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Afatinib extended OS in EGFR-mutated NSCLC

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Patients with advanced non–small cell lung cancer who harbored EGFR exon 19 deletions and who received first-line treatment with afatinib achieved significantly prolonged OS compared with patients who received chemotherapy, according to the pooled analysis of two phase 3 studies presented at the ASCO Annual Meeting.

James Chih-Hsin Yang, MD, of the National Taiwan University Hospital in Taipei, and colleagues evaluated data from 709 treatment-naive patients with stage IIIB or IV disease enrolled on the LUX-Lung 3 (LL3) and LUX-Lung 6 (LL6) trials. All patients harbored mutated EGFR in the form of exon 19 deletion (n=355) or mutated L858R (n=276).

“Patients with EGFR mutations are a very distinct subtype of patients, who are very sensitive to small molecule EGFR tyrosine kinase inhibitors,” Yang said during a presentation. “However, there are many types of EGFR mutations, and they are not really the same.”

Researchers randomly assigned 419 patients to 40 mg afatinib (Gilotrif, Boehringer Ingelheim), an ErbB family blocker of EGFR, HER-2, ErbB3 and ErbB4 signaling. The other 212 patients received six cycles of chemotherapy.

Early data from the analysis indicated afatinib improved PFS (LL3 trial, HR=0.58; LL6 trial, HR=0.28), and afatinib received FDA approval for this indication.

After 36.5 months of median follow-up, 404 (64%) patients had died.

Seventy-eight percent of patients who progressed during the study received a median of three additional subsequent systemic therapies. A majority of patients in the chemotherapy arm received an EGFR TKI (68%), and 70% of patients in the afatinib arm received chemotherapy.

Patients assigned afatinib achieved a median OS of 27.3 months, whereas patients assigned chemotherapy achieved a median OS of 24.3 months (HR=0.81; 95% CI, 0.66-0.99).

Yang and colleagues then evaluated predicting factors for response. They found that patients with deletion 19 who received afatinib demonstrated significantly improved OS (HR=0.59; 95% CI, 0.45-0.77); however patients with mutated L858R did not (HR=1.25; 95% CI, 0.92-1.71).

“Deletion 19 and L858R patients are two distinct populations and should be studied separately in the future,” Yang said.

For more information:

Yang JC. Abstract #8004. Presented at: ASCO Annual Meeting; May 30-June 3, 2014; Chicago.

Disclosure: The researchers report consultant/advisory roles with, employment/leadership positions with, and honoraria or research funding from Amgen, AstraZeneca, AVEO, Bayer, BeiGene, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharma, Clovis, Eisai, Genentech, GlaxoSmithKline, InnoPharma, Janssen, Lilly, Merck Serono, Merrimack Pharmaceuticals, Novartis, Pfizer, Roche, Taiho Pharmaceutical and Takeda.