AVEO Pharmaceuticals, a subsidiary of LG Chem, has completed the U.S. phase 2 clinical trial of ficlatuzumab, a head and neck cancer candidate, and published the results in an international journal.

As the LG Group has recently shown its commitment to developing new drugs, LG Chem's plans are drawing attention.

The results of AVEO’s phase 2 clinical trial of ficlatuzumab were published in Issue 22, Volume 41 of the Journal of Clinical Oncology (JCO) on Aug. 1. JCO is a prestigious international journal in oncology published by the American Society of Clinical Oncology (ASCO).

AVEO evaluated the efficacy and safety of ficlatuzumab in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC). AVEO enrolled 60 patients from 2018 through 2020, giving ficlatuzumab alone to 27 patients and giving ficlatuzumab plus cetuximab (Ervitux) to the other 33.

The primary endpoint was median progression-free survival (mPFS), and the secondary endpoint was objective response rate (ORR). In phase 2, AVEO evaluated the efficacy in HPV-positive and HPV-negative patients.

Results showed that researchers discontinued the single-dose regimen of ficlatuzumab due to lack of efficacy. Combined with cetuximab, the mPFS was 3.7 months (90 percent CI, 2.3 months; P=0.04), meeting the primary endpoint. The ORR as the secondary endpoint was 19 percent (six of 32 patients), with two CRs (complete remissions) and four PRs (partial remissions) confirmed.

When comparing the HPV-positive and HPV-negative groups within the combination arm, the mPFS was 2.3 months vs. 4.1 months (P=0.03), and the ORR was 0 percent (0) vs. 38 percent (6/16, P=0.02). In addition, cMet overexpression was associated with a reduced risk of progression in HPV-negative patients but not in HPV-positive patients (P interaction=0.02).

In a presentation of the results attended by Dr. Julie Bauman of the George Washington University and colleagues who conducted the phase 2 study, the researchers determined that the ficlatuzumab-cetuximab combination met significance and could proceed to phase 3. In particular, they expected the treatment to be effective in patients with HPV-negative head and neck squamous cell carcinoma.

Meanwhile, the LG Group, including LG Chem, has recently expressed its intention to develop new drugs. Last month, LG Group Chairman Koo Kwang-mo visited Boston, Mass., to inspect LG Chem's life science headquarters and AVEO.

During the visit, Koo showed his expectations, saying, "LG's bio business is a small seed now. However, it will grow into a future giant representing LG if we continue to make unwavering efforts and challenges."

LG Chem completed the acquisition of AVEO in January. AVEO also owns the kidney cancer drug Fortivda (tivozanib), which has won U.S. Food and Drug Administration approval.

However, LG Chem did not elaborate when Korea Biomedical Review asked whether and when ficlatuzumab will enter phase 3.