Lakhasly

The therapeutic value of the drug Gedatolisib 1.Safety and side effects Drug safety and side effects Oral inflammation: the most prominent common symptom; the percentage of severe cases (grade three) reached 19.2% with triple therapy and 12.3% with dual therapy.Benefits and clinical outcomes (VIKTORIA-1 trial - phase three) Benefits and clinical outcomes (VIKTORIA-1 trial - Phase III) The study was conducted on patients with advanced breast cancer (HR^+ / HER2^-) with wild-type PIK3CA gene whose disease progressed after previous treatments, and yielded the following results: The triple therapy (Gedatolisib + Fulvestrant + Palbociclib): The median progression-free survival increased to 9.3 months (compared to only 2 months with Fulvestrant alone).Mechanism of action: Inhibition of the (PI3K/AKT/mTOR) pathway to control breast cancer growth and reduce resistance to hormonal therapies and CDK4/6 inhibitors.Mechanism of action and therapeutic effect Mechanism of action and therapeutic effect A dual and potent inhibitor: it inhibits all forms of the PI3K enzyme (class I) and the mTOR complexes (both mTORC1 and mTORC2).The objective response rate was 31.5%.The objective response rate was 28.3%.2.3.4.5.

The therapeutic value of the drug Gedatolisib

1. Mechanism of action and therapeutic effect Mechanism of action and therapeutic effect
   A dual and potent inhibitor: it inhibits all forms of the PI3K enzyme (class I) and the mTOR complexes (both mTORC1 and mTORC2).
   Mechanism of action: Inhibition of the (PI3K/AKT/mTOR) pathway to control breast cancer growth and reduce resistance to hormonal therapies and CDK4/6 inhibitors.


2. Benefits and clinical outcomes (VIKTORIA-1 trial - phase three) Benefits and clinical outcomes (VIKTORIA-1 trial - Phase III)
   The study was conducted on patients with advanced breast cancer (HR^+ / HER2^-) with wild-type PIK3CA gene whose disease progressed after previous treatments, and yielded the following results:
   The triple therapy (Gedatolisib + Fulvestrant + Palbociclib):
   The median progression-free survival increased to 9.3 months (compared to only 2 months with Fulvestrant alone).
   The objective response rate was 31.5%.
   Combination therapy (Gedatolisib + Fulvestrant):
   The median progression-free survival increased to 7.4 months (compared to 2 months with Fulvestrant alone).
   The objective response rate was 28.3%.
   Overall result: Both treatment regimens significantly reduced the risk of disease progression or death compared to Fulvestrant alone (which recorded a response rate of only 1.0%).


3. Beneficial cases Benefiting cases
   It represents a promising option for patients with advanced breast cancer (\bm{HR^+ / HER2^-}) whose disease has progressed after CDK4/6 inhibitors and hormonal therapy.
   It has proven effective in patients who do not carry mutations in the \bm{PIK3CA} gene (wild type), meaning that the therapeutic benefit is not limited to the presence of the mutation only.


4. Safety and side effects Drug safety and side effects
   Oral inflammation: the most prominent common symptom; the percentage of severe cases (grade three) reached 19.2% with triple therapy and 12.3% with dual therapy.
   Hyperglycemia: The incidence rate of severe cases (grade three) decreased to only 2.3% in both groups.
   Stopping treatment: The occurrence of side effects led to discontinuation of treatment at very low rates (2.3% for the triple therapy, and 3.1% for the dual therapy).


5. Summary Conclusion
   The results of the VIKTORIA-1 trial demonstrate that the addition of Gedatolisib to Fulvestrant (with or without Palbociclib) significantly and noticeably improves progression-free survival rates in this patient group.