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Nov 11, 2024, 15:46

Tanja Obradovic: New treatment option for patients with low PDL-1 expression in head and neck cancers

Tanja Obradovic, Vice President of Oncology Scientific Affairs at ICON PLCh, shared a post on LinkedIn:

“Truly interesting development in head & neck cancer with potential to offer important new treatment option for patients with low PDL-1 expression.

CEL-SCI Corporation just announced that following good overall survival PhIII results (NCT01265849) in this patient population with resectable SCCHN of oral cavity after neoadjuvant peritumoral/perilymphatic administration of Multikine (Leukocyte Interleukin injection with defined mixture of naturally derived cytokines) it will open confirmatory trial specifically targeting PDL-1 low patient subgroup.

This development strategy is a result of discussions with FDA and indicates high interest to sufficiently verify positive efficacy and safety outcomes in PDL-1 low patient population with prospective BM-defined design.

Interesting to point is that this development follows outcome of Keytruda in a similar setting in Keynote 689 published about month ago where neoadjuvant/adjuvant Keytruda (Pembrolizumab) had positive effect upon event-free survival (EFS) and major pathological response (mPR) with potential OS benefit possibly limited to PDL-1 high patient population. Considering that approximately 70% of SCCHN patients have low PDL-1 expression advance of Multikine can truly bring great benefit as a treatment option. Especially in light of PD-L1 “low” positivity definition for Multikine confirmatory study that is quite wide and includes patients with TPS less than 10. Cel-SCI announced start of the trial in 1Q of 2025.”

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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.