.png)
Oncology Updates - Key Oncology News
- Oncofocus Team
- Nov 11
- 2 min read
November 1st Week, 2025
Regulatory Events
🎯 The US FDA approved Johnson & Johnson's Darzalex Faspro (daratumumab, an anti-CD38, and hyaluronidase) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). (Ref 1)
❓ How is this approval expected to impact the treatment algorithm of this indication?
Clinical Events
🔬 In the registrational cohort of the Phase 2 IOV-LUN-202/NCT04614103 trial, Iovance Biotherapeutics, Inc.’s lifileucel monotherapy (autologous TIL therapy) elicited an ORR of 25.6% (CR: 5.1%) in patients with previously treated advanced non-squamous NSCLC without actionable genetic mutations. (Ref 2)
❓ What are the current SOC benchmarks of this indication?
🔬 In the Phase 3 UTOPIA trial, UroGen Pharma’s UGN-103 (mitomycin) demonstrated a 77.8% three-month CR rate in patients with recurrent low-grade intermediate-risk NMIBC. (Ref 3)
❓ What are the available Tx options for pts with LG-IR-NMIBC?
Special Designations
⭐ The US FDA granted the orphan drug designation to Leukogene Therapeutics, Inc.'s LTI-214 (M2T-CD33; myeloid-targeted immunotherapy) for the treatment of Acute Myeloid Leukemia. (Ref 4)
❓ What are the key unmet needs of this indication?
🛑 Gilead Sciences’ Phase 3 ASCENT-07 trial of sacituzumab govitecan (TROP2 ADC) vs chemotherapy as a first-line treatment post-endocrine therapy in HR+/HER2-negative metastatic breast cancer patients did not meet the primary endpoint of PFS as assessed by BICR. (Ref 5)
❓ Which other key Phase 3 trials are ongoing for this patient population?
🤝 Merck & Co./MSD entered into a $700 million agreement to receive funds managed by Blackstone Life Sciences for the development of sacituzumab tirumotecan (sac-TMT; TROP2 ADC). (Ref 6)
❓ What are the launch timeline estimates for this TROP2 ADC?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
🌐 References:
Comments