publication date: Feb. 28, 2020

Drugs & Targets

FDA approves neratinib for metastatic HER2-positive breast cancer

FDA approved neratinib Feb. 25 in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.

Efficacy of neratinib with capecitabine was investigated in NALA (NCT01808573), a randomized, multicenter, open-label clinical trial in 621 patients with metastatic HER2-positive breast cancer who received two or more prior anti-HER2 based regimens in the metastatic setting. Patients were randomized (1:1) to receive neratinib 240 mg orally once daily on days 1-21 with capecitabine 750 mg/m2 given orally twice daily on days one to 14 for each 21-day cycle (n=307) or lapatinib 1250 mg orally once daily on days one to 21 with capecitabine 1000 mg/m2 given orally twice daily on days one to 14 for each 21-day cycle (n=314). Patients were treated until disease progression or unacceptable toxicity.

The primary efficacy outcome measures were progression-free survival, assessed by a blinded independent central review per RECIST v1.1, and overall survival. Key secondary outcome measures were objective response rate and response duration. Median PFS was 5.6 months (95% CI: 4.9, 6.9) for patients who received neratinib with capecitabine and 5.5 months (95% CI: 4.3, 5.6) for those receiving lapatinib with capecitabine (hazard ratio 0.76; 95% CI: 0.63, 0.93; p=0.0059). The PFS rate at 12 months was 29% (95% CI: 23, 35) vs 15% (95% CI: 10, 20), respectively.

Median OS was 21 months (95% CI: 17.7, 23.8) for patients receiving neratinib with capecitabine compared to 18.7 months (95% CI: 15.5, 21.2) for those receiving  lapatinib plus capecitabine (HR 0.88; 95% CI: 0.72, 1.07; p=0.2086). The ORR was 32.8% (95% … Continue reading FDA approves neratinib for metastatic HER2-positive breast cancer

To access this members-only content, please log in.
Institutional subscribers, please log in with your IP.
If you're not a subscriber why not join today?
To gain access to the members only content click here to subscribe.
You will be given immediate access to premium content on the site.
Click here to join.

Copyright (c) 2020 The Cancer Letter Inc.