- Design
- Phase 3, multicentre, open-label, randomised trial (TAISHAN-302), interim analysis
- Population
- 451 patients with small-cell lung cancer progressing after first-line platinum therapy
- Primary outcome
- Overall survival
- Effect
- Median 13.3 vs 9.4 months; HR 0.46 (95% CI 0.35 to 0.62)
TAISHAN-302 randomised patients with relapsed small-cell lung cancer to tambotatug pelitecan, an antibody-drug conjugate targeting B7-H3, or topotecan. The prespecified interim analysis met its overall survival endpoint.
Survival, progression-free survival and response all favoured the antibody-drug conjugate, and severe toxicity was less common than with topotecan. The trial was open-label, so investigator-assessed endpoints such as progression may carry some bias, but overall survival does not.
Topotecan remains the standard comparator in most settings, including India. Access to this class depends on approval and trials.
- Median overall survival was 13.3 months against 9.4 with topotecan.
- Median progression-free survival was 7.4 months against 2.8.
- Confirmed responses occurred in 59% against 10%.
- Grade 3 or higher adverse events were less frequent (55% vs 78%).
- The trial was published on 12 September 2026.
Why it matters
Second-line small-cell lung cancer has had few options beyond topotecan, and this is a large overall survival gain with less severe toxicity.
Don't overread it
This is an interim analysis of an open-label trial, and the trial report does not establish regulatory approval anywhere.
The statistics, in plain English
A hazard ratio of 0.46 means the death rate was roughly halved. Interim analyses can overestimate effects if stopped early, but this one is large with a tight interval.
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