DS-3939 shows promising results in early trials against solid tumors

TOKYO/BASKING RIDGE - Daiichi Sankyo (TSE:4568), a prominent player in the pharmaceuticals industry with over $13 billion in annual revenue and an impressive 78.5% gross profit margin, presented initial clinical data for DS-3939, a potential first-in-class tumor-associated mucin-1 (TA-MUC1) directed antibody drug conjugate, showing promising activity in patients with previously treated advanced solid tumors. According to InvestingPro analysis, the company maintains a "GREAT" financial health score, positioning it well for continued research and development investments.

The preliminary results from the dose escalation part of a phase 1/2 trial were shared Sunday at the European Society for Medical Oncology conference. The study included 64 patients with various advanced solid tumors who had received a median of three prior therapies. With a strong current ratio of 2.31 and moderate debt levels, Daiichi Sankyo demonstrates the financial stability needed to advance its clinical programs.

The data showed one confirmed complete response in an ovarian cancer patient and 10 confirmed partial responses in patients with ovarian cancer, non-small cell lung cancer, and breast cancer. Additionally, 39 cases of stable disease were observed across multiple tumor types after a median follow-up of 8.8 months.

Common treatment-related adverse events included nausea (60.9%), vomiting (35.9%), and fatigue (28.1%). Grade 3 or higher adverse events occurred in 46.9% of patients, with decreased neutrophil count (15.6%) and anemia (10.9%) being most common. Treatment-related interstitial lung disease or pneumonitis occurred in 10.9% of patients, with two fatal cases reported after the data cutoff date.

"These initial results are encouraging for patients with advanced solid tumors where treatment options remain limited once standard therapies are no longer effective," said Dr. Manish R. Patel, Director of Drug Development at Florida Cancer Specialists and Sarah Cannon Research Institute, according to the press release.

DS-3939 targets TA-MUC1, a tumor-specific transmembrane glycoprotein overexpressed in most human epithelial cancers. Currently, no TA-MUC1 directed medicines are approved for any type of cancer.

The trial is ongoing and enrolling patients across multiple tumor types at sites in Asia, Europe, and North America. DS-3939 is the sixth antibody drug conjugate from Daiichi Sankyo’s oncology pipeline to show clinical data. The company’s robust research initiatives are supported by strong revenue growth of 14% year-over-year. InvestingPro analysis suggests the stock is currently undervalued, with 10 additional ProTips available to subscribers, including insights on dividend stability and cash flow strength.

In other recent news, Daiichi Sankyo and Merck’s investigational drug Raludotatug deruxtecan showed a 50.5% response rate in a phase 2 trial for ovarian cancer. Meanwhile, Daiichi Sankyo and AstraZeneca’s ENHERTU demonstrated a significant improvement in pathologic complete response rate for high-risk HER2 positive early-stage breast cancer, achieving a rate of 67.3% compared to 56.3% with standard treatment. The same drug also showed a 92% invasive disease-free survival rate at three years in another trial for HER2 positive early breast cancer, reducing the risk of invasive disease recurrence or death by 53% compared to trastuzumab emtansine. Additionally, the TROP2 directed antibody drug conjugate DATROWAY, developed by Daiichi Sankyo and AstraZeneca, showed promising results in urothelial cancer with a 68.2% objective response rate in previously untreated patients. For those previously treated with platinum-based chemotherapy, the response rate was 38.9%. Furthermore, AstraZeneca reported that Datroway met its primary goals in a phase 3 trial for metastatic triple-negative breast cancer, showing improvements in both overall and progression-free survival. These developments reflect ongoing advancements in cancer treatment by Daiichi Sankyo and its partners.

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