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TOKYO & BASKING RIDGE, N.J. - Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) announced positive results from the phase 3 DESTINY-Breast09 trial, indicating that their drug ENHERTU®, when combined with pertuzumab, significantly improved progression-free survival (PFS) for patients with HER2 positive metastatic breast cancer. The trial marks the first in over a decade to show improved outcomes in the first-line treatment setting for this patient group.
The trial compared ENHERTU® plus pertuzumab to the standard treatment combination of taxane, trastuzumab, and pertuzumab (THP). The results, which will be presented at the American Society of Clinical Oncology (#ASCO25) Annual Meeting, showed that ENHERTU® plus pertuzumab reduced the risk of disease progression or death by 44%. The median PFS was 40.7 months for patients treated with ENHERTU® and pertuzumab, versus 26.9 months for those receiving THP.
The study found consistent PFS benefits across various subgroups, including patients with de novo or recurrent disease and different hormone receptor statuses. The objective response rate (ORR) with ENHERTU® plus pertuzumab was also higher at 85.1% compared to 78.6% with THP. Furthermore, the median duration of response (DOR) exceeded three years for the ENHERTU® combination, outperforming the THP regimen.
While overall survival (OS) data was not mature at the time of the interim analysis, an early trend favored ENHERTU® plus pertuzumab. The trial also includes an investigational arm assessing ENHERTU® monotherapy, which remains blinded and will continue to the final PFS analysis.
The safety profile of ENHERTU® plus pertuzumab was consistent with known individual therapy profiles, with no new safety concerns identified. Grade 3 or higher treatment-related adverse events occurred in 54.9% of patients in the ENHERTU® combination arm, with neutropenia, hypokalemia, and anemia being the most common. According to InvestingPro data, Daiichi Sankyo maintains a GREAT financial health score of 3.32, with a notably low PEG ratio of 0.49, suggesting strong growth potential relative to its current valuation. InvestingPro analysis indicates the stock is currently undervalued based on its Fair Value model.
Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute and Principal Investigator in the DESTINY-Breast09 trial, noted the significant potential of the ENHERTU® combination to become a new standard of care, with a median PFS of more than three years. Want deeper insights? InvestingPro subscribers get access to 8 additional ProTips about Daiichi Sankyo, including detailed analysis of its dividend history and debt management, plus exclusive Fair Value models and financial health scores.
These findings are based on a press release statement and have not been independently verified.
In other recent news, Daiichi Sankyo reported strong fourth-quarter earnings that exceeded expectations, with income rising by 21% year-over-year to ¥519 billion, which was 7% above the FactSet consensus. The company also announced a significant share buyback program valued at ¥200 billion. Core operating profit for the fourth quarter more than doubled to ¥83 billion, outperforming consensus by 91%, driven largely by a substantial milestone in Enhertu sales. Enhertu’s revenue soared by 45% year-over-year to ¥651 billion, significantly contributing to the company’s overall revenue growth. Sales of the anticoagulant Edoxaban also increased by 20% year-over-year to ¥344 billion. Despite these positive results, Daiichi Sankyo has issued cautious guidance for the Datroway product, projecting only a modest increase in sales. The company forecasts a 6% increase in sales to ¥2 trillion for the fiscal year ending March 2026, slightly below consensus estimates, but anticipates a 12% growth in core operating profit to ¥350 billion, which is above expectations. Additionally, Daiichi Sankyo expects a slight rise in its gross profit margin and core operating profit margin in the coming fiscal year.
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