Amgen’s Vectibix fails late stage trial
pharmafile | August 12, 2010 | News story | Research and Development, Sales and Marketing | Amgen, Vectibix, head and neck cancer
Amgen’s potential head and neck cancer treatment Vectibix has failed to meet its primary endpoint of improving overall survival in a phase III trial.
The US-based biotech firm was evaluating the drug as a first-line treatment in patients with recurrent and/or metastatic squamous cell head and neck cancer.
The SPECTURM study found that the addition of Vectibix to platinum-based chemotherapy agents did not result in a statistically significant improvement in overall survival compared to chemotherapy alone and therefore failed its primary endpoint.
Amgen said in statement that the secondary endpoints of progression-free survival were numerically improved, but were “not tested for statistical significance”.
Roger Perlmutter, executive VP of research and development at Amgen, said: “The outcome of this study is disappointing. However, Vectibix remains an important monotherapy treatment option for patients with metastatic colorectal cancer whose disease has progressed on other therapies.”
The SPECTRUM study enrolled 658 patients who were randomised to receive a standard platinum-based chemotherapy (cisplatin and 5-FU), with or without Vectibix (9 mg/kg) every three weeks. The primary endpoint was overall survival. The secondary endpoints included progression-free survival, objective response rate, duration of response, time to progression, time to response, patient reported outcomes and safety.
The most frequently reported adverse events in the Vectibix plus chemotherapy arm included nausea, rash, neutropenia (reduction in white blood cells) and vomiting.
Vectibix is a monoclonal antibody that works as an anti-EGFR (epidermal growth factor receptor), an agent that aims at stopping rapid cell division common to head and neck and colorectal cancers.
It currently has a limited license by the European Commission for EGFR-expressing metastatic colorectal cancer (mCRC) with wild-type KRAS genes after failure of standard chemotherapy regimens.
The drug has been launched in over 20 countries including Switzerland, Australia and Canada, with further applications pending.
Full data on the SPECTRUM study will be presented at the ESMO Congress in October.
Ben Adams
Related Content
FDA approves Amgen’s Imdelltra for extensive-stage small cell lung cancer
Amgen has announced that the US Food and Drug Administration (FDA) has approved Imdelltra (tarlatamab-dlle) …
Amgen opens new biomanufacturing facility in Ohio, US
Amgen has announced that it has opened a new manufacturing site in Central Ohio, US. …
AstraZeneca and Amgen asthma drug shows positive results in Phase III trial
AstraZeneca and Amgen’s new tezepelumab drug for the treatment of severe asthma has shown superiority …
