Benzinga | Nov 30, 2020 04:01PM EST

Final Data from the Phase Ib Study of Acelarin plus Cisplatin in Patients with Advanced Biliary Tract Cancer Published Online Ahead of Print in The Oncologist

Acelarin plus Cisplatin's High Objective Response Rate and Favorable Safety Profile Confirmed

NuTide:121 Global Phase III Study Recruitment Ongoing

EDINBURGH, United Kingdom, Nov. 30, 2020 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA) announced that the final results of the Phase Ib study of Acelarin plus cisplatin for patients with advanced biliary tract cancer (ABC-08) have been published online ahead of print in The Oncologist. Encouraging interim data had previously been reported and the final data confirm the high objective response rate and favorable safety profile of Acelarin plus cisplatin in this patient population.

In the efficacy-evaluable patient population, the Objective Response Rate was 44%. By comparison, in the ABC-02 study, which led to gemcitabine plus cisplatin becoming the current standard of care for the first-line treatment of patients with advanced biliary tract cancer, an Objective Response Rate of 26% was achieved in the efficacy-evaluable population.

Dr. Mair?ad McNamara, Co-Chief Investigator of the ABC-08 study and Senior Lecturer and Honorary Consultant in Medical Oncology at the University of Manchester and The Christie NHS Foundation Trust remarked: "Acelarin combined with cisplatin demonstrated a favorable safety profile and achieved good tumor control. Responses were seen across all five biliary tract cancer sub-types, including a Complete Response in one patient, a very rare occurrence in this patient population. In ABC-02, only one out of 161 efficacy-evaluable patients who received gemcitabine plus cisplatin achieved a Complete Response. Additionally, one patient with Stable Disease, whose tumor had initially been considered unsuitable for surgical resection, was able to have complete surgical removal of the tumor following treatment with Acelarin plus cisplatin. Four patients were still alive at the end of follow-up, having survived between 16 and 36 months."

"We are very encouraged by the final efficacy and safety data from ABC-08", said Hugh S. Griffith, NuCana's founder and CEO. "We are committed to developing Acelarin plus cisplatin as the first approved front-line treatment for patients with advanced biliary tract cancer. We continue to drive recruitment in the ongoing Phase III NuTide:121 Study where we believe we have the potential opportunity to apply for accelerated approval based on Objective Response Rate. We remain on track to enroll the required number of patients in NuTide:121 by the end of 2021 in order to conduct the first interim analysis in 2022."

Professor Juan Valle, Co-Chief Investigator of the ABC-02, ABC-08 and NuTide:121 studies and Professor and Honorary Consultant in Medical Oncology at the University of Manchester and The Christie NHS Foundation Trust said: "Biliary tract cancer is a devastating disease for which more effective treatments are desperately needed. While targeted therapies and immunotherapies may play a role in the treatment of biliary tract cancer in the future, chemotherapy will remain the backbone of treatment. Medicines like Acelarin, with the potential for improved efficacy and safety, would be welcome additions to the treatment options for patients with biliary tract cancer."