FDA Grants Fast Track Designation to LYT-200 in Head and Neck Cancers

Tumor microenvironment background with cancer cells: © ratatosk - stock.adobe.com

• The FDA granted fast track designation to LYT-200 plus anti-PD-1 therapy for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
• Ongoing phase 1/2 clinical trials are evaluating the agent in HNSCC and hematologic malignancies.
• In March 2024, the FDA granted orphan drug designation to the agent in acute myeloid leukemia (AML).

LYT-200, an antibody directed against galectin-9, has been granted a fast track designation by the FDA for the treatment of patients with recurrent or metastatic HNSCC, according to PureTech Health.¹

The fast track designation was created to streamline the development and assessment of drugs that fill serious unmet needs.

“In the US, there are approximately 66,000 people diagnosed with head and neck cancers each year, and the prognosis for metastatic disease is unfavorable, with a median survival rate of about 10 months,” said Eric Sherman, MD, Memorial Sloan Kettering Cancer Center and an investigator in PureTech’s phase 1/2 clinical trial, in a press release. “There is an important need to explore promising new mechanisms and targets such as galectin-9 to bring therapeutic innovation to this patient population.”

LYT-200 is the subject of 2 ongoing clinical trials. A phase 1/2 trial (NCT04666688) is evaluating the agent alone and in combination with chemotherapy or tislelizumab (Tevimbra) in patients with locally advanced or metastatic solid tumors, including HNSCC.² The study’s primary end points are safety, tolerability, and preliminary efficacy. Secondary end points include pharmacokinetics and pharmacodynamics.

Part 1 of the study is a dose escalation of single-agent LYT-200, followed by dose expansion of LYT-200 plus gemcitabine/nab-paclitaxel or tislelizumab. Part 2 of the study is a combination dose expansion based on outcomes from part 1.

Patients with HNSCC or urothelial carcinoma are eligible for enrollment in the study, which is recruiting across sites in California, Colorado, Florida, Massachusetts, Michigan, New York, Tennessee, and Texas.

“By granting fast track designation to LYT-200 for head and neck cancers, the FDA continues to highlight areas of critical need within oncology as well as the potential for LYT-200,” said Aleksandra Filipovic, MD, PhD, head of oncology at PureTech, in a press release.¹ “As galectin-9’s role in suppressing immune-mediated activity has been well-validated, it represents an important area of clinical research, especially in aggressive cancers with increased mortality.”

The FDA granted an orphan drug designation to LYT-200 in AML in March 2024.1 A phase 1 study (NCT05829226) is investigating the agent in patients with relapsed/refractory AML or myelodysplastic syndrome.³

REFERENCES:

1. PureTech receives FDA fast track designation for LYT-200 in head and neck cancers. News release. April 11, 2024. Accessed April 11, 2024. https://tinyurl.com/4bum5hkk

2. LYT-200 alone and in combination with chemotherapy or tislelizumab in patients with locally advanced or metastatic solid tumors. ClinicalTrials.gov. Updated April 2, 2024. Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT04666688

3. A phase 1 study with LYT-200 in patients with relapsed/refractory acute myeloid leukemia (AML) or with relapsed/refractory, high-risk myelodysplastic syndrome (MDS). ClinicalTrials.gov. Updated January 11, 2024. Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT05829226