Photo Credit: Peddalanka Ramesh Babu
Inavolisib, in combination with palbociclib and fulvestrant, met its primary endpoint of progression-free survival (PFS) in patients with PIK3CA-mutated, HR-positive/HER2-negative metastatic breast cancer (mBC) in the INAVO120 trial. The FDA has determined that the benefit-risk assessment is favorable for using this triplet combination in this patient population.
The phase 3 INAVO120 trial (NCT04191499) enrolled patients with PIK3CA-mutated, HR-positive/HER2-negative mBC with endocrine resistance, a population associated with poor prognosis1,2. Suparna Wedam, MD, CDER, US Food and Drug Administration, discussed the positive outcome of this trial that led to the FDA approval of inavolisib in this patient group3. The participants were randomly assigned in a 1:1 ratio to receive either inavolisib, a PI3Kα inhibitor (n=161), or a placebo (n=164), in combination with palbociclib and fulvestrant.
The trial achieved its primary endpoint of significantly longer PFS in the inavolisib group compared to the placebo group, with a median PFS of 15 months versus 7.3 months (HR 0.43; 95% CI 0.32–0.59; P<0.001). PFS results evaluated by blinded independent committee review supported the primary endpoint. The interim OS results were immature, but the final OS results will be submitted in due course. Increased AE rates were observed in the inavolisib group, particularly for hyperglycemia, diarrhea, and stomatitis. The patient-reported outcomes supported these clinically observed AEs. “The increased toxicity seen with this triplet combination does present an opportunity for future dose optimization,” Dr. Wedam commented.
Dr. Wedam concluded that “inavolisib is the first FDA-approved treatment to be used in a triplet combination specifically for the first-line treatment of patients with PIK3CA-mutated locally advanced or metastatic HR-positive/HER2-negative breast cancer considered to be endocrine resistant.” The results were positively received, with one of the panel members adding that they would prescribe this treatment in the patient who recurs during or shortly after adjuvant endocrine therapy with a PIK3CA mutation, high disease volume, and visceral metastases.
Medical writing support was provided by Kulsoom Abdul.
Copyright ©2024 Medicom Medical Publishers
