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AstraZeneca AZN has announced positive results from the phase III CAPItello-281 study, which evaluated a combination regimen involving its ATK inhibitor Truqap (capivasertib) in certain patients with prostate cancer.
The CAPItello-281 study evaluated the combination of Truqap, J&J’s JNJ Zytiga (abiraterone) and androgen deprivation therapy (ADT) in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC).
Results from the study showed that patients treated with this combination achieved a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) when compared to those patients who only received standard of care (SoC) therapy, which is JNJ’s Zytiga plus ADT.
Though data for the key secondary endpoint of overall survival (OS) were not mature at the time, management claimed that the study showed an early trend toward OS improvement in patients treated with the Truqap combination. AstraZeneca intends to continue the study to assess the OS endpoint.
Per AstraZeneca, the above results are the first to show that adding an ATK inhibitor to SoC can benefit mHSPC patients with tumor PTEN deficiency, an aggressive form of prostate cancer with a poor prognosis. Management claims that about 200,000 patients are diagnosed with mHSPC, out of which nearly a quarter have PTEN-deficient tumors.
AZN Stock Performance
Year to date, AstraZeneca’s shares have lost 1.4% against the industry’s 5.7% growth.
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Recent Developments With AstraZeneca’s Truqap
Truqap has already approved by the FDA in combination with Faslodex to treat adult patients with advanced HR-positive breast cancer since last year. This combination received approval in the EU earlier this June to treat adult patients with advanced ER-positive breast cancer.
The above results are likely to provide relief to investors after a combination therapy involving Truqap missed a late-stage study goal in certain breast cancer patients. Earlier in June, AstraZeneca announced results from the CAPItello-290 study, which evaluated the combination of Truqap and paclitaxel for the first-line treatment of patients with locally advanced (inoperable) or metastatic triple-negative breast cancer. Data from the study showed that treatment with this combination failed to achieve one of the dual primary endpoints of OS.
Apart from the above studies, AZN is also evaluating Truqap in two separate late-stage studies – one in breast cancer and another in prostate cancer – in combination with established treatments.