Tanja Obradovic: Important lesson in development of the PDL-1 inhibitor just came in

Tanja Obradovic posted on LinkedIn:

“Important lesson in the development of the PDL-1 inhibitor just came in. China-developed PD-L1 inhibitor called Envafolimab in-licensed by Biotech Tracon Pharmaceuticals for North America announced negative results for its subcutaneous PD-L1 inhibitor Envafolimab, in patients with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) (NCT 04480502). Envafolimab administration resulted in responses in four out of 82 patients so the number was below the 11% response rate the phase 2 trial was targeting as its primary endpoint. Tracon is stopping further development of Envafolimab including a planned combination with Ipilimumab.

Envafolimab has Chinese approval in advanced microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors received in 2021 and is developed by China-based 3DMedicines and Alphamab Oncology. With this latest development, US based access to Envafolimab is likely not in the future.

What comes as somewhat surprising is the choice of sarcoma as an indication targeted for Phase II development. Sarcomas have been reported with very variable PDL-1 expression depending on different reports/methodologies and with limited efficacy of PD(L)-1 inhibitors either in monotherapy or in combos depending on histology and with small numbers of patients reported in studies raising high uncertainty of results in terms of the larger population even within limited histology.”

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Source: Tanja Obradovic/LinkedIn

Tanja Obradovic is the Vice President of Oncology Scientific Affairs at ICON PLCh. She has over 20 years of clinical research experience and has led major pharmaceutical companies for 13 years. Her research focuses on small molecules, antibodies, cell and gene therapy, and major immunotherapy of PD1 inhibitors.