Zai Lab To Await More Trial Data Before Filing For Regulatory Approval For Experimental Cancer Drug

Zai Lab (ZLAB) announced on Wednesday that it plans to await the results of a trial evaluating Bemarituzumab in combination with Nivolumab and chemotherapy before filing for regulatory approval for the experimental cancer drug.

The data from the trial is expected by the end of 2025 or the first half of 2026, the company said in a filing with the Hong Kong stock exchange. Nasdaq-listed shares of Zai Lab were down 4% at the time of writing.

On Stocktwits, retail sentiment around ZLAB stayed within ‘bullish’ territory over the past 24 hours, while message volume stayed at ‘normal’ levels.

The announcement from the company follows its partner Amgen's (AMGN) completion of the final analysis of the late-stage trial evaluating Bemarituzumab in combination with Chemotherapy in first-line gastric cancer.

Amgen said in late June that Bemarituzumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival as compared to placebo plus chemotherapy in people living with certain types of unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer. Overall survival refers to the total length of time a patient with cancer remains alive after diagnosis or the initiation of treatment.

However, Zai Lab said on Wednesday that, upon final analysis of the trial, the magnitude of the previously observed survival benefit was reduced, leading the company to await the results of another trial.

Zai Lab holds co-development and commercialization rights for Bemarituzumab for mainland China, Hong Kong, Macau, and Taiwan.

ZLAB shares are up 22% this year and approximately 66% over the past 12 months.

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