Cell Therapeutics is planning to amend its pivotal STELLAR 2 trial of Xyotax (paclitaxel poliglumex) in the wake of the failure of STELLAR 3 to show superiority for front-line treatment of non-small cell lung cancer.

CTI will pursue a special protocol assessment for the amended second-line STELLAR 2 trial, to use non-inferiority as a primary endpoint. It is currently designed as a superiority trial.

"We will be discussing with FDA in the upcoming days our STELLAR 2 amendment and the preliminary results of STELLAR 3," CEO James Bianco told investors March 7.

STELLAR 3 compared Xyotax plus carboplatin to carboplatin in combination with conventional paclitaxel in 400 poor performance status (PS2) patients.

CTI's proprietary paclitaxel formulation failed to demonstrate superiority over the conventional paclitaxel arm in the primary survival analysis. However, Xyotax did meet statistical significance for a pre-specified non-inferiority analysis.

Data from other pivotal trials will be released in the coming months: STELLAR 2, Xyotax versus docetaxel, results are expected in April; STELLAR 4, comparing Xyotax to either gemcitabine or vinorelbine in PS2 patients, results are expected in late April/early May.

"Quite honestly, given what we're seeing in the data, there's a very clear potential treatment effect with the drug and…STELLAR 4 has a lower hurdle than STELLAR 3 did to show that," Bianco said.

"We're not trying to say that we're hedging, so to speak, but at a minimum, if STELLAR 2 does get the ability to use either superiority or non-inferiority as its endpoint, then we will have at least two trials that will have the ability to support a potential application on a non-inferiority basis if STELLAR 2 should go out in that direction."

CTI plans to present STELLAR 3 data at the American Society of Clinical Oncology meeting in May.

Xyotax offers a more water-soluble formulation of the gold standard oncologic paclitaxel.

- Lee Szilagyi

STELLAR Failure Prompts Cell Therapeutics To Amend Next Xyotax Trial

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