(Gastric Cancer) Is Enhertu Monotherapy Effective?

• May 29, 2020
• Read time: 2 minutes

From May 29–31, 2020, Kohei Shitara presented at the ASCO 2020 Virtual Scientific Program results from the DESTINY-Gastric01 Phase II clinical trial evaluating the efficacy and safety of Enhertu monotherapy in HER2-positive advanced gastric or gastroesophageal junction cancer patients with two or more prior treatment experiences.

DESTINY-Gastric01 was a non-blinded trial conducted jointly at multiple facilities, randomizing HER2-positive advanced gastric or gastroesophageal junction cancer patients with two or more prior treatment experiences in a 2:1 ratio. The primary endpoint was objective response rate; secondary endpoints were disease control rate, progression-free survival, and overall survival:

1. Enhertu group: 3-week cycles, Enhertu 6.4 mg/kg, N=125
2. Chemotherapy group: physician's choice of chemotherapy, N=62

Trial results: Primary endpoint objective response rate was 51.3% for the Enhertu group (N=61/119) vs. 14.3% for the chemotherapy group (8/56).

Secondary endpoint disease control rate was 85.7% for Enhertu vs. 62.5% for chemotherapy. Median progression-free survival was 5.6 months for Enhertu vs. 3.5 months for chemotherapy.

Median overall survival was 12.5 months for Enhertu vs. 8.4 months for chemotherapy. The 12-month overall survival rate was 52.1% for Enhertu vs. 28.9% for chemotherapy.

Regarding safety, Grade 3+ adverse event incidence was 85.6% for Enhertu vs. 56.5% for chemotherapy. The most commonly confirmed adverse events were: neutropenia (51.2% Enhertu vs. 24.2% chemotherapy), anemia (37.6% Enhertu vs. 22.6% chemotherapy), and leukopenia (20.8% Enhertu vs. 11.3% chemotherapy). Enhertu-related interstitial lung disease was 9.6% (N=12).

Based on DESTINY-Gastric01 trial results, Kohei Shitara concluded: In HER2-positive advanced gastric or gastroesophageal junction cancer patients with two or more prior treatment experiences, Enhertu monotherapy demonstrated significant improvement in objective response rate and overall survival compared to current standard treatments.

Disclaimer: The clinical trial data and pharmaceutical information translated by "Medical Supporter" are not intended to encourage participation in clinical trials or use of new drugs. The translated information is for reference only and not for medication guidance. Please consult with healthcare professionals, and refer to the original source text at the bottom of the article for accurate information.

Source: Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma: A randomized, phase II, multicenter, open-label study (DESTINY-Gastric01). (2020 ASCO VIRTUAL SCIENTIFIC PROGRAM, Abstract No: 4513)

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