Oncology Weekly News - October 6th 2025

Oncology Update: Enhertu Superiority, Tecentriq Combo Approval, New Trials & More!

From Enhertu’s win over T-DM1 in early HER2-positive breast cancer to FDA approval of Tecentriq plus lurbinectedin in small-cell lung cancer, this week brings pivotal oncology milestones. Nuvation launched its Phase 3 ROS1-positive lung cancer trial, while Ensem secured Fast Track for its PI3Kα degrader in breast cancer. Cellectar and Lisata reported promising survival and resectability data, Candel advanced prostate cancer outcomes, and UroGen reinforced NMIBC durability. Preclinical KRAS breakthroughs and Boryung’s Taxotere acquisition round out global oncology progress.

In Today’s Newsletter

💊 Enhertu outperforms T-DM1 in early HER2-positive breast cancer [1] [Global • 29 Sep 2025]

https://www.astrazeneca.com/media-centre/press-releases/2025/enhertu-improved-idfs-in-early-bc-in-db-05.html
Context: DESTINY-Breast05 Phase 3 trial, n = 1,635 patients.
Key point: Enhertu (trastuzumab deruxtecan) improved invasive disease-free survival vs T-DM1 after neoadjuvant therapy; safety consistent with prior studies.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 FDA approves Tecentriq + lurbinectedin combo for ES-SCLC [2] [US • 03 Oct 2025]

https://www.roche.com/media/releases/med-cor-2025-10-03b

Context: IMforte Phase 3 (n = 483 randomized).
Key point: Combo cut risk of progression or death by 46% and death by 27% vs Tecentriq alone in first-line maintenance.
Implication: May influence prescriber choice and payer reviews pending full data.

🫁 Nuvation Bio starts Phase 3 TRUST-IV of IBTROZI (taletrectinib) [3] [US • 30 Sep 2025]

https://investors.nuvationbio.com/news/news-details/2025/Nuvation-Bio-Enrolls-First-Patient-in-TRUST-IV-Phase-3-Study-of-IBTROZI-taletrectinib
Context: First patient enrolled; ~180 planned globally for ROS1+ stage IB–IIIA NSCLC.
Key point: Evaluates adjuvant taletrectinib vs placebo after resection; follows 2025 FDA approval in metastatic setting.
Implication: May influence prescriber choice and payer reviews pending full data.

⚛️ Ensem Therapeutics ETX-636 earns Fast Track for PIK3CA-mutant breast cancer [4] [US • 01 Oct 2025]

https://finance.yahoo.com/news/ensem-therapeutics-announces-etx-636-120000987.html
Context: Early Phase 1/2 first-in-human trial underway.
Key point: ETX-636 is a mutant-specific PI3Kα inhibitor and degrader designed to avoid wildtype toxicity; Fast Track granted for HR+/HER2- advanced breast cancer.
Implication: Signals pipeline investment and modality expansion.

☢️ Cellectar iopofosine I-131 shows survival signal in pediatric glioma [5] [US • 30 Sep 2025]

https://investor.cellectar.com/press-releases/detail/375/cellectar-biosciences-presented-compelling-data-in-oral

Context: CLOVER-2 Phase 1b trial (n = 14 r/r pediatric high-grade glioma).
Key point: Patients ≥55 mCi dose had median PFS ≈ 5.4 mo and OS ≈ 8.6 mo (ongoing) vs historical ≈ 2.3 mo / 5.6 mo; well tolerated.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Lisata Therapeutics reports encouraging CENDIFOX pancreatic cancer data [6] [US • 29 Sep 2025]

https://ir.lisata.com/news-releases/news-release-details/lisata-therapeutics-announces-encouraging-preliminary-results
Context: Phase 1/2a investigator-initiated trial at KU Cancer Center.
Key point: Certepetide + FOLFIRINOX in resectable PDAC was safe and feasible (R0 rate 50%, 2-yr OS 60%); enhanced immune cell infiltration.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 Candel Therapeutics Phase 3 CAN-2409 boosts prostate DFS [7] [US • 29 Sep 2025]

https://ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-presents-phase-3-clinical-trial-can-2409
Context: Phase 3 (n = 745) in intermediate-to-high-risk localized prostate cancer.
Key point: CAN-2409 + valacyclovir improved disease-free survival (30% gain; p = 0.0155) across radiation regimens; well tolerated.
Implication: May influence prescriber choice and payer reviews pending full data.

💧 ZUSDURI clinical review supports durable efficacy in NMIBC [8] [US • 02 Oct 2025]

https://www.biospace.com/press-releases/zusduri-clinical-review-published-in-reviews-in-urology-highlights-durable-efficacy-and-manageable-safety-profile-in-recurrent-low-grade-intermediate-risk-non-muscle-invasive-bladder-cancer
Context: Review in Reviews in Urology™ summarized OPTIMA II, ATLAS, ENVISION trials.
Key point: ZUSDURI (mitomycin RTGel) showed CR rates 65–80% and durable responses >18 mo with manageable safety.
Implication: Could inform practice and payer discussions; interpretation depends on study design.

🧬 Silexion SIL204 shows pan-KRAS activity in preclinical models [9] [Global • 30 Sep 2025]

https://www.globenewswire.com/news-release/2025/09/30/3158625/0/en/Silexion-Therapeutics-Announces-Positive-New-Human-Cell-Line-Data-Confirming-Pan-KRAS-Activity-of-SIL204-Demonstrating-Up-to-99-7-Inhibition-and-First-Evidence-in-Gastric-Cancer.html
Context: Human cell-line data across 11 lines from 5 tumor types.
Key point: SIL204 inhibited multiple KRAS mutations (G12D, G12V, G13D etc.) by 83–99.7%; first activity in gastric cancer.
Implication: Signals pipeline investment and modality expansion.

💼 Boryung to acquire Taxotere from Sanofi in 19 countries [10] [KR • 30 Sep 2025]

https://www.boryung.co.kr/en/news/detail/1382
Context: Asset purchase ≈ €175 million subject to regulatory clearance.
Key point: Boryung will manufacture Taxotere (docetaxel) at its Yesan facility and manage global distribution in Europe, Asia, and Latin America.
Implication: Introduces competition that may affect pricing and formulary access.

Why it matters

Growing use of antibody–drug conjugates and radioconjugates expands precision-oncology reach beyond metastatic disease.
Multi-region regulatory actions (Enhertu, Tecentriq) continue to shape standards in early and maintenance settings.
Early-stage platforms (Ensem, Silexion, Lisata) highlight next-generation targeting of resistant oncogenic pathways.
The return of cytotoxic legacy assets via Boryung underscores supply-chain and pricing pressures in essential oncology drugs.

📢 Stay Ahead in Oncology Research!

✅ Contact LucidQuest at info@lqventures.com for strategic guidance on oncology innovations and clinical research.

FAQ

What distinguishes Enhertu’s new data? [1]

Enhertu (trastuzumab deruxtecan) is the first ADC to show superior IDFS to T-DM1 in early HER2-positive breast cancer, potentially redefining post-neoadjuvant therapy.

How does Roche’s new Tecentriq approval extend its SCLC franchise? [2]

The FDA cleared Tecentriq + lurbinectedin for first-line maintenance in ES-SCLC, the first combo to reduce progression risk vs immunotherapy alone.

What is the goal of Nuvation Bio’s TRUST-IV trial? [3]

To assess whether taletrectinib prevents recurrence after surgery in ROS1+ early-stage NSCLC, expanding its use beyond metastatic disease.

Why is ETX-636 notable among PI3K inhibitors? [4]

It selectively targets mutant PI3Kα and degrades the enzyme, aiming to reduce hyperglycemia seen with non-selective agents.

How do Certepetide and CAN-2409 differ in modality? [6][7]

Certepetide enhances drug penetration and immune activation in solid tumors; CAN-2409 is a viral gene therapy eliciting tumor-specific T-cell responses.

What does Boryung’s Taxotere deal mean for the market? [10]

It transfers manufacturing and distribution of docetaxel’s originator brand to a Korean firm, potentially stabilizing supply and creating pricing competition.

Entities / Keywords

AstraZeneca (Daiichi Sankyo, Enhertu); Roche (Tecentriq, lurbinectedin); Nuvation Bio (IBTROZI, taletrectinib); Ensem Therapeutics (ETX-636, PI3Kα); Cellectar (iopofosine I-131); Lisata (certepetide); Candel (CAN-2409); UroGen (ZUSDURI / mitomycin RTGel); Silexion (SIL204 pan-KRAS RNAi); Boryung (Sanofi, Taxotere / docetaxel).