Merck KGaA and Pfizer assert Phase III JAVELIN Lung 200 trial results

Merck KGaA, Darmstadt, Germany, and Pfizer assert results from the Phase III JAVELIN Lung 200 trial comparing avelumab to docetaxel in patients with unresectable, recurrent or metastatic non-small cell lung cancer (NSCLC) whose disease progressed after treatment with a platinum-containing doublet therapy.

JAVELIN Lung 200 is a Phase III, randomized, open-label, multicenter trial investigating avelumab versus docetaxel in patients with locally advanced unresectable, metastatic or recurrent NSCLC whose disease has progressed after a platinum-containing doublet chemotherapy.

Improvements in OS versus the control arm were observed in the moderate-to-high PD-L1+ expression (50% or greater, which represented approximately 40% of the study population) and high PD-L1+ expression population (PD-L1+ expression 80% or greater, which represented approximately 30% of the study population) (HR: 0.67 [95% CI: 0.51-0.89], p-value 0.0052, two-sided; and HR 0.59 [95% CI: 0.42-0.83], p-value 0.0022, two-sided, respectively.

Fabrice Barlesi, M.D., Ph.D., Head of Multidisciplinary Oncology and Therapeutic Innovations Department at Aix-Marseille University and the Assistance Publique Hôpitaux de Marseille, France said “With immune checkpoint inhibitors approved for patients with previously treated, advanced non-small cell lung cancer, higher percentages of immunotherapy-naïve patients are receiving subsequent checkpoint inhibitors in their progressive treatments. This was observed in the JAVELIN Lung 200 control arm and may have confounded the primary outcome of the study.”

avelumab first received accelerated approval by the US Food and Drug Administration (FDA) for metastatic Merkel cell carcinoma (mMCC) and for previously treated patients with locally advanced or metastatic urothelial carcinoma (mUC) in 2017.