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Oncology Updates - Key Oncology News
- Oncofocus Team
- Aug 6
- 2 min read
August 1st Week, 2025
Regulatory Events
🎯 AbbVie submitted a sNDA to the US FDA for AbbVie and Roche’s venetoclax (BCL-2 inhibitor) + acalabrutinib (fixed-duration, all-oral combo) in previously untreated patients with chronic lymphocytic leukemia. (Ref 1)
❓ What are the combo’s pros and cons vs approved CLL therapies?
Clinical Events
🔬 Eli Lilly and Company’s Phase 3 BRUIN CLL-314 trial of pirtobrutinib (non-covalent, reversible BTK inhibitor) vs ibrutinib (covalent BTK inhibitor) met its primary endpoint of non-inferiority in ORR for chronic lymphocytic leukemia or small lymphocytic lymphoma. (Ref 2)
❓ How are these results expected to impact the treatment paradigm?
Special Designations
⭐ The US FDA accepted and granted Priority Review to AstraZeneca’s sBLA for neoadjuvant durvalumab (anti-PD-L1) + chemo followed by adjuvant durvalumab + chemo, then durvalumab mono for resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers. (Ref 3)
❓ What were the outcomes based on which the sBLA was accepted?
⭐ The US FDA granted the Fast Track designation to MAIA Biotechnology, Inc.'s ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) for the treatment of NSCLC. (Ref 4)
❓ What is the current development status of ateganosine?
⭐ The US FDA granted the Fast Track designation to Calidi Biotherapeutics' CLD-201 (SuperNova; allogeneic adipose stem-cell loaded oncolytic virus) for the treatment of soft tissue sarcoma. (Ref 5)
❓ Who are the key players developing oncolytic virus?
⭐ The US FDA granted the Orphan Drug designation to Sanofi's SAR446523 (anti-GPRC5D) for the treatment of relapsed or refractory multiple myeloma. (Ref 6)
❓ What are the key unmet needs for this indication?
Setbacks
🛑 Exelixis discontinued the Phase 2/3 STELLAR-305 trial of zanzalintinib (multi-targeted TKI of VEGFR, MET, and the TAM kinases) + pembro vs placebo + pembro as a first-line treatment for PD-L1 CPS ≥1, R/M SCCHN, based on emerging Ph2 data, competition in SCCHN, and assessment of other potentially larger commercial opportunities. (Ref 7)
❓ What was the rationale for the Ph2/3 STELLAR-305 trial?
🛑 GSK's Phase 3 COSTAR Lung trial of dostarlimab (anti-PD-1) + docetaxel ± cobolimab (anti-TIM-3) combinations did not meet the primary endpoint of improving OS vs docetaxel alone in advanced NSCLC that has progressed on prior PD-(L)1 therapy and chemo. (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.
🌐 References:
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