CHINA MEDICAL UNIVERSITY

FDA Grants Orphan Drug Designation to Elicera Therapeutics' ELC-100 for Pancreatic Neuroendocrine Tumors

4 months ago

• Elicera Therapeutics' drug candidate ELC-100, an oncolytic virus, has received Orphan Drug Designation (ODD) from the FDA for pancreatic neuroendocrine tumor (NET) treatment. • The ODD provides Elicera with benefits such as tax credits for clinical trials and potential market exclusivity for seven years post-approval. • ELC-100 is currently in a Phase I/II clinical trial to determine the maximum tolerated dose and evaluate safety in patients with metastatic NETs. • Final data from the first part of the Phase I/II trial are expected in mid-2025, marking a significant step in developing new NET treatments.

Sacituzumab Tirumotecan Shows Promising Activity in Pretreated Endometrial and Ovarian Cancers

6 months ago

• Sacituzumab tirumotecan (sac-TMT) demonstrates antitumor activity in patients with pretreated advanced endometrial and ovarian cancers, offering a potential new treatment option. • In endometrial cancer patients, sac-TMT achieved an objective response rate (ORR) of 34.1% and a disease control rate (DCR) of 75.0% at a median follow-up of 7.2 months. • Ovarian cancer patients treated with sac-TMT showed an ORR of 40.0% and a DCR of 75.0% at a median follow-up of 28.2 months, indicating durable responses. • The safety profile of sac-TMT was manageable, with common treatment-related adverse events being generally reversible with dose modifications and supportive care.

Sacituzumab Tirumotecan Demonstrates Antitumor Activity in Advanced Endometrial and Ovarian Cancers

6 months ago

• Sacituzumab tirumotecan (sac-TMT) monotherapy shows promising antitumor activity in patients with previously treated advanced endometrial cancer, with an objective response rate (ORR) of 34.1%. • In patients with previously treated advanced ovarian cancer, sac-TMT monotherapy achieved an ORR of 40.0% and a disease control rate (DCR) of 75.0%. • The phase 2 KL264-01 trial highlights a manageable safety profile for sac-TMT, with common treatment-related adverse events including anemia and decreased white blood cell count. • A phase 3 trial, TroFuse-005 (NCT06132958), is underway to further evaluate sac-TMT versus chemotherapy in advanced endometrial cancer patients.