Promega Partners with GSK to Develop MSI Companion Diagnostic IVD Kit for Jemperli
Promega Corporation has announced a strategic collaboration with GSK to develop and commercialize a microsatellite instability (MSI) companion diagnostic (CDx) IVD kit. This kit aims to identify adult cancer patients with MSI-high solid tumors who may be eligible for potential treatment with GSK’s Jemperli (dostarlimab-gxly).
The companion diagnostic test currently under development, will utilize Promega’s PCR-based five-marker MSI panel to identify potential patients for Jemperli, an anti-PD-1 monoclonal antibody (mAb). Jemperli is currently approved for patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, who have progressed following prior treatment and have no satisfactory alternative treatment options. The FDA granted accelerated approval to Jemperli for this indication in August 2021. The development of this CDx IVD kit aligns with GSK’s commitment to the FDA to provide a companion diagnostic to support the safe and effective use of Jemperli in patients with MSI-high solid tumors.
Alok Sharma, Global Clinical Market Director at Promega, emphasized the importance of this collaboration, stating, “This collaboration underscores our commitment to enabling patient access to targeted therapies. The results of our MSI biomarker test will be a critical step in identifying patients who may be eligible to receive this drug marketed by GSK.”
Microsatellite instability (MSI) is a genetic condition characterized by the accumulation of errors or mutations in short repetitive DNA sequences known as microsatellites. Tumors with MSI-High (MSI-H) status often exhibit higher response rates to immune checkpoint inhibitor (ICI) therapies such as anti-PD-1 mAb drugs. Consequently, MSI testing has become a crucial tool for identifying cancer patients who may benefit from these therapies. Promega boasts over 19 years of experience in MSI research, with its PCR method being widely used in clinical research globally. This method is supported by more than 225 independent peer-reviewed publications across 25 different cancer types.