Oncology Today—November 17, 2025

LucidQuest

1 day ago

This week in oncology, we spotlight the most relevant updates, approvals, and progress driving the biopharma space.

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🧠 Servier SNO 2025 slate in IDH-mutant glioma [1] [US • 10 Nov 2025]

https://servier.mediaroom.com/2025-11-10-Serviers-Clinical-and-Real-World-Data-at-2025-SNO-Congress-Showcase-Leadership-in-IDH-Mutant-Glioma
Context: Seven company abstracts and two investigator-initiated; INDIGO Phase 3 post-hoc plus Phase 1b VORANIGO plus temozolomide in Grade 4 IDH-mutant astrocytoma.
Key point: INDIGO analysis suggests 3D volumetrics may better capture progression than 2D in Grade 2 trials; combo safety profiled (endpoint specifics not stated).
Implication: May influence prescriber choice and payer reviews pending full data.

🫁 Avenzo AVZO-1418 earns FDA Fast Track in EGFR-mutated NSCLC [2] [US • 10 Nov 2025]

https://avenzotx.com/press-releases/avenzo-therapeutics-granted-fast-track-designation-for-avzo-1418-a-potential-best-in-class-egfr-her3-bispecific-adc-for-the-treatment-of-patients-with-egfr-mutated-tki-pretreated-nsclc/
Context: Phase 1/2 open-label trial in advanced solid tumors, monotherapy and combinations.
Key point: Fast Track covers unresectable or metastatic NSCLC with EGFR Ex19del or L858R after EGFR TKI.
Implication: Introduces competition that may affect pricing and formulary access.

🧯 BetaGlue CTA approved in UK for YntraDose in LA-PDAC [3] [UK • 12 Nov 2025]

https://betaglue.com/mhra-approves-betaglue-therapeutics-clinical-trial-application-for-yntradose-in-unresectable-locally-advanced-pancreatic-cancer-ula-pdac/
Context: Early feasibility clinical investigation in unresectable locally advanced PDAC.
Key point: YntraDose is a percutaneous Y-90 microsphere, glue-matrix locoregional radio-ablation therapy.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧬 ITM-11 NDA accepted in GEP-NETs, PDUFA 28 Aug 2026 [4] [13 Nov 2025]

https://www.globenewswire.com/news-release/2025/11/13/3187074/0/en/ITM-Announces-FDA-Acceptance-of-New-Drug-Application-NDA-and-PDUFA-Date-for-n-c-a-177Lu-edotreotide-ITM-11-in-Gastroenteropancreatic-Neuroendocrine-Tumors-GEP-NETs.html
Context: Phase 3 COMPETE randomized 309 patients vs everolimus, open-label.
Key point: Met primary endpoint, longer PFS and higher ORR vs everolimus with favorable safety per release.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Daiichi Sankyo doses first patient with STING-agonist ADC DS3610 [8] [10 Nov 2025]

https://www.daiichisankyo.com/files/news/pressrelease/pdf/202511/20251110_E.pdf
Context: First-in-human Phase 1 dose-escalation in advanced, metastatic or unresectable solid tumors.
Key point: DS3610 delivers an immunomodulatory STING-agonist payload via ADC to activate anti-tumor immunity; safety, PK and exploratory efficacy endpoints planned.
Implication: Signals pipeline investment and modality expansion.

🧫 Lyell acquires GCC-targeted CAR T LYL273, early US mCRC data [5] [US • 10 Nov 2025]

https://ir.lyell.com/news-releases/news-release-details/lyell-immunopharma-acquires-exclusive-global-rights-next
Context: Exclusive global rights ex-Greater China from ICT; US Phase 1 ongoing with dose levels tested.
Key point: Higher dose cohort reported 67% ORR and 83% DCR in small sample with manageable safety and one DLT; enrollment continues to RP2D.
Implication: Signals pipeline investment and modality expansion.

🧴 Hamlet BioPharma pivotal-path FDA feedback for Alpha1H in NMIBC [6] [12 Nov 2025]

https://hamletbiopharma.com/press-release-lund-november-10th-2025-hamlet-biopharma-receives-fda-pivotal-study-feedback-for-novel-neoadjuvant-therapy-in-non-muscle-invasive-bladder-cancer/
Context: Written FDA feedback on proposed pivotal design and endpoints in low-risk NMIBC.
Key point: Alignment on population and endpoints such as CR rate, duration of response, event-free survival, plus central review plans.
Implication: May influence prescriber choice and payer reviews pending full data.

🧷 HCW Biologics SITC preclinical update on HCW11-040 PD-1 fusion [7] [US • 10 Nov 2025]

https://www.globenewswire.com/news-release/2025/11/10/3184373/0/en/HCW-Biologics-Shares-the-Latest-Data-for-its-Second-Generation-Immune-Checkpoint-Inhibitor-Presented-at-the-40th-Annual-Meeting-of-the-Society-for-Immunotherapy-of-Cancer.html
Context: TRBC platform tetra-valent pembrolizumab-based fusion with IL-15, IL-7 and TGF-β trap; preclinical only.
Key point: PD-1/PD-L1 blockade equivalent to pembrolizumab with added TPEX expansion and organoid activity; SC dosing anticipated.
Implication: Signals pipeline investment and modality expansion.

🧭 Leucid AERIAL Phase I/IIa update for LEU011 lateral CAR-T [9] [UK • 10 Nov 2025]

https://www.leucid.com/news
Context: Multi-centre dose-escalation in relapsed or refractory solid tumors; SITC 2025 poster.
Key point: Proof-of-concept with tumor infiltration and disease control at lowest dose; generally well tolerated.
Implication: May influence prescriber choice and payer reviews pending full data.

🤝 SCRI and BMS expand collaboration to broaden trial access [10] [US • 12 Nov 2025]

https://news.bms.com/news/details/2025/Sarah-Cannon-Research-Institute-and-Bristol-Myers-Squibb-Expand-Strategic-Collaboration-to-Accelerate-Patient-Enrollment-and-Broaden-Access-to-Innovative-Cancer-Research/default.aspx
Context: Accelero model across 200+ locations and 1,300 physicians to streamline operations.
Key point: Reported 45 percent reduction in startup timelines across eight BMS trials in early phase.
Implication: May expand screening, initiation, and follow-up at scale.

Why It Matters

Radiopharma momentum: ITM’s NDA in GEP-NETs and BetaGlue’s UK CTA in pancreatic cancer advance targeted radiotherapies.
ADC innovation: DS3610 brings immunomodulatory STING payloads into ADCs, beyond classic cytotoxics.
Solid-tumor cell therapy: Early signals from Lyell and Leucid suggest incremental progress on long-standing barriers.
Ops as strategy: SCRI–BMS push operational acceleration to complement scientific innovation.
Neuro-oncology endpoints: Servier’s volumetrics vs bidirectional analysis could shape glioma trial designs.

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FAQ

What is the PDUFA date for ITM-11 and what backs the NDA?

The FDA set 28 Aug 2026 for 177Lu-edotreotide (ITM-11) in GEP-NETs. The NDA cites Phase 3 COMPETE, which showed longer PFS and higher ORR vs everolimus in 309 patients [4] (open-label).

Which patients are covered by Avenzo’s Fast Track for AVZO-1418?

Adults with unresectable, locally advanced or metastatic NSCLC harboring EGFR Ex19del or L858R after EGFR TKI therapy, per FDA Fast Track designation [2].

What are the key early data for Lyell’s LYL273 in mCRC?

At the higher dose in a small US Phase 1 cohort, ORR was 67 percent and DCR 83 percent with a manageable safety profile and one DLT, per company report. Enrollment continues to define RP2D [5].

How might Servier’s INDIGO analysis affect glioma endpoints?

It suggests 3D volumetrics may better reflect progression than 2D in Grade 2 IDH-mutant glioma, potentially informing future endpoint selection [1] (metrics not specified).

What is BetaGlue’s YntraDose and what study was cleared?

A percutaneous Y-90 microsphere therapy in a glue matrix for local radio-ablation. The UK MHRA approved a Clinical Trial Application for an early feasibility study in unresectable locally advanced PDAC [3].

What is DS3610 and why is it notable?

An investigational STING-agonist ADC entering first-in-human testing in solid tumors, aiming to activate innate immunity within tumors via targeted delivery [8].

What did FDA tell Hamlet about Alpha1H’s pivotal path?

Alignment on population and endpoints such as CR rate, duration of response and event-free survival, with central reviews and standardized cystoscopy intervals [6].

What did HCW show at SITC on HCW11-040?

Preclinical data indicate pembrolizumab-equivalent PD-1/PD-L1 blockade plus added TPEX expansion and organoid anti-tumor activity, with SC administration planned [7].

What is Leucid’s LEU011 mechanism and early readout?

A lateral CAR targeting NKG2D ligands and co-expressing CXCR2 to enhance trafficking. Early biopsies show tumor infiltration and disease control at the lowest dose [9].

How will SCRI–BMS change trial access?

By embedding trials in community sites and using the Accelero model, they report shorter startup timelines and aim to reach underserved populations at scale [10].

Entities / Keywords

Servier; VORANIGO; INDIGO; IDH-mutant glioma | Avenzo Therapeutics; AVZO-1418; EGFR/HER3 bispecific ADC; NSCLC | BetaGlue Therapeutics; YntraDose; Y-90; pancreatic cancer | ITM Isotope Technologies Munich; 177Lu-edotreotide; ITM-11; GEP-NETs; COMPETE | Daiichi Sankyo; DS3610; STING-agonist ADC | Lyell Immunopharma; LYL273; GCC19CART; metastatic colorectal cancer | Hamlet BioPharma; Alpha1H; NMIBC | HCW Biologics; HCW11-040; TRBC platform; PD-1; TGF-β trap | Leucid Bio; LEU011; lateral CAR; NKG2D; CXCR2 | Sarah Cannon Research Institute; Bristol Myers Squibb; Accelero.