Gynecologic cancers, cancers that begin in the female reproductive system, remain common and challenging for women. In ovarian cancer, more than 70% of patients with stage 3 to 4 will have a recurrence within five years after diagnosis and treatment decisions become increasingly complex with disease progression. Because of this, there is an ongoing need to better understand the biology of these diseases and explore new, more personalized treatment approaches.
One area of growing focus is biomarker testing. Biomarkers are genes, proteins or other substances that can be tested for to reveal important details about a person’s cancer. As research continues to evolve, one biomarker is receiving increased attention for its role in disease behavior and treatment potential: HER2.
What is HER2?
HER2 (Human Epidermal Growth Factor Receptor 2) is a protein found on the surface of some cells that regulates cell growth and division. In certain cancers, HER2 becomes overexpressed or uncontrolled, driving tumors to develop quickly. As our understanding of HER2 and its role deepens, its relevance across gynecologic tumors has become increasingly clear.
Gopi Unnikrishnan, Associate Director, U.S. Medical Affairs
The Challenges
“HER2-positive gynecologic cancer is associated with more aggressive tumor behavior, poorer prognosis, and, in certain cancers, significantly worse survival outcomes and higher rates of recurrence. Compounding these challenges, some gynecologic cancers, such as ovarian cancer, often present with few or nonspecific symptoms in their early stages, and effective diagnostic tools are limited. As a result, many patients are diagnosed at more advanced stages of disease.”
What Does HER2 Mean for Endometrial Cancer?
Endometrial cancer begins in the lining of the uterus and is the most common gynecologic cancer in the United States. Studies show that HER2 overexpression is often associated with more aggressive tumor growth and poorer outcomes. Additional biomarker driven, targeted treatment approaches are needed to address disease recurrence and improve outcomes for patients with HER2 expressing disease.
What Does HER2 Mean for Ovarian Cancer?
Ovarian cancer is another common gynecologic cancer and is frequently diagnosed at advanced stages. Many patients with ovarian cancer experience relapse after initial treatment, underscoring the need for maintenance options that prolong disease control.
The identification of biomarkers has become increasingly important in the diagnosis and treatment of ovarian cancers, especially as newer biomarkers emerge. As with endometrial cancer, no HER2-directed maintenance therapies are currently approved for ovarian cancer. A HER2-directed maintenance therapy could represent an important step toward more personalized care, helping to address an unmet need and expand treatment strategies for patients with HER2-expressing disease.
Cecilia Orbegoso Aguilar, M.D., Executive Director, Late-Stage Oncology Clinical Development
Impact Potential
“The prognostic impact of HER2 expression in gynecologic cancers varies by tumor type, but overall, it is recognized as an actionable biomarker. As molecular profiling becomes more integrated into staging and treatment decisions, HER2 is increasingly viewed not only as a potential prognostic factor, but also as an important predictive biomarker that enables the use of HER2-directed therapies and supports a more personalized, biomarker-driven approach to care.”
What Could New Treatment Options Mean?
Advances in cancer research continue to expand our understanding of how biomarkers such as HER2 may influence gynecologic cancers. Building on scientific progress across multiple tumor types, Daiichi Sankyo is committed to exploring how targeted approaches may help address unmet needs in gynecologic oncology. This work reflects a broader focus on understanding cancer at the molecular level and supporting the development of treatment strategies that are informed by tumor biology.
Julie Jeanes, VP, Global Team Lead, Oncology R&D
Advancing Innovation
“Our work in gynecologic cancers reflects a long-term commitment to understanding where HER2-directed therapies may offer the greatest benefit to patients. Beyond demonstrating clinical activity, the focus is on how targeted approaches might be integrated earlier in the treatment journey and aligned with evolving biomarker testing, with the goal of advancing more personalized and durable treatment strategies for patients.”
As understanding of HER2 continues to evolve, advancing biomarker-driven strategies holds the potential to change the treatment landscape for gynecologic cancers and deliver more personalized care for patients facing these challenging diseases.
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