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Daiichi Sankyo, AstraZeneca Begin Phase II Study of Enhertu in Colorectal Cancer

NEW YORK – Daiichi Sankyo and AstraZeneca on Tuesday began a Phase II study of trastuzumab deruxtecan (Enhertu) in HER2-overexpressing advanced colorectal cancer.

The sponsors started the Phase II DESTINY-CRC02 study of trastuzumab deruxtecan in this setting following promising results in the earlier DESTINY-CRC01. The trial is evaluating the activity of the antibody-drug conjugate in two dose cohorts, 5.4 mg/kg and 6.4 mg/kg, in patients with HER2-positive locally advanced, unresectable, or metastatic colorectal cancer that has progressed after chemotherapy. Patients must also have BRAF wild-type or RAS wild-type mutated cancer to be included in the study.

The trial will enroll about 120 patients. The first 80 participants will be randomized to one of the dose cohorts. Once that stage is complete, the remaining 40 patients will join the 5.4 mg/kg dose arm. The primary endpoint for the study is objective response rate.

At the American Society of Clinical Oncology's annual meeting last year, researchers reported data from the earlier DESTINY-CRC01 trial, in which 45 percent of HER2-positive, metastatic colorectal cancer patients responded to a 6.4mg/kg dose of trastuzumab deruxtecan. The disease control rate was 83 percent and the median progression-free survival was 6.9 months in the study.

Last month, Daiichi Sankyo and AstraZeneca also began a Phase II trial of trastuzumab deruxtecan in HER2-mutated non-small cell lung cancer.

Trastuzumab deruxtecan, comprising a HER2 monoclonal antibody linked to a topoisomerase I inhibitor payload, has accelerated approval in the US for previously treated, HER2-positive, unresectable or metastatic breast cancer patients; this indication is under conditional authorization in the UK and in Europe, as well as conditional early approval in Japan. The drug is also approved in the US and Japan for HER2-positive, advanced gastric or gastroesophageal junction cancer.