Piqray (alpelisib) plus Faslodex (fulvestrant) confirmed a major and clinically significant enchancment in progression-free survival (PFS) in contrast with Faslodex alone in sufferers with CDK4/6 inhibitor–pretreated, PIK3CA-mutated, hormone receptor–optimistic, HER2-negative superior breast most cancers, assembly the first finish level of the section 3 EPIK-B5 examine.
Findings introduced throughout the 2025 San Antonio Breast Most cancers Symposium demonstrated that, as of the information cutoff of October 15, 2024, the median PFS per RECIST 1.1 standards by blinded impartial central assessment (BICR) amongst sufferers who obtained Piqray plus Faslodex (94 sufferers) was 7.4 months versus 2.8 months with placebo plus Faslodex (94 sufferers). The general response charges (ORRs) per BICR had been 23.4% and 4.3%, respectively.
“EPIK-B5 met its major finish level, demonstrating a PFS enchancment that was statistically vital and clinically significant in sufferers with hormone receptor–optimistic, HER2-negative PIK3CA-mutated [disease] who progressed on earlier remedy with CDK4/6 inhibitors,” Dr. Michelino De Laurentiis, the chair of the Division of Breast and Thoracic Oncology at Nationwide Most cancers Institute IRCCS “Fondazione Pascale” in Napoli, Italy stated throughout the presentation.
In Could 2019, the FDA accepted Piqray plus Faslodex for the remedy of postmenopausal ladies and men with PIK3CA-mutated, hormone receptor–optimistic, HER2-negative superior or metastatic breast most cancers as detected by an FDA-approved check following development on or after an endocrine-based routine. The regulatory determination was supported by knowledge from the section 3 SOLAR-1 trial which confirmed that sufferers who obtained the mixture achieved a major PFS profit in contrast with those that obtained Faslodex alone.
How was the examine designed?
EPIK-B5 enrolled grownup postmenopausal ladies and men with PIK3CA-mutated, hormone receptor–optimistic, HER2-negative superior breast most cancers who skilled illness development or relapse on or after remedy with a CDK4/6 inhibitor and an aromatase inhibitor. Sufferers had been required to have at the least 1 measurable lesion per RECIST 1.1 standards as assessed by the investigator, have obtained not more than 1 prior line of chemotherapy, excluding neoadjuvant/adjuvant chemotherapy, and ample tumor tissue for PIK3CA mutational standing evaluation by a central laboratory.
Sufferers had been randomly assigned 1:1 to obtain Piqray at 300 mg together with Faslodex at 500 mg or placebo plus Faslodex. Crossover to the mixture arm was permitted on the time of illness development per RECIST 1.1 standards by BICR.
The first finish level was PFS per BICR. Secondary finish factors included ORR, length of response, and time to response primarily based on BICR evaluation. General survival (OS), security, ECOG efficiency standing, high quality, and time to second illness development had been additionally secondary finish factors.
At baseline, the median ages within the mixture and placebo arms had been 62 years and 61.5 years, respectively. Most sufferers in each arms had an ECOG efficiency standing of 0 (56.4% versus 63.8%), visceral metastasis (71.3% versus 71.3%), and had obtained a previous CDK4/6 inhibitor for at the least six months (86.2% versus 89.4%). Sufferers in each arms obtained prior adjuvant chemotherapy (28.7% versus 31.9%) and metastatic chemotherapy (12.8% versus 18.1%).
What had been the extra efficacy and security knowledge seen with the mixture?
At a knowledge cutoff of Could 26, 2025, up to date OS knowledge revealed that sufferers within the mixture (105 sufferers) and placebo (107 sufferers) achieved a median OS of 29.5 months and 23.8 months, respectively.
By way of security, the commonest any-grade negative effects within the mixture arm (92 sufferers) that occurred in at the least 10% of sufferers had been hyperglycemia (72.8%), diarrhea (51.1%), nausea (44.6%), decreased urge for food (30.4%) and rash (30.4%). The most typical any-grade negative effects within the placebo arm (94 sufferers) had been asthenia (16%), arthralgia (16%), elevated alanine aminotransferase ranges (14.9%), and elevated gamma-glutamyl transferase ranges (14.9%). Sufferers within the mixture and placebo arms skilled any-grade negative effects at respective charges of 100% and 86.2%; grade 3 or greater negative effects occurred at charges of 70.7% and 33%, respectively.
“There have been no new security indicators and the protection profile is in step with what we already know [about Piqray],” De Laurentiis stated in his conclusion. “These knowledge verify and prolong the SOALR-1 findings and assist using Piqray plus Faslodex as an efficient remedy choice for sufferers with hormone receptor–optimistic, HER2-negative PIK3CA-mutated [breast cancer] after development on CDK4/6 inhibitors.”
References
- “Alpelisib plus fulvestrant for PIK3CA-mutated, HR-positive, HER2-negative superior breast most cancers after a CDK4/6 inhibitor” by Dr. De Laurentiis, et al., San Antonio Breast Convention Symposium.
- “FDA approves alpelisib for metastatic breast most cancers.” FDA.
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