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Subset analysis data presented at ASCO-GI (Gastrointestinal Cancers Symposium) highlight the potential of masitinib in pancreatic cancer. In particular, the improvement in overall survival of six months in patients with a specific biomarker compares very favourably with other combinations. A decision on European approval is conditional on both this and the GIST indication due in Q4/13, which is likely to be a key value driver for the shares.

Impressive subset analyses in easy to identify populations
More details on the masitinib subset analyses in pancreatic cancer were presented at ASCO-GI in January. Overall survival (OS) in pain patients treated with masitinib improved by 2.7 months versus gemcitabine alone (p=0.01). This population included even mild pain patients, defined by a score of >20mm on the VAS 100mm scale. 18 month survival rates were 18.2% for masitinib versus 7.8% for placebo. Data were even more impressive in patients with a specific, but as yet unknown, biomarker with OS improved six months versus gemcitabine alone (p=0.000038). 18 month survival rates were 18.5% for masitinib versus 4.2% for placebo. Although the overall trial did not hit its primary endpoint, with no significant difference in OS between masitinib (7.7 months) versus placebo (7.0 months), these subset analyses appear very favourable compared with recent headline data for Celgene’s Abraxane which demonstrated a 1.8-month OS improvement versus gemcitabine alone.

Data could pave the way for conditional approval this year
AB Science (AB) intends to confirm these results in prospectively designed Phase III clinical trials, and is working with Skuldtech on a companion diagnostic for the biomarker. In the meantime, masitinib is filed with EMA for conditional approval in pancreatic cancer, with a decision due Q413.

Masitinib could have significant potential
Pancreatic cancer and GIST (gastro-intestinal stromal tumour) are critical, unmet medical challenges; hence masitinib could have significant potential for both. It has also been filed for approval in Europe in GIST, with a decision due Q413, and is being investigated in a number of other indications including mastocytosis, asthma and Alzheimer’s disease.

Valuation: EV of c €598m
Based on Q312 net cash of €27.6m implies an EV of €598m. Share price movements will likely be driven by masitinib newsflow. In FY13, there should be more data reported in mastocytosis, multiple myeloma, GIST and most importantly, the potential EMA conditional approvals in pancreatic cancer and GIST in Q413.

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