Pfizer Inc. (NYSE:PFE) on Monday reported mixed topline results from its Phase 3 SigVie-002 trial of investigational antibody-drug conjugate sigvotatug vedotin in previously treated advanced non-squamous non-small cell lung cancer (NSCLC).
While the study missed its primary overall survival endpoint in the broader patient population, it showed encouraging signals in second-line patients.
SigVie-002 Falls Short On Overall Survival Endpoint
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.
Pfizer Sees Opportunity In Earlier Treatment Settings
“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.
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.
Pfizer 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 US drug giant added that the pipeline development supports the company’s goal of delivering 8 potential Oncology breakthroughs by 2030.
PFE Price Action: Pfizer shares were down 0.74% at $24.89 at the time of publication on Tuesday, according to Benzinga Pro data.
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