Otolaryngology ·
FDA approves Voceryq, first U.S. plasmid DNA immunotherapy, for RRP; petosemtamab improves head and neck cancer survival; proton reirradiation works
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The Food and Drug Administration (FDA) granted accelerated approval Oct. 30 to Inovio Pharmaceuticals' Voceryq for adults with recurrent respiratory papillomatosis. The agency said it is the first plasmid DNA-based immunotherapy approved in the U.S. A multicenter phase 2 trial in Cancer reported that proton reirradiation met locoregional control end points in recurrent head and neck cancer.
Genmab said petosemtamab plus pembrolizumab improved overall survival in first-line recurrent or metastatic head and neck cancer, according to topline results.
THE DETAILS
- FDA Oct 30, 2026The Food and Drug Administration (FDA) granted accelerated approval Oct. 30 to Inovio Pharmaceuticals' Voceryq for adults with recurrent respiratory papillomatosis, based on reduced frequency of surgery, an intermediate end point the agency said is reasonably likely to predict clinical benefit. In an open-label multicenter trial of 32 adults, seven of 26 patients (27%) with at least three baseline surgeries needed no surgery in the first year after treatment. Voceryq is given by intramuscular injection with the CELLECTRA 5PSP device. Post-approval trials must verify its clinical benefit.Source: FDA
- Research Oct 28, 2026Genmab reported topline results from the phase 3 LiGeR-HN1 trial in first-line PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma that could not be treated with curative-intent local therapy. Adding petosemtamab, a bispecific antibody against EGFR and LGR5, to pembrolizumab gave a hazard ratio for overall survival of 0.50 (95% CI 0.37 to 0.67; P < .0001) at the first interim analysis, with an odds ratio for objective response of 3.17, regardless of HPV status. No new safety signals were identified, the company said. Full results have not been presented or peer reviewed.
- Research Oct 30, 2026In a multicenter prospective phase 2 trial in Cancer, 85 patients with previously irradiated head and neck cancer received fractionated proton reirradiation (57 patients) or a QUAD shot regimen (28 patients). Locoregional recurrence-free rates were 71% at 12 months for the fractionated approach and 76% at six months for QUAD shot, both surpassing prespecified success thresholds. Late toxicity attributable to reirradiation reached grade 3 in 20% of patients, grade 4 in 11% and grade 5 in 4%, and five-year overall survival was 29%.
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