Itovebi (inavolisib)-u200c Is inalisib on the market?

On October 10, 2024, the U.S. Food and Drug Administration (FDA) approved Itovebi (inavolisib) for sale in combination with palbociclib 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 that has relapsed on or after completion of adjuvant endocrine therapy, as measured by an FDA-approved trial. PIK3CA mutations are found in approximately 40% of HR-positive metastatic breast cancers.

The PI3K pathway plays a key role in disease progression and has been a challenging target. Itovebi-based regimens more than doubled progression-free survival and maintained manageable safety and tolerability, adding a new standard for the treatment of PIK3CA mutant breast cancer. With the approval of this Itovebi-based regimen, it continues its long track record in cancer treatment and provides an important new first-line option for patients with PIK3CA-mutated HR-positive breast cancer.

This approval is based on the results ofINAVO120's pivotal Phase III study, which showed that Itove was more effective than palbocicliband fulvestrant alone. The bi-based regimen reduced the risk of disease progression or death by 57% (15.0 months vs. 7.3 months; hazard ratio [HR] = 0.43, 95% CI: 0.32-0.59, p<0.0001), demonstrating a statistically significant and clinically meaningful benefit. At the time of preliminary analysis, overall survival (OS) data were immature, but a clear positive trend was observed (HR=0.64, 95% CI: 0.43-0.97, p=0.0338 [cutoff 0.0098]). The follow-up work of OS will continue with the next step of analysis.

Based on INAVO120 study results, an Itovebi-based regimen was used, while usingFDA-approved tests for early, comprehensive biomarker testing, such as Foundation Medicine's FoundationOne Liquid CDx, can help identify patients with HR-positive, HER2-negative, PIK3CA-mutated breast cancer.