Accès ouvert
2026
article
OpenAlex
Vaishali L. Chudasama, Helen Kastrissios, Hossam Kadry, Daping Zhang et autres
Enfortumab vedotin is a nectin-4-directed antibody-drug conjugate currently approved in combination with pembrolizumab for the first-line treatment of locally advanced or metastatic urothelial cancer. Here we describe the exposure-response relationship between enfortumab vedotin exposures and efficacy/safety endpoints in patients who received ≥1 …
us, py
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Accès ouvert
2026
article
OpenAlex
Vaishali L. Chudasama, Gabriela Patilea‐Vrana, Hong Mu, Salaheldin Hamed et autres
Enfortumab vedotin (EV) is approved for previously treated locally advanced or metastatic urothelial cancer (mUC), based on results from pivotal trials (phase 2, EV-201; phase 3, EV-301) evaluating EV monotherapy at 1.25 mg/kg 3Q4W (Days 1, 8, and 15 of a 28-day …
us, py
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Accès ouvert
2026
article
OpenAlex
Paulien Ravenstijn, Toru Kakinuma, Salaheldin Hamed, Takeshi Kadokura et autres
Antibody-drug conjugates (ADCs) have evolved in the last decade or two from carrying a single chemotherapy payload to carrying highly potent tubulin inhibitors and DNA damaging agents. While the latter have shown success in the clinic, efficacy has been constrained by therapeutic …
nl, jp, us
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Accès ouvert
2025
article
OpenAlex
Antonio Giordano, Arif Awan, Justine Y. Bruce, Hope S. Rugo et autres
PURPOSE EV-202 (ClinicalTrials.gov identifier: NCT04225117 ) evaluated enfortumab vedotin (EV), a nectin-4–directed antibody-drug conjugate, in patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2−) and triple-negative breast cancer (TNBC). METHODS This open-label, multicohort, Phase II study included eligible adults with locally …
us, ca, jp
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Accès ouvert
2025
article
OpenAlex
Keisho Chìn, Steven B. Maron, Fadi S. Braiteh, Seiichiro Mitani et autres
BACKGROUND: Enfortumab vedotin (EV), a Nectin-4-directed antibody-drug conjugate, was evaluated in patients with solid tumors in EV-202 (NCT04225117), a multicohort, open-label, phase II study. MATERIALS AND METHODS: The gastroesophageal adenocarcinoma (GEA) or esophageal squamous cell carcinoma (ESCC) cohorts from EV-202 included adults …
jp, us
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Accès ouvert
2025
article
OpenAlex
Akihiro Yamada, Jianning Yang, Peter L. Bonate, Nakyo Heo et autres
PURPOSE: Zolbetuximab, a monoclonal antibody targeting claudin 18.2 (CLDN18.2), is approved in combination with chemotherapy for human epidermal growth factor receptor 2 (HER2)-negative, CLDN18.2-positive, unresectable, advanced or recurrent gastric cancer (in Japan) and in combination with fluoropyrimidine- and platinum-containing chemotherapy for first-line …
jp, us
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Accès ouvert
2025
article
OpenAlex
Jianning Yang, Akihiro Yamada, Kohei Shitara, Rui‐Hua Xu et autres
Zolbetuximab is a first-in-class chimeric (mouse/human) monoclonal antibody targeted to the tight junction protein claudin 18.2 (CLDN18.2), an emerging biomarker in gastric/gastroesophageal junction (G/GEJ) cancer. This review summarizes the clinical pharmacology of zolbetuximab on the basis of available clinical trial data. Population …
us, jp, cn, it
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Accès ouvert
2025
article
OpenAlex
Kei Muro, Trevor Feinstein, Joaquina Baranda, Ioana Bonta et autres
PURPOSE: Enfortumab vedotin (EV), a novel antibody-drug conjugate directed against Nectin-4, was explored in patients with non-small cell lung cancer (NSCLC) in cohorts 3 and 4 of the open-label, multicohort, Phase 2 EV-202 study (NCT04225117). METHODS: Patients with squamous and non-squamous NSCLC …
jp, us
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Accès ouvert
2025
article
OpenAlex
Akihiro Yamada, Masato Takeuchi, Kanji Komatsu, Peter L. Bonate et autres
ABSTRACT Zolbetuximab is a chimeric (mouse/human) monoclonal antibody directed against the tight junction protein claudin 18.2, which is highly expressed in gastric/gastroesophageal junction (G/GEJ) and pancreatic adenocarcinoma. We report a population pharmacokinetic (PK) and exposure‐response (E‐R) analysis of zolbetuximab in patients with …
jp, us
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Accès ouvert
2024
conference-abstract
OpenAlex
Daniel P. Petrylak, Yen Lin Chia, Evan Y. Yu, Thomas Powles et autres
4503 Background: Enfortumab vedotin (EV) is approved in combination with pembrolizumab and as a monotherapy for locally advanced or metastatic urothelial cancer (la/mUC). EV, alone and in combination with pembrolizumab, has demonstrated an OS benefit and a generally manageable safety profile in …
us, gb, fr, jp, kr
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Accès ouvert
2024
article
OpenAlex
Divya Samineni, Karthik Venkatakrishnan, Ahmed A. Othman, Yazdi K. Pithavala et autres
The landscape of oncology drug development has witnessed remarkable advancements over the last few decades, significantly improving clinical outcomes and quality of life for patients with cancer. Project Optimus, introduced by the U.S. Food and Drug Administration, stands as a groundbreaking endeavor …
us, de, es
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Accès ouvert
2024
article
OpenAlex
Brandon Lennep, Jesse Mack, Srinivasu Poondru, Elizabeth Hood et autres
Enzalutamide is an oral androgen receptor signaling inhibitor utilized in the treatment of men with prostate cancer. It is a moderate inducer of the cytochrome P450 (CYP) enzymes CYP2C9 and CYP2C19, and a strong inducer of CYP3A4. It was also shown to …
us
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