AstraZeneca has announced positive results for its investigational oral treatment Capivasertib, in combination with Faslodex, from the Phase 3 CAPItello-291 trial.
The Phase 3 trial enrolled patients with HR-positive, human epidermal growth factor receptor 2 (HER2)-low or negative locally advanced or metastatic breast cancer.
In the study, Capivasertib plus Faslodex showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS), compared to placebo plus Faslodex.
It has met both primary endpoints, improving PFS in the overall patient population and in a prespecified subgroup of patients with alterations in the PIK3CA, AKT1 or PTEN genes.
The Capivasertib plus Faslodex showed a safety profile that was similar to that observed in previous trials evaluating this combination, said AstraZeneca.
CAPItello-291 Phase III trial principal investigator Nicholas Turner said: “The CAPItello-291 Phase III trial results show capivasertib offers a clinically meaningful improvement in progression-free survival for patients with HR-positive breast cancer.
“This potential new medicine could give people more time with their cancer under control, which is a priority for patients and their families.”
In a separate development, the British drugmaker announced results from the Phase 2 SERENA-2 trial of Camizestrant in advanced estrogen receptor (ER)-positive breast cancer.
Camizestrant, the company’s next-generation oral selective estrogen receptor degrader (ngSERD), has met the primary endpoint in the Phase 2 trial.
In the study, Camizestrant was well tolerated and showed a safety profile that was consistent with that observed in previous trials with no new safety signals identified.
The drug showed a statistically significant and clinically meaningful progression-free survival (PFS) benefit compared to Faslodex in the study participants.
SERENA-2 Phase II trial lead investigator Mafalda Oliveira said: “The results from SERENA-2 show that camizestrant provides a significant improvement in progression-free survival compared to fulvestrant, which has been used to treat patients with HR-positive breast cancer for almost 20 years.
“These results are meaningful, highlighting the potential of this next-generation oral SERD and supporting the ongoing research programme.”
AstraZeneca Oncology R&D EVP Susan Galbraith said: “We look forward to advancing our comprehensive Phase III clinical programme for camizestrant.”
Furthermore, AstraZeneca intends to conduct Phase 3 SERENA-6 trial, under its clinical development programme for Camizestrant in advanced breast cancer.
