Pfizer lung cancer drug misses main goal but shows benefit in select patients
Pfizer Inc. reported mixed Phase 3 results for sigvotatug vedotin in advanced NSCLC, missing the primary overall survival endpoint but showing benefits in second-line patients. The company continues to evaluate the drug in a first-line combination study and aims to deliver 8 oncology breakthroughs by 2030.
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Pfizer Inc. on Monday reported mixed topline results from its Phase 3 SigVie-002 trial evaluating sigvotatug vedotin, an investigational antibody-drug conjugate (ADC), in adults with previously treated advanced non-squamous non-small cell lung cancer (NSCLC). While the study missed its primary overall survival (OS) endpoint in the broader patient population, it showed encouraging signals in second-line patients, highlighting potential for specific subgroups despite the overall setback.
The SigVie-002 study enrolled adults with locally advanced, unresectable, or metastatic non-squamous NSCLC who had received one or more prior lines of therapy. According to Pfizer, sigvotatug vedotin did not achieve a statistically significant improvement in overall survival compared with the chemotherapy drug docetaxel across the overall study population. The investigational therapy’s safety profile was consistent with previous studies and was considered manageable.
However, the company noted that patients who had received only one prior line of systemic therapy—representing roughly two-thirds of trial participants—demonstrated a stronger trend toward improved overall survival and progression-free survival compared with docetaxel. An exploratory analysis also failed to establish a clear relationship between integrin beta-6 (IB6) expression levels and treatment response. Detailed trial findings are expected to be presented at a future medical meeting.
"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," said Jeff Legos, Chief Oncology Officer, Pfizer. He noted that while the overall results did not demonstrate superiority, the efficacy outcomes in second-line patients were strong compared to the standard of care.
Pfizer is currently evaluating the drug candidate in an ongoing Phase 3 study in combination with pembrolizumab as a first-line treatment for advanced NSCLC. The company added that it continues to expand its antibody-drug conjugate pipeline following its acquisition of Seagen, advancing several oncology candidates, including additional IB6-targeted therapies and other investigational ADC programs. The pipeline development supports the company’s goal of delivering 8 potential Oncology breakthroughs by 2030.
| Trial Feature | Details |
|---|---|
| Trial Name | SigVie-002 (Be6A Lung-01) |
| ClinicalTrials.gov Identifier | NCT06012435 |
| Participants | 703 |
| Primary Endpoint | Overall Survival (OS) |
| Comparator | Docetaxel |
| Key Subgroup Finding | Stronger OS/PFS trend in 1L prior therapy patients |
Will the positive signals in the second-line subgroup be sufficient to support a regulatory filing for this specific patient population?
How might the lack of a clear relationship between integrin beta-6 expression and treatment response impact the future development strategy for this specific target?
What are the implications of these results for the ongoing Phase 3 study combining sigvotatug vedotin with pembrolizumab as a first-line treatment?
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