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Exploratory Analyses for JAVELIN Ovarian 200 Demonstrate Potential for Immunotherapy in Select Subgroups

Eric Pujade-Lauraine, MD, PhD
Published Online:6:04 PM, Wed June 12, 2019

Eric Pujade-Lauraine, MD, PhD, a medical oncologist at Université Paris Descartes in France, discusses the exploratory findings from the phase III JAVELIN Ovarian 200 trial, which investigated the use of combination avelumab (Bavencio) plus pegylated liposomal doxorubicin in patients with platinum-resistant, refractory ovarian cancer.

This large trial enrolled 556 patients and demonstrated clinical activity with the combination regimen. However, the activity was modest with a hazard ratio of 0.78 for progression-free survival (PFS) in this unselected patient population, says Pujade-Lauraine. There was an increased response rate of 13% with the combination therapy versus 4%, but these are still small findings.

Although the primary endpoint was not met in the trial in the overall population, Pujade-Lauraine says exploratory analyses were conducted to find specific patient populations that could benefit more from the combination versus chemotherapy alone. One prespecified analysis showed that expression of PD-L1 could predict clinical activity; there were hazard ratios of 0.65 for PFS and 0.72 for overall survival compared with chemotherapy for PD-L1–positive patients.

Patients who received chemotherapy, responded, then relapsed and became resistant to treatment seemed to have more of a benefit from the combination regimen, Pujade-Lauraine explains. Whereas, the subgroup of patients with primary resistance to chemotherapy did not experience a benefit from the addition of avelumab. However, these subgroup analyses were not preplanned, and so these data are still exploratory.

Pujade-Lauraine says that despite the findings for the overall patient population, this study was the first step toward discovering the role of immunotherapy in ovarian cancer.
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