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ARTICLE | Clinical News

Biothera begins Phase Ib/II trial of Imprime PGG plus Keytruda in NSCLC

July 21, 2017 12:27 AM UTC

Biothera Pharmaceuticals Inc. (Eagan, Minn.) began an open-label, U.S. Phase Ib/II trial to evaluate IV Imprime PGG plus IV Keytruda pembrolizumab in up to 36 patients with non-small cell lung cancer (NSCLC) whose cancer worsened during or after platinum-based chemotherapy. Patients in the Phase Ib portion will receive once-weekly 2 or 4 mg/kg Imprime PGG plus Keytruda, which will determine the maximum tolerated dose (MTD) to be evaluated in the Phase II portion.

The trial’s primary endpoints are MTD (Phase Ib) and progression-free survival (PFS) (Phase II). Secondary endpoints include safety, clinical benefit rate (CBR) and overall survival (OS)...