Kelun-Biotech's SKB500 Shows Promising Early Results in Advanced Solid Tumors

Event summary

  • Kelun-Biotech presented first-in-human study data for its B7-H3 ADC SKB500 at ASCO 2026, showing broad-spectrum antitumor activity across multiple solid tumors.
  • Among 124 patients treated at 12 mg/kg, SKB500 achieved a 42.7% objective response rate (ORR) and an 83.9% disease control rate (DCR).
  • In small cell lung cancer (SCLC) patients, SKB500 demonstrated a 65.0% ORR and a median progression-free survival (mPFS) of 7.2 months.
  • The 12 mg/kg dose showed a favorable safety profile with a 32.3% incidence of grade ≥3 treatment-related adverse events (TRAEs).
  • A Phase II exploratory study of SKB500 in combination with immunotherapy for extensive-stage small cell lung cancer (ES-SCLC) is ongoing in China.

The big picture

Kelun-Biotech's SKB500 represents a strategic push into the competitive oncology space, targeting unmet needs in aggressive cancers like SCLC. The positive early data positions the company to compete with established players in the ADC market, particularly in China where it has a strong clinical development pipeline. The success of SKB500 could validate Kelun-Biotech's OptiDC™ platform technology, potentially attracting partnerships or investment.

What we're watching

Clinical Development
The pace at which SKB500 advances through subsequent clinical trials will determine its commercial potential.
Competitive Positioning
Whether Kelun-Biotech can differentiate SKB500 in the crowded B7-H3 ADC space.
Regulatory Strategy
How Kelun-Biotech plans to leverage these early results for regulatory approvals in key markets.