BASKING RIDGE, N.J. & RAHWAY, N.J. - Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK), also known as MSD outside the United States and Canada, have announced the commencement of the REJOICE-Ovarian01 phase 2/3 clinical trial, marking the first patient dosing. This trial is designed to assess the efficacy and safety of the investigational drug raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer.
Raludotatug deruxtecan is a potential first-in-class CDH6 directed antibody drug conjugate (ADC) and is being developed under a joint collaboration between Daiichi Sankyo and Merck. The phase 2 segment of the trial aims to determine the appropriate dose of R-DXd for the subsequent phase 3 part, which will compare the drug against the investigator's choice of chemotherapy.
The initiation of this trial follows promising results from an ongoing phase 1 study that were presented at the European Society for Medical Oncology Congress 2023 and a subgroup analysis at the Society for Gynecologic Oncology 2024 Annual Meeting on Women’s Cancer.
The REJOICE-Ovarian01 trial is a global, multicenter study expected to enroll around 650 patients across continents including Asia, Europe, North America, and South America. It will evaluate patients with platinum-resistant, high-grade ovarian cancer who have undergone one to three prior systemic lines of anticancer therapy.
Ovarian cancer, which affected more than 324,000 women globally in 2022, often progresses despite standard platinum-based chemotherapy. The five-year survival rate for advanced ovarian cancer is less than 30%, indicating a dire need for new, effective treatment options.
The phase 2 component of the trial will examine the safety and tolerability of three doses of R-DXd, with the primary endpoint being the objective response rate (ORR) as assessed by a blinded independent central review. The phase 3 component will focus on efficacy and safety compared to chemotherapy, with dual primary endpoints of ORR and progression-free survival (PFS).
Raludotatug deruxtecan is part of Daiichi Sankyo's DXd ADC portfolio, which includes six ADCs in clinical development for various types of cancer. None of these investigational medicines, including R-DXd, have yet been approved for any indication.
This news is based on a press release statement and includes forward-looking statements.
InvestingPro Insights
As Daiichi Sankyo (TSE: 4568) advances its clinical trials in collaboration with Merck, investors and industry observers are keeping a close eye on the company's financial health and market performance. According to recent data from InvestingPro, Daiichi Sankyo boasts a robust market capitalization of approximately $59.19 billion USD, reflecting its significant presence in the pharmaceutical industry. This is further underscored by the company's substantial revenue growth over the last twelve months as of Q3 2024, which stands at an impressive 27.18%.
InvestingPro Tips for Daiichi Sankyo indicate that the company holds more cash than debt on its balance sheet, providing it with a strong financial foundation to support ongoing research and development activities, such as the REJOICE-Ovarian01 trial. Additionally, Daiichi Sankyo is trading at a low P/E ratio relative to near-term earnings growth, suggesting that the stock could be undervalued given its growth prospects. It's important to note that Daiichi Sankyo is also a prominent player in the Pharmaceuticals industry, which may lend additional confidence to investors considering the stock.
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With Daiichi Sankyo's next earnings date on April 25, 2024, investors will be keen to see how the company's financial performance aligns with the progress of its clinical trials and its strategic position within the pharmaceuticals market.
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