Respiratory Today—October 24, 2025

LucidQuest

2 weeks ago

Catch the latest respiratory news, featuring industry updates, clinical progress, and biopharma innovations.

In Today’s Newsletter

🩺 Vaccine push for lung disease community [1] [US • 22 Oct 2025]

https://finance.yahoo.com/news/american-lung-association-launches-campaign-100400791.html
Context: American Lung Association campaign targets 35M with chronic lung disease and 235k annual lung cancer diagnoses in US.
Key point: Calls for up-to-date flu, COVID-19, RSV vaccines ahead of 2025–2026 season, citing high 2024–2025 severity and hospitalizations.
Implication: May expand screening, initiation, and follow-up at scale.

🧬 BRAFTOVI + MEKTOVI long-term survival in BRAF V600E mNSCLC [2] [EU • 20 Oct 2025]

https://www.businesswire.com/news/home/20251017611442/en/Pfizers-BRAFTOVI-MEKTOVI-Shows-Sustained-Long-Term-Survival-in-Patients-with-Advanced-Lung-Cancer
Context: Single-arm Phase 2 PHAROS; mNSCLC with BRAF V600E; ~4-year follow-up.
Key point: Median OS 47.6 months in treatment-naïve cohort, 22.7 months post-treated; safety consistent with prior data.
Implication: May influence prescriber choice and payer reviews pending full data.

🦴 CABOMETYX benefit in lung/thymic NET subgroup of CABINET [3] [EU • 20 Oct 2025]

https://www.businesswire.com/news/home/20251016096352/en/Exelixis-Announces-Results-from-Subgroup-Analysis-of-CABINET-Phase-3-Pivotal-Trial-Evaluating-CABOMETYX-cabozantinib-in-Advanced-Lung-and-Thymic-Neuroendocrine-Tumors-at-ESMO-2025
Context: Phase 3 CABINET, epNET cohort subgroup n=49; median PFS follow-up 5.5 months.
Key point: 81% risk reduction vs placebo (HR 0.19); median PFS 8.2 vs 2.7 months; safety aligned with label.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Summit to file ivonescimab BLA, broadens Phase 3 plan [4] [US • 20 Oct 2025]

https://www.smmttx.com/pressrelease/summit-therapeutics-reports-financial-results-and-operational-progress-for-the-third-quarter-and-nine-months-ended-september-30-2025/
Context: Q3 update; ivonescimab PD-1/VEGF bispecific; multiregional HARMONi met PFS, OS trend not statistically significant.
Key point: BLA planned Q4 2025 for EGFRm NSCLC post-EGFR TKI; launches HARMONi-GI3 in 1L CRC; details HARMONi-6 superiority vs tislelizumab + chemo in China.
Implication: Signals pipeline investment and modality expansion.

🔗 Elironrasib activity post-KRAS(OFF) in KRAS G12C NSCLC [5] [US • 22 Oct 2025]

https://finance.yahoo.com/news/revolution-medicines-present-updated-elironrasib-161200683.html
Context: Phase 1 RMC-6291-001 update; previously treated, most progressed on KRAS(OFF).
Key point: Confirmed ORR 42% (n=24), DCR 79%, median DoR 11.2 months; tolerability acceptable.
Implication: May influence prescriber choice and payer reviews pending full data.

🍁 Dupixent approved in Canada for eosinophilic COPD [6] [Canada • 22 Oct 2025]

https://www.newswire.ca/news-releases/dupixent-r-dupilumab-injection-approved-in-canada-for-adults-with-inadequately-controlled-chronic-obstructive-pulmonary-disease-copd–809243479.html
Context: Health Canada approval in adults with elevated eosinophils uncontrolled on maximal inhaled therapy.
Key point: First biologic for this COPD subset; supported by BOREAS and NOTUS showing 30%–34% exacerbation reduction over 1 year.
Implication: Introduces competition that may affect pricing and formulary access.

🇨🇳 Nerandomilast (JASCAYD) approved in China for IPF [7] [China • 22 Oct 2025]

https://www.globenewswire.com/news-release/2025/10/22/3170892/0/en/JASCAYD-nerandomilast-approved-in-China-for-the-treatment-of-idiopathic-pulmonary-fibrosis-IPF.html
Context: NMPA approval following recent US approval; based on Phase 3 FIBRONEER-IPF.
Key point: Met primary endpoint on FVC change at 52 weeks vs placebo; tolerability comparable to placebo.
Implication: Introduces competition that may affect pricing and formulary access.

🇪🇺 CHMP backs BRINSUPRI for non-CF bronchiectasis [8] [EU • 17 Oct 2025]

https://investor.insmed.com/2025-10-17-CHMP-Recommends-EU-Approval-of-BRINSUPRI-TM-brensocatib-for-the-Treatment-of-Non-Cystic-Fibrosis-Bronchiectasis
Context: Positive opinion with accelerated assessment; based on Phase 3 ASPEN and Phase 2 WILLOW.
Key point: Would be first EU-approved therapy for NCFB and first-in-class DPP1 inhibitor pending EC decision.
Implication: Introduces competition that may affect pricing and formulary access.

🦠 Enanta RSV updates: pediatric symptom shortening, PEP signal [9] [US • 20 Oct 2025]

https://www.businesswire.com/news/home/20251020795690/en/Enanta-Pharmaceuticals-Presents-New-Data-for-Zelicapavir-its-N-Protein-Inhibitor-and-EDP-323-its-L-Protein-Inhibitor-Both-in-Development-for-the-Treatment-of-Respiratory-Syncytial-Virus-RSV-at-IDWeek-2025
Context: IDWeek 2025 presentations on zelicapavir and EDP-323.
Key point: Zelicapavir shortened time to complete symptom resolution in children; EDP-323 showed prevention of infection in post-exposure analysis of human challenge.
Implication: May influence prescriber choice and payer reviews pending full data.

🧷 Efdoralprin alfa hits Phase 2 endpoints in AATD emphysema [10] [EU • 22 Oct 2025]

https://www.sanofi.com/en/media-room/press-releases/2025/2025-10-22-05-00-00-3170787
Context: ElevAATe Phase 2, head-to-head vs weekly plasma-derived augmentation.
Key point: Superiority on primary and key secondary endpoints for Q3W and Q4W dosing; normalized functional AAT troughs at week 32.
Implication: May influence prescriber choice and payer reviews pending full data.

🌍 Low-carbon Ventolin MDI shows equivalence [11]

https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-pivotal-phase-iii-data-for-next-generation-low-carbon-version-of-ventolin-salbutamol-metered-dose-inhaler/
Context: Phase 3 program comparing HFA-152a vs current HFA-134a propellant.
Key point: Therapeutic equivalence and comparable safety; potential 92% per-inhaler GHG reduction; submissions planned with launch from 2026.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

👃 Tezspire approved in EU for severe CRSwNP [12] [EU • 22 Oct 2025]

https://www.astrazeneca.com/media-centre/press-releases/2025/tezspire-approved-in-eu-for-crswnp.html
Context: EC approval based on Phase 3 WAYPOINT.
Key point: Reduced polyp severity and nasal congestion, near-eliminated surgery need, and lowered systemic steroid use vs placebo.
Implication: Introduces competition that may affect pricing and formulary access.

Why it matters

New approvals and opinions across Canada, China, and EU expand options in COPD, IPF, bronchiectasis, and CRSwNP.
Targeted oncology advances continue in NSCLC and NET, with durable survival and PFS signals that may shift standards pending full data.
RSV therapeutics show movement in both treatment and prophylaxis, a long-standing gap.
Sustainability enters respiratory care via low-carbon MDIs without compromising efficacy.
Pipeline momentum in AATD and bispecific immuno-oncology could reshape treatment intervals and combinations.

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FAQ

What did Pfizer report for BRAFTOVI + MEKTOVI in BRAF V600E mNSCLC?

Updated PHAROS Phase 2 data showed median OS of 47.6 months in treatment-naïve patients, with safety consistent with prior reports [2]. These are long-term follow-up results.

Is brensocatib close to EU approval for non-CF bronchiectasis?

CHMP issued a positive opinion under accelerated assessment, based on ASPEN and WILLOW. EC decision is pending; approval would make it first-in-class in EU [8].

What is the status of Dupixent in COPD in Canada?

Health Canada approved Dupixent for inadequately controlled COPD with elevated eosinophils, supported by BOREAS and NOTUS showing exacerbation reductions over 52 weeks [6].

Did Summit’s ivonescimab meet OS?

In HARMONi, PFS was statistically significant; OS showed a positive trend without statistical significance at primary analysis. Summit plans a Q4 2025 BLA and broader Phase 3 program [4].

What progress was shown for RSV antivirals?

Enanta reported pediatric symptom-shortening with zelicapavir and a post-exposure prophylaxis signal for EDP-323 in a human challenge model [9].

What changed for Ventolin’s environmental footprint?

GSK’s HFA-152a propellant MDI was therapeutically equivalent to HFA-134a in Phase 3 and could reduce per-inhaler emissions by 92% if approved and launched from 2026 [11].

Entities / Keywords

American Lung Association; Pfizer BRAFTOVI/MEKTOVI (encorafenib, binimetinib); Exelixis CABOMETYX (cabozantinib); Summit Therapeutics ivonescimab; Akeso; Revolution Medicines elironrasib (RMC-6291); Sanofi Dupixent (dupilumab) COPD; Boehringer Ingelheim JASCAYD (nerandomilast) IPF; Insmed BRINSUPRI (brensocatib) NCFB; Enanta zelicapavir (EDP-938), EDP-323 RSV; Sanofi efdoralprin alfa (SAR447537) AATD; GSK Ventolin low-carbon MDI HFA-152a; AstraZeneca/Amgen Tezspire (tezepelumab) CRSwNP.