This week’s oncology update highlights major regulatory milestones, late-stage clinical wins, early-phase oncology innovations, next-generation RNA/ADC strategies, and emerging radiotherapy platforms—plus additional developments shaping the oncology landscape.
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🧬 AVZO-103 Fast Track in post-enfortumab urothelial cancer [1] [US • 24 Nov 2025]
Context: AVZO-103 is a Nectin4/TROP2 bispecific ADC in a Phase 1/2 first-in-human, open-label study (single-agent and combinations) in advanced solid tumours.
Key point: FDA granted Fast Track for adult patients with locally advanced or metastatic urothelial cancer previously treated with enfortumab vedotin, where no ADCs are currently approved.
Implication: May create a dedicated post-enfortumab ADC option and influence future sequencing in urothelial cancer if early safety/efficacy are confirmed.
🧱 Harbour BioMed–AstraZeneca oncology collaboration expansion [2] [Global • 24 Nov 2025]
https://www.harbourbiomed.com/news/252.html
Context: Collaboration (initiated March 2025) focuses on next-generation biotherapeutics, including ADCs and T-cell engagers, using Harbour’s Harbour Mice and HCAb/HBICE/HBICA platforms.
Key point: AstraZeneca will continue to nominate discovery programmes annually for four more years, with options to license; Harbour is eligible for option fees, milestones and tiered royalties.
Implication: Confirms sustained demand for Harbour’s antibody engines and expands AstraZeneca’s pipeline of novel oncology biologics.
⚗️ Amorphical Phase 2 in Stage IV pancreatic cancer – first patient enrolled [3] [Israel • 24 Nov 2025]
Context: Phase 2 trial at Shaare Zedek Medical Center, approved by the hospital’s Helsinki Committee and Israel MOH; readout expected Q3 2026.
Key point: Nano-amorphous mineral-based therapy aims to buffer tumour acidity to impact PFS, OS, ORR and quality of life in Stage IV pancreatic cancer.
Implication: Positive data could position tumour-pH modulation as a new mechanistic pillar in pancreatic cancer, potentially in combination with standard regimens.
🫁 Swissmedic approval – Zepzelca + atezolizumab 1L maintenance in ES-SCLC [4] [Switzerland • 24 Nov 2025]
Context: Maintenance for adults with ES-SCLC without CNS metastases whose disease has not progressed after induction with atezolizumab, carboplatin and etoposide.
Key point: IMforte showed lurbinectedin + atezolizumab reduced risk of progression or death by 46% and death by 27% vs atezolizumab maintenance alone (OS 13.2 vs 10.6 months; PFS 5.4 vs 2.1 months).
Implication: Establishes the first approved 1L maintenance combination with lurbinectedin in a European country and supports ongoing EMA review.
🧬 Silexion SIL204 KRAS RNAi – tox completed ahead of Phase 2/3 LAPC trial [5] [Israel/Germany • 25 Nov 2025]
Context: SIL204 is a next-generation siRNA therapy targeting mutant KRAS, with preclinical activity across KRAS-mutated cell lines and pancreatic cancer models.
Key point: Two-species toxicology studies showed no systemic organ toxicity, enabling regulatory submissions in Israel and Germany and keeping the Phase 2/3 LAPC trial on track for Q2 2026 start.
Implication: Advances another targeted RNAi approach into later-stage development in KRAS-driven pancreatic cancer.
🔦 LIXTE acquires Liora’s LiGHT proton therapy platform [6] [UK/US • 25 Nov 2025]
Context: Liora’s LiGHT (Linac for Image Guided Hadron Therapy) system is installed at STFC’s Daresbury Laboratory, with >$300M invested to date.
Key point: LIXTE acquires Liora as a wholly owned subsidiary, gaining the LiGHT system and partnering with STFC to build a proton-therapy center of excellence, with an eye toward a recurring revenue model via treatment centres.
Implication: Diversifies LIXTE from pure drug development into radiotherapy hardware, enabling potential drug–radiation combination strategies and new business lines.
🍽 Imfinzi perioperative approval in early gastric and GEJ cancers (US) [7] [US • 25 Nov 2025]
Context: MATTERHORN Phase 3 in resectable Stage II–IVA gastric/GEJ cancers; perioperative Imfinzi + FLOT vs FLOT alone.
Key point: FDA approved Imfinzi + FLOT neoadjuvant, followed by adjuvant Imfinzi + FLOT then Imfinzi monotherapy, based on 29% EFS risk reduction (HR 0.71; p<0.001) and 22% OS risk reduction (HR 0.78; p=0.021), with 3-year OS 69% vs 62%.
Implication: Sets a new perioperative IO standard in early gastric/GEJ disease and further embeds durvalumab in curative-intent settings.
🌍 UAE approval – Zepzelca + atezolizumab ES-SCLC maintenance [8] [UAE • 28 Nov 2025]
Context: Emirates Drug Establishment approval for ES-SCLC whose disease has not progressed after induction with atezolizumab (± hyaluronidase), carboplatin and etoposide.
Key point: IMforte data: OS 13.2 vs 10.6 months (HR 0.73; p=0.0174) and PFS 5.4 vs 2.1 months (HR 0.54; p<0.0001) vs atezolizumab maintenance alone, with consistent safety.
Implication: Extends access to the lurbinectedin + atezolizumab maintenance regimen into the Middle East via Immedica’s regional footprint.
🧬 Imugene + JW: onCARlytics + Carteyva “mark and kill” combo in solid tumours [9] [China • 28 Nov 2025]
Context: Co-development includes preclinical work followed by a Phase 1 investigator-initiated trial at leading CAR-T centres in China.
Key point: CF33-CD19 (onCARlytics) oncolytic virus is used to induce CD19 expression on tumour cells, rendering them targetable by Carteyva (CD19 CAR-T) – a first-in-class “mark and kill” strategy.
Implication: If translatable, could open a generalizable path to repurpose CD19 CAR-T into solid tumours using oncolytic viral priming.
🎯 Sacituzumab tirumotecan Phase II UC data in Annals of Oncology [10] [China/Global • 28 Nov 2025]
Context: Cohort 9 of Phase II MK-2870-001/KL264-01 evaluating sac-TMT (TROP2 ADC) in advanced/metastatic UC after chemotherapy and checkpoint inhibitors.
Key point: At 5 mg/kg Q2W (n=49; 76% with ≥2 prior lines): confirmed ORR 31% (50% in 2L setting), DCR 71%, median PFS 5.5 months, DOR not reached, 12-month response probability 53%; safety manageable with mostly hematologic AEs and stomatitis, no grade 5 TRAEs.
Implication: Strengthens evidence for sac-TMT in heavily pretreated UC and aligns with its broader global development (including with pembrolizumab) across solid tumours.
Why It Matters
- Post-ADC urothelial options: AVZO-103 Fast Track and sac-TMT data both speak to intensifying innovation in TROP2/Nectin4-targeted ADCs for UC, including post-enfortumab settings.
- Pancreatic cancer diversification: Amorphical’s tumour-pH platform and Silexion’s KRAS RNAi push beyond classic chemo/targeted approaches in one of the deadliest cancers.
- SCLC maintenance evolving: Lurbinectedin + atezolizumab now has regulatory traction in Switzerland and UAE, reinforcing IMforte as a practice-shaping dataset.
- Radiation + hardware footprint: LIXTE’s proton therapy move highlights a broader convergence of pharma and advanced radiotherapy technologies.
- Early-stage IO expansion: Imfinzi’s perioperative approval in gastric/GEJ cancers continues the trend of moving IO into curative-intent settings.
- Novel cell-therapy strategies: The onCARlytics + Carteyva collaboration explores new ways to make solid tumours CAR-T–addressable, potentially reshaping solid-tumour immunotherapy.
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FAQ
What did FDA grant to AVZO-103 and for which patients?
Fast Track for adults with locally advanced or metastatic urothelial cancer previously treated with enfortumab vedotin, based on ongoing Phase 1/2 data [1].
How strong is the evidence behind the lurbinectedin + atezolizumab maintenance approvals?
Swissmedic and UAE approvals are based on IMforte, which showed improved OS and PFS vs atezolizumab maintenance alone in ES-SCLC [4][8].
What is Silexion’s SIL204 targeting in pancreatic cancer?
SIL204 is a siRNA therapy designed to silence mutant KRAS oncogenes; recent tox data showed no systemic organ toxicity supporting a Phase 2/3 LAPC trial [5].
What is new about Imfinzi’s gastric/GEJ approval?
It is the first perioperative immunotherapy regimen in early gastric/GEJ cancer, showing significant EFS and OS benefits vs FLOT alone in MATTERHORN [7].
How does the onCARlytics + Carteyva approach work in solid tumours?
The oncolytic virus CF33-CD19 induces CD19 on tumour cells, which are then targeted by CD19 CAR-T (Carteyva), effectively “marking” solid tumours for CAR-T killing [9].
What were the key outcomes for sac-TMT in advanced UC?
Sac-TMT monotherapy showed 31% ORR (50% in 2L), DCR 71%, median PFS 5.5 months, and durable responses with manageable toxicity in heavily pretreated patients [10].
Entities / Keywords
Avenzo Therapeutics; AVZO-103; Nectin4/TROP2 bispecific ADC; urothelial cancer; enfortumab vedotin.
Harbour BioMed; AstraZeneca; ADCs; T-cell engagers; Harbour Mice; HBICE; HBICA.
Amorphical; nano-amorphous mineral therapy; tumour acidity; Stage IV pancreatic cancer.
PharmaMar; Zepzelca; lurbinectedin; atezolizumab; Tecentriq; IMforte; ES-SCLC; Swissmedic.
Silexion Therapeutics; SIL204; siRNA; KRAS; locally advanced pancreatic cancer.
LIXTE Biotechnology; Liora Technologies; LiGHT System; proton therapy; STFC Daresbury.
AstraZeneca; Imfinzi; durvalumab; FLOT; MATTERHORN; gastric cancer; GEJ cancer; perioperative IO.
Immedica; Emirates Drug Establishment; Middle East; ES-SCLC maintenance.
Imugene; JW Therapeutics; onCARlytics; CF33-CD19; Carteyva; CD19 CAR-T; “mark and kill” strategy.
Kelun-Biotech; sacituzumab tirumotecan; sac-TMT; TROP2 ADC; urothelial carcinoma; Annals of Oncology.
References
- https://avenzotx.com/press-releases/avenzo-therapeutics-granted-fast-track-designation-for-avzo-103-a-potential-best-in-class-nectin4-trop2-bispecific-antibody-drug-conjugate-for-the-treatment-of-patients-with-urothelial-cancer-previo/
- https://www.harbourbiomed.com/news/252.html
- https://www.prnewswire.com/news-releases/amorphical-announces-first-patient-enrolled-in-phase-2-clinical-trial-of-nano-amorphous-mineral-based-therapy-in-stage-iv-pancreatic-cancer-patients-302624444.html
- https://pharmamar.com/en/swiss-medical-authority-approves-pharmamars-zepzelca-lurbinectedin-and-atezolizumab-tecentriq-combination-as-first-line-maintenance-therapy-for-extensive-stage-small-cell-lung/
- https://www.globenewswire.com/news-release/2025/11/25/3194426/0/en/Silexion-Therapeutics-Successfully-Completes-Toxicology-Studies-for-SIL204-Next-Generation-RNA-Silencing-Therapy-Ahead-of-Phase-2-3-Clinical-Trial-in-Pancreatic-Cancer.html
- https://ir.lixte.com/news-events/press-releases/detail/140/lixte-biotechnology-acquires-liora-technologies-proprietary-proton-therapy-platform-for-cancer-treatment
- https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-as-first-and-only-perioperative-immunotherapy-for-patients-with-early-gastric-and-gastroesophageal-cancers.html
- https://www.immedica.com/en/press/zepzelcar-lurbinectedin-combination-atezolizumab-approved-first-line-maintenance-therapy
- https://www.prnewswire.com/news-releases/imugene-and-jw-therapeutics-announce-a-collaboration-to-advance-oncarlytics-and-carteyva-combination-in-solid-tumours-302627893.html
- https://www.prnewswire.com/apac/news-releases/the-annals-of-oncology-publishes-results-of-phase-ii-study-of-sacituzumab-tirumotecan-monotherapy-for-urothelial-carcinoma-302627886.html