tusamitamab ravtansine (SAR408701)

These findings demonstrate how early-phase data can inform optimal dose selection by quantifying benefit-risk. This robust framework and methodology is generalizable beyond Tusa, offering value to support dose selection and trial decision-making in oncology drug development.

We assessed CEACAM5 protein expression by immunohistochemistry in two separate cohorts of patients with NSCLC to include both routine clinical biopsy and resection specimens, using the anti-CEACAM5 clone 769 antibody assay protocol and scoring scheme for the tusamitamab ravtansine clinical trials...There was no prognostic effect of CEACAM5 expression on recurrence-free survival or overall survival. Our data revealed that 18% of routinely diagnosed clinical NSCLC samples had high CEACAM5 expression by immunohistochemistry, and its expression was not associated with oncogenic driver mutations or patient prognosis in a predominantly early stage NSCLC cohort.

In CEACAM5 HE, the ORR was greater with high versus low cCEA. Associations were observed between cCEA and cCEACAM5; IHC CEACAM5, cCEA, and cCEACAM5; IHC CEACAM5 and CEACAM5 mRNA, but not between IHC CEACAM5 and oncogenic drivers.

P2, N=50, Terminated, Sanofi | Completed --> Terminated; Sponsor decision, the decision is not related to any safety concern.

Corneal AEs occurred in 38.0% (35/92), typically grade 1/2, reversible, and manageable by dose modifications. Tusamitamab ravtansine demonstrated a favorable safety profile, objective responses, and antitumor activity in patients with high CEACAM5-expressing NSq NSCLC.

P3, N=389, Active, not recruiting, Sanofi | Trial completion date: Jun 2025 --> Mar 2026

Tusamitamab ravtansine demonstrated a tolerable safety profile at a dose of 80-170 mg/m2 in three different administration schedules in Japanese adults with metastatic solid tumors.

Among the many ADCs being developed, several can cause ILD of varying grades and intensity. Knowledge of their risks, diagnostic and therapeutic modalities is required in order to quickly detect and treat ADC-induced ILD.

P2, N=50, Completed, Sanofi | Active, not recruiting --> Completed

P2, N=57, Terminated, Sanofi | Active, not recruiting --> Terminated; Sponsor decision, the decision is not related to any safety concern.

P2, N=35, Terminated, Sanofi | Active, not recruiting --> Terminated; Sponsor decision, the decision is not related to any safety concern.

P2, N=35, Terminated, Sanofi | Active, not recruiting --> Terminated; Sponsor decision, the decision is not related to any safety concern.