Triple-combination therapy extends survival in HPV-positive cancers
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A triple-therapy combination extended OS compared with historical data among certain patients with advanced HPV-positive cancers, according to one of the agent’s manufacturers.
PDS0101 (PDS Biotechnology) is a T-cell HPV-specific immunotherapy shown to stimulate high levels of HPV16-specific CD8-positive and CD4-positive T cells via activation of multiple immune pathways.
The phase 2 NCT04287868 trial evaluated PDS0101 in combination with M9241 (MerckKGaA) — a tumor-targeting IL-12 fusion protein — and bintrafusp alfa (Merck KGaA), a bifunctional fusion protein that targets two independent immunosuppressive pathways, for patients with advanced HPV-positive anal, cervical, head and neck, vaginal or vulvar cancers.
All study participants had failed chemotherapy and 90% had failed radiation treatment. Some were checkpoint inhibitor naive, and others were refractory to checkpoint inhibitors.
Researchers at NCI’s Center for Cancer Research released expanded data from an interim efficacy analysis of 50 patients, including 37 with HPV16-positive disease.
Investigators reported median OS of 21 months among 29 checkpoint inhibitor-refractory patients, according to a PDS Biotechnology press release. The historical median OS for that population of 3 months to 4 months.
Three-fourths of checkpoint inhibitor-naive patients remained alive after a median follow-up of 27 months. Historical median OS for similar patients is of 7 to 11 months, according to the press release.
Researchers reported a 63% overall response rate among checkpoint inhibitor-refractory patients who received the optimal dose of the triple combination. The ORR with current approaches is less than 10%, according to the press release.
Investigators reported an ORR of 88% among checkpoint inhibitor-naive patients who received the triple combination. FDA-approved checkpoint inhibitors result in ORRs of less than 25% among patients with HPV-associated cancers, according to the press release.
Highlights of these data appeared consistent with results presented previously at ASCO Annual Meeting, as well as other interim data released last fall.
“The expanded data continue to demonstrate the durability and tolerability of the PDS0101-based triple combination therapy in advanced HPV-positive cancers, an extremely challenging population of refractory and previously untreatable HPV-positive patients,” Frank Bedu-Addo, PhD, president and CEO of PDS Biotech, said in the press release. “We are pleased to see the continued consistency in the data with each update and we look forward to meeting with the FDA to discuss the registrational pathway.”
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