MRC Technology (MRCT) is pleased to highlight that Merck, known as MSD outside the United States and Canada, announced FDA approval and subsequent United States (US) commercial availability of Keytruda (pembrolizumab), an immunotherapy treatment for advanced melanoma. UK based scientists at MRCT, with extensive expertise in antibody engineering techniques, first advanced the antibody-based treatment and carried out humanization, an essential step in the success of the therapeutic. Considered a breakthrough cancer treatment, clinical trials have shown significant improvement in the prognosis for Keytruda-treated patients even in the most advanced stages of melanoma.
Keytruda is the first to market in the USA of a new generation of PD-1 therapies that block the biological pathways cancers use to disguise themselves from the immune system. It acts by making the cancer cell ‘visible’ to the immune system and thus the cell can be destroyed by the body’s natural defence mechanisms.
Dave Tapolczay, MRC Technology’s CEO, said: “We are delighted by this news and proud that MRC Technology scientists played a significant early-stage role in bringing this new cancer treatment to patients. Clinical investigators involved in trialling Keytruda have described the treatment’s potential as ‘exciting and striking’ and a ‘paradigm shift’ for cancer therapy. This is good news for cancer sufferers and represents a significant milestone in the treatment of highly invasive tumors such as advanced melanoma.”
The UK government’s Life Sciences Minister George Freeman said: “We are proud to see UK scientists once again playing a vital role in developing an exciting new drug, which has such potential for impact on patients’ lives. This success serves to highlight the importance of continued support for the life science sector in the UK.”
An application for European (EMA) approval has been made (June 2014). The therapy also holds great potential for treatment of an array of different cancers, and by the end of 2014 it will be in 24 clinical trials for 30 tumor types, involving an estimated 6,000 patients.
MRC Technology has humanized over 55 antibodies to date, including four marketed products, Tysabri (natalizumab), Actemra (tocilizumab), Entyvio (vedolizumab) and Keytruda (pembrolizumab). A further five are in clinical trials and two more in preclinical studies.