LONDON (dpa-AFX) - British drug major AstraZeneca Plc. (AZN.L, AZN)
announced Tuesday that the CAPItello-290 Phase III trial for Truqap
(capivasertib) plus chemotherapy in patients with locally advanced (inoperable)
or metastatic triple-negative breast cancer or TNBC did not meet the dual
primary endpoints.

Breast cancer is the second most common cancer, and TNBC is defined as negative
for all three of estrogen receptors, progesterone receptors or overexpression of
human epidermal growth factor receptor.

The company noted that 1st-line treatment for advanced or metastatic TNBC
usually consists of chemotherapy alone or in combination with an immunotherapy.

CAPItello-290 is a Phase III, double-blind, randomised trial evaluating the
efficacy and safety of Truqap in combination with paclitaxel versus placebo in
combination with paclitaxel in the 1st-line treatment of patients with locally
advanced (inoperable) or metastatic TNBC.

The primary endpoints were improvement in overall survival or OS in the trial
for Truqap in combination with paclitaxel, versus paclitaxel in combination with
placebo in either the overall trial population or in a subgroup of patients with
tumours harbouring specific biomarker alterations (PIK3CA, AKT1 or PTEN).

The company noted that the safety profile of Truqap in combination with
paclitaxel in CAPItello-290 was broadly consistent with the known safety profile
of each medicine.

AstraZeneca plans to share the trial data in due course.

Peter Schmid, Barts Cancer Institute, London, UK, and principal investigator for
the trial said, '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 currently being evaluated in Phase III trials for the treatment of
breast cancer (CAPItello-292) and prostate cancer (CAPItello-280 and
CAPItello-281) in combination with established treatments.

AstraZeneca discovered Truqap subsequent to a collaboration with Astex
Therapeutics, and its collaboration with the Institute of Cancer Research and
Cancer Research Technology Limited.

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