SAR'459 monotherapy and combination with cemiplimab appeared relatively safe and tolerable in limited number of patients in dose escalation. However, the study was discontinued due to the unclear efficacy of SAR'459 and bleeding risk, particularly in HCC patients.
5 months ago
Clinical • P1 data • PK/PD data • Clinical Trial,Phase I • Journal • Combination therapy • Metastases
SAR439459 ± cemiplimab showed expected peripheral PD effects and TGFβ alteration. However, further studies are needed to identify biomarkers of response.
9 months ago
P1 data • PK/PD data • Clinical Trial,Phase I • Journal • Combination therapy • PD(L)-1 Biomarker • Metastases
P1b, N=3, Terminated, M.D. Anderson Cancer Center | Trial completion date: Nov 2025 --> Dec 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2025 --> Dec 2022; The industry supporter discontinued the study and lead drug, SAR439459, due to toxicity.
over 1 year ago
Trial completion date • Trial termination • Trial primary completion date • IO biomarker • Metastases
Coupled with CD8+ T cell modulation in TME, these findings suggest the identification of early PD biomarkers impacted by SAR439459 which is consistent with the mechanism of action and biological activity of TGFβ blockade therapy. Trial Registration NCT03192345
3 years ago
Clinical • P1 data • PK/PD data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
In addition, we show that combination therapy was associated with increase in the intra-tumoral levels of proinflammatory cytokines - IFNγ, IL-1β, TNF-α as well as enhanced expression of anti-tumor immune related genes. Based on these data, clinical testing of SAR439459 (TGF-β antibody) and Cemiplimab (anti-PD1) combination has recently been initiated in HCC patients (NCT03192345).