Gilead founded as Oligogen in 1987, has focused on innovative medications since its inception. It has a legacy of extraordinary advances in antiviral space by reducing HIV from a death sentence to chronic disease and curing hepatitis C. Building on to their strengths, Gilead is now expanding into immunomodulation, inflammatory disease, and oncology. Gilead had reported $22.1 billion sales in 2019 globally, $16.6 billion from the United States.
In 2017, Gilead took early steps into oncology by acquiring Kite Pharma for $11.9 billion. This came at a strategically crucial time when, Kite has just submitted BLA application for axicabtagene ciloleucel, which was set to become the first CAR T cell therapy approved in treatment for refractory aggressive non-Hodgkin lymphoma. CAR T cell therapy has the potential to become one of the most powerful anti-cancer agents for hematologic cancers with several ongoing trials.
Building on to it’s newly acquired heme-oncology portfolio, Gilead announced on 13th September 2020, intention to acquire Immunomedics. The transaction, which values Immunomedics at approximately $21 billion, was approved by Boards of Directors of both and is expected to close during the fourth quarter of 2020.
Gilead gains sacituzumab govitecan (branded as Trodelvy), a first in class Trop-2 directed antibody-drug conjugate that earned FDA accelerated approval for double refractory triple-negative breast cancer in April 2020. Immunomedics is expected to submit sBLA to support full approval by end of this year. Filing for approval in Europe is expected in early 2021. Trodelvy is a Trop-2-directed antibody and topoisomerase inhibitor conjugate drug. It targets the Trop-2 antigen, a humanized monoclonal antibody, expressed on various tumor cells and delivers SN-38, a topoisomerase I inhibitor, to the tumors directly, causing cell death.
Todelvy has managed to significantly improve progression free survival and overall survival in ongoing pivotal trial ASCENT in metastatic TNBC. The trial was stopped as primary endpoints were met early. Detailed results from this study are expected to be presented at the upcoming ESMO Virtual Congress 2020 in Late Breaking Abstract #17.
Beyond mTNBC where it is expected to become the market leader, Trodelvy is also being studied in an ongoing Phase 3 trial in third-line HR+/HER2- breast cancer (TROPiCS 02). Next target for the drug is Urothelial cancer, where pivotal trial TROPHY U-01 is designed to support accelerated approval. Further studies are ongoing to gauge the potential of Trodelvy in treatment for NSCLC (TROPiCS 03) and other solid tumor types like urothelial cancer (TROPiCS-04, TROPHY U-01). The asset is being evaluated in both monotherapy and combination with immunotherapy and other non-immuno agents by Immunomedics. These include a trial in collaboration with Roche (MORPHEUS), Clovis Oncology (SEASTAR), and Everest. TROPHY-U-01 cohort 1 final results clinical data for Trodelvy metastatic urothelial cancer that has progressed after platinum and checkpoint inhibitors will also be presented at ESMO 2020 in Late Breaking Abstract #24.
Trodelvy has substantial potential in breast cancer and other solid tumors. Trodelvy has brought to Gilead a key product that enriches the company’s solid tumor pipeline, building on to the currently marketed assets and pipeline products for hematological malignancies at Kite and Gilead.