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Merck, Pfizer Report Positive Top-line Results From Phase III JAVELIN 101 Study

Merck KGaA, and Pfizer Inc. (PFE) announced positive top-line results from the pivotal Phase III JAVELIN Renal 101 study evaluating BAVENCIO (avelumab) in combination with INLYTA (axitinib), compared with SUTENT (sunitinib) as initial therapy for patients with advanced renal cell carcinoma. The company said an independent Data Monitoring Committee has confirmed that the trial showed a statistically significant improvement in progression-free survival by central review for patients treated with the combination whose tumors had programmed death ligand-1?positive expression greater than 1% (primary objective), as well as in the entire study population regardless of PD-L1 tumor expression (secondary objective).

JAVELIN Renal 101 is a global Phase III, multicenter, randomized study investigating the efficacy and safety of BAVENCIO in combination with INLYTA as a first-line treatment option compared with SUTENT monotherapy in 886 patients with advanced renal cell carcinoma across all risk groups.

The company said the JAVELIN Renal 101 will continue as planned to the final analysis for the other primary endpoint of overall survival. The alliance intends to pursue a regulatory submission in the US based on the interim results.

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