Policy & Regulation
Puma biotechnology Presents Results from the Hormone Receptor Positive Subgroup in Phase III ExteNET Trial of Neratinib for HER2-Amplified, Early Stage Breast Cancer at the 2018 San Antonio Breast Cancer Symposium
10 December 2018 - - US-based biopharmaceutical company Puma biotechnology, Inc. (NASDAQ: PBYI) recently presented results from the subgroup of patients with hormone receptor positive (HR-positive) breast cancer from the company's Phase III ExteNET Trial of neratinib for early stage HER2-Amplified breast cancer are being presented at the 2018 San Antonio Breast Cancer Symposium (SABCS), the company said.

The presentation entitled, "Efficacy of neratinib in hormone receptor-positive patients who initiated treatment within 1 year of completing trastuzumab-based adjuvant therapy in HER2+ early stage breast cancer: subgroup analyses from the phase III ExteNET trial," was presented at a poster session by Dr. Frankie Ann Holmes, Texas Oncology/US Oncology Research, Houston Texas on December 6.

In September 2018, the European Commission granted marketing authorisation for NERLYNX (neratinib) for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.

This poster presentation highlights the data that was the basis for the EC approval.

ExteNET was a Phase III multicenter, randomised, double-blind, placebo-controlled trial of neratinib in adult patients (n=2,840) with early stage HER2-positive breast cancer following adjuvant trastuzumab treatment. Participants were randomized to receive either neratinib (n=1420) or placebo (n=1420) for one year.

In the subgroup of 1334 patients with hormone receptor positive disease and who were less than one year from the completion of prior adjuvant trastuzumab based therapy, the data, presented in the poster, demonstrated that after two years of follow-up, invasive disease-free survival was 95.3% in the patients treated with neratinib compared with 90.8% in those receiving placebo (hazard ratio = 0.49; 95% CI: (0.30, 0.78); p=0.002).

The presentation also showed that after five years of follow-up, invasive disease-free survival was 90.8% in the patients treated with neratinib compared with 85.7% in those receiving placebo (hazard ratio = 0.58; 95% CI: (0.41, 0.82); p=0.002).

The poster highlighted that in this same subgroup, distant disease-free survival was 96.1% in the patients treated with neratinib compared with 92.9% in those receiving placebo (hazard ratio = 0.53, 95% CI: (0.31, 0.88); p=0.015) after two years of follow-up. After five years of follow-up, distant disease-free survival was 92.4% in the patients treated with neratinib compared with 87.7% in those receiving placebo (hazard ratio = 0.57; 95% CI: (0.39, 0.83); p=0.003).

Additionally, in this population, there were 295 patients who did not achieve a pathological complete response after treatment with neoadjuvant therapy.

This exploratory subgroup is similar to the patient population in the Phase III KATHERINE trial of Kadcyla.

The data presented demonstrated that in this subgroup, after two years of follow-up, invasive disease-free survival was 89.9% in the patients treated with neratinib compared with 85.2% in those receiving placebo (hazard ratio = 0.64; 95% CI: (0.30, 1.29)).

Longer term follow up demonstrated that at five years, invasive disease-free survival was 85.0% in the patients treated with neratinib compared with 77.6% in those receiving placebo (hazard ratio = 0.60; 95% CI: (0.33, 1.07)).

The profile and frequency of treatment-emergent adverse events in this subgroup of patients with hormone receptor positive disease and who are less than one year from the completion of prior adjuvant trastuzumab was similar compared with the overall safety population.

The most common grade 3 treatment-emergent adverse events in this subgroup were diarrhea (neratinib, 39% vs placebo, 1%), nausea (1% vs
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