AstraZeneca’s capivasertib (Truqap) combined with fulvestrant (Faslodex) receives FDA approval as a groundbreaking treatment for HR-positive, HER2-negative advanced breast cancer with specific genetic biomarker alterations, offering new hope to patients facing progression or resistance to standard therapies.
In addition to the treatment approval, the FDA also authorized a companion diagnostic test to identify the PIK3CA, AKT1, and PTEN genetic alterations, enabling personalized treatment.
This milestone signifies a substantial advancement in the treatment landscape for patients with advanced HR-positive breast cancer, addressing an unmet need and potentially extending the duration of disease control. Clinical trial results showed a remarkable 40% reduction in the risk of disease progression among patients receiving the combination therapy, leading to a significant extension in progression-free survival (PFS) compared to those on a placebo plus Faslodex regimen.
New Combination Shows Impressive Progression-Free Survival and Response Rates in Breast Cancer
The combination therapy achieved a median PFS of 7.2 months, doubling the PFS observed in the placebo group. Notably, the objective response rate (ORR) also demonstrated a substantial improvement, with 22.9% of patients responding to Truqap plus Faslodex versus 12.2% in the placebo group.
Furthermore, for patients with tumors exhibiting AKT pathway mutations, the combination therapy demonstrated even more remarkable results, with a median PFS of 7.3 months and an ORR of 28.8%, highlighting its effectiveness in this specific subgroup.
The most frequently reported grade 3 or higher adverse events (AEs) in patients treated with Truqap plus Faslodex were rashes, diarrhea, and hyperglycemia. Although some patients experienced AEs leading to discontinuation, this therapy offers a promising alternative for patients who have developed resistance to other treatments.
Swift Approval of Truqap: Personalized Hope for Breast Cancer Patients
HR-positive breast cancer represents a significant portion of breast cancer cases, and many patients exhibit genetic mutations that contribute to endocrine resistance. While current therapies can lose efficacy over time, this approval opens the door to a more effective and personalized treatment approach for a substantial number of patients.
AstraZeneca’s swift approval of Truqap underscores the importance of identifying PI3K/AKT/PTEN pathway alterations in HR-positive breast cancer patients and emphasizes the critical role of timely genetic testing. This development marks a crucial milestone in improving treatment options and outcomes for patients in the US and holds promise for those worldwide facing this specific type of breast cancer.
Resource: PharmExec, November 17, 2023
This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.
