The largest trial of patients with EGFR mutation-positive NSCLC

RIDGEFIELD, Conn., June 4, 2012 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the companys pivotal Phase III clinical trial, LUX-Lung 3, investigating afatinib as a first-line treatment in patients with stage IIIb or IV non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) mutation, met its primary endpoint of progression-free survival (PFS).

The study evaluated 345 patients with NSCLC across a variety of EGFR mutations. Results showed that within the general study population, patients assigned to the afatinib arm lived for 11.1 months before their tumor started to grow again (PFS) versus 6.9 months for those patients in the chemotherapy arm (pemetrexed/cisplatin). The hazard ratio was 0.58 (95% CI: 0.43-0.78) (p=0.0004). Approximately 90 percent of patients in the study had the most common EGFR mutations (Del19 and L858R). In this subset, patients in the afatinib arm lived for a median of 13.6 months before their tumor started to grow again, versus a median of 6.9 months for those patients in the chemotherapy arm. The hazard ratio in this patient subset was 0.47 (95% CI: 0.34-0.65) (p<0.0001). Data were presented today in a late-breaking oral presentation at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

"Data from LUX-Lung 3 show that in patients with EGFR genetic mutations, afatinib demonstrated a significant and clinically meaningful delay in the progression of NSCLC, compared with combination pemetrexed and cisplatin," said Berthold Greifenberg, MD, Vice President, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. "These results add to the growing body of evidence supporting EGFR testing as an opportunity to inform and personalize the treatment of patients with EGFR mutation-positive NSCLC. This further underscores Boehringer Ingelheims commitment to advancing the research and development of its compounds with the goal of improving the lives of patients with cancer."

The most common drug-related adverse events observed in the afatinib treatment arm were diarrhea (95%), rash (62%) and paronychia (57%). The most common drug-related adverse events observed in the chemotherapy arm (pemetrexed /cisplatin) were nausea (66%), decreased appetite (53%) and vomiting (42%). There was a low discontinuation rate associated with treatment-related adverse events in the trial (8% discontinuation rate for afatinib; 12% for chemotherapy). One percent of patients in the afatinib arm discontinued due to diarrhea.

"Now that we are testing more patients for specific subtypes of lung cancer, we realize that EGFR mutation-positive lung cancer is a big problem. There may be up to 38,000 Americans diagnosed with this disease each year," said Lecia V. Sequist, MD, MPH, Medical Oncologist at Massachusetts General Hospital Cancer Center, Assistant Professor of Medicine at Harvard Medical School, and one of the Principal Investigators for LUX-Lung 3. "There is still a great need for additional treatment options, particularly in the United States, where there are currently no therapies approved specifically for use in EGFR mutation-positive lung cancer."

 

Cindy