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Patients with Relapsed/Refractory AML may Benefit from Treatment with Ficlatuzumab + Chemotherapy - OncoZine

Patients with Relapsed/Refractory AML may Benefit from Treatment with Ficlatuzumab + Chemotherapy - OncoZine

Patients with Relapsed/Refractory AML may Benefit from Treatment with Ficlatuzumab + Chemotherapy - OncoZine
Jul 18, 2021 2 mins, 35 secs

Ficlatuzumab (formerly known as AV-299), a potent hepatocyte growth factor (HGF) immunoglobulin G1 (IgG1) inhibitory antibody that binds to the HGF ligand with high affinity and specificity, in combination with cytarabine (also known as arabinofuranosyl cytidine or ara-C), demonstrates signs of clinical efficacy in patients with relapsed/refractory acute myeloid leukemia (AML).

Results of a study were published in Blood Cancer Discovery, a journal of the American Association for Cancer Research (AACR) shows that the investigational drug being developed by Aveo Oncology, nine of 17 patients (53%) participating in the trial, had a complete response, and four of the responding patients had no signs of minimal residual disease.

In their study, Andreadis and colleagues evaluated the safety and efficacy of an investigational agent targeting a shared chemical pathway in combination with single-agent chemotherapy in patients with relapsed/refractory AML.

The phase I clinical trial enrolled 17 adult patients with AML that was either refractory to prior treatment or that had relapsed within 12 months of prior treatment.

A total of nine of 17 participating patients (53 percent) had a complete response, and four of the responding patients had no signs of minimal residual disease.

“The 53 percent response rate was quite striking to us since historical response rates for the standard-of-care treatment are in the 30 percent range,” Andreadis said.

“While these results need to be validated in a larger study, they suggest that ficlatuzumab in combination with single-agent chemotherapy may lead to better responses with less toxicity in patients with relapsed/refractory AML.”.

Clinical response to ficlatuzumab treatment was associated with reduced phosphorylation of the S6 protein and increased expression of genes involved in myeloid and leukocyte activation, whereas non-responding patients were more likely to have increased expression of HGF, increased phosphorylation of S6, and expression of genes involved in protein translation, cell adhesion, and type I interferon signaling.

“This approach provided novel insight into the molecular changes that occur upon treatment, which could have clinical implications for tracking treatment response or identifying patients likely to respond,” Wang added.

The study results demonstrated a favorable safety profile and promising clinical activity of ficlatuzumab and cytarabine in high-risk AML patients, supporting further investigation of this combination in a randomized trial.  The results also showed the utility of a novel application using multiplexed single-cell analyses to detect on-target activity and identify biomarkers of response.

Earlier results from an unrelated randomized confirmatory Phase 2 study of ficlatuzumab as a single agent (20 mg/kg IV) or in combination with cetuximab (Erbitux®; Merck KGaA; 500 mg/m2 IV every two weeks), an EGFR-targeted antibody, in patients who relapsed or were refractory to prior immunotherapy, chemotherapy, and cetuximab (pan-refractory) with metastatic head and neck squamous cell carcinoma (HNSCC) demonstrated that the ficlatuzumab and cetuximab combination arm met the study’s primary endpoint of median PFS, with the 32 evaluable patients in the arm demonstrating a median PFS of 3.6 months  (lower bound 90% confidence interval [CI] 2.3 months; p=0.04), and 1.8 months (lower bound 90% CI: 1.7 months) for the 26 evaluable patients receiving ficlatuzumab alone

Inhibition of MET Signaling with Ficlatuzumab in Combination with Chemotherapy in Refractory AML: Clinical Outcomes and High-Dimensional Analysis Blood Cancer Discov July 16, 2021, DOI: 10.1158/2643-3230.BCD-21-0055

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