For Certain Asian NSCLC Patients, Afatinib Is Better than Chemotherapy

The gist: Certain Asian patients with non-small cell lung cancer (NSCLC) have better survival results when treated with the drug afatinib (Gilotrif) than with standard chemotherapy. In a clinical trial, these results were true for patients whose tumors had a particular mutation called del19 EGFR. But patients with the Leu858Arg EGFR mutation did just as well on Gilotrif as on standard chemotherapy.

“In an analysis of overall survival in the phase III LUX-Lung 3 and LUX-Lung 6 trials reported in The Lancet Oncology, Yang et al found no significant difference between afatinib (Gilotrif) vs pemetrexed (Alimta)-cisplatin (LUX-Lung 3) or vs gemcitabine-cisplatin (LUX-Lung 6) in previously untreated, predominantly Asian patients with EGFR mutation-positive stage IIIB or IV lung adenocarcinoma. A significant difference favoring afatinib was found among patients with exon 19 deletion (del19) in both trials, with no difference observed among patients with the Leu858Arg mutation…

“The investigators concluded: ‘Although afatinib did not improve overall survival in the whole population of either trial, overall survival was improved with the drug for patients with del19 EGFR mutations. The absence of an effect in patients with Leu858Arg EGFR mutations suggests that EGFR del19-positive disease might be distinct from Leu858Arg-positive disease and that these subgroups should be analysed separately in future trials.’ ”

Afatinib Works Best in Patients Whose Lung Cancer Has Specific Mutation in EGFR Gene

The gist: Afatinib (Gilotrif) works better than chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumors have a specific mutation in the EGFR gene. This mutation is known as exon 19 deletion. In a recent clinical trial, some patients with exon 19 deletion were treated with Gilotrif and some with chemotherapy. The patients who received Gilotrif lived significantly longer than the patients who received chemotherapy. All patients had stage IIIB or IV lung adenocarcinoma.

“Patients with lung adenocarcinoma who harbored exon 19 deletion EGFR mutations experienced significantly longer OS when treated with first-line afatinib instead of chemotherapy, according to analyses of results from two phase 3 trials.

“However, researchers did not observe the survival benefit among patients with other types of EGFR mutations.

“ ‘These data provide important evidence about the use of afatinib in patients whose tumors have the del19 mutation and tell us that the standard treatments and approaches should no longer be assumed equivalent for every EGFR mutation,’ Lecia V. Sequist, MD, MPH, medical oncologist at Massachusetts General Hospital Cancer Center and associate professor of medicine at Harvard Medical School, said in a press release.”

ASCO 2014 Lung Cancer Roundup

Every year, thousands of people gather in Chicago, Illinois, for the American Society of Clinical Oncology (ASCO) Annual Meeting. The largest meeting of its kind, ASCO brings together doctors, researchers, nurses, patient advocates, pharmaceutical company representatives, and more to discuss the latest in cancer research. Here are some of the most exciting new developments in lung cancer research presented last week at ASCO 2014: Continue reading…

MEDIA ALERT New Data Show Giotrif® (Afatinib) Provided More than One Year Additional Survival for Lung Cancer Patients with the Most Common Type of EGFR Mutation (del19) Compared to Chemotherapy

“Boehringer Ingelheim today announced results of the pre-specified individual, as well as the exploratory combined, analyses of two Phase III trials (LUX-Lung 3 and LUX-Lung 6). These data, to be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), demonstrated for the first time that patients with NSCLC with the most common epidermal growth factor receptor (EGFR) mutation (exon 19 deletions; del19) lived more than one year longer if treated with first-line afatinib compared to chemotherapy.”

Editor’s note: This article discusses the results of a clinical trial that tested a targeted drug called afatinib (aka Giotrif, or Gilotrif)  on volunteer patients with non-small cell lung cancer (NSCLC). The trial found that patients whose tumors had a particular mutation called del19 in the EGFR gene lived more than one year longer if treated with afatinib than if treated with chemotherapy. EGFR mutations and other mutations are detected via molecular testing, and can be used by oncologists to help develop personalized lung cancer treatment plans.

Thwarting Drug Resistance in Lung Cancer

If you’ve read up on lung cancer research in the last few years, you probably know that large strides have been made in targeted therapies for non-small cell lung cancer (NSCLC). Targeted therapies are drugs that identify and attack specific mutated proteins that are detected in tumors. Because noncancerous cells do not have these specific mutations, targeted therapies can make a beeline for cancer, while leaving healthy tissue unharmed. Continue reading…

NICE Draft Guidance Recommends Boehringer Ingelheim’s Giotrif

“UK drugs watchdog the National Institute for Health and care Excellence (NICE) this morning issued new draft guidance recommending German family-owned drug major Boehringer Ingelheim’s Giotrif (afatinib) as an option for treating locally-advanced or metastatic non-small-cell lung cancer (NSCLC) in people whose tumors test positive for the EGFR-TK mutation and have not received a EGFR-TK inhibitor.”

Editor’s Note: In the US, this drug is called Gilotrif. It is meant for patients whose tumors have a mutation in the EGFR gene, as detected by molecular testing. Learn more about molecular testing to guide treatment decisions.

Gilotrif Shows Effectiveness in Various Patient Populations with EGFR-Mutant Lung Cancer

Afatinib (Gilotrif) is a new lung cancer drug for people with non-small cell lung cancer (NSCLC) who have mutations in the EGFR gene. The LUX-Lung 3 clinical trial demonstrated that Gilotrif is superior to chemotherapy as first-line treatment in a global population of patients with EGFR-mutant NSCLC. The LUX-Lung 6 trial confirmed these findings specifically in an Asian population; Asia has a three times higher rate of EGFR-mutant NSCLC than Western countries. More recent evidence indicates that Gilotrif is as effective in patients with rare EGFR mutations as it is in those with common mutations. Finally, Gilotrif recently showed effectiveness in NSCLC patients whose cancer had spread to the brain.

Cancer Researcher: No Need for Further EGFR Inhibitor Versus Chemotherapy Trials

No more trials comparing EGFR inhibitors to chemotherapy in patients with non-small cell lung cancer (NSCLC) should be conducted, argues an editorial by cancer researcher Corey Langer. Eight separate trials have found that EGFR inhibitors like erlotinib (Tarceva), gefitinib (Iressa), and afatinib (Gilotrif) produce better results than chemotherapy in NSCLC patients who have mutations in the EGFR gene. No further confirmation is needed, Langer contends. Instead, research should focus on ways to overcome the drug resistance that many patients eventually develop to EGFR inhibitors, meaningfully extending overall survival in NSCLC, and directly comparing the relative effectiveness and safety of Tarceva, Iressa, and Gilotrif.

Gilotrif to Be Commercially Available in the U.S. Soon

Afatinib (Gilotrif), a new drug for the treatment of some lung cancers, will become commercially available in the U.S. beginning the week of September 2. Gilotrif is approved as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) who have certain mutations in the EGFR gene. A companion diagnostic, the therascreen EGFR RGQ PCR Kit, can detect these specific EGFR mutations, so-called exon 19 deletions or exon 21 (L858R) substitutions. The makers of the drug will offer a patient support program to provide financial and other support to help patients who might otherwise not have access to Gilotrif.