In today’s episode, we had the pleasure of speaking with Komal Jhaveri, MD, FACP, about the phase 3 INAVO120 trial (NCT04191499), which is investigating inavolisib (GDC-0077) plus palbociclib (Ibrance) and fulvestrant (Faslodex) in patients with PIK3CA-mutant, hormone...
Phase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced or Metastatic Breast CancerPurposeTo investigate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor ...
as assessed by investigators, defined as the time from randomization in the clinical trial to the time when the disease progresses, or a patient dies from any cause. Secondary endpoints include overall survival, objective
The INAVO120 trial showed a median progression-free survival of 15.0 months for the inavolisib group versus 7.3 months for the placebo group. SHOW MORE The FDA approved inavolisib plus palbociclib/fulvestrant for select PIK3CA-mutated, HR-positive, HER2-negative,...
The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm. The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from randomization in the clinical trial to the time when the disease progresses, ...
Data also show a longer median time to deterioration for patients in the inavolisib arm in phase 3 INAVO120 trial. "This triple combination is a promising new treatment option for patients with PIK3CA-mutated [hormone receptor]-positive, HER2-negative metastatic breast cancer," according to lead...
INAVO120 (NCT04191499) was a randomized (1:1), double-blind, placebo-controlled trial evaluating the efficacy of ITOVEBI in combination with palbociclib and fulvestrant in adult patients with endocrine-resistant PIK3CA-mutated, HR-positive, HER2-negative (defined as IHC 0 or 1+, or IHC 2+/...
The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm. The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from...
Phase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy forPIK3CA-Mutated, Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor... advanced/metastatic breast cancer (ClinicalTrials.gov identifier:NCT03006172).#Women ≥18 years of age received inavolisib, palbociclib, and ...
Discontinuation of any trial agent because of adverse events occurred in 6.8% of the patients in the inavolisib group and in 0.6% of those in the placebo group.Conclusions In patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer, in...