Capivasertib plus Faslodex showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS), compared to placebo plus Faslodex, and met both primary endpoints in the study
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.