Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Jul 28
- 2 min read
Updated: Jul 30
27/07/2026
Sone‑Ve delivers statistically significant OS benefit in CLDN18.2‑positive gastric/GEJ cancers, while PFS endpoint was not met (Ref)
AstraZeneca's Phase 3 CLARITY-Gastric01 trial of sonesitatug vedotin (Sone-Ve; CLDN18.2 targeting ADC) showed a statistically significant and clinically meaningful overall survival (OS) benefit in 2nd and later‑line CLDN18.2‑positive gastric/GEJ cancers compared to investigator’s choice therapy
The trial met its dual primary endpoint of OS in 3rd+ line; also improved OS in 2nd+ line setting
The other primary endpoint, progression-free survival across the full trial population, showed a positive trend but did not reach statistical significance
Safety results were consistent with Sone-Ve's known profile, with no new safety concerns identified
Detailed data will be presented at a future medical conference and submitted to global regulatory authorities
Philogen resubmits EMA application for Nidlegy with extended Phase III data (Ref)
Philogen resubmitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Nidlegy™ (Daromun; bifikafusp alfa/ onfekafusp alfa) in the neoadjuvant treatment of locally advanced, fully resectable Melanoma
The resubmission follows previously communicated timelines
The updated submission is based on clinical data from the randomized Phase III PIVOTAL study
Longer median follow-up: 33 months vs 21 months in the 2024 submission
Updated Phase III PIVOTAL data accepted for publication in the Journal of Clinical Oncology
CG Oncology Publishes Pivotal Phase 3 BOND-003 Cohort C Results in The Lancet Oncology (Ref)
CG Oncology announced that The Lancet Oncology published results from its pivotal Phase 3 BOND-003 Cohort C trial of cretostimogene grenadenorepvec (oncolytic immunotherapy) monotherapy.
The trial targeted high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, and the study met its primary endpoint with statistical significance
Complete Response (CR): 75.5% achieved CR at any time
Durability: Median duration of response ≥27.9 months; 64.2% at 12 months, 60.1% at 24 months
Bladder Preservation: ~89% retained bladder at 12 months, 81% at 24 months
Progression-Free Survival: 96.6% free from progression to muscle-invasive disease at 48 and 96 weeks
Safety: No Grade ≥3 treatment-related adverse events; most common mild events were bladder spasm, urgency, dysuria, hematuria
Cretostimogene holds FDA Fast Track and Breakthrough Therapy designations
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