Final results of DESTINY-CRC01 investigating trastuzumab deruxtecan in patients with HER2-expressing metastatic colorectal cancer

Takayuki Yoshino, Maria Bartolomeo, Kanwal Raghav, Toshiki Masuishi, Fotios Loupakis, Hisato Kawakami, Kensei Yamaguchi, Tomohiro Nishina, Zev Wainberg, Elena Elez, Javier Rodriguez, Marwan Fakih, Fortunato Ciardiello, Kapil Saxena, Kojiro Kobayashi, Emarjola Bako, Yasuyuki Okuda, Gerold Meinhardt, Axel Grothey and Salvatore Siena ()
Additional contact information
Takayuki Yoshino: National Cancer Center Hospital East
Maria Bartolomeo: Fondazione IRCCS Istituto Nazionale dei Tumori
Kanwal Raghav: The University of Texas MD Anderson Cancer Center
Toshiki Masuishi: Aichi Cancer Center Hospital
Fotios Loupakis: Oncology Institute Veneto IOV-IRCCS
Hisato Kawakami: Kindai University Hospital
Kensei Yamaguchi: The Cancer Institute Hospital of JFCR
Tomohiro Nishina: National Hospital Organization Shikoku Cancer Center
Zev Wainberg: UCLA Medical Center
Elena Elez: Universitat Autònoma de Barcelona
Javier Rodriguez: Clinica Universidad de Navarra
Marwan Fakih: City of Hope National Medical Center
Fortunato Ciardiello: Università degli studi della Campania L. Vanvitelli
Kapil Saxena: Daiichi Sankyo
Kojiro Kobayashi: Daiichi Sankyo
Emarjola Bako: Daiichi Sankyo
Yasuyuki Okuda: Daiichi Sankyo
Gerold Meinhardt: Daiichi Sankyo
Axel Grothey: West Cancer Center
Salvatore Siena: Università degli Studi di Milano

Nature Communications, 2023, vol. 14, issue 1, 1-13

Abstract: Abstract DESTINY-CRC01 (NCT03384940) was a multicenter, open-label, phase 2 trial assessing the efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with HER2-expressing metastatic colorectal cancer (mCRC) that progressed after ≥2 prior regimens; results of the primary analysis are published. Patients received T-DXd 6.4 mg/kg every 3 weeks and were assigned to either: cohort A (HER2-positive, immunohistochemistry [IHC] 3+ or IHC 2+/in situ hybridization [ISH]+), cohort B (IHC 2+/ISH−), or cohort C (IHC 1+). Primary endpoint was objective response rate (ORR) by independent central review in cohort A. Secondary endpoints included ORR (cohorts B and C), duration of response, disease control rate, progression-free survival, overall survival, pharmacokinetics, and safety of T-DXd. 86 patients were enrolled (53 in cohort A, 15 in cohort B, and 18 in cohort C). Results of the primary analysis are published, reporting an ORR of 45.3% in cohort A. Here, we report the final results. No responses occurred in cohorts B or C. Median progression-free survival, overall survival, and duration of response were 6.9, 15.5, and 7.0 months, respectively. Overall serum exposure (cycle 1) of T-DXd, total anti-HER2 antibody, and DXd were similar regardless of HER2 status. Most common grade ≥3 treatment-emergent adverse events were decreased neutrophil count and anemia. Adjudicated drug-related interstitial lung disease/pneumonitis occurred in 8 patients (9.3%). These findings support the continued exploration of T-DXd in HER2-positive mCRC.

Date: 2023
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DOI: 10.1038/s41467-023-38032-4

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