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Results of a primary analysis of INAVO120 trial presented during the last San Antonio Breast Cancer Symposium shows that a combination of inavosilib with palbociclib and fulvestrant may represent a new standard of care for endocrine therapy-resistant PIK3CA-mutated, HR+, HER2- advanced breast cancer.
INAVO 120 study is a phase III randomized, double blind, placebo-controlled trial assessing inavosilib or placebo with palbociclib and fulvestrant in 325 patients with PIK3CA-mutated, HR+/HER2 locally advanced or metastatic breast cancer who recurred on or within 12 months of adjuvant endocrine therapy. Development of acquired resistance to a combination therapy with CDK4/6 inhibitors and endocrine therapy is nearly inevitable, therefore there is a need for additional therapies. INAVO120 trial primary analysis showed a statistically significant and clinically meaningful improvement in investigator-assessed progression-free survival (PFS), the primary endpoint of the trial: after 21.3 months median follow-up, median PFS was 15 months in the inavolisib arm and 7.3 months in the placebo arm; median PFS in the inavolisib arm at 6, 12, and 18 months was 82.9%, 55.9%, and 46.1%, respectively, compared to 55.9%, 32.6%, and 21.1% in the placebo arm. Interim overall survival, overall response rate and clinical benefit rate were higher and benefits were seen in all subgroups of patient, including patients younger than 65 years old, pre- and post-menopausal women, and those with/without visceral disease or liver metastases at enrollment. «PI3Kα inhibitors to date have faced challenges with safety and tolerability. Inavolisib is a highly potent and selective PI3Kα inhibitor that also promotes the degradation of mutant p110α, which may improve the therapeutic window», leading author Komal Laveri from Memorial Sloan Kettering Cancer Center concluded.
Results of a primary analysis of INAVO120 trial presented during the last San Antonio Breast Cancer Symposium shows that a combination of inavosilib with palbociclib and fulvestrant may represent a new standard of care for endocrine therapy-resistant PIK3CA-mutated, HR+, HER2- advanced breast cancer.
INAVO 120 study is a phase III randomized, double blind, placebo-controlled trial assessing inavosilib or placebo with palbociclib and fulvestrant in 325 patients with PIK3CA-mutated, HR+/HER2 locally advanced or metastatic breast cancer who recurred on or within 12 months of adjuvant endocrine therapy. Development of acquired resistance to a combination therapy with CDK4/6 inhibitors and endocrine therapy is nearly inevitable, therefore there is a need for additional therapies. INAVO120 trial primary analysis showed a statistically significant and clinically meaningful improvement in investigator-assessed progression-free survival (PFS), the primary endpoint of the trial: after 21.3 months median follow-up, median PFS was 15 months in the inavolisib arm and 7.3 months in the placebo arm; median PFS in the inavolisib arm at 6, 12, and 18 months was 82.9%, 55.9%, and 46.1%, respectively, compared to 55.9%, 32.6%, and 21.1% in the placebo arm. Interim overall survival, overall response rate and clinical benefit rate were higher and benefits were seen in all subgroups of patient, including patients younger than 65 years old, pre- and post-menopausal women, and those with/without visceral disease or liver metastases at enrollment. «PI3Kα inhibitors to date have faced challenges with safety and tolerability. Inavolisib is a highly potent and selective PI3Kα inhibitor that also promotes the degradation of mutant p110α, which may improve the therapeutic window», leading author Komal Laveri from Memorial Sloan Kettering Cancer Center concluded.
