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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 4 days ago
- 3 min read
15/06/2026
Midstage Pancreatic Cancer Study Fails to Meet Primary Endpoint but Will Advance to Phase 3 (Ref)
Elicio’s Phase 2 AMPLIFY‑7P trial of ELI‑002 7P (lymph node-targeted amphiphile therapeutic cancer vaccine) in adjuvant pancreatic cancer missed its primary endpoint (DFS) overall, but showed meaningful DFS benefit in R0 resected patients with strong immune correlation, guiding a refined Phase 3 strategy focused on extended dosing and registrational development
The trial did not meet its primary endpoint of disease‑free survival (DFS) in the intent‑to‑treat population
Imbalance in R1 resection patients (higher residual disease) negatively impacted the ELI‑002 arm (19% vs 10% in observation)
Post‑hoc analysis showed significant DFS benefit in R0 (completely resected) patients: HR 0.65, p=0.048; median DFS 23.8 mos vs 12.8 mos
Phase 3 Strategy:
Focus will shift to R0 resected patients
Plans include extended dosing beyond initial immunization to enhance durability of anti‑tumor immunity
Registrational Phase 3 study will use DFS as the primary endpoint
FDA accepts ozekibart BLA, setting April 2027 PDUFA for conventional Chondrosarcoma (Ref)
FDA accepted the Biologics License Application (BLA) for Inhibrx Biosciences' ozekibart (INBRX‑109) in unresectable or metastatic conventional chondrosarcoma, with no filing review issues
The PDUFA goal date is April 14, 2027
Filing is supported by positive results from the ChonDRAgon trial (206 patients, randomized, placebo-controlled)
Ozekibart reduced risk of progression or death by 52% (HR 0.479; P<0.0001), doubling median PFS to 5.52 mos vs 2.66 mos for placebo
Secondary outcomes: Improved disease control rate (54% vs 27.5%) and delayed deterioration in pain/physical function. Benefit consistent across subgroups (IDH-wild-type and mutant)
Halia Therapeutics Secures FDA Fast Track Designation for Ofirnoflast in Lower-Risk MDS (Ref)
Halia Therapeutics announced that the US FDA has granted Fast Track designation to ofirnoflast (HT-6184) for treating adult patients with lower-risk myelodysplastic syndromes (LR-MDS)
This milestone follows strong Phase 2 trial results demonstrating durable transfusion independence and multilineage hematological improvement, with full data presented at EHA2026
67% overall best on-study hematological improvement rate among 30 evaluable patients
56% of transfusion-dependent patients (10 of 18) achieved red blood cell transfusion independence for ≥8 weeks, with a median duration of 28 weeks
Halia plans to advance ofirnoflast into pivotal development, leveraging Fast Track benefits
Menarini Group's Phase 3 SENTRY trial met its first co-primary endpoint, with the selinexor + ruxolitinib combination achieving significant improvement in spleen volume reduction (SVR35) vs ruxolitinib alone in frontline Myelofibrosis (Ref)
The data was selected for a late-breaking oral presentation at the EHA 2026 Congress
Primary Endpoint Success: The combination met the first co-primary endpoint, showing significant spleen volume reduction (SVR35) - 49.8% vs 28% with ruxolitinib alone at week 24
Durable Benefit: Rapid, deep, and sustained spleen reductions were observed, consistent across subgroups and independent of ruxolitinib dose
Overall Survival Signal: Early data suggest >50% reduction in risk of death with the combination (HR 0.43), though OS data remain immature
Symptoms Endpoint: The second co-primary endpoint (Absolute Total Symptom Score) was not met; improvements were similar between arms and not statistically significant
Exploratory Endpoint: Variant Allele Frequency reduction was greater in the combination arm (32% vs 23.9%), suggesting potential disease-modifying activity
Safety Profile: Manageable and consistent with known profiles of selinexor and ruxolitinib; no new safety signals
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