In a phase 2 trial of patients with non-small-cell lung cancer, an immunotherapeutic reduced the risk for relapse after lung cancer surgery to the same extent as has been seen with chemotherapy, but with far fewer adverse events. The product, known as MAGE-A3 antigen-specific cancer immunotherapeutic (ASCI), is being developed by GlaxoSmithKline in Belgium.
“This was a very positive trial,” lead researcher John Vansteenkiste, MD, from University Hospital Gasthuisberg, in Leuven, Belgium, told Medscape Oncology. Most patients experienced only mild reactions at the injection site and fever within 24 hours of injection, in contrast to the serious adverse effects seen with chemotherapy, he said. If the ongoing phase 3 trial (known as MARGRIT) turns out to be positive, then this would be a very useful therapy for patients after surgery for lung cancer, particularly older patients and those who cannot tolerate chemotherapy.
Dr. Vansteenkiste reported results from the phase 2 study last week at the 1st European Lung Cancer Conference in Geneva, Switzerland. The meeting was organized jointly by the International Association of the Study of Lung Cancer and the European Society of Medical Oncology.
The study involved 182 patients with non-small-cell lung cancer who were assigned to receive either placebo or the immunotherapeutic after complete resection of the tumor. MAGE-A3 ASCI was administered over 27 months (5 injections at 3-week intervals, followed by 8 injections administered once every 3 months).
After 44 months, 69 patients had experienced a recurrence of the cancer, and 57 had died. There were 43 recurrences among the 122 patients taking the immunotherapeutic (35%), and 20 recurrences among the 60 patients taking placebo (43%), Dr. Vansteenkiste said. The hazard ratio for the reduction in the risk for recurrences was 0.77 (P = .12), meaning the risk was reduced by 23%, he explained. For the reduction in the risk for death, the hazard ratio was 0.81 (P = .10), meaning the risk was reduced by 19%.
This reduction in the risk for cancer relapse is similar to what has been seen with postoperative chemotherapy, Dr. Vansteenkiste told Medscape Oncology. “The magnitude of the reduction is the same,” he said, but the immunotherapeutic has far fewer adverse effects, and so could be used in more patients. “It is suitable for long-term maintenance treatment and for most patients, including older patients and patients in weak physical condition after surgery, allowing them to live a normal life while on cancer treatment,” he commented.
The ongoing phase 3 trial plans to recruit 2200 patients and will have 4 groups, Dr. Vansteenkiste said. After surgery, patients who are considered to be candidates for adjuvant chemotherapy will receive it. These patients will then be randomized to receive either the immunotherapeutic or placebo, as will the patients who do not receive chemotherapy. “The decision about chemotherapy will be left to the discretion of the investigator,” Dr. Vansteenkiste explained. It has been proven that chemotherapy improves outcomes after surgery, he commented, but many of these patients are elderly and frail and cannot tolerate such toxic therapy.
1st European Lung Cancer Conference: Abstract 1480. Presented April 25, 2008.
Reviewed by Dr. Ramaz Mitaishvili
