Pfizer has reported topline data from the Phase III SigVie-002 study investigating sigvotatug vedotin in adults with previously treated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
The investigational integrin beta-6 (IB6)-targeted antibody-drug conjugate (ADC) did not achieve a statistically significant improvement in overall survival (OS) compared to docetaxel in the overall patient population.
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The open-label, randomised, ongoing trial enrolled 703 participants who had previously received one or more lines of systemic therapy.
Its primary endpoint was OS, with progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR) as descriptive secondary endpoints.
Patients were randomised to receive sigvotatug vedotin on days one and 15 of a 28-day cycle, or docetaxel on day one of each 21-day cycle.
In the study, the safety profile of sigvotatug vedotin was reported to be manageable and consistent with prior research.
Among the population that received only one prior line of systemic therapy, about two-thirds of the total participants, a trend toward improved OS and PFS for sigvotatug vedotin over docetaxel was observed.
Pfizer chief oncology officer Jeff Legos said: “Patients with previously treated advanced NSCLC are a historically difficult-to-treat population, and there is clearly more work to be done to improve the outcomes for this population.
“Although the overall study results did not demonstrate superiority over docetaxel, it is encouraging that second-line patients treated with sigvotatug vedotin achieved strong efficacy outcomes compared to an established standard of care, alongside a manageable safety profile.”
Additionally, exploratory analyses found no clear relationship between integrin beta-6 (IB6) expression and patient response. IB6 is expressed in approximately 90% of NSCLC tumours and is associated with poor prognosis.
Pfizer continues to advance sigvotatug vedotin in ongoing Phase III studies, including combinations with pembrolizumab and PF-08634404, a bispecific antibody targeting programmed cell death protein 1 (PD-1) and vascular endothelial growth factor (VEGF).
Earlier this month, Pfizer reported detailed Phase IIb results for its investigational monthly glucagon-like peptide-1 receptor agonist (GLP-1 RA) peptide, berobenatide (PF’3944), in the treatment of obesity and type 2 diabetes.
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