Oncology Today: ADCs, PD-L1 & FDA Wins (Oct 6–13, 2025)

This week’s oncology highlights include breakthrough therapies such as ADCs (Datroway, Sac-TMT), PD-L1 degraders (Kazia’s NDL2), and innovative treatments like cintredekin besudotox for GBM, ENHERTU plus pertuzumab for HER2+ breast cancer, and HANSIZHUANG for gastric cancer. Key FDA Orphan Drug and Fast Track designations, plus global clinical trial results, are shaping the future of cancer care.

🧠 Precision NeuroMed granted FDA Orphan Drug Designation for GBM therapy [1] [US • 07 Oct 2025]

https://precisionneuromed.com/fda-orphan-drug-designation-for-gbm/

Context: Cintredekin besudotox (IL13-PE38QQR) delivered via convection-enhanced platform bypasses the blood–brain barrier.
Key point: Designation covers treatment of glioblastoma multiforme using direct intracerebral administration.
Implication: Introduces competition that may affect pricing and formulary access.

🫁 Kelun-Biotech’s Sac-TMT receives third NMPA approval in China [2] [CN • 11 Oct 2025]

https://en.kelun-biotech.com/

Context: TROP2 ADC sacituzumab tirumotecan approved for EGFR-mutant NSCLC after EGFR-TKI failure.
Key point: OptiTROP-Lung04 Phase 3 showed OS and PFS advantage over platinum chemotherapy.
Implication: May influence prescriber choice and payer reviews pending full data.

💉 ENHERTU plus pertuzumab sNDA filed in Japan for HER2+ metastatic breast cancer [3] [JP • 07 Oct 2025]

https://www.daiichisankyo.com/files/news/pressrelease/pdf/202510/20251007_E.pdf

Context: Submission based on DESTINY-Breast09 Phase 3 trial results presented at ASCO 2025.
Key point: Combination reduced risk of progression or death by 44% versus THP regimen.
Implication: May influence prescriber choice and payer reviews pending full data.

💗 Atossa Therapeutics streamlines EVANGELINE trial of (Z)-endoxifen [4] [US • 06 Oct 2025]

https://atossatherapeutics.com/

Context: Phase 2 single-arm, open-label trial in premenopausal ER+/HER2– breast cancer.
Key point: Amendment reduces n to 40–65 and focuses on short-interval objective endpoints to accelerate NDA plans.
Implication: Signals pipeline investment and modality expansion.

🧬 Datroway improves OS and PFS in metastatic TNBC patients [5] [06 Oct 2025]

https://www.astrazeneca.com/media-centre/press-releases/2025/datroway-improved-os-and-pfs-in-tropion-breast02.html

Context: Phase 3 TROPION-Breast02 met dual primary endpoints vs chemotherapy in 1L setting.
Key point: First therapy to significantly improve OS for immunotherapy-ineligible TNBC patients.
Implication: May influence prescriber choice and payer reviews pending full data.

🍽 Henlius HANSIZHUANG hits primary endpoint in gastric cancer [6] [CN • 09 Oct 2025]

https://www.prnewswire.com/apac/news-releases/phase-3-clinical-trial-of-hansizhuang-plus-chemotherapy-meets-primary-endpoint-in-neoadjuvantadjuvant-gastric-cancer-greenlighting-early-nda-submission-302579744.html

Context: ASTRUM-006 Phase 3 compared serplulimab plus chemotherapy vs placebo plus chemotherapy in perioperative setting.
Key point: Combination significantly improved event-free survival with >3× higher pCR rate.
Implication: May influence prescriber choice and payer reviews pending full data.

☢️ AlphaMedix achieves all Phase 2 endpoints in GEP-NETs [7] [FR • 08 Oct 2025]

https://www.sanofi.com/en/media-room/press-releases/2025/2025-10-08-05-00-00-3163053

Context: ALPHAMEDIX-02 Phase 2 study of ²¹²Pb-DOTAMTATE in unresectable/metastatic SSTR+ GEP-NETs.
Key point: Demonstrated meaningful ORR, PFS, and OS benefit across PRRT-naïve and pretreated cohorts.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 Adcendo’s ADCE-D01 receives FDA Fast Track for soft-tissue sarcoma [8] [EU • 09 Oct 2025]

https://adcendo.com/adcendo-aps-announces-fda-fast-track-designation-granted-to-adce-d01-for-the-treatment-of-soft-tissue-sarcoma/

Context: uPARAP-targeting ADC with Topoisomerase I payload P1021 in Phase I/II ADCElerate1 trial.
Key point: Recognition reflects potential to address unmet need in mesenchymal-origin cancers.
Implication: Signals pipeline investment and modality expansion.

🧩 Werewolf Therapeutics receives FDA Fast Track for WTX-124 [9] [US • 08 Oct 2025]

https://investors.werewolftx.com/news-and-events/press-releases

Context: Conditionally activated IL-2 INDUKINE therapy tested alone and with pembrolizumab.
Key point: Fast Track supports development for advanced cutaneous melanoma after immunotherapy.
Implication: Signals pipeline investment and modality expansion.

🔬 Kazia Therapeutics in-licenses first-in-class PD-L1 degrader program [10] [AU • 07 Oct 2025]

https://www.prnewswire.com/news-releases/kazia-therapeutics-announces-collaboration-and-in-licensing-agreement-for-first-in-class-pd-l1-protein-degrader-program-302576571.html

Context: Exclusive collaboration with QIMR Berghofer for NDL2, a bicyclic PD-L1 protein degrader.
Key point: Targets intracellular and surface PD-L1 to overcome resistance to checkpoint inhibitors.
Implication: Signals pipeline investment and modality expansion.

Why It Matters

Demonstrates a globally distributed oncology innovation surge across the US, China, Japan, EU, and Australia.
Confirms ADCs as dominant modality, with new efficacy data in NSCLC and TNBC plus multiple regulatory milestones.
Expedited regulatory designations (Orphan, Fast Track, early NDA) reflect FDA’s increasing oncology acceleration.
Strategic capital discipline (Atossa, Kazia) shows biotechs optimizing resource use toward near-term clinical proof.

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FAQ

What benefits does FDA Orphan Drug Designation provide for Precision NeuroMed? [1]

It grants tax credits, fee waivers, and seven-year exclusivity for cintredekin besudotox if approved for GBM.

What distinguishes Kelun-Biotech’s Sac-TMT in lung cancer? [2]

It’s the first ADC to demonstrate overall survival improvement over platinum doublet chemotherapy in EGFR-mutant NSCLC.

What does Daiichi Sankyo’s Japan filing mean for ENHERTU? [3]

It could move ENHERTU plus pertuzumab into the first-line setting for HER2+ metastatic breast cancer.

How does Atossa’s EVANGELINE amendment affect development? [4]

It trims the study size and accelerates data readouts to support 2026 NDA activities.

Why are Datroway’s TROPION-Breast02 results significant? [5]

They establish the first OS benefit for metastatic TNBC patients who cannot receive immunotherapy.

What makes HANSIZHUANG’s gastric cancer data pivotal? [6]

It achieved both EFS and pCR improvement, supporting an early NDA for perioperative immunotherapy.

How does AlphaMedix differ from existing radiotherapies? [7]

It uses lead-212 alpha particles for targeted delivery, offering short-range potency with limited off-target toxicity.

What does Fast Track mean for Adcendo and Werewolf? [8][9]

It enables frequent FDA meetings, rolling review, and potential accelerated approval for both ADC and cytokine candidates.

What advantage does Kazia’s PD-L1 degrader offer? [10]

NDL2 eliminates resistant intracellular PD-L1 pools, potentially overcoming checkpoint inhibitor failure mechanisms.

Entities / Keywords

Precision NeuroMed; Cintredekin Besudotox; Glioblastoma • Kelun-Biotech; Sacituzumab Tirumotecan (Sac-TMT; SKB264/MK-2870); EGFR-mutant NSCLC • Daiichi Sankyo; ENHERTU (trastuzumab deruxtecan); Pertuzumab • Atossa Therapeutics; (Z)-Endoxifen; EVANGELINE • AstraZeneca; Daiichi Sankyo; Datroway (datopotamab deruxtecan); TNBC • Henlius; HANSIZHUANG (serplulimab; Hetronifly) • Sanofi; Orano Med; AlphaMedix (²¹²Pb-DOTAMTATE); GEP-NETs • Adcendo; ADCE-D01; uPARAP • Werewolf Therapeutics; WTX-124; IL-2 INDUKINE • Kazia Therapeutics; QIMR Berghofer; NDL2 PD-L1 degrader.