FDA Grants PYX-201 Fast Track Status in HNSCC

• The FDA granted fast track designation to PYX-201 for the treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
• This indication is specifically for patients whose disease has progressed after receiving treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody.
• Two trials are actively examining PYX-201 across tumor types and recruiting patients (NCT05720117; NCT06795412).

The FDA has granted PYX-201, a first-in-concept antibody-drug conjugate (ADC), fast track designation for the potential treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody.¹

The ADC works by targeting Extra Domain-B Fibronectin. This is a non-cellular structural component within the tumor extracellular matrix that is highly expressed across a number of tumor types.¹

There are currently 2 trials evaluating PYX-201 that are actively recruiting patients.

Cancer Cell Image: © sipgus - stock.adobe.com

“Receiving fast track designation for PYX-201 from the FDA marks a significant milestone for Pyxis Oncology, recognizing our potential to address the significant medical need in R/M HNSCC. This designation underscores the urgency of bringing differentiated treatment options to patients and will help accelerate the development of PYX-201 as we actively recruit patients for our trial,” said Lara S. Sullivan, MD, president and chief executive officer, in a press release. “We look forward to working with the FDA to advance this promising therapy as efficiently as possible.”

The first trial titled PYX-201-101 plans to evaluate PYX-201 as monotherapy for the treatment of patients with R/M HNSCC.² The open-label, multicenter, dose-escalation, phase 1 trial is assessing the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PYX-201. Further, investigators will determine the recommended doses of PYX-201 for further study.

The study is including patients with relapsed/refractory solid tumors, including non–small cell lung cancer (NSCLC), hormone receptor–positive breast cancer, ovarian cancer, thyroid cancer, pancreatic ductal adenocarcinoma, soft tissue sarcoma, hepatocellular carcinoma, and kidney cancer. Patients are required to have an ECOG performance status of 0 or 1, a life expectancy of 3 months or more, in the opinion of the investigator, adequate hematologic, hepatic, and renal function, and an adequate coagulation profile.

In the second trial, PYX-201-102, is a phase 1/2 combination study where investigators are evaluating the PYX-201 with pembrolizumab (Keytruda) in patients with histologically or cytologically confirmed advanced solid tumors, including advanced or metastatic triple-negative breast cancer, HR-positive and HER2-negative breast cancer, gastric cancer, cervical cancer, and second-line and higher R/M HNSCC.

This open-label, global, multicenter, dose-escalation and dose-expansion trial is now actively recruiting patients and is on track to initiate dosing.

REFERENCES:

1. Pyxis Oncology granted FDA fast track designation for PYX-201 monotherapy in patients with recurrent or metastatic head and neck cancer. News release. Pyxis Oncology, Inc.February 26, 2025. Accessed February 26, 2025. https://tinyurl.com/3ppysht8

2. Study of PYX-201 in solid tumors. ClinicalTrials.gov. Updated February 6, 2025. Accessed February 26, 2025. https://clinicaltrials.gov/study/NCT05720117?term=NCT05720117&viewType=Table&rank=1

3. Pyxis Oncology initiates new PYX-201 combination trial and initiates cohort expansions of ongoing monotherapy trial. News release. Pyxis Oncology, Inc. February 4, 2025. February 26, 2025. https://tinyurl.com/4y6avp33