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12:00 AM
 | 
Mar 23, 2015
 |  BioCentury  |  Product Development

Approval or bust

How Nektar plans to make case for etirinotecan pegol in metastatic breast cancer

Following the failure of a Phase III trial that was the first-ever controlled study of etirinotecan pegol in breast cancer, Nektar Therapeutics is getting ready to roll the dice with regulators. The company will argue that its lead internal program should be added to the armamentarium for metastatic breast cancer based on improved tolerability in the study population at large, and a survival advantage in two prespecified subgroups.

If that doesn't work, the compound will be canned.

Last week, Nektar said etirinotecan pegol (NKTR-102) missed the primary endpoint of overall survival in the open-label Phase III BEACON trial. In 852 patients with previously treated metastatic breast cancer, the compound dosed every three weeks increased OS by 2.1 months compared with physician's choice of single chemotherapy control, but the benefit was not statistically significant (12.4 months vs. 10.3 months; HR=0.87; p=0.08).

The compound also missed the secondary endpoints of progression-free survival (PFS) and overall response rate (ORR), although data for those endpoints were not disclosed.

The compound did show a statistically significant survival advantage in two prespecified subgroups. In 67 patients with brain metastases, the compound more than doubled OS to 10 months compared with 4.8 months for control (HR=0.51; p<0.001). In 456 patients with liver metastases, the survival advantage was 2.6 months (10.9 months vs. 8.3 months; HR=0.73; p<0.002).

The compound also had a better safety profile. The incidence of grade 3 or higher AEs for the treatment group was 48% vs. 63% for control, including a lower rate of severe neuropathy (0.5% vs. 3.7%) and neutropenia (9.6% vs. 30.8%). P-values were not disclosed.

"While we were disappointed by the miss, I don't think anyone would argue that this drug isn't highly active. If you look at...

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