Pfizer Inc. (PFE) announced that its investigational candidate Sigvotatug vedotin did not show a statistically significant improvement in the primary endpoint of overall survival compared to Docetaxel in the Phase 3 SigVie-002 study for locally advanced, unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) who had received one or more lines of prior therapy.
Trial Details
The Phase 3 SigVie-002 study, previously known as Be6A Lung-01, is an ongoing, open-label, randomised, global study evaluating Sigvotatug vedotin, an investigational integrin beta-6 (IB6) directed antibody-drug conjugate, compared with Docetaxel in 703 adult participants with previously treated locally advanced, unresectable, or metastatic NSCLC.
Patients were randomised to receive Sigvotatug vedotin administered intravenously on days 1 and 15 of each 28-day cycle, or Docetaxel administered intravenously on day 1 of each 21-day cycle.
Key Findings
-In the study, Sigvotatug vedotin did not show a statistically significant improvement in the primary endpoint of overall survival compared to Docetaxel.
-Meanwhile, in patients who received only one prior line of systemic therapy, which represents two-thirds of the study population, a numerical trend was observed for overall survival (OS) and progression-free survival (PFS) with Sigvotatug vedotin compared with Docetaxel.
-Also, in the exploratory analysis, no clear correlation between IB6 expression levels and the clinical response relationship was observed.
Detailed results from the study will be submitted for presentation at a future medical congress, said Pfizer.
Conclusion
Pfizer is also evaluating Sigvotatug vedotin in ongoing studies at other stages and in other patient populations for NSCLC and solid tumours.
Regarding the mixed results reported in the Phase 3 SigVie-002 study, Solange Peters, Chair of Medical Oncology & Thoracic Cancers Clinic, Lausanne University Hospital, Switzerland, said, "Although the study did not meet its overall survival endpoint, in second-line patients the data suggest a clinically meaningful survival benefit for Sigvotatug vedotin over docetaxel, supporting continued scientific evaluation of Sigvotatug vedotin in earlier lines in combination with immunotherapy".
PFE has traded between $23.11 and $28.75 over the last year. The stock closed Monday's trade at $25.08, down 0.52%. In the overnight market, PFE is down 1.40% at $24.73.
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Business News
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