Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Jun 10
- 1 min read
08/06/2026
Zai Lab secures China NMPA approval for TIVDAK®, the first ADC for recurrent/metastatic cervical cancer (Ref)
China’s NMPA approved TIVDAK® (tisotumab vedotin) for adult patients with recurrent or metastatic cervical cancer progressing after chemotherapy. It is the first ADC approved for this indication in China
Approval is based on the global Phase 3 innovaTV 301 trial, which met its primary endpoint of overall survival (OS) benefit vs chemotherapy
Global ITT population: HR=0.70 (p=0.0038)
China subpopulation: HR=0.55, showing a 45% reduction in risk of death
Benefit was consistent regardless of prior PD-(L)1 therapy exposure
Merck & Gilead halt Phase 3 KEYNOTE-D46/EVOKE-03 trial as Trodelvy + Keytruda fails to show statistically significant survival benefit in first-line PD-L1–high NSCLC (Ref)
Merck and Gilead's Phase 3 KEYNOTE-D46/EVOKE-03 study evaluating Trodelvy (sacituzumab govitecan-hziy) + KEYTRUDA (pembrolizumab) vs KEYTRUDA alone in previously untreated metastatic NSCLC patients with PD-L1 ≥50% has been discontinued following eDMC recommendation
Progression-free survival showed numerical improvement but was not statistically significant; overall survival is unlikely to reach statistical significance at final analysis
Data will be presented at a future medical meeting
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