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Cited by 16Bladder and Urothelial Cancer TreatmentsLung Cancer Treatments and MutationsCancer therapeutics and mechanisms

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Datopotamab deruxtecan in locally advanced/metastatic urothelial cancer: Preliminary results from the phase 1 TROPION-PanTumor01 study.

Lisberg, Aaron, Drakaki, Alexandra, Meric-Bernstam, Funda, Alhalabi, Omar, Kojima, Takahiro, Kato, Manabu, Spira, Alexander I., Salkeni, Mohamad Adham, Heist, Rebecca, Gao, Xin, Bhave, Manali A., Klauss, Gunnar, Sakaki, Hayato, Kakurai, Yasuyuki, KOGAWA, TAKAHIRO·2024·Journal of Clinical Oncology
DOI 10.1200/jco.2024.42.4_suppl.603
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Abstract

603 Background: Datopotamab deruxtecan (Dato-DXd) is an antibody-drug conjugate consisting of a humanized anti-TROP2 IgG1 monoclonal antibody covalently linked to a highly potent topoisomerase I inhibitor payload via a plasma-stable, tumor-selective, tetrapeptide-based cleavable linker. Dato-DXd has shown encouraging antitumor activity and a manageable safety profile in patients (pts) with solid tumors. We report preliminary results in pts with advanced/metastatic (a/m) urothelial cancer from the ongoing phase 1 TROPION-PanTumor01 study (NCT03401385). Methods: Pts with unresectable a/m urothelial cancer treated with ≥1 prior line of therapy received intravenous Dato-DXd 6 mg/kg Q3W. Primary study objectives were safety and tolerability. Secondary endpoints were objective response rate (ORR; complete response [CR] + partial response [PR]), and disease control rate (DCR; CR + PR + stable disease) per RECIST 1.1 by BICR. This is the first data disclosure from this cohort in an ongoing expansion cohort study. Results: At data cutoff (May 18, 2023), 18 pts had received Dato-DXd. Median follow-up was 9.1 (range 5–17) months; 6 (33.3%) pts were receiving ongoing treatment. Median age was 63.5 (range 46–79) yrs. Pts were heavily pretreated, 15 (83.3%) had received ≥3 prior regimens. All pts received prior immunotherapy, 17 (94.4%) prior platinum-based chemotherapy, and 4 (22.2%) prior taxanes. Treatment-emergent adverse events (TEAEs) occurred in 100% (any grade [gr]) and 44.4% (gr ≥3) of pts, and drug-related TEAEs occurred in 94.4% (any gr) and 16.7% (gr ≥3) of pts. No drug-related serious AEs were reported, and no TEAEs associated with death were observed. Any gr TEAEs associated with reduction, interruption, and discontinuation of treatment were reported in 11.1%, 33.3%, and 5.6% of pts, respectively (Table). Adjudicated drug-related interstitial lung disease (gr 2) occurred in 1 (5.6%) pt. Confirmed ORR was 27.8% (95% CI 9.7–53.5); 1 pt achieved a CR and 4 achieved a PR. DCR was 77.8% (95% CI 52.4–93.6). Clinical evaluation of this cohort is ongoing and updated results will be presented. Conclusions: In heavily pretreated pts with a/m urothelial cancer, Dato-DXd demonstrated a tolerable and manageable safety profile with encouraging antitumor activity. Dato-DXd is being evaluated in pts with urothelial cancer as part of the phase 1/2 TROPION-PanTumor02 (NCT05460273) and the phase 2 TROPION-PanTumor03 (NCT05489211) studies. Clinical trial information: NCT03401385 . [Table: see text]

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  • In TROPION-PanTumor01 and TROPION-PanTumor02 phase I clinical trials, Dato-DXd demonstrated meaningful clinical activity and a manageable safety profile in advanced/metastatic HR+/HER2- and triple-negative breast cancers, urothelial carcinoma, and NSCLC.

    “In the TROPION-PanTumor01 and TROPION-PanTumor02 phase I clinical trials, Dato-DXd demonstrated meaningful clinical activity and a manageable safety profile in advanced/metastatic HR + /HER2– and triple-negative breast cancers, urothelial carcinoma, and non-small cell lung cancer (NSCLC) (NCT03401385, NCR05460273)131–133.”

    From The evolving landscape of antibody-drug conjugates (ADCs) for treatment of prostate cancer (2025) · cites this paper as [132]

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Authors
Lisberg, A., Drakaki, A., Meric-Bernstam, F., Alhalabi, O., Kojima, T., Kato, M., Spira, A. I., Salkeni, M. A., Heist, R., Gao, X., Bhave, M. A., Klauss, G., Sakaki, H., Kakurai, Y., & KOGAWA, T.
Affiliations
  • University of California, Los Angeles (US)
  • Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX
  • The University of Texas MD Anderson Cancer Center (US)
  • Aichi Cancer Center (JP)
  • Virginia Cancer Specialists (US)
  • Massachusetts General Hospital (US)
  • Emory University (US)
  • Daiichi Sankyo (United States) (US)
  • Daiichi-Sankyo (Japan) (JP)
  • The Cancer Institute Hospital (JP)
ORCID
Venue
Journal of Clinical Oncology
Publisher
American Society of Clinical Oncology (ASCO)
Published
2024-02-01
Volume
42
Issue
4_suppl
Pages
603-603
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
DOI
10.1200/jco.2024.42.4_suppl.603
OpenAlex
W4391303295
Cited by
15
References
0
Citations by year
2026: 2 · 2025: 9 · 2024: 4
Type
conference abstract
Language
en
Open access
closed
Locations
Journal of Clinical Oncology (publishedVersion)
Funders
Daiichi Sankyo (N/A)
Topics
  • Health Sciences › Medicine › Surgery › Bladder and Urothelial Cancer Treatments
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Cancer therapeutics and mechanisms
Keywords
datopotamab deruxtecan, urothelial carcinoma, metastatic urothelial carcinoma, locally advanced urothelial cancer, TROP2, antibody-drug conjugates, topoisomerase I inhibitor, safety and tolerability, objective response rate, disease control rate, platinum-based chemotherapy

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