Oncology Today—November 10, 2025

LucidQuest

15 hours ago

This week’s Oncology update spotlights key developments, regulatory milestones, and the latest progress shaping the biopharma landscape.

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🧬 iLeukon gets FDA IND clearance for Phase 2 ILKN421H + pembro in NSCLC [1] [US • 03 Nov 2025]

https://www.biospace.com/press-releases/ileukon-receives-fda-clearance-of-ind-application-for-a-phase-ii-study-of-mrna-based-non-alpha-il-2-variant-ilkn421h-in-advanced-non-small-cell-lung-cancer-nsclc
Context: mRNA non-alpha IL-2v (HSA–IL-2v) LNP, IV q3w; Phase 1 showed tolerability, no DLTs (n=45).
Key point: FDA cleared Phase 2 to evaluate ILKN421H + pembrolizumab first-line and post-IO NSCLC; Phase 1 combo reported 80% confirmed ORR in first-line NSCLC (endpoint details per source).
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Henlius updates HLX07 + serplulimab in EGFR-high first-line sqNSCLC [2] [CN • 02 Nov 2025]

https://www.henlius.com/en/NewsDetails-5538-26.html
Context: Phase 2 randomized dose-exploration, Part III; median follow-up 23.5 months (n=27).
Key point: ORR ~70% in both dose arms, DCR ≥92%, PFS 17.4 months in high-dose arm, safety manageable; mOS and mDOR not reached.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 A2 Bio reports first CAR T complete response in NSCLC (A2B694) [3] [US • 07 Nov 2025]

https://www.a2bio.com/a2-biotherapeutics-presents-initial-safety-and-efficacy-data-from-ongoing-phase-1-2-everest-2-study-including-first-report-of-a-complete-response-to-car-t-cell-therapy-in-a-patient-with-nsclc/
Context: Phase 1/2 EVEREST-2, mesothelin-targeted logic-gated Tmod CAR T; 9 patients treated across dose levels.
Key point: First reported CR in NSCLC post-A2B694, confirmed by central review at day 180; safety manageable, no DLTs, expansion and tumor infiltration observed.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧬 Aulos imneskibart shows activity in CPI-refractory melanoma, early NSCLC signals [4] [US • 07 Nov 2025]

https://aulosbio.com/new-phase-2-data-for-aulos-biosciences-imneskibart-reveal-clinical-activity-in-melanoma-and-non-small-cell-lung-cancer/
Context: Phase 1/2 update, 93 patients as of 29 Sep 2025; imneskibart + low-dose aldesleukin ± checkpoint inhibitor.
Key point: Deep, durable tumor regressions in melanoma and early reductions in PD-L1+ NSCLC; pharmacodynamic increases in CD8/Treg ratio associated with longer time on treatment.
Implication: May influence prescriber choice and payer reviews pending full data.

📜 Akeso’s ivonescimab gets 4th CDE Breakthrough Therapy Designation (TNBC) [5] [CN • 02 Nov 2025]

https://akesobio.com/en/media/akeso-news/251103/
Context: PD-1/VEGF bispecific; multiple Phase 3 programs ongoing in NSCLC and other tumors.
Key point: New BTD for first-line TNBC with chemotherapy, adding to three prior BTDs in NSCLC indications.
Implication: Signals pipeline investment and modality expansion.

💊 Gilead’s ASCENT-07 misses PFS in first treatment post-endocrine HR+/HER2- mBC [6]

https://www.gilead.com/news/news-details/2025/gilead-provides-update-on-phase-3-ascent-07-study
Context: Global Phase 3 Trodelvy vs chemotherapy post-endocrine therapy; OS not mature.
Key point: Primary PFS endpoint not met by BICR; early OS trend favored Trodelvy; safety consistent.
Implication: May influence prescriber choice and payer reviews pending full data.

💧 UroGen’s UTOPIA hits 77.8% 3-month CR; FDA aligns on UGN-103 NDA path [7] [US • 06 Nov 2025]

https://investors.urogen.com/news-releases/news-release-details/urogen-reports-778-three-month-complete-response-rate-phase-3
Context: Single-arm Phase 3 in recurrent LG-IR-NMIBC (n=99 planned); UGN-103 uses RTGel technology.
Key point: 3-month CR 77.8% with confidence interval reported; FDA agrees CR and durability from UTOPIA can support NDA. Implication: Introduces competition that may affect pricing and formulary access.

💧 Relmada gets FDA feedback on two registrational paths for NDV-01 in NMIBC [8] [US • 04 Nov 2025]

https://www.biospace.com/press-releases/relmada-announces-fda-feedback-supporting-2-separate-acceptable-registrational-study-paths-for-ndv-01-in-non-muscle-invasive-bladder-cancer
Context: Type B pre-IND minutes; 505(b)(2) path, no additional non-clinical required.
Key point: Single-arm study may be acceptable in high-grade refractory BCG-unresponsive; RCT vs observation in intermediate-risk generally acceptable; Phase 2 follow-up shares directional response data.
Implication: Signals pipeline investment and modality expansion.

💰 Merck secures Blackstone funding for sac-TMT TROP2 ADC program [9] [US • 04 Nov 2025]

https://www.merck.com/news/merck-enters-into-research-and-development-funding-agreement-with-blackstone-life-sciences-for-sacituzumab-tirumotecan-sac-tmt/
Context: $700M non-refundable funding to support 2026 development costs; 15 Phase 3 trials across six tumor types.
Key point: Blackstone eligible for low-to-mid single-digit royalties contingent on first-line TNBC approval in US; Merck retains control.
Implication: Signals pipeline investment and modality expansion.

🧬 Nurix oral CBL-B inhibitor NX-1607 shows immune activation, TME remodeling [10] [US • 07 Nov 2025]

https://ir.nurixtx.com/news-releases/news-release-details/nurix-therapeutics-presents-new-translational-data-first-human
Context: Phase 1a solid tumors; SITC translational poster expands on ESMO data.
Key point: Dose-dependent PD, increased PD-1+Ki67+ CD8 cells in patients with stable disease, and biopsy-level CD8+ TIL increases in a case study.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧪 Lamassu SA53 MDM2 inhibitor shows favorable safety in Phase 1/2a [11] [US • 03 Nov 2025]

https://www.lamassubiotech.com/2025/11/03/sa53-mdm2-inhibitor-lamassu-biotech-reports-significant-progress-and-favorable-safety-profile-in-phase-1-2a-clinical-trial/
Context: Dose-escalation in p53 wild-type sarcoma and solid tumors; third cohort reached.
Key point: No DLTs or serious safety signals to date, progressing toward MTD and preliminary efficacy assessment.
Implication: May influence prescriber choice and payer reviews pending full data.

Why It Matters

IL-2 pathway innovation advances on two fronts, mRNA non-alpha IL-2v and IL-2-redirecting antibody, potentially broadening IO backbones.
Solid-tumor cell therapy shows a milestone signal with first reported CAR T complete response in NSCLC.
ADC landscape bifurcates with program acceleration financing for sac-TMT while another Trop-2 ADC study misses PFS in HR+/HER2- mBC.
Bladder cancer sees parallel momentum, high CR in a Phase 3 hydrogel mitomycin program and FDA-aligned registrational paths for sustained-release Gem/Doce.
China’s BTD pipeline continues to scale, with ivonescimab expanding across first-line settings.

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FAQ

What is ILKN421H and how will it be tested?

ILKN421H is an LNP-mRNA encoding a non-alpha IL-2 variant fused to HSA, designed to expand CD8 and NK cells with reduced toxicity. FDA cleared a Phase 2 in combination with pembrolizumab for first-line and post-IO NSCLC [1].

How durable are Henlius’ HLX07 + serplulimab results in EGFR-high sqNSCLC?

At 23.5-month median follow-up, ORR ~70% and DCR ≥92% with PFS 17.4 months in the higher dose arm, and no new safety signals; mOS and mDOR not reached [2].

What is notable about A2B694’s EVEREST-2 update?

It includes the first reported complete response to CAR T therapy in an NSCLC patient, with manageable safety and evidence of expansion, persistence, and tumor infiltration [3].

What happened in Gilead’s ASCENT-07?

The study in first treatment post-endocrine HR+/HER2- mBC did not meet the PFS primary endpoint by BICR; OS was immature with an early trend favoring Trodelvy. Safety was consistent [6].

What regulatory path did UroGen secure for UGN-103?

FDA agreed that 3-month CR and durability from the Phase 3 UTOPIA trial can support an NDA for recurrent LG-IR-NMIBC [7].

What paths did FDA outline for Relmada’s NDV-01?

A single-arm registrational study may be acceptable in high-grade refractory BCG-unresponsive NMIBC, and a randomized adjuvant study vs observation is generally acceptable in intermediate-risk NMIBC; no additional non-clinical studies are required for 505(b)(2) [8].

Entities / Keywords

iLeukon Therapeutics; ILKN421H; pembrolizumab; non-alpha IL-2 variant;
Henlius; HLX07; serplulimab; EGFR-high sqNSCLC;
A2 Biotherapeutics; A2B694; Tmod CAR T; mesothelin;
Aulos Bioscience; imneskibart (AU-007); aldesleukin; PD-L1+ NSCLC; CPI-refractory melanoma;
Akeso; ivonescimab; PD-1/VEGF bispecific; Breakthrough Therapy Designation; TNBC;
Gilead; Trodelvy (sacituzumab govitecan-hziy); ASCENT-07; HR+/HER2- mBC;
UroGen; UGN-103; RTGel; UTOPIA; LG-IR-NMIBC;
Relmada Therapeutics; NDV-01; sustained-release Gem/Doce; BCG-unresponsive; intermediate-risk NMIBC;
Merck; sacituzumab tirumotecan (sac-TMT); Blackstone Life Sciences; TROP2 ADC;
Nurix Therapeutics; NX-1607; CBL-B inhibitor; tumor microenvironment;
Lamassu Biotech; SA53; MDM2 inhibitor; p53 wild-type tumors.