Industry Trend Analysis - SDP Will Face Challenges As Napabucasin Falters In Advanced Gastric Cancer - AUG 2017


BMI View : Sumitomo Dainippon Pharma is set to face challenges with receiving market approval for napabucasin in advanced gastric cancer. The company will aim to obtain market authorisation in other indications. Positive results i n any of these trials will lead to an increase in investor confidence .

Sumitomo Dainippon Pharma (SDP) will face difficulty to claim a market share of the oncology market, with its most advanced product struggling to make the clinical primary endpoint of its potential market approval Phase III study. The firm decided to unblind the BRIGHTER study, a Phase III global study in patients with gastric and gastro-oesophageal junction (GEJ) cancer of napabucasin (BBI608), an investigational cancer stemness inhibitor, based on a recommendation by the study's independent Data and Safety Monitoring Board (DSMB), following a pre-specified interim analysis. The study will be continued as an open label study to follow all endpoints as defined in the protocol. The DSMB determined that the study was unlikely to reach its primary endpoint of superior overall survival (OS) for the napabucasin arm versus the control arm at the conclusion of the study. No safety concerns were identified by the DSMB. SDP remains committed to other ongoing Phase III studies (CanStem303C for colorectal cancer [CRC], CanStem111P for pancreatic cancer [PC]) with an aim to obtain marketing authorisation of napabucasin as early as possible.

The BRIGHTER study is a randomised, double-blind global Phase III study to evaluate the efficacy and safety of administration of napabucasin+weekly paclitaxel in comparison with weekly paclitaxel alone. A total of 714 patients with advanced gastric and GEJ cancer were previously treated with one prior line of platinum/fluoropyrimidine-containing regimen, randomised in a 1:1 ratio to receive napabucasin+weekly paclitaxel or weekly paclitaxel alone. The primary endpoint is OS in the general study population; secondary endpoints include progression free survival (PFS), OS and PFS in a predefined biomarker-positive sub-population, objective response rate, disease control rate and safety.

Napabucasin Slow To Set Off
Napabucasin Estimated Product Revenues (USDmn)
Source: Bloomberg, BMI

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