PIK3CA

Inavolisib plus fulvestrant and palbociclib significantly improved progression-free survival (PFS) in HR+, HER2-, PIK3CA-mutated breast cancer patients, reducing progression risk by 57% compared to palbociclib alone (PFS 15.0 vs 7.3 months, HR 0.43). FDA approved inavolisib regimen in October 2024, supported by INAVO120 data.

The INAVO120 trial showed a three-drug combo (inavolisib, palbociclib, and fulvestrant) delayed advanced breast cancer progression by 15 months, compared to 7.3 months with palbociclib and fulvestrant alone. The new therapy has been FDA-approved and aims to become the standard of care.

October 2024 saw significant FDA actions in oncology, including priority reviews for T-DXd in HER2-low/ultra-low breast cancer, acalabrutinib for frontline mantle cell lymphoma, and approvals for nivolumab plus chemotherapy in operable NSCLC, Cologuard Plus for CRC screening, and zolbetuximab for HER2-negative gastric cancer. Other notable actions included fast track designations, orphan drug designations, and expanded approvals for various cancer treatments.

Precision oncology and germline genetic testing have revolutionized breast cancer care by revealing genetic underpinnings, facilitating personalized treatments, and advancing early detection through polygenic risk scores. The discovery of BRCA1 and BRCA2 genes and the use of omics data from diverse populations have provided comprehensive genomic insights, highlighting the importance of TP53, PIK3CA, and other gene mutations in cancer progression and treatment response. Proteomics and integrative approaches further translate genetic changes into biological mechanisms, supporting the development of individualized treatment strategies.

FDA approved inavolisib plus palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer, showing 58% response rate vs 25% with placebo, and median duration of response of 18.4 months vs 9.6 months.

Roche announced the publication of INAVO120 phase III results in NEJM, showing Itovebi + palbociclib + fulvestrant reduced disease worsening/death risk by 57% in HR+/HER2- breast cancer. FDA approved the regimen for endocrine-resistant, PIK3CA-mutated cases. Submissions to global health authorities are ongoing.

A three-drug therapy for advanced breast cancer, including inavolisib, palbociclib, and fulvestrant, delays disease progression by 15 months, compared to 7.3 months with palbociclib and fulvestrant alone, according to the INAVO120 study. The new combination has been FDA-approved and aims to become the standard of care for HR+, HER2- breast cancer.

A new three-drug combination therapy, including inavolisib, palbociclib, and fulvestrant, doubles progression-free survival in advanced breast cancer, delaying disease progression by 15 months compared to 7.3 months with current NHS-approved drugs. The INAVO120 study, led by Professor Nicholas Turner, demonstrated the therapy's potential for PIK3CA-mutated HR+, HER2- breast cancer, leading to FDA approval and hope for it becoming the standard of care.

Roche announced phase III INAVO120 trial results for Itovebi in NEJM, showing 57% reduction in HR-positive, HER2-negative breast cancer progression or death risk with median progression-free survival of 15.0 months vs. 7.3 months. FDA approved Itovebi as first-line treatment for PIK3CA-mutated cases.