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Innovent:phase 3 Study On Advanced Lung Cancer Meets Predefined Primary Endpoint

Innovent Biologics Inc. and Eli Lilly and Co. (LLY) said that a phase 3 ORIENT-12 trial of TYVYT in combination with Gemzar and platinum chemotherapy in first-line advanced or metastatic squamous non-small cell lung cancer or sqNSCLC met the predefined primary endpoint of progression-free survival or PFS.

TYVYT in combination with gemcitabine and platinum chemotherapy demonstrated a statistically significant improvement in PFS compared to placebo in combination with gemcitabine and platinum chemotherapy, meeting the pre-defined endpoint. The safety profile of TYVYT in this trial was consistent with previously reported studies, and no new safety signals were identified.

Innovent and Lilly will initiate regulatory discussions for registration with the National Medical Products Administration of China in the near future.

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