Efficacy and Safety of Inavolisib in Combination with Palbociclib and Fulvestrant for Treating Advanced-Stage PIK3CA-Mutated Breast Cancer
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on December 9th, 2024
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Activating mutations in the phosphatidylinositol 3-kinase complex (PIK3CA) are found in 35% to 40% of breast cancer patients, contributing to worsened disease progression. Inavolisib is a potent PIK3CA inhibitor with a high affinity for its target, leading to fewer severe side effects. Roche recently sponsored a study to evaluate the effectiveness of inavolisib in treating advanced-stage breast cancer.
The phase 3 clinical trial involved 325 participants diagnosed with locally advanced or metastatic breast cancer with a PIK3CA mutation. The patients were randomly assigned to receive either a placebo or inavolisib at a daily dose of 9 mg, along with the standard treatment of palbociclib and fulvestrant. After a median follow-up of approximately 21 months, the researchers found that adding inavolisib extended progression-free survival by 57% compared to the placebo. Subgroup analysis revealed that this benefit was primarily observed in patients under the age of 65. Additionally, inavolisib treatment resulted in partial or complete tumor shrinkage in 58.4% of participants, significantly higher than the 25% in the placebo group. Adverse events such as hyperglycemia, stomatitis, and diarrhea were more common in those treated with inavolisib, leading to a higher rate of treatment discontinuation. The researchers concluded that the combination of inavolisib with palbociclib and fulvestrant was effective due to its ability to inhibit three critical signaling pathways: PI3K, estrogen receptor, and CDK4/6 pathways.
The phase 3 clinical trial involved 325 participants diagnosed with locally advanced or metastatic breast cancer with a PIK3CA mutation. The patients were randomly assigned to receive either a placebo or inavolisib at a daily dose of 9 mg, along with the standard treatment of palbociclib and fulvestrant. After a median follow-up of approximately 21 months, the researchers found that adding inavolisib extended progression-free survival by 57% compared to the placebo. Subgroup analysis revealed that this benefit was primarily observed in patients under the age of 65. Additionally, inavolisib treatment resulted in partial or complete tumor shrinkage in 58.4% of participants, significantly higher than the 25% in the placebo group. Adverse events such as hyperglycemia, stomatitis, and diarrhea were more common in those treated with inavolisib, leading to a higher rate of treatment discontinuation. The researchers concluded that the combination of inavolisib with palbociclib and fulvestrant was effective due to its ability to inhibit three critical signaling pathways: PI3K, estrogen receptor, and CDK4/6 pathways.