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Oncology Updates - Key Oncology News
- Oncofocus Team
- 4 days ago
- 2 min read
May 1st Week, 2025
Regulatory Events
🎯 Summit Therapeutics, Inc. and Akeso Biopharma’s ivonescimab (PD-1 x VEGF BsAb) mono has been approved in China for the 1L Tx of NSCLC with PD-L1 ≥1%. (Ref 1)
❓ When can we expect ivonescimab to receive the first approval in the key markets?
🎯 The UK’s MHRA approved Bristol Myers Squibb’s nivolumab (anti-PD-1) subcutaneous formulation for a broad range of cancers, including kidney, melanoma, lung, head and neck, bladder, colorectal, liver, stomach, and cancers of the oesophagus. (Ref 2)
❓ What are the other subcutaneous formulations of immune checkpoint inhibitors under development?
Special Designation
⭐The US FDA granted the Fast Track designation for BioInvent International AB’s BI-1808 (anti-TNFR2) for the Tx of R/R mycosis fungoides and Sézary syndrome. (Ref 3)
❓ What are the outcomes of BI-1808 that supported the Fast Track designation?
⭐ The US FDA granted the Fast Track designation for Incyclix Bio’s INX-315 (CDK2 inhibitor) for the Tx of CCNE1-amplified platinum-R/R ovarian cancer. (Ref 4)
❓ What are the key competitor drugs that have also received the Fast Track designation in this setting?
⭐ The US FDA granted the Breakthrough Device Designation for Roche’s VENTANA TROP2 (EPR20043) RxDx Device making it the first among the computational pathology companion diagnostic devices. (Ref 5)
❓ Which are the other companies developing similar diagnostic devices?
Clinical Events
🔬In the Phase 3 CREST trial, Pfizer’s sasanlimab (anti-PD-1) + BCG (induction and maintenance) met its primary endpoint of EFS vs BCG alone (induction and maintenance) in BCG-naïve, high-risk NMIBC. However, interim OS data suggested no difference between the Tx arms. (Ref 6)
❓ Does the combo have the potential to become the SOC based on the EFS benefit?
🔬The Phase 2/3 KN026-001 trial of Alphamab Oncology and CSPC Pharmaceutical Group ’s KN026 (anti-HER2 BsAb) + chemotherapy met the primary endpoint of PFS as a ≥ 2L Tx of HER2+ve gastric or gastroesophageal junction cancer. (Ref 7)
❓ What are the current PFS benchmarks for this indication?
Setbacks
🛑 AstraZeneca discontinued the Phase 3 CAPItello-280 trial of capivasertib (ATP-competitive inhibitor) + docetaxel + ADT vs placebo + docetaxel + ADT in metastatic CRPC as it was unlikely to meet the dual primary endpoints of rPFS and OS. (Ref 8)
❓ What are the other key Phase 3 trials ongoing in this indication?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com
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