Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 16 hours ago
- 3 min read
14/07/2026
FDA frants Fast Track Designation to SOTIO’s SOT109 (CDH17-targeting) ADC for advanced Colorectal Cancer (Ref)
The US FDA has granted Fast Track Designation to SOTIO Biotech's SOT109 for advanced unresectable or metastatic colorectal cancer patients who have exhausted standard treatments
A Phase 1/2 trial of SOT109 in advanced colorectal cancer is expected to begin in Q3 2026
FDA grants full approval to selpercatinib for RET fusion positive solid tumors (Ref)
FDA granted traditional approval for selpercatinib in adults and children ≥2 years with locally advanced or metastatic RET fusion-positive solid tumors, after prior systemic therapy or with no satisfactory alternatives
Previous Status: Accelerated approval was granted in 2022 (adults) and 2024 (pediatric patients two years of age and older)
Clinical Trials:
LIBRETTO-001: Multicenter, open-label trial; 75 patients with RET fusion-positive tumors beyond NSCLC and thyroid cancer.
ORR: 47% (95% CI: 35–59), median DOR 24.5 months (95% CI: 11.2–49.1)
Responses across diverse tumor types including colorectal, pancreatic, salivary, sarcoma, cholangiocarcinoma, breast, ovarian, and neuroendocrine
LIBRETTO-121: Pediatric/young adult trial; responses seen in congenital infantile fibrosarcoma, spindle cell sarcoma, and thyroid cancer
AstraZeneca secures global rights to Zegfrovy, first oral EGFR exon 20 NSCLC therapy, in $600M upfront deal with Dizal (Ref)
AstraZeneca entered an exclusive global license agreement with Dizal Pharmaceutical for Zegfrovy, a novel oral irreversible EGFR inhibitor for lung cancer
AstraZeneca will acquire worldwide rights to develop and commercialize the drug.
Financial terms: $600M upfront, up to $900M in milestones, plus tiered royalties.
Transaction expected to close in H2 2026, with no impact on AstraZeneca’s 2026 financial guidance
Zegfrovy is approved in the US and China for adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 20 insertion mutations, post-platinum chemotherapy.
Trial & Regulatory Updates
Positive Phase III WU-KONG28 trial results in 1st-line NSCLC with exon 20 insertion mutations were presented at ASCO 2026 and published in NEJM.
Supplemental NDAs submitted to the US FDA and China’s CDE for 1st-line approval.
The US FDA and China’s CDE have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting
Zegfrovy is included in the NCCN Guidelines® as a Category 2A recommended subsequent therapy option
In a Ph3 trial, HBI-8000 + nivolumab improved PFS vs nivolumab + placebo, for advanced Melanoma (Ref)
The global Phase 3 study of HUYABIO International's HBI-8000 (HDAC inhibitor) + nivolumab met its primary endpoint, showing a clinically meaningful improvement in progression-free survival (PFS) for advanced melanoma patients
Median PFS was 11.7 months with the combination vs 7.4 months with nivolumab + placebo, a statistically significant improvement in PFS of 58%
Detailed statistical analyses are ongoing, and full data (HBI-8000-303) will be presented at upcoming medical meetings
FDA approved first generics of Gilotrif (afatinib) for EGFR‑mutant and squamous NSCLC (Ref)
The FDA has approved the first generic versions of Gilotrif (afatinib tablets) for:
First-line treatment of metastatic NSCLC with non-resistant EGFR mutations (confirmed by an FDA-approved test)
Treatment of metastatic squamous NSCLC progressing after platinum-based chemotherapy
Generic afatinib tablets carry the same warnings as Gilotrif, including risks of diarrhea, bullous/exfoliative skin disorders, ILD, hepatic toxicity, GI perforation, keratitis, and embryo-fetal toxicity
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