Long-Term Follow-Up of Phase I Trial of Oncolytic Adenovirus-Mediated Cytotoxic and Interleukin-12 Gene Therapy for Treatment of Metastatic Pancreatic Cancer.
Aseem Rai BhatnagarFarzan SiddiquiGazala KhanRobert PompaDavid KwonShyam NyatiPublished in: Biomedicines (2024)
The long-term follow-up findings of the phase I trial evaluating the efficacy of oncolytic adenovirus-mediated cytotoxic and interleukin-12 gene therapy in metastatic pancreatic cancer (mPC) seem very promising. The study employed a replication-competent Adenovector in combination with chemotherapy in a dose-escalation format. The trial demonstrated a clinically meaningful median overall survival (OS) benefit, with patients in the highest dose cohort exhibiting an impressive median OS of 18.4 months. This contrasts starkly with patients receiving lower doses who experienced a median OS of 4.8 and 3.5 months, respectively. Remarkably, subject number 10, who received the highest dose, demonstrated an extraordinary survival of 59.1 months, presenting a compelling case for further exploration. Additionally, this patient displayed complete responses in lung and liver metastases, a rare occurrence in mPC treatment. Statistical analyses supported the observed survival benefit. The unprecedented OS results emphasize the potential of this treatment strategy and pave the way for future investigations into this promising gene therapy approach.
Keyphrases
- gene therapy
- study protocol
- squamous cell carcinoma
- small cell lung cancer
- clinical trial
- phase iii
- end stage renal disease
- chronic kidney disease
- randomized controlled trial
- liver metastases
- phase ii
- risk assessment
- newly diagnosed
- radiation therapy
- open label
- combination therapy
- replacement therapy
- smoking cessation
- chemotherapy induced