Third failure for Sanofi/Merrimack cancer drug
pharmafile | November 27, 2013 | News story | Research and Development, Sales and Marketing | Cancer, Sanofi, merrimack, mm-121
Sanofi and partner Merrimack have posted yet more disappointing results for their investigational cancer medicine MM-121.
In the latest study results the drug failed to increase progression-free survival (PFS) when combined with Pfizer’s Aromasin (exemestane) compared to Aromasin alone.
The drugs were looking to treat ER/PR+ metastatic breast cancer patients who have previously failed anti-estrogen therapy.
The firms said that its overall survival data was still too immature but added it “trended in favour of the MM-121 arm”.
The two firms were also at pains to point out that the drug did show some benefit in a small sub-population of patients after analysing a series of biomarkers.
“The biomarker results of this study support the hypothesis that ErbB3 signalling is an important pathway of resistance for some breast and ovarian cancers,” said Michaela Higgins, assistant Professor of Medicine at Harvard Medical School and principal investigator on the study.
“The data from this study suggest that MM-121 may enhance response to standard-of-care therapy among patients whose tumours are dependent on this pathway,” Prof Higgins added.
A second study found that patients taking a combination of MM-121 and chemotherapy agent paclitaxel achieved a pathologic complete response rate of 10.8% compared to 3.3% in the control arm – there was no primary endpoint set for this study, however.
Not third time lucky
This is now the third time the drug has failed to hit its primary endpoint for three different cancer targets.
Earlier this month Merrimack announced that MM-121 had failed to increase PFS in ovarian cancer, and in April it also produced poor results for patients with a type of lung cancer.
Its partner Sanofi will not be pleased. Chief executive Chris Viehbacher had said that oncology is one of the areas he wants the firm to focus on, but this latest setback will not help its cancer portfolio.
Sanofi paid Merrimack $60 million upfront to partner on MM-121 back in 2009, adding $470 million in promised milestones. But this investment does not yet seem to be rewarding the company.
The French major has also had a series of setbacks from its own oncology division. Just last week it had to stop trials of fedratinib when myelofibrosis patients developed Wernicke’s encephalopathy – a neurological condition incited by biochemical brain lesions.
This compounded the failure of iniparib earlier in the year after back-to-back Phase III failures for lung cancer, costing the firm $285 million.
Ben Adams
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