FX.co ★ AstraZeneca: Phase III Truqap Trial Plus Chemotherapy Fails To Meet Primary Goals In Breast Cancer

AstraZeneca Plc. (AZN.L, AZN), a major player in the British pharmaceutical industry, announced on Tuesday that its CAPItello-290 Phase III trial for Truqap (capivasertib) in combination with chemotherapy did not achieve the dual primary endpoints. This trial focused on patients with locally advanced (inoperable) or metastatic triple-negative breast cancer (TNBC).

Breast cancer ranks as the second most common cancer, with TNBC characterized by the absence of estrogen receptors, progesterone receptors, and the human epidermal growth factor receptor. Standard first-line treatments for advanced or metastatic TNBC typically involve chemotherapy, either alone or combined with immunotherapy.

The CAPItello-290 study is a Phase III, double-blind, randomized trial assessing the efficacy and safety of Truqap combined with paclitaxel, compared to a placebo with paclitaxel, as a first-line treatment for patients with advanced or metastatic TNBC. The primary endpoints were set to measure improvements in overall survival (OS) for patients receiving Truqap with paclitaxel versus those on paclitaxel with a placebo, across the entire trial population as well as in a subgroup of patients whose tumors exhibit specific biomarker alterations (PIK3CA, AKT1, or PTEN).

According to AstraZeneca, the safety profile of Truqap combined with paclitaxel in the CAPItello-290 trial was consistent with the known safety profiles of both drugs.

AstraZeneca intends to release the trial data in the near future. Commenting on the results, Peter Schmid of Barts Cancer Institute in London, and the principal investigator of the trial, stated, "Despite modest advances, triple-negative breast cancer remains one of the most challenging forms of disease to treat due to the lack of known actionable biomarker targets, and chemotherapy-based regimens continue to be the mainstay of treatment. While the CAPItello-290 trial results have not shown what we hoped, they provide important information to further understand this aggressive form of breast cancer where patients are in urgent need of new treatments."

Truqap is also under evaluation in several other Phase III trials, including CAPItello-292 for breast cancer and CAPItello-280 and CAPItello-281 for prostate cancer in combination with established treatments.

The development of Truqap follows a collaboration between AstraZeneca, Astex Therapeutics, the Institute of Cancer Research, and Cancer Research Technology Limited.

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