July saw important advances in respiratory medicine, including new drug approvals and promising clinical trial results. Notable progress was made in treatments for lung cancer, cystic fibrosis, and pulmonary arterial hypertension, reflecting ongoing efforts to address challenging respiratory conditions. These developments highlight a dynamic period of innovation with the potential to improve patient outcomes and expand therapeutic options.
Regulatory decisions
- FDA greenlights sunvozertinib for difficult-to-treat lung cancerÂ
Sunvozertinib, an oral epidermal growth factor receptor (EGFR) inhibitor, has received accelerated FDA approval for treating non–small-cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations after progression on platinum-based chemotherapy.1 Approval was based on a global phase I/II WU-KONG1 Part B study (NCT03974022), which showed a 46% overall response rate and a median response duration of 11.1 months.2,3 Key safety concerns include interstitial lung disease, gastrointestinal and skin reactions, ocular toxicity, and embryo-foetal toxicity. A phase III trial, WU-KONG28 (NCT05668988), is ongoing to evaluate its use as a first-line therapy. If successful, sunvozertinib could become a preferred option for this difficult-to-treat NSCLC subset.
- European Commission approval of deutivacaftor/tezacaftor/vanzacaftor cystic fibrosisÂ
The European Commission approved the use of deutivacaftor/tezacaftor/vanzacaftor as a once-daily treatment for individuals aged six years and older with cystic fibrosis (CF) who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.4
This decision followed two pivotal head-to-head clinical trials (NCT05033080 and NCT05076149) that demonstrated the combination’s non-inferiority to ivacaftor/tezacaftor/elexacaftor with ivacaftor in improving percent predicted forced expiratory volume in one second (ppFEV1), while showing superior efficacy in reducing sweat chloride concentrations.5,6,7 These findings indicated a greater improvement in CFTR protein function, suggesting that deutivacaftor/tezacaftor/vanzacaftor may bring more patients closer to normal CFTR activity.
- FDA grants priority review for sotatercept-csrk to update label following ZENITH trial
The FDA granted priority review to a supplemental Biologics License Application (sBLA) for sotatercept-csrk, seeking to update the product label based on data from the phase III ZENITH trial (NCT04896008).8 The current indication for sotatercept-csrk includes treatment of adults with pulmonary arterial hypertension (PAH, Group 1). The FDA has set a target action date of October 25, 2025.
The ZENITH trial was a global, double-blind, placebo-controlled phase III study evaluating sotatercept-csrk in patients with advanced PAH at high risk of mortality.9 The trial was stopped early due to overwhelming efficacy. Sotatercept-csrk demonstrated a 76% reduction in the risk of a composite endpoint of all-cause death, lung transplantation, or PAH-related hospitalization ≥24 hours compared to placebo. The safety profile was consistent with prior studies.
If approved, the label update would incorporate these outcome-based data, marking the first PAH phase III study to use a primary endpoint consisting solely of major morbidity and mortality events.
Trial results
- Promising results for osimertinib combination from the phase III FLAURA2 trialÂ
In the final overall survival analysis from the phase III FLAURA2 trial, osimertinib combined with pemetrexed and platinum-based chemotherapy significantly prolonged overall survival compared to osimertinib alone in patients with first-line locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).10,11
The global study enrolled 557 patients who were randomized to receive either osimertinib with chemotherapy or osimertinib monotherapy. Osimertinib–chemotherapy showed a clinically meaningful survival benefit with a manageable safety profile. Adverse events were more frequent in the combination arm, primarily due to chemotherapy, but discontinuation rates remained low.
These results support the use of osimertinib plus chemotherapy as standard of care for EGFR-mutated NSCLC. The data will be presented at an upcoming medical meeting and shared with regulatory authorities.
- Topline results announced from the phase IIb ALIENTO and phase III ARNASA trials
Topline results were announced from the phase IIb ALIENTO (NCT05037929) and phase III ARNASA (NCT05595642) trials, evaluating the efficacy and safety of astegolimab in individuals with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving standard maintenance therapy.12,13,14 Both studies included a broad population of current and former smokers, regardless of blood eosinophil count, with a history of frequent exacerbations.
In the ALIENTO trial, astegolimab met the primary endpoint, demonstrating a statistically significant 15.4% reduction in annualised exacerbation rate (AER) at 52 weeks when administered every two weeks. However, in the larger ARNASA trial, the primary endpoint was not met, with astegolimab showing a non-significant 14.5% reduction in AER over the same period. Fewer exacerbation events than anticipated were reported in both studies.
Secondary endpoints were generally consistent across trials, and the safety profile of astegolimab remained in line with previous data, with no new safety signals identified. Full results from both trials will be presented at an upcoming medical meeting.
References
- FirstWord. Dizal’s Zegfrovy gets US nod for hard-to-treat lung cancer subset. 2025. [Press release]. Available at: https://firstwordpharma.com/story/5977826 (accessed 3 July 2025).
- ClinicalTrials.gov. Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer with EGFR or HER2 Mutation (WU-KONG1). ClinicalTrials.gov identifier: NCT03974022. Available at: clinicaltrials.gov/study/NCT03974022 (accessed 3 July 2025).
- Chih-Hsin Yang J, Doucet L, Wang M, et al. A multinational pivotal study of sunvozertinib in platinum pretreated non-small cell lung cancer with EGFR exon 20 insertion mutations: Primary analysis of WU-KONG1 study. Journal of Clinical Oncology. 2025;42(Suppl. 16), Abstract 8513.
- Vertex. Vertex Announces European Commission Approval of ALYFTREK®, a New Once-Daily CFTR Modulator for the Treatment of Cystic Fibrosis. 2025. [Press release]. Available at: https://news.vrtx.com/news-releases/news-release-details/vertex-announces-european-commission-approval-alyftrekr-new-once (accessed 7 August 2025).
- Keating C, Yonker LM, Vermeulen F, et al. Vanzacaftor–tezacaftor–deutivacaftor versus elexacaftor–tezacaftor–ivacaftor in individuals with cystic fibrosis aged 12 years and older (SKYLINE Trials VX20-121-102 and VX20-121-103): results from two randomised, active-controlled, phase 3 trials. The Lancet Respiratory Medicine. 2025;13:256–271.
- ClinicalTrials.gov. A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/​MF). ClinicalTrials.gov identifier: NCT05033080. Available at: https://clinicaltrials.gov/study/NCT05033080 (accessed 4 August 2025).
- ClinicalTrials.gov. A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/​G) or Residual Function (F/​RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation. ClinicalTrials.gov identifier: NCT05076149. Available at: https://clinicaltrials.gov/study/NCT05076149 (accessed 4 August 2025).
- Pharmacy times. FDA Grants Priority Review to Update Label for Sotatercept-csrk. 2025. [Press release]. Available at: www.pharmacytimes.com/view/fda-grants-priority-review-to-update-label-for-sotatercept-csrk (accessed 4 August 2025).
- ClinicalTrials.gov. A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/​ZENITH) (ZENITH). ClinicalTrials.gov identifier: NCT04896008. Available at: clinicaltrials.gov/study/NCT04896008 (accessed 4 August 2025).
- AstraZeneca. Tagrisso plus chemotherapy demonstrated statistically significant and clinically meaningful improvement in overall survival in EGFR-mutated advanced lung cancer. 2025. [Press release]. Available at: https://www.astrazeneca.com/media-centre/press-releases/2025/tagrisso-plus-chemotherapy-demonstrated-statistically-significant-and-clinically-meaningful-improvement-in-overall-survival-in-egfr-mutated-advanced-lung-cancer.html (accessed 4 August 2025).
- ClinicalTrials.gov. A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2) (FLAURA2). ClinicalTrials.gov identifier: NCT04035486. Available at: https://clinicaltrials.gov/study/NCT04035486 (accessed 4 August 2025).
- Roche. Roche provides update on astegolimab in chronic obstructive pulmonary disease. 2025. [Press release]. Available at: https://www.roche.com/media/releases/med-cor-2025-07-21 (accessed 4 August 2025).
- ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease. ClinicalTrials.gov identifier: NCT05037929. Available at: https://clinicaltrials.gov/study/NCT05037929Â (accessed 4 August 2025).
- ClinicalTrials.gov. A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (ARNASA). ClinicalTrials.gov identifier: NCT05595642. Available at: https://clinicaltrials.gov/study/NCT05595642 (accessed 4 August 2025).
Editor: Victoria Smith, Senior Content Editor.
Disclosures: This article was created by the touchRESPIRATORY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
Cite: July respiratory medicine roundup: key regulatory decisions and clinical trial results. touchRESPIRATORY. 11 August 2025.
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