A novel drug developed by a mainland Chinese biotechnology company, D3Bio, has shown promising results against three difficult-to-treat cancers—non-small cell lung, colorectal, and pancreatic—according to a multinational study led by the Chinese University of Hong Kong (CUHK). The drug, named D3S-001, targets the KRAS-G12C gene mutation, which currently has limited treatment options.
KRAS mutations are common drivers in many solid tumours, with the KRAS-G12C subtype being the most prevalent. It is found in approximately 11 to 15 percent of non-small cell lung cancer cases, 3 to 5 percent of colorectal cancers, and 1 to 3 percent of other solid tumours globally. In Hong Kong, lung cancer was the leading cancer type in 2022, with non-small cell lung cancer accounting for the majority of cases. Colorectal and pancreatic cancers also ranked among the most common and deadliest cancers in the city.
The phase one clinical trial tested D3S-001’s safety, tolerance, and dosage in 42 patients with the KRAS-G12C mutation who had never received inhibitors before. They received daily doses ranging from 50mg to 900mg. Results showed that about 70 percent of these patients experienced significant tumour shrinkage or complete disappearance, while over 97 percent maintained tumour stability. Tumour control lasting six months was observed in roughly 70 percent of participants. Common side effects included nausea and diarrhoea.
In a second trial phase involving 20 patients with non-small cell lung cancer who had previously used other KRAS-G12C inhibitors and experienced disease progression, 30 percent saw notable tumour shrinkage. Around 80 percent maintained stable tumours.
One patient, diagnosed with stage four lung cancer, reported significant improvement after 60 weeks on D3S-001, with reduced tumour size and improved breathing capacity.
Led by CUHK’s Professor Tony Mok Shu-kam, the study also included researchers from mainland China, South Korea, Australia, and the United States. Published recently in Nature Medicine, the study highlights collaboration between Hong Kong’s academic sector and the mainland pharmaceutical industry.
The research team plans to expand the trial to 80 to 100 patients and eventually compare D3S-001 directly with first-generation inhibitors in phase three. While a market launch timeline remains uncertain, the drug shows potential as a first-line therapy for cancers driven by KRAS-G12C mutations.
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