‘Stellar’ performance from targeted lung cancer drug
pharmafile | June 9, 2010 | News story | Research and Development | Pfizer, biomarkers, crizotinib
A new targeted treatment for non small cell lung cancer has produced spectacular results in a sub-group of patients.
Pfizer’s crizotinib is in a new class of drugs that inhibit the ALK gene, which is thought to play a key role in a sub-set of non small-cell lung cancer (NSCLC) tumours.
Crizotinib produced a 90% response rate in NSCLC patients whose tumours had a rearrangement of the ALK gene, and who had failed two previous chemotherapies.
The phase II clinical trial results were presented at the American Society of Clinical Oncology 2010 Annual Meeting, and generated considerable excitement.
“This is stellar, compared with what we see in non selected NSCLC patients treated with chemotherapy,” said principal investigator Alice Shaw, MD, PhD, a thoracic oncologist at the Massachusetts General Hospital Cancer Center in Boston.
“This response rate is unprecedented in lung cancer,” Anil Potti, MD, associated professor of medicine at Duke University in Durham, North Carolina, told Medscape Oncology.
“This is a huge success for biomarker-driven clinical trials,” He added. Saying he hoped the results would make tumour type tests the norm, and signal an end to testing drugs in unselected patient groups.
Crizotinib is now entering a randomised phase III trial (PROFILE 1007) and a central laboratory is currently carrying out the lung cancer tissue genotyping.
The study was presented by Yung-Jue Bang, MD, from Seoul National University College of Medicine in Korea. It was conducted in 82 patients with NSCLC who had the ALK fusion gene and who had progressed on previous chemotherapy regimens (a median of three).
More than 90% of patients showed tumour shrinkage, and responses lasted up to 15 months, and patients had a 72% probability of being progression-free at six months.
The drug was well tolerated, and the most commonly reported adverse effects were nausea, diarrhea, and vomiting, but they were mild and subsided with time.
Nearly all patients (87% at eight weeks) who received crizotinib responded to treatment and experienced tumour shrinkage or disease stabilisation. Among those, 57% had tumour shrinkage. The median duration of treatment was approximately six months.
A phase III trial (PROFILE- 1007) has already begun that is compareing crizotinib to standard second-line chemotherapy.
Meanwhile, Lilly/BMS and Merck Serono’s Erbitux looks set to become a first line therapy for another sub-group of NSCLC patients. Those with EFGR KRAS ‘wild type’ tumours respond well to the drug, and testing of patients for this is becoming standard practice.
EGRF mutations are found in about 10% of non-small cell patients, and the ALK gene rearrangements are seen in a separate group of about 3% to 5% patients.
Added together, this means that up to 15% of NSCLC patients could now have targeted treatment available to them.
Lung cancer is one of the commonest cancers, so 3- 5% of NSCLC patients with the ALK gene represents a total of 6,000 – 10,000 patients in the US alone.
Andrew McConaghie
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