Geneos Therapeutics announced that two patients with aggressive cancers have achieved remarkable long-term survival outcomes with the company's personalized immunotherapy for cancer (PIC) monotherapy. One patient with glioblastoma multiforme (GBM) has remained recurrence-free for more than six years, while another with advanced hepatocellular carcinoma (HCC) has achieved over five years of recurrence-free survival. Both patients achieved complete responses and experienced no PIC-related adverse events greater than Grade 1.
Exceptional Survival Outcomes in Difficult-to-Treat Cancers
The glioblastoma patient, who presented at age 21 with an IDH-positive, methylated tumor, has now reached 75 months of recurrence-free survival and is 87 months from surgical resection. This represents a significant improvement over the median recurrence-free survival of 26 months and overall survival of 40 months typically seen in this setting. The patient received standard of care treatment including surgery, radiation, and temozolomide, plus two experimental treatments before beginning PIC monotherapy one year after diagnosis.
The hepatocellular carcinoma patient, age 61 at presentation, had a beta catenin mutated form of HCC that had progressed despite liver resection and treatment with an oncolytic virus and sorafenib. After enrollment in Geneos' GT-30 Phase 1b/2a trial, the patient received two years of combination therapy with PIC and pembrolizumab before converting to PIC monotherapy per protocol. This patient has achieved 60 months of recurrence-free survival, substantially exceeding the median overall survival of 14 months and progression-free survival of three to four months typically observed in PD-1 treated HCC patients.
DNA-Based Personalized Immunotherapy Platform
PICs are DNA-based tumor-infiltrating lymphocyte (TIL)-inducing agents containing up to 43 of a patient's specific cancer neoantigens. According to Geneos, these therapies have demonstrated a 100% success rate in inducing CD8+ activated cytotoxic T effector memory cells that traffic to tumors, representing the first immunotherapeutic to achieve this metric. Unlike experimental mRNA-based personalized immunotherapeutics typically administered for no more than nine months, the tolerability profile of PICs supports uninterrupted treatment over years to maintain TIL response and minimize recurrence or progression risk.
Regulatory Alignment and Clinical Development
The U.S. Food and Drug Administration recently released draft guidance identifying overall survival as a key endpoint in oncology trials. Geneos believes the long-term survival observed in PIC-treated patients aligns with these regulatory expectations 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 Ildiko Csiki, M.D., Ph.D., Geneos Chief Medical Officer. "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."
Future Clinical Development
Geneos is actively preparing to advance PIC monotherapy development in the upcoming GT-31 Phase 2b randomized, controlled clinical trial as adjuvant immunotherapy for patients with HCC. Additional clinical trial patients with GBM and advanced HCC receiving PIC monotherapy continue to progress toward five years of recurrence-free survival.
"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 – living rich, fulfilling lives," said Niranjan Sardesai, Ph.D., President and Chief Executive Officer of Geneos. "These cases, together with our broader clinical trial results, highlight the durability and tolerability we believe to be achievable with our DNA-based PIC therapy."
