The FDA recently approved the combination of inavolisib, fulvestrant, and palbociclib in this patient population.
Inavolisib (Itovebi) plus fulvestrant and palbociclib (Ibrance) led to a statistically significant and clinically meaningful benefit in progression-free survival (PFS) vs fulvestrant and palbociclib alone in patients with hormone receptor-positive (HR+), HER2-negative (HER2–), PIK3CA-mutated breast cancer, according to the latest data from the phase 3 INAVO120 study (NCT04191499) published in The New England Journal of Medicine.1
The inavolisib regimen reduced the risk of disease progression or death by 57% compared with palbociclib alone, with PFS of 15.0 months vs 7.3 months, respectively (HR, 0.43; 95% CI, 0.32-0.59; P <.001). The PFS benefit was observed across all prespecified subgroups, including in patients with disease that had spread to 3 or more sites.
Overall survival (OS) data were immature at the time of this analysis but demonstrated a positive trend with a stratified HR of 0.64 (95% CI, 0.43-0.97; P =.03).
“With a doubling of progression-free survival and consistent benefits in [patients] whose disease had spread to multiple challenging-to-treat locations, including the liver and lungs, these INAVO120 data are significant for patients,” said Komal Jhaveri, MD, section head for the endocrine therapy research portfolio and clinical director of the early drug development service at Memorial Sloan Kettering Cancer Center and a principal investigators of the INAVO120 study, in a press release. “I’m confident this [inavolisib]-based regimen could become a new first-line standard of care for this patient population with one of the most commonly mutated genes in metastatic breast cancer, associated with a poor prognosis.”
On October 10, 2024, the FDA approved the inavolisib regimen patients with HR+, HER2–, locally advanced or metastatic breast cancer following recurrence on or after completing adjuvant endocrine therapy. The approval was supported by data from INAVO120.2
Data from INAVO120 were also presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. In the ASCO results, the time from randomization to end of next-line treatment was 24.0 months with the addition of inavolisib vs 15.1 months for palbociclib and fulvestrant alone (HR, 0.54; 95% CI, 0.38-0.77). The time to first chemotherapy was not yet reached with the addition of inavolisib compared with 15.0 months with placebo (unstratified HR, 0.54; 95% CI, 0.37-0.78).3
The INAVO121 (NCT05646862) and INAVO122 (NCT05894239) trials are also evaluating different inavolisib combinations for the treatment of patients with PIK3CA-mutated breast cancer.1
HER2-Low and -Ultralow Populations Benefit from T-DXd in HR+ mBC
November 13th 2024During a Case-Based Roundtable® event, Aditya Bardia, MD, MS, FASCO, discussed data from the DESTINY-Breast04 and DESTINY-Breast06 trials for HER2-low breast cancer in the second article of a 2-part series.
Read More
Breast Cancer Leans into the Decade of Antibody-Drug Conjugates, Experts Discuss
September 25th 2020In season 1, episode 3 of Targeted Talks, the importance of precision medicine in breast cancer, and how that vitally differs in community oncology compared with academic settings, is the topic of discussion.
Listen
HER2-Low and -Ultralow Populations Benefit from T-DXd in HR+ mBC
November 13th 2024During a Case-Based Roundtable® event, Aditya Bardia, MD, MS, FASCO, discussed data from the DESTINY-Breast04 and DESTINY-Breast06 trials for HER2-low breast cancer in the second article of a 2-part series.
Read More
Breast Cancer Leans into the Decade of Antibody-Drug Conjugates, Experts Discuss
September 25th 2020In season 1, episode 3 of Targeted Talks, the importance of precision medicine in breast cancer, and how that vitally differs in community oncology compared with academic settings, is the topic of discussion.
Listen
2 Commerce Drive
Cranbury, NJ 08512