AstraZeneca (AZN) and Merck (MRK) announced detailed results from the Phase 3 SOLO-1 trial testing LYNPARZA 300 mg tablets twice daily as a maintenance treatment for patients with newly-diagnosed advanced BRCA-mutated ovarian cancer who were in complete or partial response following first-line standard platinum-based chemotherapy. Results of the trial confirm the statistically-significant and clinically-meaningful improvement in progression-free survival for LYNPARZA as compared to placebo, reducing the risk of disease progression or death by 70%. At 41 months of follow-up, the median PFS for patients treated with LYNPARZA was not reached compared to 13.8 months for patients treated with placebo. Of those receiving LYNPARZA, 60.4% remained progression-free at 36 months, compared to 26.9% of women in the placebo arm. The SOLO-1 safety profile was in line with that observed in prior clinical trials. 71% of patients on LYNPARZA remained on the recommended starting dose. Additionally, 88% of patients on LYNPARZA continued treatment without an AE-related discontinuation. Further, 48% of patients on LYNPARZA did not have a dose interruption as a result of an AE. Per SOLO-1 protocol guidelines, patients who demonstrated a complete response at two years stopped treatment with LYNPARZA; patients who demonstrated a partial response and, who in the opinion of the treating physician can derive further benefit from continuous treatment, were treated beyond two years. AstraZeneca and Merck are exploring additional trials in ovarian cancer, including the ongoing GINECO/ENGOTov25 Phase 3 trial, PAOLA-1. This trial is testing the effect of LYNPARZA in combination with bevacizumab as a maintenance treatment for patients with newly-diagnosed advanced ovarian cancer regardless of their BRCA status. Results are expected during the second half of 2019. LYNPARZA is not currently FDA-approved for advanced BRCAm ovarian cancer treatment in the first-line maintenance setting. LYNPARZA is indicated for the maintenance treatment of recurrent ovarian cancer in response to platinum-based chemotherapy regardless of BRCA mutation status, and for the treatment of advanced ovarian cancer patients with a germline BRCA mutation previously treated with three or more lines of chemotherapy. Physicians should select advanced ovarian cancer patients for therapy based on a FDA-approved companion diagnostic.

NuCana announced combined results from cohorts one and two of the ABC-08 study at the European Society for Medical Oncology Congress 2018 in Munich, Germany. In this Phase Ib multi-center, open-label study in front-line treatment of patients with advanced biliary tract cancer, Acelarin combined with cisplatin was observed to continue to achieve approximately a doubling of the response rate expected with the standard of care, gemcitabine plus cisplatin. In addition, results showed the combination was well-tolerated and several patients achieved significant reductions in their tumor volume as well as further tumor shrinkage over time. Fourteen patients with advanced/metastatic biliary tract cancer received Acelarin and cisplatin on days one and eight of a three-week cycle. In the intent-to-treat group of patients, a Complete Radiological Response was achieved in one patient and a Partial Response in six patients, resulting in an Objective Response Rate of 50%. In the eleven Efficacy Evaluable patients, an Objective Response Rate of 64% was achieved. Additionally, the combination of Acelarin and cisplatin was well-tolerated over multiple cycles with no unexpected adverse events, no dose-limiting toxicities, no discontinuations due to Acelarin-associated toxicity and no Grade 4 adverse events. Based on these data from the ABC-08 study and discussions with the U.S. Food and Drug Administration, NuCana anticipates initiating a global randomized Phase III clinical study comparing Acelarin and cisplatin with gemcitabine and cisplatin in patients with front-line advanced biliary tract cancer.