What happened
Shares of Zai Lab (ZLAB 1.08%) were up more than 10% as of 11 a.m. on Tuesday. The Chinese biotech stock rose after the company announced positive phase 3 trial data regarding Tivdak as a front-line therapy to treat metastatic cervical cancer in patients who have had no more than two prior systemic regimens. The stock is down more than 6% this year.
So what
Seagen (SGEN) and Genmab (GMAB 2.51%) are collaborating with Zai Lab on the development of Tivdak. The companies announced on Tuesday that the drug's overall survival rate met its primary endpoint in the trial compared to patients who received chemotherapy alone. The companies said that patients' progression-free survival rates and objective response rates showed improvements with Tivdak.
Zai Lab's own trial on the drug in China has begun and is continuing to enroll patients.
Now what
Tivdak is likely to get accelerated approval for this new indication from the Food and Drug Administration (FDA), so the payoff could come later this year or early next year. Looking past that, the companies see the therapy as having potential to treat other cancers. The therapy was approved in 2021 to treat adults with recurrent or metastatic cervical cancer who were already having chemotherapy or had chemotherapy but still had disease progression.
Zai Lab has a deep pipeline, particularly in oncology therapies, and a growing product portfolio. In the second quarter, the company reported revenue of $68.9 million, up 45% year over year, and an earnings per share (EPS) loss of $0.13, compared to an EPS loss of $0.14 in the same period a year ago. Zai Lab's increased revenue could soon help the company turn a corner toward profitability.
