How much improvement did Kelun-Biotech’s endometrial cancer data show?

  • In TroFuse-005, the first global Phase III trial of Kelun-Biotech’s TROP2 ADC sac-TMT, median overall survival among patients with advanced endometrial cancer was 19.0 months, versus 12.1 months in the control group; median progression-free survival was 7.2 months and 3.9 months, respectively. The control treatment was physician’s choice of doxorubicin or paclitaxel.
  • The improvement in efficacy was accompanied by a higher rate of serious adverse events: grade 3 or higher treatment-related adverse events occurred in 54.4% of the sac-TMT group, versus 41.4% in the control group.

Why were KeyMed’s gastric cancer trial results mixed?

  • KeyMed Biosciences’ CLDN18.2 ADC CMG901 met one of its dual primary endpoints in previously treated patients with CLDN18.2-positive gastric or gastroesophageal junction cancer: median overall survival was 10.0 months for patients receiving third-line or later treatment, versus 5.0 months in the control group.
  • The other primary endpoint was not met: median progression-free survival was 4.2 months for patients receiving second-line or later treatment, versus 3.8 months in the control group. The two endpoints corresponded to different lines of treatment and cannot be treated directly as a complete efficacy result for the same group of patients.

What progress has Hengrui’s HER3 ADC made in lung cancer?

  • Nomura said Hengrui Pharmaceuticals’ SHR-A2009 was the first HER3 ADC to achieve positive Phase III results. In the HERON-Lung01 trial, median progression-free survival for patients with advanced EGFR-mutated non-small cell lung cancer treated with the drug was 8.3 months, versus 5.4 months in the chemotherapy group.
  • The hazard ratio for progression-free survival between the two groups was 0.47, with a one-sided P value below 0.0001; this result measures the time to disease progression or death, and the report did not provide overall survival data at this point.

How far have Hansoh’s osteosarcoma data progressed?

  • In the Phase III ARTEMIS-011 trial in relapsed or refractory osteosarcoma, Hansoh Pharma’s B7-H3 ADC Ris-Rez achieved median progression-free survival of 5.5 months, versus 1.4 months in the standard chemotherapy group, a statistically significant difference.
  • Overall survival data are not yet mature but show a favorable trend; therefore, the main clear result at present is an extension of progression-free survival.