Elinzanetant Achieves All Goals in OASIS 4 Phase III Trial for Breast Cancer-Induced Vasomotor Symptoms

In a recent announcement, Bayer revealed encouraging outcomes from their Phase III study, OASIS 4, which focused on evaluating elinzanetant. This compound is being developed as a non-hormonal alternative for managing moderate to severe vasomotor symptoms (VMS) triggered by adjuvant endocrine therapy in women with hormone receptor positive breast cancer or at high risk of developing it. The study, conducted outside the United States, successfully achieved its primary and secondary goals, marking a significant step forward in addressing a previously unmet medical need.

Vasomotor symptoms, commonly known as hot flashes, are a frequent side effect of adjuvant endocrine therapies like tamoxifen and aromatase inhibitors, which are standard treatments for hormone receptor positive breast cancer. These therapies, while effective in reducing cancer recurrence, often lead to uncomfortable side effects such as VMS, impacting patients' quality of life and adherence to treatment regimens. As no approved non-hormonal treatments for VMS exist, the results from OASIS 4 offer new hope for those affected.

Elinzanetant showed a statistically significant reduction in the frequency and severity of these symptoms when compared to a placebo, according to the study findings. Patients receiving elinzanetant experienced notable relief in VMS frequency as early as one week into treatment, with continued improvements observed at weeks four and twelve. Additionally, participants reported better sleep quality and overall enhancements in menopause-related quality of life, suggesting that elinzanetant could offer comprehensive benefits beyond the primary symptom management.

The safety profile of elinzanetant over the 52-week study duration was consistent with previous studies, reinforcing its potential as a reliable treatment option. This consistency across multiple trials, including OASIS 1, 2, and 3, strengthens the case for elinzanetant's efficacy and safety, underscoring its promise as a novel therapeutic approach.

Dr. Christian Rommel, leading Bayer’s Pharmaceuticals Division in Research and Development, emphasized the significance of OASIS 4. As the first pivotal international trial to assess a non-hormonal treatment for women undergoing or at risk from adjuvant endocrine therapy, elinzanetant provides a much-needed alternative for managing VMS in this demographic. This endeavor aligns with Bayer's commitment to developing innovative health solutions tailored to women's needs.

Globally, breast cancer is the most prevalent cancer among women, with 2.3 million new cases in 2020 alone. Nearly 70% of these cancers are hormone receptor positive, making effective adjuvant endocrine therapy crucial. While these therapies significantly lower mortality rates, they can also result in challenging side effects that are currently inadequately addressed by available treatments. Thus, the development of a non-hormonal option like elinzanetant represents a breakthrough in patient care.

Dr. Fatima Cardoso, Principal Investigator of the OASIS 4 study, highlighted the potential impact of these findings. The positive results bring the medical community closer to offering a viable non-hormonal solution for managing VMS in patients affected by breast cancer treatments. For many women, this could mean improved quality of life and better adherence to cancer therapies, ultimately impacting long-term health outcomes.

Bayer continues to pursue regulatory approvals for elinzanetant in various markets, including the US and EU, with hopes of making this innovative treatment available to patients worldwide. As the first dual neurokinin-1 and 3 receptor antagonist in late-stage development, elinzanetant holds promise for addressing the complex needs of women experiencing VMS due to menopause or medical interventions.