NuCana plc NCNA announced that it has suspended enrollment of patients in the ongoing phase III ACELARATE study on its most advanced pipeline candidate Acelarin. The study was evaluating the safety and efficacy of Acelarin as a monotherapy compared to Eli Lilly’s LLY Gemzar (gemcitabine) for the treatment patients with metastatic pancreatic cancer, unsuitable for combination chemotherapy.
The decision to stop the enrollment process came after a prespecified futility analysis carried out by the Independent Safety and Data Monitoring Committee, which showed that the primary efficacy endpoint was unlikely to be achieved. The primary objective of the study was to check whether Acelarin as a monotherapy could demonstrate 42% reduction in death risk compared to Gemzar.
Per the company, the imbalances in unfavorable prognostic factors might have impacted the futility analysis for patients in the Acelarin arm. Moreover, in the same arm, 54% patients was diagnosed at the most advanced stage T4 compared with only 36% in the Gemzar arm.
The company will now allow the data to mature and conduct additional sub-group analyses including biomarker assessment to decide the path forward for this study.
NuCana was informed by the Clatterbridge Cancer Centre, the sponsor of this ongoing late-stage study, to discontinue enrollment in the same. Notably, this study targets a difficult-to-treat patient population, facing particularly poor outcomes with very limited treatment options.
However, despite this negative outcome, which indicated that the study was unlikely to meet its overall survival goal, it still showed positive survival trends in patient sub-groups, who received Acelarin.
Shares of NuCana have plunged 45.1% so far this year, wider than the industry’s decline of 1.2%.
We would like to remind investors that Acelarin is a ProTide transformation of Gemzar. The ProTide technology is a prodrug approach used in molecular biology and drug design.
In June this year, the FDA granted an orphan drug designation to Acelarin for the treatment of patients with biliary tract cancer, better known as cholangiocarcinoma.
Notably, a phase Ib study is evaluating Acelarin in combination with the chemotherapy drug cisplatin compared to the combo of Lilly’s Gemzar plus cisplatin, which is the current standard of care treatment. The study showed that the combo of Acelarin+cisplatin nearly doubled the expected response rate compared to the standard of care.
NuCana plans to begin a global phase III study later in 2019 on the Acelarin combo as a front-line treatment for patients with advanced biliary tract cancer. The candidate is also being evaluated in a phase II study for treating patients with platinum-resistant ovarian cancer. Interim results from this study are also expected later this year.
Zacks Rank & Stocks to Consider
NuCana currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Alexion Pharmaceuticals, Inc. ALXN and Alder BioPharmaceuticals, Inc. ALDR, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Alexion’s earnings estimates have been revised 4.2% upward for 2019 and 2.1% for 2020 over the past 60 days. The stock has rallied 14.5% year to date.
Alder BioPharmaceuticals’ loss per share estimates have been narrowed 6.8% for 2019 and 2.6% for 2020 over the past 60 days.
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