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New data for Gilotrif® shows a significant improvement in overall survival in lung cancer patients whose tumors have the most common EGFR mutation

has announced new overall survival data of two Phase III clinical trials (LUX-Lung 3 and LUX-Lung 6). Patients with advanced non-small cell lung cancer (NSCLC) whose tumors have the most common epidermal growth factor receptor () mutation (exon 19 deletion) lived longer if treated with first-line afatinib compared to chemotherapy. An oral presentation at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) on June 2nd will discuss these data in more depth, providing further insights into their impact on clinical practice and patient care. Data from six other abstracts involving afatinib and other compounds in ’s oncology portfolio will also be presented or published at ASCO in Chicago, May 30-June 3.

Overall survival results

In the pooled analysis from two of the largest trials in this patient population, afatinib prolonged survival of lung cancer patients whose tumors have common EGFR mutations compared with standard chemotherapy by a median of 3 months (27.3 to 24.3 months) and significantly reduced the risk of death by 19% (HR=0.81, p=0.037). The most pronounced reduction in risk of death was 41% (HR=0.59, CI 0.45, 0.77) in patients whose tumors have the most common EGFR mutation (exon 19 deletion of the EGFR gene); for patients with the exon 21 (L8585R) mutation there was no impact on overall survival (HR=1.25, CI 0.92, 1.71). Exon 19 deletions occur with a frequency of approximately 48% in EGFR-mutant lung tumors. See abstract (#8004) for full details.

The analysis of the delay in tumor growth (progression-free survival) and adverse events associated with afatinib in comparison with standard chemotherapy were consistent with previously published results of the primary data from these two trials.

“Our lung cancer patients urgently need more treatments that can improve overall survival,” said Lecia V. Sequist, M.D., MPH, medical oncologist at Massachusetts General Hospital Cancer Center and associate professor of medicine at Harvard Medical School. “These results provide encouraging perspective about overall survival when patients whose tumors have the most common EGFR mutation are treated with afatinib.”

The LUX-Lung 3 Phase III clinical trial compared afatinib with chemotherapy (pemetrexed/cisplatin) as a first-line treatment in patients with advanced NSCLC with EGFR mutations. The LUX-Lung 6 Phase III clinical trial evaluated afatinib versus chemotherapy (gemcitabine/cisplatin) as a first-line treatment for Asian patients with advanced NSCLC with EGFR mutations.

Investigation of afatinib treatment beyond disease progression

Results from another Phase III study in NSCLC patients (LUX-Lung 5) also presented at ASCO met its primary endpoint by showing an improvement in progression-free survival (PFS) when continuing treatment with afatinib in combination with chemotherapy after the tumor started to grow on afatinib alone (treatment beyond progression). This Phase III study compared afatinib and paclitaxel versus investigator’s choice of chemotherapy alone in patients with late-stage NSCLC whose disease has progressed after afatinib alone and have also failed several treatments, including chemotherapy, erlotinib or gefitinib.

Those patients who continued afatinib treatment, with the addition of chemotherapy, after progressing on afatinib alone, had a further delay in tumor growth compared to the group who stopped afatinib treatment and received chemotherapy only (tumor growth was delayed by 5.6 months and 2.8 months respectively, p=0.003). This corresponded to a 40% reduction in risk of disease progression (HR=0.60). The most common adverse events in patients treated with afatinib and chemotherapy versus chemotherapy were diarrhea (53.8% vs. 6.7%), hair loss or alopecia (32.6% vs. 15%) and weakness or asthenia (27.3% vs. 28.3%). See abstract (#8019) for full details.

Berthold Greifenberg, M.D., vice president, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. commented: “These findings provide additional insights into afatinib’s potential in patients with advanced lung cancer and across different stages of treatment. We now know that lung cancer represents an array of diseases, and we are proud to be conducting research on afatinib in a variety of treatment settings that may ultimately expand treatment options for patients with this devastating disease.”

About Metastatic NSCLC and Common EGFR Mutations

In some people, genetic mutations lead to the constant activation of the EGFR protein, which is associated with uncontrolled cell division and the development and progression of NSCLC. Among patients diagnosed with NSCLC (the most common form of lung cancer) , it is estimated that between 10 and 15% of Caucasians and approximately 40% of Asians have EGFR mutations – which in 90% of cases are one of the two most common EGFR mutations (exon 19 deletions or exon 21 L858R).

About Gilotrif® (afatinib) tablets

GILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations.

GILOTRIF is an oral, once-daily kinase inhibitor that is designed to irreversibly bind and inhibit the following receptors: EGFR (ErbB1), HER2 (ErbB2) and ErbB4.


Boehringer Ingelheim