7.3 months versus 3.1. That gap in progression-free survival is the headline number behind the Food and Drug Administration’s November 16, 2023 approval of capivasertib, sold as Truqap, for a slice of advanced breast cancer patients.
Here is who qualifies. The pill is cleared for adults with hormone receptor-positive, HER2-negative breast cancer that is locally advanced or has spread, and whose tumors carry one or more PIK3CA, AKT1 or PTEN alterations. They also need prior endocrine-based treatment in the metastatic setting that stopped working, or a recurrence that arrived within a year of finishing adjuvant therapy. It is given together with fulvestrant, not on its own.
The trial behind it
The evidence comes from CAPItello-291, a randomized, double-blind, placebo-controlled study of 708 patients. Of those, 289 had tumors with the targeted alterations. Everyone had progressed on aromatase inhibitor treatment, and enrollees were allowed two earlier endocrine therapies and a single chemotherapy line.
Half got capivasertib, half got a placebo, and both arms received fulvestrant at 500 mg by injection. In the 289 patients with altered tumors, median progression-free survival was 7.3 months on capivasertib plus fulvestrant and 3.1 months on placebo plus fulvestrant (hazard ratio = 0.50, 95% CI = 0.38–0.65, P < .0001).
The picture was less striking in the other 313 patients, 44% of the trial, whose tumors had no such alteration. Their hazard ratio was 0.79 (95% CI = 0.61–1.02), which led the FDA to conclude that the overall benefit came mainly from the altered group. That is why the approval is tied to a genetic test, and the agency cleared the FoundationOne CDx assay alongside the drug to find eligible patients.
How it is taken, and what to expect
Capivasertib is taken by mouth, with no infusion chair involved. The recommended dose is 400 mg by mouth twice daily, spaced roughly 12 hours apart, with meals or without. Patients take it for four days, then stop for three, and repeat that pattern until the disease progresses or side effects become unacceptable.
Among side effects, these showed up in 20% or more of patients: diarrhea, skin reactions, raised blood sugar, nausea, fatigue, vomiting and stomatitis, along with lab changes such as lower lymphocytes, hemoglobin, leukocytes and neutrophils, and higher triglycerides and creatinine.
Sources
- FDA Approves Capivasertib With Fulvestrant for Breast Cancer – The ASCO Post
- FDA Approves Truqap Plus Hormone Therapy for Some With HR-Positive, HER-Negative Breast Cancer – CURE
