivas, Petros, Hoimes, Christopher J., Gupta, Shilpa, Bellmunt, Joaquim, Campbell, Matthew T, Alva, Ajjai Shivaram, and Koshkin, Vadim S

Published
2024
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13. Sequencing of erdafitinib (erda) and enfortumab vedotin (EV) in patients (pts) with fibroblast growth factor receptor (FGFR2/3) altered (alt) advanced urothelial cancer (aUC): Analysis of UNITE database.

Author

Jiang, Cindy Y., Hwang, Hyunsoo, Jindal, Tanya, Qiao, Wei, Epstein, Ilana, Nguyen, Charles B, Gupta, Shilpa, Shah, Sumit, Bilen, Mehmet Asim, Milowsky, Matthew I., Hoimes, Christopher J., Kilari, Deepak, Zakharia, Yousef, Emamekhoo, Hamid, Grivas, Petros, Bellmunt, Joaquim, Alva, Ajjai Shivaram, Koshkin, Vadim S, Campbell, Matthew T, and Alhalabi, Omar

Published
2024
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14. Extended follow-up report of a randomized phase II trial comparing gemcitabine and cisplatin with or without berzosertib in patients with advanced urothelial carcinoma.

Author

Parikh, Mamta, Pal, Sumanta Kumar, Frankel, Paul Henry, Ruel, Christopher, Mortazavi, Amir, Milowsky, Matthew I., Vaishampayan, Ulka N., Lyou, Yung, Wang, Peng, Parikh, Rahul Atul, Teply, Benjamin A., Dreicer, Robert, Emamekhoo, Hamid, Michaelson, Dror Dror, Hoimes, Christopher J., Zhang, Tian, Srinivas, Sandy, Kim, William Y., Liu, Glenn, and Lara, Primo N

Published
2024
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15. Outcomes in patients (pts) with advanced urothelial carcinoma (aUC) treated with enfortumab vedotin (EV) after switch maintenance avelumab (MAv) in the UNITE study.

Author

Nizam, Amanda, Jindal, Tanya, Jiang, Cindy Y., Alhalabi, Omar, Bakaloudi, Dimitra Rafailia, Talukder, Rafee, Davidsohn, Matthew P., Nguyen, Charles B, Oh, Eugene, Taylor, Amy K, Lemke, Emily, Kilari, Deepak, Hoimes, Christopher J., Emamekhoo, Hamid, Gupta, Shilpa, Bellmunt, Joaquim, Grivas, Petros, Campbell, Matthew T, Alva, Ajjai Shivaram, and Koshkin, Vadim S

Published
2024
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19. Assessing the utility of molecular diagnostic classification for cancers of unknown primary.

Author

Moore, Elle C., Blobe, Gerard C., DeVito, Nicholas C., Hanks, Brent A., Harrison, Michael R., Hoimes, Christopher J., Jia, Jingquan, Morse, Michael A., Jayaprakasan, Parvathy, MacKelfresh, Andrew, Mulder, Hillary, Hockenberry, Adam J., Zander, Alia, Stumpe, Martin C., Michuda, Jackson, Beauchamp, Kyle A., Perakslis, Eric, Taxter, Timothy, and George, Daniel J.

Subjects
CANCER of unknown primary origin, TUMOR classification, TREATMENT effectiveness
Abstract

Background: Roughly 5% of metastatic cancers present with uncertain origin, for which molecular classification could influence subsequent management; however, prior studies of molecular diagnostic classifiers have reported mixed results with regard to clinical impact. In this retrospective study, we evaluated the utility of a novel molecular diagnostic classifier by assessing theoretical changes in treatment and additional testing recommendations from oncologists before and after the review of classifier predictions. Methods: We retrospectively analyzed de‐identified records from 289 patients with a consensus diagnosis of cancer of uncertain/unknown primary (CUP). Two (or three, if adjudication was required) independent oncologists separately reviewed patient clinical information to determine the course of treatment before they reviewed results from the molecular diagnostic classifier and subsequently evaluated whether the predicted diagnosis would alter their treatment plan. Results: Results from the molecular diagnostic classifier changed the consensus oncologist‐reported treatment recommendations for 235 out of 289 patients (81.3%). At the level of individual oncologist reviews (n = 414), 64.7% (n = 268) of treatment recommendations were based on CUP guidelines prior to review of results from the molecular diagnostic classifier. After seeing classifier results, 98.1% (n = 207) of the reviews, where treatment was specified (n = 211), were guided by the tissue of origin‐specific guidelines. Overall, 89.9% of the 414 total reviews either expressed strong agreement (n = 242) or agreement (n = 130) that the molecular diagnostic classifier result increased confidence in selecting the most appropriate treatment regimen. Conclusions: A retrospective review of CUP cases demonstrates that a novel molecular diagnostic classifier could affect treatment in the majority of patients, supporting its clinical utility. Further studies are needed to prospectively evaluate whether the use of molecular diagnostic classifiers improves clinical outcomes in CUP patients. [ABSTRACT FROM AUTHOR]

Published
2023
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21. Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer.

Author

O'Donnell, Peter H., Milowsky, Matthew I., Petrylak, Daniel P., Hoimes, Christopher J., Flaig, Thomas W., Mar, Nataliya, Moon, Helen H., Friedlander, Terence W., McKay, Rana R., Bilen, Mehmet A., Srinivas, Sandy, Burgess, Earle F., Ramamurthy, Chethan, George, Saby, Geynisman, Daniel M., Bracarda, Sergio, Borchiellini, Delphine, Geoffrois, Lionnel, Maroto Rey, Jose Pablo, and Ferrario, Christiano

Published
2023
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24. Efficacy and Safety of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma: Updated Results From a Phase 1/2 Open-label Study

Author

Powles, Thomas, OʼDonnell, Peter H., Massard, Christophe, Arkenau, Hendrik-Tobias, Friedlander, Terence W., Hoimes, Christopher J., Lee, Jae Lyun, Ong, Michael, Sridhar, Srikala S., Vogelzang, Nicholas J., Fishman, Mayer N., Zhang, Jingsong, Srinivas, Sandy, Parikh, Jigar, Antal, Joyce, Jin, Xiaoping, Gupta, Ashok K., Ben, Yong, and Hahn, Noah M.

Published
2017
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25. Immune checkpoint inhibitors in advanced upper and lower tract urothelial carcinoma: a comparison of outcomes.

Author

Esagian, Stepan M., Khaki, Ali Raza, Diamantopoulos, Leonidas N., Carril‐Ajuria, Lucia, Castellano, Daniel, De Kouchkovsky, Ivan, Park, Joseph J., Alva, Ajjai, Bilen, Mehmet A., Stewart, Tyler F., McKay, Rana R., Santos, Victor S., Agarwal, Neeraj, Jain, Jayanshu, Zakharia, Yousef, Morales‐Barrera, Rafael, Devitt, Michael E., Nelson, Ariel, Hoimes, Christopher J., and Shreck, Evan

Subjects
IMMUNE checkpoint inhibitors, TRANSITIONAL cell carcinoma, OVERALL survival, TREATMENT effectiveness, PATIENT selection, IPILIMUMAB
Abstract

Objectives: To compare clinical outcomes between patients with locally advanced (unresectable) or metastatic urothelial carcinoma (aUC) in the upper and lower urinary tract receiving immune checkpoint inhibitors (ICIs). Patients and Methods: We performed a retrospective cohort study collecting clinicopathological, treatment, and outcome data for patients with aUC receiving ICIs from 2013 to 2020 across 24 institutions. We compared the objective response rate (ORR), overall survival (OS), and progression‐free survival (PFS) between patients with upper and lower tract UC (UTUC, LTUC). Uni‐ and multivariable logistic and Cox regression were used to assess the effect of UTUC on ORR, OS, and PFS. Subgroup analyses were performed stratified based on histology (pure, mixed) and line of treatment (first line, subsequent line). Results: Out of a total of 746 eligible patients, 707, 717, and 738 were included in the ORR, OS, and PFS analyses, respectively. Our results did not contradict the hypothesis that patients with UTUC and LTUC had similar ORRs (24% vs 28%; adjusted odds ratio [aOR] 0.73, 95% confidence interval [CI] 0.43–1.24), OS (median 9.8 vs 9.6 months; adjusted hazard ratio [aHR] 0.93, 95% CI 0.73–1.19), and PFS (median 4.3 vs 4.1 months; aHR 1.01, 95% CI 0.81–1.27). Patients with mixed‐histology UTUC had a significantly lower ORR and shorter PFS vs mixed‐histology LTUC (aOR 0.20, 95% CI 0.05–0.91 and aHR 1.66, 95% CI 1.06–2.59), respectively). Conclusion: Overall, patients with UTUC and LTUC receiving ICIs have comparable treatment response and outcomes. Subgroup analyses based on histology showed that those with mixed‐histology UTUC had a lower ORR and shorter PFS compared to mixed‐histology LTUC. Further studies and evaluation of molecular biomarkers can help refine patient selection for immunotherapy. [ABSTRACT FROM AUTHOR]

Published
2021
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26. Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303.

Author

Galsky, Matthew D, Hoimes, Christopher J, Necchi, Andrea, Shore, Neal, Witjes, J Alfred, Steinberg, Gary, Bedke, Jens, Nishiyama, Hiroyuki, Fang, Xiao, Kataria, Ritesh, Sbar, Eric, Jia, Xieyang, and Siefker-Radtke, Arlene

Subjects
THERAPEUTIC use of monoclonal antibodies, THERAPEUTIC use of antineoplastic agents, BLADDER tumors, RESEARCH, CLINICAL trials, RESEARCH methodology, MEDICAL cooperation, EVALUATION research, TRANSITIONAL cell carcinoma, COMPARATIVE studies, RANDOMIZED controlled trials, RESEARCH funding, COMBINED modality therapy
Abstract

Muscle-invasive bladder cancer (MIBC) is associated with high rates of recurrence and poor prognosis despite aggressive treatment. Neoadjuvant chemotherapy before radical cystectomy (RC) improves outcomes in cisplatin-eligible patients; however, the improvement in overall survival is modest. Standard of care for cisplatin-ineligible patients remains RC; more effective systemic therapies are needed. Recent Phase Ib/II studies suggest pembrolizumab monotherapy and combination therapy are effective neoadjuvant therapies for MIBC. The randomized Phase III KEYNOTE-866 and KEYNOTE-905/EV-303 studies are being conducted to evaluate efficacy and safety of perioperative pembrolizumab or placebo with chemotherapy in cisplatin-eligible patients with MIBC (KEYNOTE-866) and of pembrolizumab monotherapy versus pembrolizumab plus enfortumab vedotin versus RC plus pelvic lymph node dissection alone in cisplatin-ineligible patients with MIBC (KEYNOTE-905/EV-303). Clinical trial registration: NCT03924856 & NCT03924895 (ClinicalTrials.gov). [ABSTRACT FROM AUTHOR]

Published
2021
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27. Impact of performance status on treatment outcomes: A real-world study of advanced urothelial cancer treated with immune checkpoint inhibitors.

Author

Khaki, Ali Raza, Li, Ang, Diamantopoulos, Leonidas N., Bilen, Mehmet A., Santos, Victor, Esther, John, Morales‐Barrera, Rafael, Devitt, Michael, Nelson, Ariel, Hoimes, Christopher J., Shreck, Evan, Assi, Hussein, Gartrell, Benjamin A., Sankin, Alex, Rodriguez‐Vida, Alejo, Lythgoe, Mark, Pinato, David J., Drakaki, Alexandra, Joshi, Monika, and Isaacsson Velho, Pedro

Subjects
IMMUNE checkpoint inhibitors, TREATMENT effectiveness, ODDS ratio, CANCER chemotherapy, CANCER-related mortality, RESEARCH, RESEARCH methodology, RETROSPECTIVE studies, EVALUATION research, MEDICAL cooperation, SEVERITY of illness index, URINARY organs, CANCER, COMPARATIVE studies, KAPLAN-Meier estimator, RESEARCH funding, IMMUNOTHERAPY, ANTIGENS, PROPORTIONAL hazards models
Abstract

Background: Immune checkpoint inhibitors (ICIs) represent an appealing treatment for patients with advanced urothelial cancer (aUC) and a poor performance status (PS). However, the benefit of ICIs for patients with a poor PS remains unknown. It was hypothesized that a poor Eastern Cooperative Oncology Group (ECOG) PS (≥2 vs 0-1) would correlate with shorter overall survival (OS) in patients receiving ICIs.Methods: In this retrospective cohort study, clinicopathologic, treatment, and outcome data were collected for patients with aUC who were treated with ICIs at 18 institutions (2013-2019). The overall response rate (ORR) and OS were compared for patients with an ECOG PS of 0 to 1 and patients with an ECOG PS ≥ 2 at ICI initiation. The association between a new ICI in the last 30 and 90 days of life (DOL) and death location was also tested.Results: Of the 519 patients treated with ICIs, 395 and 384 were included in OS and ORR analyses, respectively, with 26% and 24% having a PS ≥ 2. OS was higher in those with a PS of 0 to 1 than those with a PS ≥ 2 who were treated in the first line (median, 15.2 vs 7.2 months; hazard ratio [HR], 0.62; P = .01) but not in subsequent lines (median, 9.8 vs 8.2 months; HR, 0.78; P = .27). ORRs were similar for patients with a PS of 0 to 1 and patients with a PS ≥ 2 in both lines. Of the 288 patients who died, 10% and 32% started ICIs in the last 30 and 90 DOL, respectively. ICI initiation in the last 30 DOL was associated with increased odds of death in a hospital (odds ratio, 2.89; P = .04).Conclusions: Despite comparable ORRs, ICIs may not overcome the negative prognostic role of a poor PS, particularly in the first-line setting, and the initiation of ICIs in the last 30 DOL was associated with hospital death location. [ABSTRACT FROM AUTHOR]

Published
2020
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28. Pembrolizumab for Treatment-Refractory Metastatic Castration-Resistant Prostate Cancer: Multicohort, Open-Label Phase II KEYNOTE-199 Study.

Author

Antonarakis, Emmanuel S., Piulats, Josep M., Gross-Goupil, Marine, Goh, Jeffrey, Ojamaa, Kristiina, Hoimes, Christopher J., Vaishampayan, Ulka, Berger, Ranaan, Sezer, Ahmet, Alanko, Tuomo, de Wit, Ronald, Li, Chunde, Omlin, Aurelius, Procopio, Giuseppe, Fukasawa, Satoshi, Tabata, Ken-ichi, Park, Se Hoon, Feyerabend, Susan, Drake, Charles G., and Wu, Haiyan

Published
2020
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29. A plain language summary exploring a new treatment combination for untreated locally advanced or metastatic urothelial cancer: enfortumab vedotin plus pembrolizumab.

Author

Hoimes, Christopher J, Flaig, Thomas W, Milowsky, Matthew I, Friedlander, Terence W, Bilen, Mehmet Asim, Gupta, Shilpa, Srinivas, Sandy, Merchan, Jaime R, McKay, Rana R, Petrylak, Daniel P, Sasse, Carolyn, Moreno, Blanca Homet, Yu, Yao, Carret, Anne-Sophie, and Rosenberg, Jonathan E

Abstract

This summary provides the results of a study of two treatments for cancer, enfortumab vedotin and pembrolizumab, that were studied together against locally advanced or metastatic urothelial cancer (la/mUC), a cancer that occurs most commonly in the bladder. In the 45 patients studied, around 16% did have serious side effects, but most side effects were manageable. Twenty-four percent of patients, however, stopped the study treatment because of their side effects. Within about 2 months of starting treatment, most patients' (73%) tumors were smaller and stayed smaller, on average, for more than 2 years. The combination of enfortumab vedotin plus pembrolizumab is a new treatment option for patients with locally advanced or metastatic urothelial cancer when they cannot receive the typical treatment, cisplatin. Advanced or metastatic urothelial cancer is a type of cancer where the cancer has already spread outside of the bladder or urinary tract. [ABSTRACT FROM AUTHOR]

Published
2024
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30. A phase 1 trial of SGN-CD70A in patients with CD70-positive, metastatic renal cell carcinoma.

Author

Pal, Sumanta K., Forero‐Torres, Andres, Thompson, John A., Morris, John C., Chhabra, Saurabh, Hoimes, Christopher J., Vogelzang, Nicholas J., Boyd, Thomas, Bergerot, Paulo G., Adashek, Jacob J., Li, Hong, Yu, Xuesong, Gartner, Elaina M., Carret, Anne‐Sophie, Smith, David C., Forero-Torres, Andres, and Carret, Anne-Sophie

Subjects
RENAL cell carcinoma, BENZODIAZEPINES, THERAPEUTIC use of immunoglobulins, ANEMIA, CLINICAL trials, DRUG dosage, DRUG toxicity, EDEMA, FATIGUE (Physiology), HETEROCYCLIC compounds, KIDNEY tumors, RESEARCH funding, THROMBOCYTOPENIA, TRANQUILIZING drugs
Abstract

Background: Cluster of differentiation 70 (CD70) is frequently expressed in renal cell carcinoma (RCC) and has immunomodulatory properties. An antibody-drug conjugate targeting CD70, SGN-CD70A, was developed to treat patients with CD70-positive RCC.Methods: The objective of this phase 1, open-label, dose-escalation, multicenter study was to evaluate the safety and tolerability of SGN-CD70A and establish its maximum tolerated dose in patients with CD70-positive, metastatic RCC (mRCC). All subtypes of RCC were permitted, and no limit was set on the number of prior therapies. Safety assessments consisted of monitoring and recording all adverse events (AEs) and dose-limiting toxicities (DLTs). Treatment response was assessed by radiographic tumor evaluation according to the Response Evaluation Criteria for Solid Tumors, version 1.1. A model-based, modified continual-reassessment method was used to estimate the probabilities of DLT and response.Results: The maximum tolerated dose was determined to be 30 μg/kg, with thrombocytopenia as the DLT. The most common AEs were fatigue (67%), anemia (61%), and thrombocytopenia (56%). Of 18 enrolled patients, 1 achieved a partial response and 13 achieved stable disease, for a clinical benefit rate of 78%. Limitations of the study included the heavily pretreated nature of patients, receipt of a median of 4 prior lines of therapy (range, 1-8 prior lines of therapy), and diminishing response potential.Conclusions: The modest antitumor activity of SGN-CD70A does not support its development in mRCC. However, given the high disease control rate in a heavily pretreated population and the modest toxicity profile, CD70 remains of interest because of its immunomodulatory properties. [ABSTRACT FROM AUTHOR]

Published
2019
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31. Characterization of metastatic urothelial carcinoma via comprehensive genomic profiling of circulating tumor DNA.

Author

Agarwal, Neeraj, Pal, Sumanta K., Hahn, Andrew W., Nussenzveig, Roberto H., Pond, Gregory R., Gupta, Sumati V., Wang, Jue, Bilen, Mehmet A., Naik, Gurudatta, Ghatalia, Pooja, Hoimes, Christopher J., Gopalakrishnan, Dharmesh, Barata, Pedro C., Drakaki, Alexandra, Faltas, Bishoy M., Kiedrowski, Lesli A., Lanman, Richard B., Nagy, Rebecca J., Vogelzang, Nicholas J., and Boucher, Kenneth M.

Subjects
METASTASIS, TRANSITIONAL cell carcinoma, GENOMICS, CIRCULATING tumor DNA, CANCER genetics
Abstract

Background: Biomarker-guided clinical trials are increasingly common in metastatic urothelial carcinoma (mUC), yet patients for whom contemporary tumor tissue is not available are not eligible. Technological advancements in sequencing have made cell-free circulating DNA (cfDNA) next-generation sequencing (NGS) readily available in the clinic. The objective of the current study was to determine whether the genomic profile of mUC detected by NGS of cfDNA is similar to historical tumor tissue NGS studies. A secondary objective was to determine whether the frequency of genomic alterations (GAs) differed between lower tract mUC (mLTUC) and upper tract mUC (mUTUC).Methods: Patients from 13 academic medical centers in the United States who had a diagnosis of mUC between 2014 and 2017 and for whom cfDNA NGS results were available were included. cfDNA profiling was performed using a commercially available platform (Guardant360) targeting 73 genes.Results: Of 369 patients with mUC, 294 were diagnosed with mLTUC and 75 with mUTUC. A total of 2130 GAs were identified in the overall mUC cohort: 1610 and 520, respectively, in the mLTUC and mUTUC cohorts. In the mLTUC cohort, frequently observed GAs were similar between cfDNA NGS and historical tumor tissue studies, including tumor protein p53 (TP53) (P = 1.000 and .115, respectively), AT-rich interaction domain 1A (ARID1A) (P = .058 and .058, respectively), phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) (P = .058 and .067, respectively), erb-b2 receptor tyrosine kinase 2 (ERBB2) (P = .565 and .074, respectively), and fibroblast growth factor receptor 3 (FGFR3) (P = .164 and .014, respectively). No significant difference was observed with regard to the frequency of GAs between patients with mLTUC and mUTUC.Conclusions: Among patients with mUC for whom no tumor tissue was available, cfDNA NGS was able to identify a similar profile of GAs for biomarker-driven clinical trials compared with tumor tissue. Despite the more aggressive clinical course, cases of mUTUC demonstrated a circulating tumor DNA genomic landscape that was similar to that of mLTUC. Cancer 2018;124:2115-24. © 2018 American Cancer Society. [ABSTRACT FROM AUTHOR]

Published
2018
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32. Randomized placebo-controlled trial of intravenous vitamin C plus docetaxel in metastatic prostate cancer.

Author

Paller, Channing Judith, Zahurak, Marianna, Heath, Elisabeth I., Kelly, William Kevin, Hoimes, Christopher J., Taksey, Jason David, Marshall, Catherine Handy, Markowski, Mark Christopher, Barata, Pedro C., Rudek, Michelle A., Nauroth, Julie, Wang, Lin, Durham, Jennifer N., Eisenberger, Mario A., Carducci, Michael Anthony, Denmeade, Samuel R., and Levine, Mark

Published
2023
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33. Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients (pts) with muscle invasive bladder cancer (MIBC): Updated results for Cohort H.

Author

Flaig, Thomas W., Rosenberg, Jonathan E., Hoimes, Christopher J., O'Donnell, Peter H., Mar, Nataliya, Gourdin, Theodore Stewart, Henry, Stephanie, Bilen, Mehmet Asim, George, Saby, Barata, Pedro C., Srinivas, Sandy, Rao, Santosh Keshay, Assikis, Vasily J., Burgess, Earle F, Ramamurthy, Chethan, Haas, Gabriel P., Lukas, Jason Jerome, Mildiner-Earley, Shirly, Yu, Yao, and Petrylak, Daniel P.

Published
2023
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34. Independent biomarkers predictive of outcomes with enfortumab vedotin (EV) in patients (pts) with advanced urothelial carcinoma (aUC): Analysis of the UNITE study.

Author

Jindal, Tanya, Zhang, Li, Jiang, Cindy, Kilari, Deepak, Alhalabi, Omar, Nizam, Amanda, Basu, Arnab, Bilen, Mehmet Asim, Zakharia, Yousef, Milowsky, Matthew I., Shah, Sumit, Hoimes, Christopher J., Davis, Nancy B., Gupta, Shilpa, Emamekhoo, Hamid, Grivas, Petros, Bellmunt, Joaquim, Campbell, Matthew T, Alva, Ajjai Shivaram, and Koshkin, Vadim S

Published
2023
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35. Enfortumab vedotin (EV) with or without pembrolizumab (P) in patients (pts) who are cisplatin-ineligible with previously untreated locally advanced or metastatic urothelial cancer (la/mUC): Additional 3-month follow-up on cohort K data.

Author

Friedlander, Terence W., Milowsky, Matthew I., O'Donnell, Peter H., Petrylak, Daniel P., Hoimes, Christopher J., Flaig, Thomas W., Mar, Nataliya, Moon, Helen H, McKay, Rana R., Bilen, Mehmet Asim, Borchiellini, Delphine, Iafolla, Marco, Carret, Anne-Sophie, Yu, Yao, Guseva, Maria, Kataria, Ritesh S., and Rosenberg, Jonathan E.

Published
2023
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36. Phase 2 study of batiraxcept (AVB-S6-500, an AXL inhibitor) as monotherapy, in combination with cabozantinib (cabo), and in combination with cabo and nivolumab (nivo) in patients with advanced clear cell renal cell carcinoma (ccRCC).

Author

Beckermann, Katy, Campbell, Matthew T, Haas, Naomi B., Ornstein, Moshe Chaim, Gao, Xin, Mao, Shifeng S., Hammers, Hans J., George, Saby, Nelson, Ariel Ann, Gourdin, Theodore Stewart, Keshava-Prasad, Holavanahalli, Hussain, Arif, Hoimes, Christopher J., Yan, Hongxia, Esquibel, Vanessa, McIntyre, Gail, Geller, Robert B., Voss, Martin H, Rini, Brian I., and Shah, Neil J.

Published
2023
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37. Study EV-103 dose escalation/cohort A: Long-term outcome of enfortumab vedotin + pembrolizumab in first-line (1L) cisplatin-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC) with nearly 4 years of follow-up.

Author

Gupta, Shilpa, Rosenberg, Jonathan E., McKay, Rana R., Flaig, Thomas W., Petrylak, Daniel P., Hoimes, Christopher J., Friedlander, Terence W., Bilen, Mehmet Asim, Srinivas, Sandy, Burgess, Earle F, Merchan, Jaime R., Tagawa, Scott T., Brown, Jason R, Yu, Yao, Carret, Anne-Sophie, Wirtz, Heidi, Guseva, Maria, Homet Moreno, Blanca, and Milowsky, Matthew I.

Published
2023
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38. Association of tumor-informed minimal residual disease (MRD) with clinical outcomes for muscle invasive bladder cancer (MIBC): A multicenter retrospective real-world analysis.

Author

Kommalapati, Ajitha, Laliotis, George, Glover, Michael, Selig, Grayce, Kollipara, Revathi, Mahmood, Tamara, Shah, Sumit, Hoimes, Christopher J., Stewart, Tyler F., Sharma, Shruti, Malhotra, Meenakshi, Pajak, Natalia, Calhoun, Mark, ElNaggar, Adam, Liu, Minetta C., Basu, Arnab, Galsky, Matt D., and Tan, Alan

Published
2023
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40. Enfortumab vedotin (EV) outcomes with and without immediate prior immune checkpoint inhibitor (ICI) in patients (pts) with advanced urothelial carcinoma (aUC).

Author

Koshkin, Vadim S, Henderson, Nicholas, Kilari, Deepak, Jindal, Tanya, Alhalabi, Omar, Freeman, Dory, Basu, Arnab, Barata, Pedro C., Bilen, Mehmet Asim, Zakharia, Yousef, Emamekhoo, Hamid, Shah, Sumit, Milowsky, Matthew I., Davis, Nancy B., Gupta, Shilpa, Hoimes, Christopher J., Grivas, Petros, Bellmunt, Joaquim, Campbell, Matthew T, and Alva, Ajjai Shivaram

Published
2023
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41. Enfortumab vedotin (EV) alone or in combination with pembrolizumab (P) in previously untreated cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer (la/mUC): Subgroup analyses of confirmed objective response rate (cORR)...

Author

O'Donnell, Peter H., Rosenberg, Jonathan E., Hoimes, Christopher J., Petrylak, Daniel P., Milowsky, Matthew I., McKay, Rana R., Srinivas, Sandy, Friedlander, Terence W., Ramamurthy, Chethan, Bilen, Mehmet Asim, Burgess, Earle F, Mar, Nataliya, Moon, Helen, Geynisman, Daniel M., George, Saby, Carret, Anne-Sophie, Yu, Yao, Guseva, Maria, Homet Moreno, Blanca, and Flaig, Thomas W.

Published
2023
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42. Biomarkers of response to enfortumab vedotin (EV) in patients (pts) with advanced urothelial carcinoma (aUC): Analysis of the UNITE study.

Author

Jindal, Tanya, Kilari, Deepak, Alhalabi, Omar, Nizam, Amanda, Khaki, Ali Raza, Basu, Arnab, Barata, Pedro C., Bilen, Mehmet Asim, Shah, Sumit, Zakharia, Yousef, Milowsky, Matthew I., Bellmunt, Joaquim, Emamekhoo, Hamid, Davis, Nancy B., Grivas, Petros, Gupta, Shilpa, Hoimes, Christopher J., Campbell, Matthew T, Alva, Ajjai Shivaram, and Koshkin, Vadim S

Published
2023
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44. Patient-reported outcomes (PROs) in cisplatin-ineligible patients (pts) with locally advanced or metastatic urothelial cancer (la/mUC) treated with enfortumab vedotin (EV) alone or in combination with pembrolizumab (P) in the phase 1b/2 EV-103 Cohort...

Author

Milowsky, Matthew I., O'Donnell, Peter H., Hoimes, Christopher J., Petrylak, Daniel P., Flaig, Thomas W., Moon, Helen H, Friedlander, Terence W., Mar, Nataliya, McKay, Rana R., Srinivas, Sandy, Gravis, Gwenaelle, Ramamurthy, Chethan, Bupathi, Manojkumar, Bracarda, Sergio, Wright, Phoebe, Carret, Anne-Sophie, Yu, Yao, Matsuda, Tara, Kataria, Ritesh S., and Rosenberg, Jonathan E.

Published
2023
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45. Redefining hormone resistance in prostate cancer.

Author

Hoimes, Christopher J. and Kelly, W. Kevin

Abstract

Prostate cancer relies on signaling through the androgen receptor (AR) for maintenance and progression; and androgen-deprivation therapy remains a cornerstone of treatment for advanced prostate cancer. An effective clinical classification of prostate cancer should account for the extent of the disease as well as the mechanisms that are driving the growth of the tumor. The previous terms hormone-sensitive and hormone-refractory described response to treatment. It has become clear that these terms do not reflect the mechanism of disease relapse; however over the last decade there has been a better understanding of androgen-receptor mediated signaling effects and incomplete suppression of androgens in prostate cancer. The Prostate Cancer Clinical Trials Working Group 2 (PCWG2) now recommends addressing the spectrum of clinical states based on castration status as this ligand-centered terminology can more accurately describe the patients’ disease, and ultimately provides a useful framework for patient management and drug development. Optimized use of androgen-deprivation therapy, low molecular weight inhibitors of adrenal androgen biosynthesis, and new AR antagonists are promising new therapeutics that can further define the meaning of castrate state. As hormone resistance is redefined to include patients that are refractory to treatments that ablate adrenal and in situ tumoral androgens, a meaningful new clinical state in patients will be forged. We propose a model for incorporating these patients into the current PCWG2 conceptualization of the disease. [ABSTRACT FROM PUBLISHER]

Published
2010
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47. Novel therapies are changing treatment paradigms in metastatic prostate cancer.

Author

Powers, Eric, Karachaliou, Georgia Sofia, Kao, Chester, Harrison, Michael R., Hoimes, Christopher J., George, Daniel J., Armstrong, Andrew J., and Zhang, Tian

Subjects
CASTRATION-resistant prostate cancer, POLY(ADP-ribose) polymerase, PROSTATE cancer, METASTASIS
Abstract

Metastatic castration-resistant prostate cancer (mCRPC) remains a terminal diagnosis with an aggressive disease course despite currently approved therapeutics. The recent successful development of poly ADP-ribose polymerase (PARP) inhibitors for patients with mCRPC and mutations in DNA damage repair genes has added to the treatment armamentarium and improved personalized treatments for prostate cancer. Other promising therapeutic agents currently in clinical development include the radiotherapeutic 177-lutetium-prostate-specific membrane antigen (PSMA)-617 targeting PSMA-expressing prostate cancer and combinations of immunotherapy with currently effective treatment options for prostate cancer. Herein, we have highlighted the progress in systemic treatments for mCRPC and the promising agents currently in ongoing clinical trials. [ABSTRACT FROM AUTHOR]

Published
2020
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48. Editorial Comment.

Author

Hoimes, Christopher J. and Madabhushi, Anant

Subjects
*EDITORIAL boards, *PERIODICAL editors, *PERIODICAL publishing, *PUBLISHING, *PERIODICAL articles, *MAGNETIC resonance imaging, *PROSTATE tumors, *PROSTATE-specific antigen, *DIAGNOSIS
Published
2016
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50. Myeloid derived suppressor cells (MDSC) correlate with inflammatory biomarkers in metastatic urothelial carcinoma (mUC).

Author

Grivas, Petros, Diaz-Montero, C. Marcela, Rayman, Patricia A., Elson, Paul, Haywood, Samuel, Sub Kim, Jin, Pavicic, Paul G, Finke, James, Rini, Brian I., Stephenson, Andrew J., Lamenza, Marcelo, Dann, Priscilla, Schach, Kim, Devonshire, Sarah, Ko, Jennifer S., Farouk Fergany, Amr, Ernstoff, Marc S., Hoimes, Christopher J., Garcia, Jorge A., and Chaim Ornstein, Moshe

Subjects
*SUPPRESSOR cells, *BIOMARKERS, *TRANSITIONAL cell carcinoma
Published
2017
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