Positive Phase III Results for Truqap in PTEN-Deficient Metastatic Prostate Cancer
AstraZeneca reported positive results from the Phase III CAPItello-281 trial. The trial tested Truqap (capivasertib) together with abiraterone and androgen deprivation therapy (ADT) in patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC). This combination improved radiographic progression-free survival (rPFS) significantly compared to abiraterone and ADT with a placebo.
Dr. Karim Fizazi, a principal investigator at the trial, highlighted the urgent need for new treatments for this aggressive cancer. He noted the poor prognosis for patients with PTEN deficiency and emphasized that the trial results represent progress.
CAPItello-281 enrolled 1,012 adults with confirmed mHSPC. The primary endpoint was rPFS, while overall survival (OS) serves as a secondary endpoint. OS data were still immature at the latest analysis. However, the Truqap combination showed early signs of improved OS compared to the standard treatment.
Susan Galbraith, AstraZeneca’s executive vice president for oncology R&D, stated that the trial shows the benefit of adding an AKT inhibitor to standard therapy for patients with PTEN-deficient disease. She acknowledged the need for further analysis on OS.
What are the potential side effects of Truqap (capivasertib) in the treatment of prostate cancer?
Interview with Dr. Karim Fizazi on AstraZeneca’s CAPItello-281 Trial
News Directory 3: We are joined today by Dr. Karim Fizazi, a principal investigator in the CAPItello-281 trial. Thank you for your time, Dr. Fizazi. Can you please provide an overview of the trial and its significance?
Dr. Fizazi: Thank you for having me. The CAPItello-281 trial was designed to evaluate the effectiveness of Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC). The significance of this trial lies in the urgent need for new and effective treatments for this aggressive form of cancer, especially as patients with PTEN deficiency often have a poor prognosis.
News Directory 3: What were the main findings from the trial?
Dr. Fizazi: We found that the combination therapy significantly improved radiographic progression-free survival (rPFS) compared to the conventional treatment of abiraterone and ADT with a placebo. This is a crucial advancement, particularly for those struggling with PTEN-deficient mHSPC. Although overall survival data is still being analyzed, we observed early indicators of improved outcomes in that area as well.
News Directory 3: With 1,012 participants enrolled, what can you tell us about the trial’s design and endpoints?
Dr. Fizazi: The trial was robustly designed to include 1,012 adults with confirmed mHSPC. The primary endpoint was radiographic progression-free survival (rPFS), an important measure of the treatment’s effectiveness in delaying disease progression. Overall survival (OS) was secondary, and while that data remains immature, early trends suggest a potential benefit from the combination therapy.
News Directory 3: Susan Galbraith from AstraZeneca mentioned the therapeutic implications of adding an AKT inhibitor. Could you expound on that?
Dr. Fizazi: Absolutely. The addition of the AKT inhibitor Truqap brings a new dimension to standard therapy for patients with PTEN-deficient disease. This approach targets a pathway that is crucial in the progression of cancer. The results from CAPItello-281 suggest that integrating an AKT inhibitor can improve outcomes for this particular patient population, marking a promising step forward in addressing their treatment needs.
News Directory 3: AstraZeneca has also recently seen success with the CAPItello-291 trial in breast cancer. What does this mean for the future of targeted therapies?
Dr. Fizazi: The approval of Truqap in combination with Faslodex for treating ER-positive, HER2-negative advanced breast cancer further highlights the expanding role of targeted therapies in oncology. It shows that molecules like Truqap can be effective across different cancer types, reinforcing the importance of biomarker-driven approaches in developing and personalizing treatment options.
News Directory 3: What are the next steps following these promising findings in the CAPItello-281 trial?
Dr. Fizazi: Moving forward, we will continue to analyze the overall survival data to gain a clearer picture of the long-term benefits of this combination therapy. Additionally, we aim to further explore the treatment’s implications in broader patient populations and to ensure that patients with PTEN deficiency have access to effective therapies.
News Directory 3: Thank you, Dr. Fizazi, for sharing your insights on the CAPItello-281 trial and the exciting progress in prostate cancer treatment.
Dr. Fizazi: Thank you for having me. It’s crucial that we keep pushing forward in our fight against cancer, and discussions like these help spread awareness about the need for innovation in treatment options.
Earlier in June, AstraZeneca announced the approval of Truqap combined with Faslodex (fulvestrant) in the EU for treating adults with ER-positive, HER2-negative advanced breast cancer. This approval came from the Phase III CAPItello-291 trial, which showed that the Truqap-Faslodex combination reduced disease progression or death by 50% compared to Faslodex alone for biomarker-altered patients.
For further details, please refer to AstraZeneca’s press releases on the CAPItello-281 and CAPItello-291 trials.