Evidence map›Paper›PMID 42717277›Full record

ArticleClinical pharmacology and therapeutics2026

Exposure-Response Analysis of Enfortumab Vedotin Plus Pembrolizumab as First-Line Therapy for Locally Advanced or Metastatic Urothelial Cancer.

Vaishali L Chudasama, Helen Kastrissios, Hossam Kadry, Daping Zhang, Salaheldin Hamed, Srinivasu Poondru, Souvik Bhattacharya, Russ Wada, Amit Garg, Yen Lin Chia

Abstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Vaishali L ChudasamaPfizer Inc, New York, New York, USA.ORCID https://orcid.org/0000-0001-6309-214X
Helen KastrissiosQuanTx Consulting, Mountain View, California, USA.
Hossam KadryPfizer Inc, New York, New York, USA.ORCID https://orcid.org/0000-0002-2745-2811
Daping ZhangPfizer Inc, New York, New York, USA.ORCID https://orcid.org/0009-0000-1646-094X
Salaheldin HamedAstellas Pharma, Northbrook, Illinois, USA.
Srinivasu PoondruAstellas Pharma, Northbrook, Illinois, USA.
Souvik BhattacharyaAstellas Pharma, Northbrook, Illinois, USA.
Russ WadaQuanTx Consulting, Mountain View, California, USA.
Amit GargPfizer Inc, New York, New York, USA.ORCID https://orcid.org/0000-0002-4553-9216
Yen Lin ChiaBeOne Medicines, San Carlos, California, USA.ORCID https://orcid.org/0000-0003-0607-7247

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 dose of enfortumab vedotin 1.25 mg/kg (on days 1 and 8 of a 21-day dosing cycle) plus pembrolizumab (recommended dosage) and had evaluable pharmacokinetics in the EV-103 (N = 121) and EV-302 (N = 432) studies. Overall, most patients were older (median age of 69 years), White (74%), and male (77%), with median body weight in EV-103 (79 kg) trending higher than that in EV-302 (75 kg). Higher exposures of enfortumab vedotin were associated with consistently higher objective response rates across all exposure quartiles in both studies, and longer survival than chemotherapy in EV-302. Increased and faster incidence of treatment-related adverse events (Grade ≥ 3 hyperglycemia, Grade ≥ 3 skin reactions, and Grade ≥ 2 peripheral neuropathy) was also observed with increased exposures. However, dose modifications were effective in managing most adverse events, with most patients having at least partial resolution (hyperglycemia, >75%; skin reactions, >85%; and peripheral neuropathy, >50%). Responses attained with higher early cycle exposure were not impacted by subsequent dose modifications. Overall, exposure-response analysis supports the use of enfortumab vedotin at a starting dose of 1.25 mg/kg and in combination with pembrolizumab for first-line treatment of locally advanced or metastatic urothelial cancer.

Identifiers

PMID42717277
PMCPMC13558467

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.