Daiichi Sankyo has announced encouraging early data from the dose escalation phase of its first-in-human Phase 1/2 trial of DS‑3939. The treatment showed promising clinical activity in patients with advanced solid tumors that had progressed despite standard therapies.
DS‑3939 is a specially engineered antibody-drug conjugate (ADC) targeting tumor-associated mucin-1 (TA-MUC1), a protein found in high levels in many epithelial cancers. Currently, no approved cancer therapies specifically target TA-MUC1, making DS‑3939 a potential first-in-class treatment. The drug uses Daiichi Sankyo’s proprietary DXd ADC technology.
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The study included 64 patients with various advanced solid tumors. These included non-small cell lung cancer, pancreatic cancer, ovarian cancer, breast cancer, urothelial carcinoma, colorectal cancer, and biliary tract cancer. Patients had received a median of three previous treatments, with some having undergone up to 17. At the time of analysis, 15 patients were still receiving treatment with DS‑3939.
The safety profile was evaluated across dose levels ranging from 1.0 mg/kg to 10.0 mg/kg. The most common side effects were nausea, vomiting, fatigue, anemia, constipation, decreased appetite, diarrhea, and reduced neutrophil counts. Nearly half of the patients experienced Grade 3 or higher adverse events, including anemia, decreased neutrophil counts, and pneumonitis. Interstitial lung disease or pneumonitis occurred in 10.9% of patients, with most cases being mild or moderate, though a few severe cases were reported.
In terms of early efficacy, one patient with ovarian cancer achieved a confirmed complete response. Additionally, ten patients had confirmed partial responses, including those with ovarian, lung, and breast cancers. Another 39 patients experienced stable disease across multiple tumor types. The median follow-up period was nearly nine months.
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Dr. Manish R. Patel, Director of Drug Development at Florida Cancer Specialists and Sarah Cannon Research Institute, noted that the results offer hope for patients with limited treatment options. He said the early data show real potential for patients who have exhausted current standard therapies.
Ken Takeshita, MD, Global Head of R&D at Daiichi Sankyo, said these results support the idea that targeting TA‑MUC1 could be a promising new approach for treating multiple types of cancer. He added that DS‑3939 is the sixth ADC in their pipeline to show encouraging early-phase results, further demonstrating the adaptability of their DXd platform.
Enrollment is continuing in the dose expansion phase of the trial, which will provide additional data to better understand how DS‑3939 may fit into the treatment landscape for advanced solid tumors.
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