The 2024 ESMO Annual Congress will be held in Barcelona, Spain, from September 13 to 17 local time. At this conference, Sanofi announced for the first time itsPhase 1 Clinical Data of CD3 X CD28 X HER2 Tri-specific Antibody SAR443216 in the Treatment of Advanced Solid Tumors。Insight DatabaseShow,SAR443216 was the world's first CD3 X CD28 X HER2 trispecific antibody to enter clinical stage.。In the Q4 2023 Earnings PPT,Sanofi stated that it hasAbandoned the clinical development of this drug。The data disclosed at this ESMO may provide some insights and reflections for industry professionals.
Screenshot source: ESMO Congress official websiteSAR443216 is a novel trispecific antibody that activates T cells by binding to CD3, CD28, and HER2, thereby lysing HER2-positive (+) cancer cells.Selected for this year's conference is a Phase I/Ib study (NCT05013554) Results of the dose escalation for intravenous injection. In this study, adult patients with HER2+ metastatic solid tumors received SAR443216 once weekly via intravenous infusion, with dose escalation over 2 weeks (Dose 18–720 μg) or 3 weeks (Dose 480–900 μg), for a total of 9 doses (DL)。The primary endpoint of the study is dose-limiting toxicity (DLT), and treatment-related adverse events (TEAE), Serious Adverse Events, etc.. Secondary endpoints are efficacy, PK, and anti-drug antibodies for SAR443216 (ADA)。As of March 6, 2024, 40 patients received intravenous SAR443216, with at least 3 patients in each DL. All patients had previously been treated for HER2+ and/or HER2-mutated metastatic solid tumors.In the study,Three cases of DLT were observed., all occurred in the DL with a 2-week dose escalation regimen (One case of heart failure with a dose of 180 μg; two cases of elevated transaminases with a dose of 720 μg.). All DL inThe most common TEAEs were cytokine release syndrome, elevated ALT and AST, and fever.. Only one patient discontinued treatment due to AE. No grade 5 TEAEs were observed apart from disease progression. The maximum tolerated dose of SAR443216 was not reached.No objective responses have been observed to date, with a disease control rate of 35%.(14/40 patients). Within the explored dose range, PK was mostly dose-proportional, with a terminal T1/2 of 1-2 days. Moderate immunogenicity was observed after intravenous injection (ADA approximately 20%, 6/28`). An increase in serum pro-inflammatory cytokines was observed after each infusion.(INFγ and IL2) A brief increase.
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One-Click Access to ESMO Congress DataThe regular abstract texts of this year's ESMO Congress have been available since September 9, and the LBA texts will be released successively starting from September 13. The clinical trial results module in the Insight database is continuously updating the 2024 ESMO data. A quick screening option has already been launched for direct access to the latest 2024 ESMO clinical results data with one click. Welcome to click "Read More" to apply for a trial!
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