Capivasertib for AKT1 E17K-Mutated Metastatic including Breast Cancer: NCI-MATCH EAY131-Y
- 3 years ago
As reported in JAMA Oncology by Kevin Kalinsky, MD, MS, and colleagues, the NCI-MATCH trial’s phase II subprotocol EAY131-Y has shown activity of the pan-AKT inhibitor capivasertib in a range of metastatic tumors with an AKT1 E17K mutation.
The NCI-MATCH trial, which opened in 2015, is an initiative that uses genomic testing to evaluate investigational molecularly targeted treatments in patients with disease refractory to standard treatments. The trial includes subprotocols representing nearly 40 single-group phase II trials.
Study Details
The phase II trial enrolled 35 evaluable adult patients with an AKT1 E17K–mutated metastatic tumor between July 2016 and August 2017 whose disease had progressed on standard treatment. Patients received oral capivasertib at 480 mg twice daily for 4 days on and 3 days off weekly in 28-day cycles until disease progression or unacceptable toxicity. Among patients with metastatic breast cancer receiving hormone therapy, the dose was 400 mg twice daily. The primary endpoint was objective response rate.
The most common cancers included in the trial were breast cancer (n = 18, 51%)—including 15 patients with hormone receptor (HR)-positive/HER2-negative disease and 3 with triple-negative disease—and gynecologic cancers (n = 11, 31%).
Responses
An objective response was achieved in 10 patients (28.6%, 95% confidence interval = 15%–46%, P
The NCI-MATCH trial, which opened in 2015, is an initiative that uses genomic testing to evaluate investigational molecularly targeted treatments in patients with disease refractory to standard treatments. The trial includes subprotocols representing nearly 40 single-group phase II trials.
Study Details
The phase II trial enrolled 35 evaluable adult patients with an AKT1 E17K–mutated metastatic tumor between July 2016 and August 2017 whose disease had progressed on standard treatment. Patients received oral capivasertib at 480 mg twice daily for 4 days on and 3 days off weekly in 28-day cycles until disease progression or unacceptable toxicity. Among patients with metastatic breast cancer receiving hormone therapy, the dose was 400 mg twice daily. The primary endpoint was objective response rate.
The most common cancers included in the trial were breast cancer (n = 18, 51%)—including 15 patients with hormone receptor (HR)-positive/HER2-negative disease and 3 with triple-negative disease—and gynecologic cancers (n = 11, 31%).
Responses
An objective response was achieved in 10 patients (28.6%, 95% confidence interval = 15%–46%, P