Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC, Nasdaq:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer biology, announced the initiation of a Phase 1b/2 investigator-sponsored clinical trial to evaluate the safety and effectiveness of sapacitabine in combination with olaparib in patients with BRCA mutant breast cancer. The trial will be conducted at the Dana-Farber Cancer Institute with collaborators Cyclacel and AstraZeneca providing sapacitabine investigational drug and the approved PARP-inhibitor olaparib (LynparzaTM), respectively.
“Despite advancements in the treatment of BRCA positive breast cancer, we are continually searching for ways to improve on the standard of care for this disease which carries a poor prognosis for the majority of individuals,” said Sara M. Tolaney, MD, MPH, instructor of medicine, Harvard Medical School, attending physician of medical oncology, Dana-Farber Cancer Institute and Principal Investigator of the study. “PARP inhibitor monotherapy is the current standard of care for breast and ovarian cancers with homologous recombination deficient (HRD) cancers, which include those positive for BRCA mutations. The study will help determine if the all-oral combination of sapacitabine and olaparib could provide additional benefit to these patients for whom limited treatment options exist.”
“Preclinical data support additivity or synergy of sapacitabine with PARP inhibitors. We believe that dual targeting of the DNA damage response pathway with the addition of sapacitabine to olaparib may enhance the efficacy of the current standard of care for patients with BRCA positive breast cancer,” said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. “We are excited about this collaboration and the potential to improve outcomes for a difficult to treat patient population with a convenient, orally administered drug combination.”
The investigator-sponsored Phase 1b/2 study will enroll approximately 64 patients with breast cancer and BRCA1 or BRCA2 mutation. The primary endpoints are to determine maximum tolerated dose, recommended Phase 2 dose and objective response rate. Progression-free survival will be assessed as a secondary endpoint. The first of two parts of the study will assess safety and tolerability of escalating doses of the combination. The second part will assess efficacy of the recommended Phase 2 dose in 18 patients. If a prespecified number of these patients achieve a complete or partial response per RECIST 1.1 criteria, the study will be expanded to a further 28 patients (www.clinicaltrials.gov, NCT03641755).