^
Association details:
| Biomarker: | PIK3CA mutation + HR positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | Ibrance (palbociclib) (CDK4 inhibitor, CDK6 inhibitor) + Itovebi (inavolisib) (PIK3CA inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
FDA approves Roche’s Itovebi, a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation
Published date:
10/11/2024
Excerpt:
United States Food and Drug Administration (FDA) approved Itovebi™ (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.
Trial ID:
Source:
Title:
FDA Grants Priority Review to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
Published date:
05/28/2024
Excerpt:
...U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application and granted Priority Review to inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant.
Secondary therapy:
fulvestrant
Source:
Title:
FDA Grants Breakthrough Therapy Designation to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation
Published date:
05/21/2024
Excerpt:
Genentech, a member of the Roche Group...announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.
Secondary therapy:
fulvestrant
Source:
Title:
Roche announces positive Phase III results for inavolisib combination in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation
Published date:
12/05/2023
Excerpt:
Roche...announced today positive results from the Phase III INAVO120 study of the investigational therapy, inavolisib, in combination with palbociclib (Ibrance®) and fulvestrant as a potential first-line treatment option for people with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The study met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement compared to palbociclib and fulvestrant alone. Overall survival data were immature at this time, but a clear positive trend has been observed.
Secondary therapy:
fulvestrant
Trial ID:
Source:
Title:
A phase I/Ib study evaluating GDC-0077 + palbociclib (palbo) + fulvestrant in patients (pts) with PIK3CA-mutant (mut), hormone receptor- positive/HER2-negative metastatic breast cancer (HR+/HER2- mBC)
Published date:
11/17/2020
Excerpt:
Data from GDC-0077 + palbo + fulvestrant in pts with PIK3CAmut, HR+/HER2- mBC are presented herein....preliminary antitumor activity (clinical benefit rate [CBR]: RECIST v1.1 stable disease for ≥ 24 weeks, partial response [PR], or complete response) of 9 mg oral once daily GDC-0077 + 125 mg palbo 21/28 days + 500 mg intramuscular fulvestrant on day 1 (and day 15 of cycle 1) of 28-day cycles were assessed in Arms E and F,....Overall, 7/25 pts (28%) with measurable disease had a PR (5/10 [50%] pts in Arm E; 2/15 [13%] pts in Arm F...
Secondary therapy:
fulvestrant
Trial ID:
