Novel Chemotherapy Drug Demonstrates Activity in Advanced Breast Cancer

“The novel chemotherapy drug etirinotecan pegol demonstrated a trend toward improved survival compared with treatment of physician’s choice among patients with late-stage advanced breast cancer, according to findings from a phase 3 trial presented at the ASCO Annual Meeting.

“Although treatment with etirinotecan pegol (NKTR-102; Nektar Therapeutics) did not reach the pre-determined statistically significant benefit in all patients, subgroups of patients — particularly those with brain or liver metastases — experienced significantly improved OS with etirinotecan pegol.

“ ‘Chemotherapy remains the backbone of management of many patients with advanced breast cancer,’ Edith A. Perez, MD, Deputy Director at Large for the Mayo Clinic Cancer Center in Jacksonville, Florida, director of the Mayo Clinic Breast Cancer Translational Genomics program and a HemOnc Today Editorial Board member, said in an interview. ‘So we are looking for novel chemotherapy agents with better pharmacokinetics and no neuropathy to speak of and very little myelosuppression or cardiac toxicity.’ “

NKTR-102 Improves Survival in Women with Brain and Liver Metastases from Breast Cancer

“Nektar Therapeutics (NASDAQ: NKTR) announced topline results from its Phase 3 BEACON study evaluating single-agent NKTR-102 in patients with advanced breast cancer. BEACON compared NKTR-102 to an active control arm comprised of a single chemotherapy agent of physician’s choice (TPC) in patients who were heavily pre-treated with a median of three prior therapies for metastatic disease. In a topline analysis of 852 patients from the trial, NKTR-102 provided a 2.1 month improvement in median overall survival (OS) over TPC (12.4 months for patients receiving NKTR-102 compared to 10.3 months for patients receiving TPC). Based on a stratified log-rank analysis, the primary endpoint measuring the Hazard Ratio (HR) for survival in the NKTR-102 group compared to the active control arm was 0.87 with a p-value of 0.08, which did not achieve statistical significance.

“In a pre-specified subgroup of patients with a history of brain metastases, NKTR-102 showed an improvement of 5.2 months in median OS (10.0 months compared to 4.8 months, n=67, HR 0.51, p-value <0.01). The proportion of patients with brain metastases with 12-month survival was 44.4% in the NKTR-102 arm as compared to 19.4% in the control arm.”