Pfizer and Merck have announced that avelumab alone or in combination with pegylated liposomal doxorubicin (PLD) has failed to improve overall survival (OS) or progression-free survival (PFS) rate in phase III Javelin Ovarian 200 trial.
The companies reported that the trial assessing avelumab alone or in combination with PLD has not achieved the pre-specified primary endpoints of OS or PFS compared with PLD alone in patients with platinum-resistant or refractory ovarian cancer.
Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody, which holds capacity to engage both the adaptive and innate immune functions.
In preclinical models, avelumab was demonstrated to release the suppression of the T cell-mediated antitumor immune response by blocking the interaction of PD-L1 with PD-1 receptors.
Pfizer global product development’s immuno-oncology and early development and translational oncology head and senior vice president Dr Chris Boshoff said: “Javelin Ovarian 200 enrolled a high proportion of patients with aggressive, refractory disease that had no response to prior platinum-based chemotherapy, a population known to have disease that is challenging to treat; as such, this group of patients is typically not included in Phase III ovarian cancer trials.”
Javelin Ovarian 200 is a multicenter and randomized trial designed to evaluate the efficacy and safety of avelumab alone or in combination with PLD against PLD alone in 566 women with ovarian cancer that is resistant or refractory to platinum chemotherapy.
The primary objectives of the trial were to show superior OS or PFS for one or both avelumab-based treatment regimens compared with PLD.
The ovarian cancer clinical program is also comprised of various ongoing clinical trials assessing avelumab in combination with other therapies.
Javelin Ovarian 100 is an open-label, international, multicenter and randomized phase III study of avelumab in combination with and/or as follow-on (maintenance) treatment to platinum-based chemotherapy in previously untreated patients with locally advanced or metastatic (stage III or stage IV) epithelial ovarian cancer.
Merck biopharma business’ research and development global head and executive vice president Dr Luciano Rossetti said: “Although OS and PFS did not reach statistical significance, study results indicate potential clinical activity of the combination of avelumab and chemotherapy which will be analyzed further.”