On June 22, 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 in North America with Eli Lilly and Company (Lilly) to evaluate ficlatuzumab in combination with ERBITUX (cetuximab), an anti-EGFR antibody, in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (Press release, AVEO, JUN 22, 2022, View Source [SID1234616168]). Ficlatuzumab is AVEO’s investigational potent humanized immunoglobulin G1 monoclonal antibody that targets hepatocyte growth factor.
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"This clinical trial collaboration and supply agreement with Lilly follows a similar engagement we entered into with Merck KGaA, Darmstadt, Germany earlier this year, both of which we believe serve as validation for our ficlatuzumab clinical development plan. We expect these collaborations will play an important role in the advancement of the combination of ficlatuzumab and cetuximab," said Michael Bailey, president and chief executive officer of AVEO. "We reported positive Phase 2 clinical data last year that show ficlatuzumab in combination with cetuximab has the potential to play a meaningful role in the treatment of patients with human papillomavirus (HPV) negative R/M HNSCC, which is associated with particularly poor outcomes. We continue to be in discussions with regulators on the final design of a potential pivotal study for this combination therapy, which we expect to commence in the first half of 2023."
Under the terms of the agreement, Lilly will provide cetuximab clinical drug supply in the U.S. and Canada for AVEO’s potential 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 trial execution.
In June 2021, AVEO announced positive results from a randomized 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, including two patients with complete responses, and median progression free survival superior to historical data for current standards of care. In September 2021, the FDA awarded Fast Track designation for the combination of ficlatuzumab and cetuximab in HPV negative relapsed/recurrent HNSCC. A copy of the presentation is available at www.aveooncology.com.
AVEO recently commenced manufacturing of ficlatuzumab clinical supply in the second quarter of 2022, with the potential registrational study expected to be initiated in the first half of 2023. AVEO 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 pancreatic cancer. The U.S. Food and Drug Administration designated as a Fast Track development program the investigation of ficlatuzumab and ERBITUX (cetuximab) for relapsed/recurrent HNSCC in September 2021.