On January 4, 2022 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, reported that it has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany to evaluate ficlatuzumab in combination with ERBITUX (cetuximab), an EGFR-targeted antibody, in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (Press release, AVEO, JAN 4, 2022, View Source [SID1234598050]). Ficlatuzumab is AVEO’s investigational potent humanized immunoglobulin G1 monoclonal antibody that targets hepatocyte growth factor.
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"This collaboration with Merck KGaA, Darmstadt, Germany will play an important role in the advancement of both the ficlatuzumab and cetuximab programs," said Michael Bailey, president and chief executive officer of AVEO. "The ficlatuzumab and cetuximab combination has demonstrated the potential to play a meaningful part in the treatment of patients with human papillomavirus (HPV) negative R/M HNSCC, which is associated with particularly poor outcomes. We look forward to continuing our dialogue with regulators to finalize the design of a pivotal study, which we now expect to commence in the first half of 2023."
Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will provide cetuximab clinical drug supply in all countries outside of the U.S. and Canada for AVEO’s future registrational study, which will assess ficlatuzumab with cetuximab in HPV negative R/M HNSCC. AVEO will serve as the study sponsor and will be responsible for costs associated with the trial execution.
In June 2021, the Company announced positive results from a randomized confirmatory Phase 2 study of ficlatuzumab alone or in combination with cetuximab in patients with pan-refractory metastatic HNSCC. Of note, patients with HPV negative disease, a subgroup normally associated with poorer outcomes, who received the ficlatuzumab and cetuximab combination demonstrated both a superior overall response rate and median progression free survival over single agent ficlatuzumab. A copy of the presentation is available at www.aveooncology.com.
The Company expects to commence manufacturing of ficlatuzumab clinical supply in the second quarter of 2022, subject to availability of key raw materials and manufacturing supplies also used in COVID-19 vaccine manufacturing, with the initiation of a registrational study now anticipated in the first half of 2023. The Company expects to continue to discuss potential ficlatuzumab pivotal study designs with the FDA and to continue ongoing partnership dialogues.
About Ficlatuzumab
Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) immunoglobulin G1 (IgG1) inhibitory antibody that binds to the HGF ligand with high affinity and specificity. HGF is the natural ligand of c-Met and blocking HGF inhibits signaling through the HGF/c-Met signaling pathway. Ficlatuzumab is currently being evaluated in squamous cell carcinoma of the head and neck (HNSCC) and metastatic pancreatic ductal cancer (PDAC). Ficlatuzumab was granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of patients with recurrent or metastatic HNSCC.