AstraZeneca's Truqap AKT inhibitor fails triple-negative breast cancer trial

AstraZeneca announced on Tuesday that a Phase III clinical trial of Truqap (capivasertib) combined with paclitaxel for treating patients with locally advanced or metastatic triple-negative breast cancer (TNBC) did not achieve its primary objectives. Truqap, an AKT inhibitor, is already approved in multiple regions, including the United States and Japan, and is used alongside fulvestrant to treat adults with HR+/HER2- locally advanced or metastatic breast cancer with specific genetic mutations, such as PIK3CA, AKT1, or PTEN.

The recent study, named CAPItello-290, enrolled 923 adults whose TNBC was histologically confirmed. Participants were randomly assigned to receive either Truqap or a placebo, both in combination with paclitaxel, as a first-line treatment. The dual primary endpoints of the trial were to evaluate overall survival across all participants and specifically in those whose tumors exhibited certain alterations in the PI3K/AKT pathway.

Peter Schmid, the principal investigator, commented on the study results, stating, "While the outcomes did not meet our expectations, they offer crucial insights into understanding this particularly aggressive type of breast cancer, for which patients urgently need new treatment options."

Truqap is already utilized internationally for treating HR+/HER2- breast cancer when combined with fulvestrant, specifically targeting cases with one or more PIK3CA, AKT1, or PTEN alterations. Additionally, research is ongoing to explore the efficacy of Truqap in treating other forms of breast and prostate cancer in combination with existing therapies.

The CAPItello-290 trial aimed to fill a significant gap in treatment options for TNBC, a subtype known for its poor prognosis and limited therapeutic choices. Despite the setback in the primary endpoints, the data gathered from this trial are expected to contribute valuable information for future research efforts.

TNBC is a particularly challenging form of breast cancer to treat, partly due to the lack of hormone receptors, which makes conventional hormonal therapies ineffective. The insights gained from the CAPItello-290 trial emphasize the necessity of continued research and development to find more effective treatments for this aggressive cancer.

In summary, AstraZeneca's Phase III trial of Truqap in combination with paclitaxel did not meet its primary endpoints in treating locally advanced or metastatic TNBC. Despite the disappointment, the findings provide critical information that could pave the way for future advancements in understanding and treating this difficult form of cancer. The pursuit of new therapeutic options remains essential for improving outcomes for patients battling TNBC.