By Kirsty Oswald, medwireNews Reporter
Results from a phase III trial have shown that tecemotide is no more effective than placebo as maintenance therapy in patients with non-small-cell lung cancer (NSCLC).
However, the START (Stimulating Targeted Antigenic Response To NSCLC) study indicates that there may be a survival benefit specifically for patients who received previous concurrent chemoradiotherapy.
“Considering the lack of effective therapies in this setting and disappointing outcomes in trials of maintenance chemotherapy, this result has some promise,†comment study authors Charles Butts (Cross Cancer Institute, Edmonton, Alberta, Canada) and colleagues in The Lancet Oncology.
“A confirmatory randomised trial of tecemotide after concurrent chemoradiotherapy in patients with stage III non-small-cell lung cancer is now being planned.â€
The international, randomized START trial included 1239 patients who received eight consecutive weekly injections of tecemotide (806 µg lipopeptide; n=829) or placebo followed by a maintenance injection every 6 weeks in the absence of progression or toxicity. Patients in the tecemotide group also received cyclophosphamide 300 mg/m2 3 days before beginning treatment and those in the placebo group received saline.
All patients had unresectable stage III NSCLC and had stable disease or an objective response following chemoradiotherapy.
After a median follow-up of 39.9 months in the tecemotide group and 37.7 months in the placebo group, there was a nonsignificant difference in median overall survival, at 25.6 months and 22.3 months, respectively.
In stratified analyses, the only variable associated with a significant difference in outcomes between tecemotide- and placebo-treated patients was previous concurrent chemoradiotherapy. Among the 806 patients who had previously received concurrent chemoradiotherapy, the 538 who received tecemotide survived a median of 30.8 months compared with 20.6 months in those treated with placebo (hazard ratio= 0.78).
By contrast, in patients who received sequential radiotherapy, there was no significant difference in survival between tecemotide- and placebo-treated patients.
A benefit to tecemotide was also observed in some predefined subgroups among patients previously treated with concurrent chemoradiotherapy including women, those of White race, patients with non-adenocarcinoma histology, and ever smokers.
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