PHILADELPHIA, PA — Geneos Therapeutics announced that two patients with aggressive cancers have achieved long-term survival on its personalized immunotherapy for cancer (PIC) monotherapy, with one patient living more than six years recurrence free after treatment for glioblastoma multiforme (GBM) and another remaining cancer free for over five years following treatment for advanced hepatocellular carcinoma (HCC).
Both patients achieved complete responses and remain healthy, with no PIC-related serious adverse events reported. Additional patients in Geneos’ clinical trials for GBM and HCC continue to approach five years of recurrence-free survival, results that the company says underscore the potential durability and tolerability of its DNA-based approach.
“Geneos’ PICs as monotherapy have now enabled patients with two distinct, difficult-to-treat, rapidly progressing cancers to live beyond five years, recurrence free and healthy,” said Niranjan Sardesai, Ph.D., President and Chief Executive Officer of Geneos. “These results are encouraging and we look forward to advancing our clinical program so that we may bring this potential new treatment option to people living with aggressive cancers rapidly.”
The U.S. Food and Drug Administration recently issued draft guidance identifying overall survival as a key endpoint in oncology trials. Geneos believes the long-term survival observed in its patients aligns with this regulatory framework and strengthens the case for broader clinical development.
“Durable overall survival of five years or more in GBM and advanced HCC are uncommon, while recurrence-free survival is almost unheard of,” said Geneos Chief Medical Officer Ildiko Csiki, M.D., Ph.D. “If confirmed in larger datasets, we expect these results to align with FDA’s guidance on overall survival as a primary endpoint for registrational studies.”
The GBM patient began PIC monotherapy one year after diagnosis and has now reached 75 months of recurrence-free survival, compared with a median of 26 months for standard treatment. The HCC patient, treated initially with a PIC-pembrolizumab combination before moving to monotherapy, has now achieved 60 months of recurrence-free survival, well above the typical 14-month median overall survival for similar cases.
PICs are designed to induce tumor-infiltrating lymphocytes by incorporating up to 43 patient-specific cancer neoantigens, a process that Geneos says consistently generates robust CD8+ T cell responses. Unlike mRNA-based immunotherapies, which are often limited to short treatment durations, PICs are engineered for long-term tolerability, enabling sustained therapy to reduce recurrence risks.
Geneos plans to advance development of PIC monotherapy through its GT-31 Phase 2b trial, which will evaluate the treatment as adjuvant immunotherapy for patients with HCC.
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