PIK3CA

Sunil Adige, MD, highlights the importance of Breast Cancer Awareness Month for early detection through mammograms and the evolution of personalized medicine, which tailors treatments based on cancer biomarkers and next-generation sequencing, offering more effective and less adverse treatment options.

FDA approves inavolisib (Itovebi) with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer. INAVO120 trial showed median PFS of 15.0 months vs 7.3 months with placebo, and ORR of 58% vs 25%. Inavolisib recommended dose is 9 mg once daily.

Inavolisib (GDC-0077) showed a disease control rate (DCR) of 60% at 8 weeks and 32% at 16 weeks in patients with PIK3CA-mutated advanced solid tumors, with a favorable safety profile. The median progression-free survival was 3.52 months, and the 12-month overall survival rate was 51%. The most common adverse effects were hyperglycemia, diarrhea, fatigue, and constipation, mostly grade 1 or 2.

FDA reviews DFD-29 for rosacea, eladocagene exuparvovec for AADC deficiency, inavolisib for PIK3CA-mutated HR-positive breast cancer, acoramidis for transthyretin amyloid cardiomyopathy, and zanidatamab for HER2-amplified biliary tract cancer, with PDUFA dates in November 2024.

Novel anti-estrogen therapies, including PI3K pathway inhibitors like inavolisib, show promise in treating ER-positive advanced breast cancer, particularly in patients with PIK3CA mutations. These therapies, often used in combination with existing treatments like palbociclib and fulvestrant, aim to improve progression-free survival and overall outcomes. Personalized treatment strategies are evolving, focusing on identifying specific patient subgroups that may benefit most from these novel agents.

DelveInsight's 'Breast Cancer Pipeline Insight 2024' highlights a robust pipeline with 100+ companies developing 120+ drugs, driven by rising incidence, tech advancements, and increased awareness. Key companies and drugs include Ambrx, CSPC ZhongQi, Merus, and ARX788, DP303c, SHR-A1811, among others. FDA fast-track designations and breakthrough therapy designations for drugs like 9MW2821 and inavolisib underscore significant progress.

The article examines the development, efficacy, pricing, and cost-effectiveness of novel breast cancer drugs approved by the FDA between 2000 and 2023. It highlights that while new drugs have transformed treatment, only a few significantly improve patient-centered outcomes like overall survival (OS) and quality of life (QoL). Despite rising drug prices, there's no clear correlation between price and clinical benefits. The study emphasizes the need for innovative product types, validated biomarkers, and patient-centered clinical endpoints in clinical trials to optimize breast cancer drug development and align drug value with price.

A 54-year-old woman with ER+/PR+, HER2 low grade 2 IDC initially treated with docetaxel, cyclophosphamide, radiation, and anastrozole, later developed bone metastases. After 3 years, she started anastrozole plus palbociclib, then switched to capivasertib plus fulvestrant, showing reduced bone pain and lesion avidity. The choice of capivasertib over alpelisib was due to easier management and fewer side effects.