ORR Up to 100%: Chinese-developed PD-L1/VEGF Bispecific Antibody HB0025 Shows Promising Phase II Results in NSCLC at ESMO 2025

On October 13 local time, the main text of the regular abstract for the 2025 ESMO Annual Meeting was重磅 released. At this conference,Huaota Biopharmaceutical, a subsidiary of Huahai PharmaceuticalDisplayed PD-L1/VEGF Bispecific Antibody HB0025 Combined with Chemotherapy as First-Line Treatment for NSCLC'sPreliminary Results of Phase II Study.

Screenshot source: ESMO official website

The StudyEvaluated the efficacy and safety of HB0025 in combination with chemotherapy for the treatment of advanced NSCLC.Included were patients with locally advanced or metastatic NSCLC who had not received prior treatment and did not carry EGFR or ALK genetic mutations. Patients were divided into two groups,The Main ResearchThe primary endpoint is the objective response rate. (ORR)。

• Cohort 1(Squamous NSCLC)Chinese patients received 20mg/kg HB0025 in combination with carboplatin/paclitaxel regimen;

• Cohort 2(Non-squamous NSCLC)Chinese patients received 20mg/kg HB0025 in combination with carboplatin/pemetrexed regimen.

As of April 25, 2025, a total of 113 patients have been enrolled.(Cohort 1=58 cases, Cohort 2=55 cases). The median age was 65.0 years. The median follow-up time was 4.47 months. Among them, 87 patients had undergone at least one tumor assessment after the baseline.Progression-Free Survival（PFS）Not yet determined.

In terms of efficacy, Cohort 1ORR is83.3%（40/48），Among themThe ORR for patients with PD-L1 TPS < 1%, TPS 1~49%, and TPS ≥50% was 87.5%, respectively.（7/8）、72.7%（8/11）And 100.0%（15/15）; Disease Control Rate（DCR）For 95.8%（46/48）。

Cohort 2ORR was 56.4%（22/39），DCR is 94.9%（37/39）。

In terms of safety, 39.8%（45/113）Patients experienced ≥3 grade treatment-related adverse events（TRAE）The most common ≥3 grade TRAEs included decreased neutrophil count and decreased white blood cell count. Three patients discontinued treatment due to TRAEs, one of whom discontinued due to grade 4 acute liver failure and acute kidney injury, which was also the only fatal TRAE. 21.2%(24/113) Patients reported immune-related adverse events(irAE)`, while bleeding-related TRAE occurred in only 8.8%`(10/118) Patients.

It is worth mentioning that Huaota plans to launch a project this year.Multicenter, randomized, double-blind, controlledPhase III Clinical Study.