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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 3 hours ago
- 2 min read
11/05/2026
FDA grants Fast Track to Zai Lab’s DLL3‑targeting ADC Zocilurtatug Pelitecan (Zoci) for epNECs (Ref)
Zai Lab's : Zocilurtatug pelitecan (Zoci, formerly ZL‑1310), a DLL3‑targeting antibody‑drug conjugate (ADC), received U.S. FDA Fast Track status for extrapulmonary neuroendocrine carcinomas (epNECs) after progression on first‑line therapy
Preliminary results from a Phase 1b/2 trial (NCT06885281) showed an objective response rate (ORR) of 38.2% in heavily pretreated patients, with manageable safety (notably neutrophil count decrease as the main ≥Grade 3 adverse event)
Hansoh Pharma’s HS-20093 B7-H3 ADC wins NMPA Breakthrough Therapy nod in ESCC (Ref)
Hansoh Pharmaceutical Group’s B7-H3-targeted antibody-drug conjugate (ADC), HS-20093, has been granted Breakthrough Therapy Designation by China’s National Medical Products Administration (NMPA) on May 9, 2026
The designation applies to unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) in patients who have failed both platinum-based chemotherapy and immune checkpoint inhibitor (ICI) treatments
Innovent’s IBI363 secures third Breakthrough Therapy Designation in China, advancing to Phase III for MSS/pMMR colorectal cancer with Takeda partnership (Ref)
Innovent’s PD-1/IL-2α-bias bispecific fusion protein IBI363 received its third Breakthrough Therapy Designation (BTD) from China’s NMPA, this time for MSS/pMMR metastatic colorectal cancer in combination with bevacizumab, after failure of ≥2 prior standard therapies
A Phase III clinical trial is about to initiate in China for this indication in the near term
Early results presented at ASCO 2025 showed promising efficacy in MSS/pMMR CRC patients who had failed multiple prior therapies
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