Merck says its Erbitux in combination with Folfox improves outcomes in colorectal cancer
pharmafile | July 4, 2016 | News story | Research and Development, Sales and Marketing | Cancer, China, ESMO, Merck, colorectal cancer, drug trial, research, study
Merck said late-stage trials for its Erbitux (cetuximab) in combination with Folfox significantly improved progression free survival in metastatic colorectal cancer (mCRC).
The findings were announced at the ESMO 18th World Congress on Gastrointestinal Cancer (WCGC) and come from the pivotal Phase III study in patients from China, the first prospective trial to evaluate an anti-EGFR antibody in the first-line therapy of patients with RAS wild-type metastatic colorectal cancer.
“It [the study] really enforces two things, the value of RAS biomarker testing in all patients with mCRC, and then the efficacy of that taregted therapy,” explained Steven Hildemann, chief medical officer at Merck, in an interview with Pharmafocus.
The results show that therapy combination of Erbitux and Folfox lead to a statistically-significant improvement in outcomes including progression-free survival (PFS) and also enhanced overall survival (OS) and best overall response rate (bORR), compared with Folfox alone.
Patients receiving the combination achieved a bORR of 61.1%, a 31% decrease in the risk of disease progression and a 24% reduction in the risk of death.
Carsten Bokemayer, primary investigator for Opus study, said the trial was particularly important as it offered a ‘clear statement’ of the combination’s effectiveness in a specific group of patients.
“It confirms what we have seen in previous international pivotal studies,” Dr Bokemayer added.
Both the National Comprehensive Cancer Network in the US and the European Society for Medical Oncology clinical guidelines recommend first-line treatment with Erbitux plus either Folfox or Folfiri for patients with RAS wild-type mCRC and there is now confidence that the results form a good basis upon which approval could be gained in China.
“The study was conducted in China in 393 patients with mCRC,” Hildemann said.
Going ahead the company expects expanded approval for the drug in China, in the ‘near future.’
“This does form a very solid base to explore options to extend the approval for Erbitux in first line for mCRC in China,” Hildemann said, adding he is very confident the study has ‘global implications.’
Colorectal cancer (CRC) is the third most common cancer worldwide, with an estimated incidence of more than 1.36 million new cases annually. An estimated 694,000 deaths from CRC occur worldwide every year, accounting for 8.5% of all cancer deaths and making it the fourth most common cause of death from cancer.10 Almost 55% of CRC cases are diagnosed in developed regions of the world, and incidence and mortality rates are substantially higher in men than in women.
Erbitux is a highly active IgG1 monoclonal antibody targeting EGFR. As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites.
Anjali Shukla
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