Exhibit 99.1
Enrollment in the Independent Investigator-Sponsored Phase III Metastatic Pancreatic Study ACELARATE Has Been Suspended Following a Prespecified Futility Analysis
Imbalances in Prognostic Factors May Have Impacted Analysis
Longer-termFollow-up by Study Sponsor is Ongoing to Determine Path Forward
Encouraging Survival Trends Observed in PatientSub-Groups Receiving Acelarin Monotherapy Informs Future Development in Pancreatic Cancer
Liverpool, United Kingdom, August 20, 2019 (GLOBE NEWSWIRE) – NuCana plc (NASDAQ: NCNA) reported that it has been informed by the Clatterbridge Cancer Centre, the sponsor of the ongoing Phase III ACELARATE study, that the enrollment of new patients has been suspended on the advice of the Independent Safety and Data Monitoring Committee (ISDMC) following completion of a prespecified futility analysis. This study has enrolled 200 patients with metastatic pancreatic cancer who were not considered suitable for combination chemotherapy and is designed to evaluate the efficacy and safety of Acelarin monotherapy compared to gemcitabine, with further exploration of patientsub-groups that may derive additional benefit from Acelarin.
A futility analysis was included in the ACELARATE study design to assess the likelihood of the study achieving its primary objective of Acelarin monotherapy demonstrating at least a 42% reduction in risk of death compared to gemcitabine. This analysis indicated that this efficacy objective was unlikely to be met in this difficult to treat patient population. Upon review of the interim data by the ISDMC, the sponsor decided to suspend recruitment, allow the data to mature and conduct additionalsub-group analyses. Patients who are deriving benefit can continue treatment with Acelarin. There are 25 patients who are receiving or have received Acelarin monotherapy and who will continue to be followed by the study sponsor.
Professor Daniel Palmer, Director of the Liverpool CRUK/NIHR Experimental Cancer Medicine Centre and Chief Investigator of the ACELARATE study said: “Metastatic pancreatic cancer remains an area of high unmet need and the population included in ACELARATE have particularly poor outcomes and very limited treatment options. Importantly, there were imbalances in unfavorable prognostic factors for the patients in the Acelarin arm which may have impacted the futility analysis. In particular, 54% of the patients in the Acelarin arm were diagnosed at the most advanced stage T4, compared to 36% of patients in the gemcitabine arm. We need to allow the data to mature and conduct additional analyses, including biomarker assessment, in order to determine the most appropriate course of action.”
Professor Palmer continued: “Although this futility analysis indicated that the study was unlikely to achieve its overall survival objective, I am encouraged by the positive survival trends observed in patientsub-groups receiving Acelarin. Furthermore, there were no new safety signals.”