High-grade serous ovarian cancer (HGSOC) is characterised by genomic scarring with few driving oncogenes. Approximately 50% of HGSOCs are characterised by alterations of genes involved in the homologous recombination (HR) DNA repair pathway, most frequently BRCA1/21. HR deficient tumours are sensitive to platinum-based chemotherapy and Poly-(ADP-ribose) polymerase (PARP) inhibitors (PARPi), however, resistance to therapy is associated with acquired HR proficiency. Thus, novel approaches that circumvent primary and acquired HR proficiency will provide a major advance in ovarian cancer therapy.
Cancer cells display high rates of ribosome synthesis. The ribosome is a complex of ribosomal RNAs (rRNA) and ∼78 ribosomal proteins. Hyperactivation of RNA polymerase I (Pol I) transcription of the rRNA genes is a consistent feature of cancer cells. We have demonstrated that inhibition of Pol I transcription using CX-5461 can selectivity kill cancer cells in vivo2-4. Our studies led to phase I clinical trials of CX-5461 in haematologic (Peter Mac) and breast cancers (Canada).
We recently demonstrated that CX-5461 activates a DNA damage response (DDR) specifically in the nucleoli, the site of Pol I transcription. Furthermore, the potency of CX-5461 in killing cancer cells in vivo is significantly enhanced in combination with DDR inhibitors5. Here we demonstrate that CX-5461 has substantial efficacy in HGSOC cell lines and that sensitivity to CX-5461 is associated with BRCA1 mutation gene signature. CX-5461 exhibits synthetic lethality with HR deficiency and has significant therapeutic efficacy in vivo in HR-deficient HGSOC patients-derived xenograft (PDX) models. Notably, CX-5461 in combination with PARPi has significant therapeutic benefit in HR-proficient HGSOC cells in vitro and PARPi-refractory PDXs in vivo. Thus, our data provide direct evidence for the effectiveness of this combination approach for the treatment of acquired HR-proficient HGSOC. Hence, a phase I/II trial of CX-5461 in HGSOC will be initiated at Peter Mac in 2018.