Nerlynx – pro
The US Food and Drug Administration (FDA) has approved the first extended adjuvant therapy for early-stage, HER2-postive breast cancer. This type of drug is taken after initial treatment to lower the chances the cancer will come back. The new drug, Nerlynx (neratinib), is for women who have been previously treated with the targeted therapy drug Herceptin (trastuzumab).
Nerlynx is a type of drug called a kinase inhibitor. It’s a kind of targeted therapy that blocks certain proteins in the cancer cells. Blocking them helps keep the cells from dividing, and that can slow cancer growth.
The FDA based its approval on a study of 2,840 women with HER2-positive breast cancer in stages 1 – 3. All had completed treatment with Herceptin within the previous 2 years. The study measured how long it took for the cancer to come back or for death to occur from any cause. After 2 years, 94.2% of women who received Nerlynx were still alive with no cancer recurrence compared with 91.9% of women who did not receive Nerlynx.
More recently, NERLYNX® (neratinib) has been included as a recommended treatment option in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology Central Nervous System Cancers for Breast Cancer patients with brain metastases. The NCCN designated NERLYNX in combination with capecitabine as a category 2A treatment option and NERLYNX in combination with paclitaxel as a category 2B treatment option. Use, as designated for breast cancer patients with brain metastases, is outside the FDA approved indication for NERLYNX and considered investigational.
Nerlynx Pescribing Information 2019
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Awada A, Colomer R, Inoue K, Bondarenko I, Badwe RA, Demetriou G, Lee SC, Mehta AO, Kim SB, Bachelot T, Goswami C, Deo S, Bose R, Wong A, Xu F, Yao B, Bryce R, Carey LA. Neratinib plus paclitaxel vs trastuzumab plus paclitaxel in previously untreated metastatic ERBB2-positive breast cancer: the NEfERT-T randomized clinical trial. JAMA Oncol. 2016 Dec
For metastatic Beast Cancer:
In a recent study, Neratinib (Nerlynx) combined with capecitabine (Xeloda) reduced the risk of disease progression or death by 24% compared with lapatinib (Tykerb) plus capecitabine in patients with HER2-positive metastatic breast cancer who received at least 2 prior lines of HER2-targeted therapy.
Neratinib (Nerlynx) combined with capecitabine (Xeloda) reduced the risk of disease progression or death by 24% compared with lapatinib (Tykerb) plus capecitabine in patients with HER2-positive metastatic breast cancer who received at least 2 prior lines of HER2-targeted therapy.
The results from the phase III NALA trial, which were presented at the 2019 ASCO Annual Meeting, showed that the HR for PFS favoring neratinib was 0.76 (95% CI, 0.63-0.93; log-rank P value = .0059). Landmark analysis showed that the PFS curves began to separate after 6 months with 6-month PFS rates of 47% versus 38%, 1-year rates of 29% versus 15%, and 18-month rates of 16% versus 7% for the neratinib arm versus the lapatinib arm, respectively.
A prespecified restricted means analysis for PFS was conducted that was limited to a follow-up of 24 months. The analysis showed a mean PFS of 8.8 months for the neratinib arm compared with 6.6 months for the lapatinib arm (P = .0003).
For overall survival (OS), there was a numerical but not a statistically significant benefit with neratinib. A prespecified restricted means analysis showed a mean OS of 24.0 months for the neratinib arm compared with 22.2 months for the lapatinib arm (HR, 0.88; 95% CI, 0.72-1.07; log-rank P = .2086). The analysis was restricted to a follow-up of 48 months.
Saura C, Oliveira M, Feng Y-H, et al. Neratinib + capecitabine versus lapatinib + capecitabine in patients with HER2+ metastatic breast cancer previously treated with ≥ 2 HER2-directed regimens: Findings from the multinational, randomized, phase III NALA trial. J Clin Oncol. 2019;37 (suppl; abstr 1002).Nerlynx Pescribing Information 2019