| The following article features coverage from the ASCO Gastrointestinal Cancers Symposium 2022. Click here to read more of Cancer Therapy Advisor’s conference coverage. |
The final overall survival analysis of the DESTINY-Gastric01 trial revealed that the antibody drug conjugate trastuzumab deruxtecan (T-DXd) continued to demonstrate an overall survival benefit and clinically relevant improvement in overall response rate (ORR) compared with chemotherapy in patients with HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Results of the study were presented by Kensei Yamaguchi, MD, of The Cancer Institute Hospital of JFCR in Japan, during the ASCO Gastrointestinal Cancers Symposium 2022.
Results of a previously published primary analysis showed a significant improvement in overall survival and ORR for patients who received T-DXd compared with standard chemotherapy. The updated results are from a median survival follow-up of 18.5 months and 133 overall survival events.
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In this updated analysis (ClinicalTrials.gov Identifier: NCT03329690), T-DXd showed superior antitumor activity compared with chemotherapy.
“T-DXd is an effective treatment option for patients with HER2+ advanced gastric or GEJ adenocarcinoma who have progressed after 2 or more prior lines of therapy including trastuzumab, fluoropyrimidine, and a platinum agent,” Dr Yamaguchi said.
The phase 2 study included patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma that had progressed after 2 or more previous lines of therapy including trastuzumab. The patients were randomly assigned 2:1 to receive T-DXd or physician’s choice of irinotecan or paclitaxel.
The median overall survival was 12.5 months for T-DXd compared with 8.9 months for chemotherapy (hazard ratio [HR], 0.60; 95% CI, 0.42-0.86).
The ORR by independent central review was 51.3% for T-DXd compared with 14.3% for chemotherapy (P <.0001). The confirmed ORR was 42.0% for patients assigned to T-DXd compared with 12.5% for those assigned to chemotherapy (P =.0001). Dr Yamaguchi noted that most patients assigned to T-DXd had a reduction in tumor size compared with about half of patients assigned to chemotherapy.
The median duration of response was about 3 times longer in patients who received T-DXd compared with standard chemotherapy (12.5 vs 3.9 months).
Grade 3 or worse adverse events occurred in 85.6% of patients assigned to T-DXd compared with 56.5% of those assigned to chemotherapy.
Sixteen patients (12.8%) had T-DXd-related interstitial lung disease (ILD)/pneumonitis, as determined by an independent adjudication committee. Three of these were grade 3 and above. The median time to first onset was 102.5 days. No ILD/pneumonitis occurred in the chemotherapy arm.
There was 1 T-DXd-related death from pneumonia, as reported in the primary analysis, and no adverse event-related deaths in patients who received chemotherapy.
Disclosures: This research was supported by Daiichi Sankyo. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Read more of Cancer Therapy Advisor’s coverage of ASCO GI 2022 by visiting the conference page.
Reference
Yamaguchi K, Bang Y-J, Iwasa S, et al. Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma: Final overall survival (OS) results from a randomized, multicenter, open-label, phase 2 study (DESTINY_Gastric01). Presented at ASCO GI 2022; January 20-22, 2022. Abstract 242.
