Publication: Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-expressing biliary tract cancer (BTC) and pancreatic cancer (PC): Outcomes from DESTINY-PanTumor02 (DP-02).
0
0
Issued Date
2024-01-01
Resource Type
ISSN
0732183X
eISSN
15277755
Scopus ID
2-s2.0-105024418770
Journal Title
Journal of Clinical Oncology
Volume
42
Issue
16
Start Page
4090
End Page
4090
Rights Holder(s)
SCOPUS
Bibliographic Citation
Journal of Clinical Oncology Vol.42 No.16 (2024) , 4090-4090
Suggested Citation
Oh D.Y., Lugowska I.A., Stroyakovskiy D., Jung K.H., Dumas O., Penkov K., Dechaphunkul A., Oaknin A., Kim S.T., Starling N., Chewaskulyong B., Charonpongsuntorn C., Doroshow D.B., Hsiao S.Y., Hung Y.P., Jung L., Kuptsova-Clarkson N., Michelini F., Puvvada S.D., Meric-Bernstam F. Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-expressing biliary tract cancer (BTC) and pancreatic cancer (PC): Outcomes from DESTINY-PanTumor02 (DP-02).. Journal of Clinical Oncology Vol.42 No.16 (2024) , 4090-4090. 4090. doi:10.1200/JCO.2024.42.16_suppl.4090 Retrieved from: https://hdl.handle.net/20.500.14740/54976
Author's Affiliation
The University of Texas MD Anderson Cancer Center
Icahn School of Medicine at Mount Sinai
Chiang Mai University
Asan Medical Center
Samsung Medical Center, Sungkyunkwan university
Taipei Veterans General Hospital
Seoul National University Hospital
AstraZeneca
CHU de Québec-Université Laval
The Royal Marsden NHS Foundation Trust
Chi Mei Medical Center
Maria Sklodowska-Curie National Research Institute of Oncology
Faculty of Medicine, Prince of Songkla University
Vall d‘Hebron Institut de Oncologia
Faculty of Medicine, Srinakharinwirot University
Moscow City Oncology Hospital No. 62
Clinical Hospital “RZHD-Medicine”
Icahn School of Medicine at Mount Sinai
Chiang Mai University
Asan Medical Center
Samsung Medical Center, Sungkyunkwan university
Taipei Veterans General Hospital
Seoul National University Hospital
AstraZeneca
CHU de Québec-Université Laval
The Royal Marsden NHS Foundation Trust
Chi Mei Medical Center
Maria Sklodowska-Curie National Research Institute of Oncology
Faculty of Medicine, Prince of Songkla University
Vall d‘Hebron Institut de Oncologia
Faculty of Medicine, Srinakharinwirot University
Moscow City Oncology Hospital No. 62
Clinical Hospital “RZHD-Medicine”
Corresponding Author(s)
Other Contributor(s)
Abstract
Background: Existing late-line treatment (Tx) options for BTC and PC offer limited long-term benefit. In DP-02, T-DXd showed tumor-agnostic potential, with an objective response rate (ORR) of 37.1% (95% CI 31.3, 43.2) and clinically meaningful survival outcomes in 267 pts with HER2-expressing tumors. Here we report subgroup analyses in the BTC and PC cohorts and characterize pts with an objective response (OR). Methods: This open-label Phase 2 study (NCT04482309) evaluated T-DXd (5.4 mg/kg Q3W) in pts with HER2-expressing (immunohistochemistry [IHC] 3+/2+ by local or central testing) locally advanced/metastatic disease after ≥1 systemic Tx, or without Tx options. The primary endpoint was confirmed ORR by investigator (INV). Secondary endpoints included progression-free survival (PFS) and safety. Exploratory endpoints included efficacy outcomes by HER2 expression. Results: At data cutoff (June 2023), 41 pts with BTC and 25 pts with PC had received T-DXd (median [m] follow up [range]: 6.01 [0.7–29.1] and 4.99 [1.1–27.2] months [mo], respectively); 27 (65.9%) and 18 (72.0%) pts had ≥2 prior Tx regimens, 7 (17.1%) and 2 (8.0%) pts had prior anti-HER2 Tx, and 8 (19.5%) and 18 (72.0%) pts had prior topoisomerase 1 inhibitor Tx, respectively. In pts with BTC and IHC 3+ expression, 9 pts (56.3%; 95% CI 29.9, 80.2; primary tumor locations: n=2 ampulla of Vater; n=2 extrahepatic; n=4 gallbladder; n=1 intrahepatic) had confirmed OR by INV; of these pts, 6 had received ≥2 prior Tx regimens and 4 had PD-L1 immune cell status ≥1%. The Table shows efficacy outcomes in all pts and by central HER2 expression. In pts with BTC and PC, Grade (G) ≥3 drug-related adverse events occurred in 16/41 (39.0%) and 7/25 (28.0%) pts, respectively; adjudicated drug-related interstitial lung disease / pneumonitis occurred in 7/41 (17.1%; n=5 G2; n=1 G3; n=1 G5) and 1/25 (4.0%; n=1 G1) pts, respectively. Conclusions: T-DXd showed clinically meaningful benefit in pts with BTC across primary tumor locations. Low pt numbers limit interpretation of the PC cohort; however, data support further exploration of T-DXd in this population. Safety was consistent with the known profile. These data support T-DXd as a potential Tx for pts with HER2-expressing BTC. Clinical trial information: NCT04482309.