This week’s Immunology update highlights regulatory progress, late-stage clinical momentum, partnership activity, guidance changes, and emerging digital and cell-therapy developments.

In Today’s Newsletter

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🧬 Imfinzi approved in the EU for early gastric and GEJ cancer [1] [EU • 16 Mar 2026]

https://www.astrazeneca.com/media-centre/press-releases/2026/imfinzi-approved-in-eu-for-early-gastric-cancer.html
Context: AstraZeneca’s Imfinzi (durvalumab) was approved with perioperative FLOT for adults with resectable stage II, III, and IVA gastric and gastroesophageal junction cancer.
Key point: The approval was based on Phase 3 MATTERHORN, which showed improved event-free survival and overall survival versus chemotherapy alone.
Implication: May influence prescriber choice and payer reviews pending full data.

🧒 Cosentyx expands into paediatric hidradenitis suppurativa [2] [US • 13 Mar 2026]

https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-pediatric-patients-aged-12-moderate-severe-hidradenitis-suppurativa
Context: Novartis said Cosentyx (secukinumab) is now approved for U.S. patients aged 12 and older with moderate-to-severe hidradenitis suppurativa, with weight-based dosing for patients weighing 30 kg or more.
Key point: Novartis positioned the label as the first differentiated biologic mechanism for this paediatric population in nearly a decade and the only IL-17A inhibitor approved for it.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 New CAR-T manufacturing method aims to improve persistence [3] [US • 15 Mar 2026]

https://www.biospace.com/press-releases/a-new-method-produces-car-t-cells-to-keep-fighting-disease-longer
Context: Albert Einstein College of Medicine researchers reported in Science Advances that an IL-7/IL-15/IL-21 cytokine-fusion scaffold generated CAR-T cells enriched in long-lived T memory stem cells.
Key point: In mouse models of leukemia and HIV, the approach produced more durable recall and antiviral activity than conventionally manufactured CAR-T cells.
Implication: Could inform future cell-therapy development, though interpretation remains preclinical and model-dependent.

🌏 Almirall opens Shanghai office to deepen China partnerships [4] [China • 12 Mar 2026]

https://www.almirall.com/newsroom/news/almirall-inaugurates-offices-in-china-to-advance-innovation-in-medical-dermatology-through-partnerships
Context: Almirall inaugurated new offices in Shanghai to support dermatology-focused business development and innovation partnerships in China.
Key point: The company highlighted its Simcere alliance around IL-2muFc for alopecia areata and atopic dermatitis, and pointed to a separate local commercial deal for sarecycline in acne.
Implication: Signals pipeline investment and modality expansion.

👶 Lebrikizumab posts positive Phase 3 paediatric AD data [5] [EU • 16 Mar 2026]

https://www.almirall.com/newsroom/news/lebrikizumab*-proporciona-un-aclaramiento-de-la-piel-significativo-y-mejora-la-gravedad-de-la-enfermedad-en-ni%C3%B1os-con-dermatitis-at%C3%B3pica-moderada-a-grave-1
Context: Almirall reported topline Phase 3 ADorable-1 results in 363 patients aged 6 months to under 18 years with moderate-to-severe atopic dermatitis.
Key point: Lebrikizumab met co-primary endpoints at week 16, with reported gains in EASI-75, IGA 0/1, EASI-90, itch relief, and quality of life, with no new safety signals reported.
Implication: May influence prescriber choice and payer reviews pending full data.

📱 SkinVision and Mayo Clinic start pivotal U.S. dermatology-access trial [6] [US • 16 Mar 2026]

https://finance.yahoo.com/news/skinvision-collaborates-pivotal-trial-improve-134500153.html
Context: SkinVision and Mayo Clinic entered a research collaboration to run a pivotal study tied to SkinVision’s U.S. FDA pathway for its AI-based skin-spot assessment app.
Key point: The study is intended to evaluate app performance and intended use, while also assessing whether digital tools can improve access to dermatology guidance in the United States.
Implication: Could streamline screening and follow-up via digital triage and patient-guidance workflows.

📘 EULAR updates rheumatoid arthritis treatment guidance [7] [EU • 13 Mar 2026]

https://www.eular.org/web/static/lib/pdfjs/web/viewer.html?file=https://www.eular.org/document/download/1406/ec021a77-cdf3-4de3-ae72-57c1757db549/1325
Context: EULAR’s 2025 rheumatoid arthritis update revised its DMARD recommendations, reducing the total to nine and simplifying the treatment algorithm.
Key point: The guidance continues to call for prompt DMARD initiation after diagnosis, removes stratification by poor-outcome risk after initial treatment failure, and favors continuing DMARDs in sustained remission, with dose reduction considered rather than full cessation.
Implication: Could inform practice and payer discussions; interpretation depends on local implementation and clinician judgment.

🧪 Spyre pulls forward SKYWAY RA topline timing [8] [US • 16 Mar 2026]

https://ir.spyre.com/news-releases/news-release-details/spyre-announces-acceleration-expected-topline-readout-skyway
Context: Spyre Therapeutics completed recruitment for the rheumatoid arthritis sub-study of its SKYWAY basket trial.
Key point: Week 12 RA topline data are now expected in Q3 2026, earlier than previously guided, while PsA and axSpA remain on track for Q4 2026 readouts.
Implication: Signals pipeline execution progress and earlier proof-of-concept timing for anti-TL1A in rheumatic disease.

💉 Sun Pharma’s ILUMYA PsA filing accepted by FDA [9] [US • 16 Mar 2026]

https://www.prnewswire.com/news-releases/sun-pharma-announces-us-fda-acceptance-of-supplemental-biologics-license-sbla-application-for-ilumya-tildrakizumab-asmn-for-the-treatment-of-adults-with-active-psoriatic-arthritis-302714083.html
Context: Sun Pharma said the FDA accepted its supplemental BLA for ILUMYA (tildrakizumab-asmn) in adults with active psoriatic arthritis.
Key point: The filing is based on Phase 3 INSPIRE-1 and INSPIRE-2, and the FDA action date is 29 Oct 2026.
Implication: Introduces a potential label expansion that may affect formulary positioning and treatment sequencing.

Why it matters

  • Dermatology was the busiest theme this week, spanning paediatric atopic dermatitis, hidradenitis suppurativa, digital skin-cancer triage, and China-focused business development [2][4][5][6].
  • Immunology and rheumatology pipelines continue to move on both clinical and guidance fronts, with EULAR simplifying RA management and Spyre accelerating anti-TL1A data timing [7][8].
  • Regulatory momentum remains strong in oncology and inflammatory disease, with new approvals or review starts for Imfinzi, Cosentyx, and ILUMYA [1][2][9].
  • Platform stories matter too: the CAR-T manufacturing paper points to persistence as a central design variable across oncology and HIV applications [3].

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FAQ

What changed for Imfinzi in gastric cancer?

AstraZeneca’s Imfinzi (durvalumab) gained EU approval as a perioperative regimen with FLOT for resectable early-stage and locally advanced gastric and GEJ cancer. The decision was based on Phase 3 MATTERHORN, which showed event-free and overall survival benefit versus chemotherapy alone [1].

What is notable about the Cosentyx paediatric HS approval?

Novartis expanded Cosentyx (secukinumab) to U.S. patients aged 12 and older with moderate-to-severe hidradenitis suppurativa. The company described it as the only IL-17A inhibitor approved for this population, with support from adult studies and modelling plus paediatric data from other uses [2].

How strong are the lebrikizumab paediatric AD data so far?

Almirall reported topline Phase 3 ADorable-1 results, with co-primary endpoints met at week 16 and improvements across itch, skin clearance, and quality of life. These are topline results, so fuller subgroup and durability detail still matters [5].

What is SkinVision trying to achieve with Mayo Clinic?

SkinVision is using the collaboration to generate clinical evidence for its U.S. regulatory pathway. The pivotal trial will test app performance and intended use for AI-based skin-spot assessment in a U.S. setting [6].

What did EULAR change in the 2025 RA recommendations?

EULAR reduced the number of recommendations from 11 to 9, kept early DMARD initiation central, dropped poor-outcome risk stratification after initial treatment failure, and stressed that stopping treatment altogether is generally not advised in sustained remission [7].

Why does Spyre’s earlier RA readout matter?

Spyre now expects SKYWAY RA week 12 topline data in Q3 2026 after completing recruitment. That brings proof-of-concept timing forward for its long-acting anti-TL1A program in rheumatic disease [8].

Entities / Keywords

Imfinzi (durvalumab), AstraZeneca, MATTERHORN, FLOT, gastric cancer, gastroesophageal junction cancer, perioperative immunotherapy
Cosentyx (secukinumab), Novartis, hidradenitis suppurativa, HS, paediatric dermatology, IL-17A
CAR-T, Albert Einstein College of Medicine, HCW9206, IL-7/IL-15/IL-21, T memory stem cells, leukemia, HIV
Almirall, Shanghai, China partnerships, Simcere, IL-2muFc, sarecycline, medical dermatology
Lebrikizumab, ADorable-1, atopic dermatitis, AD, EASI-75, IGA 0/1, paediatric AD
SkinVision, Mayo Clinic, AI skin-spot assessment, digital dermatology, FDA pathway, melanoma triage
EULAR, rheumatoid arthritis, RA, DMARD, methotrexate, biologics, JAK inhibitors
Spyre Therapeutics, SKYWAY, SKYLINE, TL1A, rheumatoid arthritis, psoriatic arthritis, axSpA, ulcerative colitis
ILUMYA (tildrakizumab-asmn), Sun Pharma, psoriatic arthritis, PsA, IL-23, sBLA

References

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