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Update on Phase III JAVELIN Lung 200 Trial of Avelumab Monotherapy in Previously Treated Patients With Advanced NSCLC

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On February 15, updated results were made available from the phase III JAVELIN Lung 200 trial comparing avelumab (Bavencio) 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.

Although the trial did not meet its prespecified endpoint of improving overall survival (OS) in patients with programmed cell death ligand-1 (PD-L1)-positive (1% or higher) tumors (hazard ratio [HR] = 0.90, 96% confidence interval [CI] = 0.72­–1.12, P = .1627), the proportion of patients in the chemotherapy arm crossing over to immune checkpoint inhibitors outside the study was higher than previously reported in post-platinum immunotherapy clinical trials, and this may have confounded this trial outcome (percentage of patients receiving subsequent checkpoint inhibitor therapy: docetaxel arm, 26.4%; avelumab arm, 5.7%).

However, improvements in OS vs 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 = .0052; and HR = 0.59, 95% CI = 0.42–0.83, P = 0.0022).

The safety profile for avelumab in this trial was consistent with that observed in the overall JAVELIN clinical development program; no new safety signals were identified.  

"Avelumab performed in line with expectations in the trial from both an efficacy and safety perspective," said primary investigator Fabrice Barlesi, MD, PhD, Head of Multidisciplinary Oncology and Therapeutic Innovations Department at Aix-Marseille University and the Assistance Publique Hopitaux de Marseille, France. "With immune checkpoint inhibitors approved for patients with previously treated, advanced non–small cell lung cancer, higher percentages of immunotherapy-naive 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's overall clinical activity in this study supports its profile with expected efficacy across several endpoints and subgroups," said Luciano Rossetti, MD, Executive Vice President, Global Head of Research & Development at the Biopharma business of Merck. "However, the chemotherapy group displayed improved overall survival compared with previous PDx trials, most likely due to the impact of crossover to other checkpoint inhibitors."

Detailed results from the JAVELIN Lung 200 trial will be submitted for presentation at an upcoming medical congress, and the companies aim to share the data with regulatory agencies.

In 2017, avelumab first received accelerated approval by the U.S. Food and Drug Administration (FDA) for metastatic Merkel cell carcinoma and for previously treated patients with locally advanced or metastatic urothelial carcinoma, followed by the European Commission approval for metastatic Merkel cell carcinoma later that year.  In December 2017, the FDA granted Breakthrough Therapy designation for avelumab as a combination therapy for treatment-naive patients with advanced renal cell carcinoma.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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