Pfizer and Merck KgAa discontinue phase III trial; Use of Avelumab analyzed in untreated ovarian cancer

Mar 23, 2019 | Cancer Clinical Trials, Challenging Results, Ovarian Cancer

 Pfizer and Merck discontinued Javelin Ovarian PARP 100, the second phase III ovarian cancer trial to be discontinued within six months. In November of 2018 the JAVELIN Ovarian 200 trial was discontinued after it failed to meet endpoints.

Javelin Ovarian PARP 100 was an open-label, international, multi-center, randomized study designed to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). The primary endpoint is progression-free survival (PFS) as determined based on blinded independent central review (BICR) assessment per RECIST v1.1. The two companies determined that the degree of benefit observed with avelumab in frontline ovarian cancer in the study does not support continuation of the JAVELIN Ovarian PARP 100 trial in an unselected patient population and emphasized the need to better understand the role of immunotherapy in ovarian cancer.

 About Ovarian Cancer

Ovarian cancer is a type of cancer that begins in the ovaries. Ovarian cancer often goes undetected until it has spread within the pelvis and abdomen. At this late stage, ovarian cancer is more difficult to treat.

About avelumab

Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab had shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models. Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.

Avelumab (Bavencio) was granted accelerated approval by the FDA for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Merck KGaA and Pfizer have been collaborating on the development and commercialization of Bavencio since 2014.

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