Hanmi said Tuesday that it has presented clinical trial results for its three new immunotherapy agents -- including Rolontis, Poziotinib, and Oraxol -- at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting.
Regarding Rolontis, the company confirmed the non-inferiority of the drug after comparing it with Neulasta, its competing drug, in phase 3 clinical trial, known as the ADVANCE study. The company is undergoing pre-biologics license application (BLA) process to win it by the fourth quarter of this year.
Hanmi also presented the poster results for the phase 2 clinical trial for Poziotinib, a non-small-cell lung cancer treatment. The report contained phase 2 clinical trial results on 174 EGFR and HER2 exon 20 mutated non-small cell lung cancer patients treated with the drug at 20 U.S. medical institutions.
Athenex, Hanmi’s U.S. partner for Oraxol, an oral anti-cancer drug, unveiled two poster studies for the drug. The medication is an oral dosage form of the widely used intravenous administered tubulin-stabilizing chemotherapeutic agent paclitaxel.
One poster study described the safety, tolerability, pharmacokinetics and the drug’s activation on progressive malignant tumors, while the other compared patients who had either received Oraxol or paclitaxel once a week.