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Oncology Updates - Key Oncology News
- Oncofocus Team
- 3 days ago
- 2 min read
August 4th Week, 2025
Regulatory Events
🎯 The EC approved BeOne Medicines' tislelizumab (anti-PD-1) + platinum-containing chemo as neoadjuvant Tx followed by tislelizumab monotherapy as adjuvant Tx for resectable NSCLC at high risk of recurrence. (Ref 1)
❓ How is BeOne’s regimen positioned compared to other approved perioperative options?
Clinical Events
🔬 Per final analysis of the Phase 3 HARMONi-A trial, a statistically significant and clinically meaningful OS benefit was observed with Akeso Biopharma & Summit Therapeutics, Inc.’ ivonescimab (PD-1 x VEGF BsAb) + chemo in EGFRm non-squamous NSCLC who progressed on EGFR TKI Tx. (Ref 2)
❓ What are the other key trials ongoing for PD-(L)1 x VEGF BsAbs in this indication?
🔬 Eli Lilly and Company reported positive topline results from the primary OS analysis of the Phase 3 monarchE trial in which abemaciclib (CDK4/6 inhibitor) + endocrine therapy demonstrated a statistically significant and clinically meaningful improvement in OS vs endocrine therapy alone in HR+, HER2-, node-positive, high-risk early breast cancer. (Ref 3)
❓ How are these results going to impact the positioning of the regimen?
Special Designations
⭐ The US FDA granted the Breakthrough Therapy Designation to Genmab's rinatabart sesutecan (FRα-directed ADC) for recurrent or progressive endometrial cancer who have disease progression on or following prior Tx with a platinum-containing regimen and a PD-(L)1 therapy. (Ref 4)
❓ Which are the other key ADCs being developed for this indication?
⭐ The US FDA granted the Breakthrough Device Designation to Quest Diagnostics' Haystack MRD test for identifying MRD+ve patients with stage II colorectal cancer following curative-intent surgery who may benefit from adjuvant Tx. (Ref 5)
❓ Who are the other key players developing similar devices?
⭐ The US FDA granted the Fast Track Designation to Allarity Therapeutics' stenoparib (dual PARP and WNT pathway inhibitor) for advanced ovarian cancer. (Ref 6)
❓ What are the key unmet medical needs for this indication?
⭐ The US FDA granted the Fast Track Designation to TOLREMO therapeutics' TT125-802 (CBP/p300 inhibitor) for previously treated, locally advanced or metastatic NSCLC with (i) EGFR exon 19 deletion or exon 21 L858R substitution mutation, or (ii) KRAS-G12C mutation. (Ref 7)
❓ What were the clinical outcomes based on which the designation was granted?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
🌐 References:
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