A New Precision Oncology Breakthrough: PIK3CA-Mutated Breast Cancer Targeted Therapy Inavolisib Now Available at Shanghai Jiahui International Hospital

The highly selective PIK3CA-targeted drug Inavolisib was officially approved in China in March 2025, making China the second country after the United States to make this therapy available. Inavolisib is specifically designed for hormone receptor-positive (HR+), HER2-negative (HER2-) metastatic breast cancer patients carrying PIK3CA mutations, offering a more precise and effective treatment option for this challenging patient population.
Currently, Inavolisib is available for use at Shanghai Jiahui International Hospital.

Indications and Treatment Regimen for Inavolisib
Inavolisib is not a conventional chemotherapy drug. It is an oral PI3Kα inhibitor that should be combined with:
- Palbociclib (oral CDK4/6 inhibitor)
- Fulvestrant (injectable endocrine therapy)

This regimen is suitable for patients with confirmed PIK3CA-mutated HR+/HER2- advanced or metastatic breast cancer who have not received systemic therapy, particularly those resistant to endocrine therapy.

Outstanding Clinical Data: Significantly Prolonged Progression-Free Survival (PFS)
The efficacy of Inavolisib has been validated in the global Phase III INAVO120 study[1]:
- Progression-free survival (PFS) more than doubled, demonstrating substantial clinical benefit:
  - Inavolisib + Palbociclib + Fulvestrant group: 15.0 months
  - Placebo + Palbociclib + Fulvestrant group: 7.3 months
- Objective response rate (ORR) significantly improved:
  - Inavolisib group: 58.4%
  - Placebo group: 25.0%
- Promising long-term survival trends: 18-month overall survival (OS) rate:
  - Inavolisib group: 73.7%
  - Placebo group: 67.5%

In addition, Inavolisib demonstrates manageable safety, with common side effects including hyperglycemia, stomatitis, and diarrhea, while serious adverse events remain rare, and patient tolerability is generally good.
[1] Turner NC, Im S-A, Saura C, et al. Inavolisib-based therapy in PIK3CA-mutated advanced breast cancer. N Engl J Med. 2024;391:1584–96.

Consultation and Treatment Workflow
- Genetic testing first: Mutation status must be confirmed via tissue or blood testing before initiating therapy.
- One-stop oncology care: After receiving genetic testing results, patients are advised to consult specialists at Jiahui Cancer Center to discuss and create a personalized treatment plan. Clinicians dynamically monitor treatment efficacy and safety throughout therapy.
- Multidisciplinary medication management: During Inavolisib therapy, clinical staff and pharmacists closely monitor adverse reactions and comprehensively assess patients’ conditions, ensuring safe and effective treatment.

Shanghai Jiahui International Hospital: International-Standard Care, Globally Synchronized
The launch of Inavolisib marks the PIK3CA-targeted era in breast cancer therapy, offering HR+/HER2- advanced patients longer survival and improved quality of life. If you or a family member meets the treatment criteria, consult the oncology specialists at Shanghai Jiahui International Hospital Cancer Center to develop a personalized treatment plan.

(Data in this article are based on publicly available clinical research and drug information. Specific treatment plans should be determined by your physician.)