Merck and Pfizer have reported negative results from the Phase III JAVELIN Ovarian 200 trial that investigated the efficacy and safety of avelumab alone or in combination with pegylated liposomal doxorubicin (PLD) compared with PLD for the treatment of ovarian cancer.
The trial failed to meet the prespecified primary objectives of overall survival (OS) or progression-free survival (PFS) in patients who were resistant or refractory to platinum chemotherapy.
Avelumab safety profile was reported to be consistent with that observed in the overall JAVELIN clinical development programme and no new safety signals associated with avelumab alone or in combination were found.
Merck Biopharma research and development executive vice-president and global head 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 analysed further.
“We thank the patients, their families and the investigators who participated in the JAVELIN Ovarian 200 trial, and wish to underscore that the alliance remains committed to driving advances in ovarian cancer.”
The trial featured a multicentre, randomised study design and included 566 women with ovarian cancer resistant or refractory to platinum chemotherapy.
Overall, the JAVELIN trial comprised around 30 clinical programmes and more than 9,000 patients across 15 tumour types.