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
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