Masitinib study misses endpoint
Enlarge image

Clinical trailsFrance

Masitinib study misses endpoint

01.11.2012 - French AB Science’s cancer drug Masitinib failed to improve overall survival in a Phase III study. But certain patient groups might benefit from the treatment.

The double-blind, international Phase III trial enrolled 348 patients with pancreatic cancer and compared masitinib plus Gemzar treatment with Gemzar treatment alone. There was no significant change in the overall survival time of the patients (7.7 vs. 7 months, p=0.74), said the French drugmaker. But in a subgroup of patients with an undisclosed genetic biomarker which is thought to be indicative of aggressive disease progression, the orally administered tyrosine kinase inhibitor masitinib plus Gemzar significantly improved median overall survival vs. placebo plus Gemzar (11 vs. 5 months, p=0.000038). In a second subgroup of patients with a pain intensity level above an undisclosed threshold at baseline, the orphan drug plus Gemzar also significantly improved median overall survival vs. placebo plus Gemzar (8.1 vs. 5.4 months, p=0.01). These two independent patient populations represented 65% and 45%, respectively, of the overall population, according to AB Science.

AB Science also announced that the European Medicines Agency (EMA) has accepted to review the Marketing Authorization Application (MAA) for conditional approval of masitinib in combination with Gemzar in the treatment of non-resectable, advanced adenocarcinoma pancreatic cancer „ on the basis of results from a Phase III study that showed masitinib in combination with Gemzar significantly extends overall survival in two independent patient populations having the worst prognosis.“ Masitinib targets the stem cell factor (SCF) receptor tyrosine kinase (CD117).

Masitinib has been available in Europe since the second part of 2009 as a treatment of mast cell tumors in animals (Masivet), specifically dogs. In the US it is distributed under the name Kinavet by AB Science and has been available for veterinaries since 2011.



26.11.2015 Bioeconomy movers and shakers from every corner of the globe met this week at the world’s first Global Bioeconomy Summit in Berlin to discuss, debate and define better ways to ensure the bioeconomy succeeds on an international level.


24.11.2015 After weeks of speculation it is official: US pharma major Pfizer and Irish Botox maker Allergan will merge. With the deal, Pfizer is planning to dodge the high US taxes, causing indignation among US politicians.


23.11.2015 Amidst talk of the IPO window closing and cancelled flotations, diagnostics firms are still striking a chord with investors. Swedish Immunovia and German Curetis are successfully raising public money.


20.11.2015 French Sanofi and British AstraZeneca are giving open innovation a go: The two pharma giants will exchange thousands of compounds – for free.


19.11.2015 French gene editing company Cellectis has granted Servier the rights to bring cancer immunotherapy UCART19 to market. Servier in turn has teamed up with Pfizer to hurry development along.


17.11.2015 The first Italian accelerator specifically for biotech projects has been launched with help from Sofinnova Partners. The plan of BiovelocITA: to help Italy grow into one of Europe’s strongest biotech markets.


13.11.2015 Scientists in Bath, UK, have developed a medical dressing that turns fluorescent green when it detects infection. The researchers hope that the smart burns dressing will help fight antibiotic resistance.


13.11.2015 Out with the old: Roche is discarding four sites with 1,200 staff in an effort to restructure its manufacturing network for small molecules. Instead, a new manufacturing site will be built in Switzerland.


10.11.2015 Algae have many skills, but cancer fighting was not one of them – until now. Researchers from Australia and Germany have genetically engineered diatom algae to accurately deliver chemotherapeutic drugs.


10.11.2015 AstraZeneca has plucked Californian biopharma company ZS Pharma from under Actelion’s nose. The UK company is paying US$2.7bn (€2.5bn) to acquire ZS and its promising hyperkalaemia treatment currently under US regulatory review.


All Events


Strasbourg (F)

BioFIT 2015

Current issue

All issues

Product of the week


Stock list

All quotes


  • EPIGENOMICS (D)2.26 EUR20.86%
  • SAREUM HOLDINGS (UK)0.21 GBP10.53%


  • THERAMETRICS (CH)0.04 CHF-20.00%
  • CO.DON (D)2.35 EUR-7.84%
  • DIAMYD MEDICAL -B- (S)9.40 SEK-6.00%


  • PLETHORA (UK)5.50 GBP76.3%
  • PROTHENA PLC (IE)73.19 USD40.9%


  • EPIGENOMICS (D)2.26 EUR-49.9%
  • EVOCUTIS (UK)0.09 GBP-40.0%


  • KARO BIO (S)37.80 SEK5300.0%
  • CHRONTECH PHARMA (S)0.34 SEK1600.0%
  • GALAPAGOS (B)46.32 EUR259.1%


  • BIOTEST (D)15.77 EUR-80.4%
  • EVOCUTIS (UK)0.09 GBP-78.6%

No liability assumed, Date: 26.11.2015