Clinical Summary:

• Design/Population: A phase 2 study evaluated FID-007, a novel non-encapsulated paclitaxel, plus cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma who had progressed after prior immune checkpoint inhibitor therapy.
• Key Outcomes: FID-007 plus cetuximab demonstrated encouraging antitumor activity and higher complete response rates at the higher FID-007 dose. The regimen was generally well tolerated, with mostly low-grade toxicities and no infusion-related reactions or grade ≥3 peripheral neuropathy reported.
• Clinical Relevance: FID-007 plus cetuximab may offer an active post-immunotherapy treatment option for recurrent or metastatic head and neck squamous cell carcinoma, supporting ongoing phase 3 evaluation against standard second-line therapies.

Guilherme Rabinowits, MD, Moffitt Cancer, Tampa, Florida, discusses results from a phase 2 trial evaluating FID-007, a novel non-encapsulated paclitaxel formulation, in combination with cetuximab among patients with recurrent or metastatic head and neck squamous cell carcinoma who experienced disease progression after immune checkpoint inhibitor therapy. 

The combination demonstrated encouraging antitumor activity, including high response rates and durable disease control, while maintaining a manageable safety profile with limited severe neuropathy and no infusion-related reactions. 

Dr Rabinowits presented these results at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. 

Transcript:

Hi, my name is Guilherme Rabinowits, I'm a head and neck-endocrine medical oncologist at Moffitt Cancer Center, and I'm here to talk about the data that I presented at ASCO 2026, which is very exciting. The title of the talk is "FID-007 in combination with cetuximab in recurrent or metastatic head and neck squamous cell carcinoma."

FID-007 is a novel non-encapsulated paclitaxel designed to overcome the challenges with the poor water solubility of paclitaxel. It also takes advantage of the abnormal intratumoral neurovascularization where we normally see gaps between the myothelial cells, which allows the drug to penetrate and retain inside the tumor. We expect that the activity, it's going to be significantly better and the toxicity would be lower.

There was an early phase 1 study with a monotherapy of FID-007 before in advanced solid tumors that showed a significant response rate of 45% in patients with heavily pretreated recurrent metastatic head and neck squamous cell carcinoma. Building on this promising results, we developed this phase 2 study FID-007 in combination of cetuximab where adult patients with recurrent metastatic head and neck squamous cell carcinoma that have failed prior immune checkpoint inhibitors, but do not receive more than 1 line of prior systemic therapy and the recurrent metastatic disease were randomized to 2 different doses of FID-007. Arm A was 75 mg/m2 day 1, day 8, and day 15 every 28 days and Arm B was at 125 mg/m2 at the same dosing schedule. Both arms were combined with cetuximab at 500 mg/m2 every other week, every 28 days and starting at cycle 2 day 1 and treatment was continuing until disease progression of unacceptable toxicity.

We saw significant activity from the drug combination with a close to 62% response rate and combined both arms slightly higher for Arm B at the higher dose, including complete responses, which were seen at 23% in Arm B in comparison to about 9% in Arm A. There was only a single patient that progressed in Arm B as the best overall response in comparison to 3 in Arm A for a disease control rate of about 95% in Arm A and 72 in Arm B.

Toxicity wise was nothing truly unexpected for cetuximab or paclitaxel. Most of them were grade 1/2 with some grade 3/4 toxicities. What was interesting to see was that we did not observe any infusion-related reactions or grade 3 or higher peripheral neuropathy, which is often seen with solvent-based paclitaxel. Fortunately, there is a single patient of a grade 5 pneumonia that we felt was treatment-related, but overall the treatment was well tolerated.

Building on these promising results, phase 3, comparing this combination with standard of care second-line therapies for patients with recurrent metastatic disease is underway. I'd like to thank you so much for listening.

Source:

Rabinowits G, Chung CH, Shreenivas AV, et al. FID-007 in combination with cetuximab in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Presented at the ASCO Annual Meeting. May 29 - June 2, 2026. Chicago, Illinois. 6020.