Boehringer Ingelheim’s Giotrif has beaten AstraZeneca’s Iressa on a number of clinical measures investigated in a head-to-head study involving patients with EGFR mutation-positive advanced non-small cell lung cancer.

The company says data from the Phase IIb LUX-Lung 7 trial, published in The Lancet, show that Giotrif (afatinib) significantly cut the risk of lung cancer progression and treatment failure, and boosted the overall response rate versus Iressa (gefitinib), “without compromising overall health-related quality of life, safety and tolerability”.

Giotrif reduced the risk of disease progression by 27 percent compared to Iressa, and, after two years’ treatment, more than twice as many patients taking the drug were alive and progression free than those taking AZ’ drug (27 percent vs 15 percent after 18 months, and 18 percent vs 8 percent after 24 months).

In addition, Giotrif-treated patients had a significantly longer time on treatment and risk of treatment failure was reduced by 27 percent, while significantly more patients had an objective tumour response compared to Iressa (70 percent vs 56 percent), with a median duration of response of 10.1 months and 8.4 months, respectively.

Both drugs showed similar improvements in patient-reported outcome measures with no significant differences in health-related quality of life. Treatment with both was generally tolerable, leading to an equal rate of treatment-related discontinuation in both arms (6 percent). The overall frequency of serious adverse events was 44.4 percent for Giotrif and 37.1 percent for Iressa.

“The totality of the efficacy data from LUX-Lung 7 clearly differentiates the second-generation inhibitor afatinib from the first-generation inhibitor gefitinib with no significant differences observed in overall safety, tolerability and health-related quality of life between the two TKIs,” noted Professor Klaus Dugi, medical director and managing director, Boehringer Ingelheim UK & Ireland. “This is really good news for patients, and it will provide clinicians with further evidence to guide treatment practice in EGFR mutated NSCLC.” 

Data for the co-primary endpoint of overall survival are not yet mature and will be presented in the future, BI said.