Astellas scraps NSCLC program after look at phase 3 data

Astellas has stopped enrolling patients in ASP8273 trials after seeing the phase 3 NSCLC data.

Astellas has halted (PDF) a phase 3 trial of ASP8273 in non-small cell lung cancer (NSCLC) and scrapped plans to start other development programs targeting the indication. The decision follows a review of data generated to date by an independent data monitoring committee.

Public details of what the committee unearthed are limited. But whatever the evidence was, it led the committee to make a recommendation and Astellas to voluntarily pull the plug on the study. Astellas is halting randomization, telling investigators to stop giving the epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) ASP8273 to patients and planning to terminate other proposed NSCLC programs before they begin.

Astellas began the first-line phase 3 trial that triggered this flurry of activity last year. The plan was to enroll 600 patients, randomize them to receive either ASP8273 or one of two active controls and assess their progression-free survival. Investigators gave Roche and Astellas’ Tarceva or AstraZeneca’s Iressa to patients in the control arm.


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At the 2016 ASCO Annual Meeting, Astellas reported a preliminary median progression-free survival of 6.7 months. When paired with other data, that was enough to encourage Astellas to keep pushing ahead. But 15 months after starting the trial, it has seen enough to scrap work on the drug altogether.

With no new patients being enrolled in trials of ASP8273, the actions amount to a full-scale retreat from a drug that until recently was involved in a growing clutch of clinical trials. lists seven active clinical trials of the TKI asset, six of which are in NSCLC. The seventh was enrolling patients with any solid tumors with EGFR mutations, a receptor that, while best known for links to lung cancer, is also found in multiple other cancers.

Astellas started three of the trials in the past nine months, but the phase 3 data have prompted it to quickly reverse its plans.

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