The EMA Committee for Orphan Medicinal Products supported the designation after recognising a strong unmet need in neuroendocrine carcinomas.
The Phase Ib/II trial will assess safety, tolerability, and early signs of clinical activity. Researchers will combine Boehringer Ingelheim’s investigational T-cell engager, obrixtamig, with Zai Lab’s antibody-drug conjugate (ADC), zocilurtatug pelitecan (zoci).
The NMPA based its decision on compelling evidence from the TRIDENT-1 study, a pivotal Phase I/II clinical trial that demonstrated the drug’s effectiveness over time.