NERLYNX significantly improved invasive disease-free survival (iDFS) versus placebo after adjuvant therapy

iDFS at 2 years in HER2+ patients with HR+ disease1

93% of the patients with HER2+, HR+ disease had concomitant endocrine therapy.2

CI: confidence interval; HER2: human epidermal growth factor receptor 2; HR: hazard ratio; HR+: hormone receptor-positive

Recurrence is defined as an invasive disease event or death.

NERLYNX significantly improved invasive disease-free survival (iDFS) versus placebo after adjuvant therapy

iDFS at 2 years1

iDFS in patients with centrally confirmed tumor tissue samples at 2 years = 94.6% in the NERLYNX arm, 91.4% in the placebo arm, representing a 43% reduction in the risk of recurrence for patients taking NERLYNX (3.2% absolute benefit), HR: 0.57 (95% CI: 0.39, 0.84).8,†

CI: confidence interval; HER2: human epidermal growth factor receptor 2; HR: hazard ratio

Recurrence is defined as an invasive disease event or death.

Central confirmation was not a stratification factor. In the prespecified analysis, 76.1% of patients enrolled had tumor tissue ascertained by central testing for HER2 gene amplification.

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Diarrhea: Aggressively manage diarrhea occurring despite recommended prophylaxis with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.

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NERLYNX maintained a statistically significant treatment benefit at 5 years

Invasive disease-free survival (iDFS) at 5 years in HER2+ patients with HR+ disease2

93% of the patients with HER2+, HR+ disease had concomitant endocrine therapy.

The iDFS results of ExteNET are supported by an exploratory analysis of 5-year follow-up with 74.5% (2117/2840) of patients reconsented.

CI: confidence interval; HER2+: human epidermal growth factor receptor 2; HR: hazard ratio; HR+: hormone receptor-positive

Recurrence is defined as an invasive disease event or death.

At the 5-year exploratory analysis, NERLYNX iDFS results were consistent with the 2-year data

Invasive disease-free survival (iDFS) at 5 years2

The iDFS results of ExteNET are supported by an exploratory analysis of 5-year follow-up with 74.5% (2117/2840) of patients reconsented.

CI: confidence interval; HR: hazard ratio

Recurrence is defined as an invasive disease event or death.

Select IMPORTANT SAFETY INFORMATION

Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.

Please see additional IMPORTANT SAFETY INFORMATION below.


NERLYNX provided an iDFS benefit across several prespecified subgroups