EntreMed’s Phase I/II lung cancer study meets endpoint

The Phase I/II study was designed to first evaluate a dose of MKC-1 to be used safely in combination with pemetrexed (Alimta) to treat patients with advanced non-small cell lung cancer (NSCLC). Patients were subsequently enrolled into the Phase II portion where the primary endpoint was tumor response.

The primary endpoint has been met and EntreMed is considering options for further studies in NSCLC patients. Options include the continuation of the current single arm study or a randomized Phase II study in the same patient population.

MKC-1 is a novel, orally active cell cycle inhibitor with in vitro and in vivo efficacy against a range of human solid tumor cell lines, including multi-drug resistant cell lines. Data from previous studies with MKC-1 demonstrate broad-acting antitumor effects, showing tumor growth inhibition or regression in multiple preclinical models, including paclitaxel-resistant models, the company said.

Carolyn Sidor, EntreMed’s vice president and chief medical officer, said: “We are pleased to have met the primary efficacy endpoint in the first stage of this study. We are now considering whether to continue the current study or pursue additional options such as a randomized Phase II study in patients with NSCLC.

“We will continue to collect data over the next few months from patients participating in this trial to determine the most efficient path forward in this indication.”