Henlius Launches 1,618-Patient Head-to-Head NSCLC Trial of HLX37 vs Keytruda

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What Happened

On October 8, Henlius registered a randomized, triple-blind Phase II/III trial (NCT07865910) of HLX37, a PD-L1×VEGF bispecific antibody, combined with chemotherapy as first-line treatment for advanced NSCLC, with a control arm of Keytruda plus chemotherapy. The trial totals 1,618 patients (180 in Phase II, 1,438 in Phase III) across 16 Chinese sites, making it the largest head-to-head registration study for a domestic PD-L1/VEGF bispecific in first-line NSCLC.

Bottom Line

Henlius is advancing a large head-to-head trial of its PD-L1/VEGF bispecific against Keytruda in first-line NSCLC, signaling confidence in its IO 2.0 strategy.

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