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.

FDA Approves Afatinib/Gilotrif for Lung Cancer Treatment

Based on the positive results of a recent clinical trial, the FDA approved afatinib for first-line treatment of patients with late-stage, non-small cell lung cancer (NSCLC) who have a mutation in the EGFR gene. The drug, which will be marketed under the name Gilotrif, is specifically intended for patients with two particular EGFR mutations: exon 19 deletion and exon 21 L858R substitution. The FDA also approved the therascreen EGFR RGQ PCR Kit, a companion diagnostic used to test for EGFR mutations. Afatinib differs from other EGFR inhibitors like erlotinib (Tarceva) and gefitinib (Iressa) in that it irreversibly destroys the EGFR protein, instead of just reversibly blocking it, and also inhibits several other related proteins.

Afatinib May Be Candidate for First-Line Treatment in Certain Lung Cancers

Results from the LUX-Lung 3 clinical trial show that afatinib appears to be well tolerated and more effective than chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) who have a mutation in the EGFR gene. Afatinib produced higher response rates and longer periods without cancer progression than cisplatin (Platinol) plus pemetrexed (Alimta), suggesting that it could be considered as a first-line therapy in advanced EGFR-mutant NSCLC. Afatinib, which is under priority review for approval by the FDA, may be effective in patients resistant to other EGFR inhibitors like erlotinib (Tarceva) and gefitinib (Iressa). However, no trials so far have directly compared afatinib with Tarceva or Iressa.

Adding Paraplatin to Alimta Increases Survival in Lung Cancer Study

Results from a phase III clinical trial suggest that adding carboplatin (Paraplatin) to pemetrexed (Alimta) can improve outcomes in non-small cell lung cancer (NSCLC). Over 200 patients with advanced NSCLC received first-line treatment with Alimta either by itself or in combination with Paraplatin. The combination of the two chemotherapy agents extended the time before the cancer started growing again, and prolonged survival compared to Alimta alone. However, the combination treatment group had a higher incidence of serious side effects and four treatment-associated deaths.

Two Upcoming Clinical Trials to Investigate New Lung Cancer Drug OGX-427

OncoGenex Pharmaceuticals plans to launch two phase II clinical trials of its new cancer drug, OGX-427, in lung cancer patients. The Cedar trial will be conducted by the UK National Cancer Research Network and the UK Experimental Cancer Medicine Network at cancer centers throughout the UK. It will examine the effectiveness of OGX-427 in combination with chemotherapy in previously untreated patients with advanced squamous cell carcinoma (SCC) of the lung, a type of non-small cell lung cancer (NSCLC). The Spruce trial will be performed in the U.S. in collaboration with the Sarah Cannon Research Institute and will enroll patients with advanced non-squamous NSCLC. OGX-427 inhibits Hsp27, a protein that is overexpressed in many cancer cells.

FDA Approves Expanded Use and Companion Diagnostic for Tarceva

The FDA has approved the use of erlotinib (Tarceva) as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) who have a mutation in the EGFR gene. Tarceva, a tyrosine kinase inhibitor (TKI) that inhibits EGFR, had already been approved for patients with advanced NSCLC as a second- or later-line treatment if at least one chemotherapy regimen had failed, or as maintenance treatment if their disease had not progressed after four cycles of chemotherapy. At the same time, the FDA approved, for the first time, a test for EGFR mutations, the cobas EGFR Mutation test. The test enables doctors to identify which patients have EGFR mutations and are therefore candidates for first-line treatment with Tarceva, making it a so-called ‘companion diagnostic’ for Tarceva.

New Clinical Trial of Drug OGX-427 Aims to Help Patients Ineligible for Targeted Therapies

OncoGenex Pharmaceuticals announced that it will begin the Spruce clinical trial, a phase II study investigating the use of their cancer drug OGX-427 in non-small cell lung cancer (NSCLC). Patients with advanced non-squamous NSCLC will receive first-line treatment with chemotherapy using carboplatin (Paraplatin) and pemetrexed (Alimta), either with or without the addition of OGX-427. OGX-427 inhibits a protein called Hsp27, which is elevated in many cancers. The study investigators suggest that OGX-427 may be especially helpful for patients whose cancers lack certain mutations that would make them eligible for currently available targeted therapies.

Systemic Chemotherapy Is Effective in SCLC with Brain Metastases

Between one-tenth and one-fourth of patients with small cell lung cancer (SCLC) have brain metastases (cancer that has spread to the brain) when they are first diagnosed and up to half will develop them at some point during the course of their disease. There have not been many studies on the use of systemic chemotherapy (ie, chemotherapy in which drugs are allowed to circulate throughout the body) in these patients, but research suggests that it is an effective first- or second-line treatment. Systemic chemotherapy is especially recommended for SCLC patients with brain metastases who do not yet show symptoms.

Avastin-Containing Chemotherapy May Be Safe in Lung Cancer Patients with Brain Metastases

Bevacizumab (Avastin), which is approved for treatment of a number of advanced-stage cancer types, is commonly avoided in patients with brain metastases (cancer that has spread to the brain) because of fear of brain hemorrhages (bleeding in the brain). A retrospective study of 52 patients with advanced non-small cell lung cancer (NSCLC) who had received chemotherapy containing Avastin found no cases of serious bleeding events and no significant differences in survival or treatment side effects between patients with or without brain metastases. Avastin may therefore be a safe treatment option in NSCLC with brain metastases.

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