Top oncology news covered in this video includes pediatric glioma, lung, breast, gastric cancer, and sarcoma/melanoma, highlighting regulatory momentum and advances in targeted therapies.
Watch Our Video Summary Capturing Oncology News from the Last Two Weeks
🧠 Cellectar’s iopofosine I-131 shows durable benefit in pediatric glioma
Context: CLOVER-2 Phase 1b in relapsed/refractory pediatric high-grade glioma (n = 14).
Key point: Patients on ≥ 55 mCi achieved mean PFS 5.4 m and OS 8.6 m; two objective responses; favorable safety.
Implication: May influence prescriber choice and payer reviews pending full data.
💉 Roche’s Tecentriq + lurbinectedin approved for ES-SCLC maintenance
https://www.roche.com/media/releases/med-cor-2025-10-03b
Context: Phase 3 IMforte trial; 483 patients randomized post-induction with Tecentriq + chemotherapy.
Key point: Combo cut risk of progression or death by 46% and death by 27% vs Tecentriq alone; OS 13.2 m vs 10.6 m.
Implication: May influence prescriber choice and payer reviews pending full data.
🫁 Nuvation Bio starts TRUST-IV Phase 3 adjuvant trial of IBTROZI (taletrectinib)
Context: Global Phase 3 trial (~180 ROS1+ early-stage NSCLC patients) after surgery.
Key point: IBTROZI vs placebo to test disease-free survival; completion expected 2033.
Implication: May influence prescriber choice and payer reviews pending full data.
🧩 Ensem Therapeutics ETX-636 earns FDA Fast Track for PIK3CA-mutant breast cancer
https://finance.yahoo.com/news/ensem-therapeutics-announces-etx-636-120000987.html
Context: PI3Kα mutant-selective allosteric inhibitor-degrader; designed via Kinetic Ensemble® platform.
Key point: Phase 1/2 study (NCT06993844) underway in PIK3CA-mutant solid tumors; aims to reduce wildtype toxicity.
Implication: Signals pipeline investment and modality expansion.
💊 ENHERTU + pertuzumab sNDA filed in Japan for first-line HER2+ metastatic breast cancer
https://www.daiichisankyo.com/files/news/pressrelease/pdf/202510/20251007_E.pdf
Context: DESTINY-Breast09 Phase 3 late-breaking ASCO data.
Key point: ENHERTU + pertuzumab reduced progression risk by 44 % vs THP; median PFS > 3 years.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Henlius HANSIZHUANG + chemo meets EFS endpoint in gastric cancer Phase 3
Context: ASTRUM-006 perioperative trial in early-stage gastric cancer.
Key point: Met EFS primary endpoint; > 3× higher pCR rate vs control; favorable safety; early NDA recommended.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 Adcendo ApS gains FDA Fast Track for ADCE-D01 in soft-tissue sarcoma
Context: First-in-class ADC targeting uPARAP; Phase 1/2 ADCElerate1 ongoing in US and EU.
Key point: Preclinical data show strong anti-tumor activity and tolerability; Fast Track to accelerate regulatory review.
Implication: Signals pipeline investment and modality expansion.
🔬 Werewolf Therapeutics WTX-124 granted FDA Fast Track for melanoma
https://investors.werewolftx.com/news-and-events/press-releases
Context: IL-2 INDUKINE™ therapy evaluated in Phase 1/1b for advanced solid tumors.
Key point: Designation based on clinical activity in post-checkpoint melanoma and tolerable safety.
Implication: Signals pipeline investment and modality expansion.
Why It Matters
- Multiple oncology programs advanced across pediatric, adjuvant and perioperative settings.
- Approvals and Fast Track designations highlight global regulatory momentum.
- ADCs and targeted biologics continue to dominate solid-tumor innovation.
- Asia–US coordination (ENHERTU, HANSIZHUANG) reflects broad trial integration.
📢 Stay Ahead in Oncology research!
✅ Like, share, and subscribe to our YouTube channel for future highlights. Don’t miss our weekly newsletters with the latest updates.
🚀 Partner with LucidQuest to accelerate your success.
FAQ
What did Cellectar report from CLOVER-2?
Cellectar presented Phase 1b interim data showing extended PFS and OS in pediatric high-grade glioma with no off-target toxicity.
What regimen did Roche secure FDA approval for?
Roche won approval for Tecentriq (atezolizumab) + lurbinectedin as the first and only maintenance option for ES-SCLC.
What is Nuvation Bio studying in TRUST-IV?
Nuvation Bio is testing IBTROZI (taletrectinib) vs placebo as adjuvant therapy in ROS1+ early-stage NSCLC post-surgery.
How does Ensem’s ETX-636 differ from other PI3K inhibitors?
Ensem targets mutant PI3Kα selectively, sparing wildtype to limit hyperglycemia and adverse events.
What data support Daiichi Sankyo’s ENHERTU submission in Japan?
Daiichi Sankyo relied on DESTINY-Breast09 showing a 44 % risk reduction in progression vs THP.
Why is Henlius’ ASTRUM-006 notable?
Henlius achieved EFS improvement with HANSIZHUANG + chemo, potentially replacing adjuvant chemo in perioperative gastric care.
Which companies recently received FDA Fast Track status?
Adcendo (ADCE-D01 in sarcoma), Werewolf (WTX-124 in melanoma), and Ensem (ETX-636 in breast cancer) were each granted designation.
Entities / Keywords
Cellectar Biosciences | iopofosine I-131 | Roche | Tecentriq | lurbinectedin | Nuvation Bio | IBTROZI (taletrectinib) | Ensem Therapeutics | ETX-636 | Daiichi Sankyo | ENHERTU (trastuzumab deruxtecan) | Henlius | HANSIZHUANG (serplulimab) | Adcendo ApS | ADCE-D01 | Werewolf Therapeutics | WTX-124
References
https://www.roche.com/media/releases/med-cor-2025-10-03b
https://finance.yahoo.com/news/ensem-therapeutics-announces-etx-636-120000987.html
https://www.daiichisankyo.com/files/news/pressrelease/pdf/202510/20251007_E.pdf
https://investors.werewolftx.com/news-and-events/press-releases