Dr Weiss on Outcomes With Versamune HPV Plus Pembrolizumab in HPV16+ HNSCC

Jared Weiss, MD, professor, medicine, Division of Oncology, Department of Medicine, University of North Carolina (UNC) School of Medicine;associate director, finance, UNC Lineberger Clinical Protocol Office,UNC Lineberger Comprehensive Cancer Center in Chapel Hill, discusses outcomes with the novel therapeutic cancer vaccine Versamune HPV (PDS0101) plus standard first-line pembrolizumab (Keytruda) in patients with human papillomavirus (HPV)16–positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Results from the phase 2 VERSATILE-002 trial (NCT04260126), presented at the 2024 ESMO Congress, demonstrated strong clinical activity and a tolerable safety profile in patients with HPV16-positive HNSCC, Weiss begins. Patients with recurrent or metastatic HPV16-positive HNSCC were enrolled onto the study and treated with a standard dose of pembrolizumab plussubcutaneous injection of Versamune HPV.

At the data cutoff of May 17, 2024, and with a median follow-up of 16 months, patients with a combined positive score of 1 or higher (n = 53) achieved a median overall survival of 30 months (95% CI, 19.7-not evaluable) and a median progression-free survival of 6.3 months, he states.

The objective response rate (ORR) was 35.8%, including 9.4% complete responses, and the disease control rate (DCR) was 77.4%. Notably, 21% of patients experienced tumor shrinkage between 90% and 100%. Twenty-seven patients remain in follow-up for survival, and 10 were still on treatment at the time of this analysis.

The safety profile was consistent with expectations for pembrolizumab, based on results from the phase 3 KEYNOTE-048 trial (NCT02358031) and typical clinical practice, Weiss continues. Most treatment-related adverse events were mild, with injection site reactions (grade 1 or 2) being the only notable addition. Notably, 9 patients reported grade 3 or higher adverse effects, he adds.

These results support the ongoing investigation of the Versamune HPV vaccine combined with pembrolizumab in the phase 3 VERSATILE-003 trial, which will compare the regimen against pembrolizumab monotherapy in patients with HPV16-positive HNSCC.