FDA Grants Alectinib Priority Review in NSCLC

“Alectinib has received an FDA priority review designation for patients with ALK-positive, locally advanced or metastatic non–small cell lung cancer (NSCLC) who have progressed or are intolerant to crizotinib (Xalkori), according to Genentech, the manufacturer of the oral second-generation ALK inhibitor. The FDA’s action date for an approval decision is March 4, 2016.

“The priority review is based on two phase II trials (NP286731and NP287612) which demonstrated that alectinib had robust activity in patients with ALK-positive NSCLC following progression on crizotinib (Xalkori), including individuals with CNS metastases.

“ ‘Alectinib was granted priority review by the FDA based on results from two studies showing the medicine shrank tumors in people with ALK-positive NSCLC that progressed on crizotinib,’ Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, said in a statement. ‘There is a need for new treatment options in this patient population, especially because the disease often spreads to the brain at progression.’ “


ASTRO Issues Guideline on Definitive and Adjuvant RT for Locally Advanced Non-Small Cell Lung Cancer

“The American Society for Radiation Oncology (ASTRO) is issuing a new guideline, “Definitive and adjuvant radiotherapy in locally advanced non-small cell lung cancer: An American Society for Radiation Oncology (ASTRO) evidence-based clinical practice guideline.” The guideline’s executive summary is published in the May-June issue of Practical Radiation Oncology (PRO), ASTRO’s clinical practice journal. The complete guideline, which cites 35 years of data to help guide current treatment and future research, is available online as an open-access article in PRO. The American Society of Clinical Oncology (ASCO) today issued an endorsement of ASTRO’s guideline.

“ASTRO’s guideline panel included 14 leading lung cancer oncologists in the U.S. and Canada, reviewed 74 studies from English language publications within the PubMed database, published from January 1, 1966 to March 15, 2013. The panel developed five Key Questions on the role of definitive and adjuvant radiation therapy (RT) for locally advanced non-small cell lung cancer (LA NSCLC), which represents nearly one-quarter of all lung cancer patients. In addition to the 74 studies, 27 published clinical practice guideline documents that were relevant to one or more of the five Key Questions were reviewed to ensure the guideline panel obtained all appropriate clinical trial reports.”


New Drug to be Tested in Certain Patients with Advanced Non-Small Cell Lung Cancer

“Merrimack Pharmaceuticals, Inc. MACK, +1.95% today announced the initiation of a global, open-label, biomarker-selected, randomized Phase 2 clinical trial of MM-121, a fully human monoclonal antibody targeting ErbB3, in combination with docetaxel or pemetrexed versus docetaxel or pemetrexed alone in patients with heregulin positive, locally advanced or metastatic non-small cell lung cancer.

” ‘This marks the first MM-121 trial we’ve initiated where only patients with a high heregulin biomarker profile will be enrolled into the study. It builds on our learnings from the previous MM-121 Phase 2 clinical trials we completed across lung, ovarian and breast cancers where we saw a clear trend of patients in those studies with this biomarker profile benefitting from combining MM-121 with standard therapies,’ said Akos Czibere, MD, PhD, MM-121 Global Development Lead at Merrimack. ‘This study is a significant step toward preparing a registration trial of MM-121 in non-small cell lung cancer, and further supports Merrimack’s systems biology approach and its impact on drug discovery and development. We look forward to applying our clinical biomarker findings to future studies with MM-121 and ultimately improving outcomes in patients who no longer respond to standard-of-care therapies.’ “


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.


Diabetes Drug Glucophage May Make Radiation Therapy More Effective

Past studies have suggested that the diabetes drug metformin (Glucophage) may make lung cancer tumors more susceptible to radiation and therefore, make radiation therapy more effective. Researchers therefore analyzed the medical records of patients with locally advanced non-small cell lung cancer (NSCLC) who had been treated with radiation and chemotherapy. Sixteen of these patients had been taking Glucophage at the time. All of the Glucophage-treated patients are still alive and the cancer has returned in only two so far (an average of 10.4 months after the treatment)–better outcomes than what was seen in the patients who were not on Glucophage. Glucophage also made tumors more sensitive to radiation treatment in a mouse model of lung cancer.


Radiation and Chemotherapy before Surgery Best Option in Patients with Stage IIIA(N2) NSCLC

Disagreement persists about the best treatment for non-small cell lung cancer (NSCLC) patients with stage IIIA(N2) disease, that is, cancer that has spread to lymph nodes just outside the lung. A recent study compared the outcomes of different treatments. Patients who had received neoadjuvant chemoradiotherapy (chemotherapy and radiation administered before surgery) followed by lobectomy (removal of the lung subsection containing the cancer) had higher 5-year survival rates than patients treated with:

-neoadjuvant chemoradiotherapy and pneumonectomy (removal of the whole lung containing the cancer);

-either lobectomy or pneumonectomy plus adjuvant therapy (chemotherapy and/or radiation administered after surgery);

-concurrent chemoradiotherapy (chemotherapy and radiation delivered at the same time, without surgery).

These findings suggest that neoadjuvant chemoradiotherapy followed by lobectomy is the preferable treatment for stage IIIA(N2) NSCLC.


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.

Research paper: https://www.jstage.jst.go.jp/article/acrt/20/2/20_47/_pdf


Overexpression of IGF1R and EGFR Genes May Worsen Lung Cancer Prognosis

The roles of the genes IGF1R and EGFR in lung cancer were examined in patients with non-small cell lung cancer (NSCLC) who had their primary tumor surgically removed. Patients whose tumors had increased expression of both IGFR1R and EGFR were more likely to experience recurrence of the cancer after a shorter amount of time and had shorter survival times after surgery. This finding suggests that concurrent overexpression of IGF1R and EGFR is a negative prognosis factor in NSCLC and may indicate patients who are more likely to benefit from novel treatments with IGF1R inhibitors.

Research paper: http://link.springer.com/article/10.1007/s00280-012-2056-y/fulltext.html


Study Suggests Iressa Effective for Elderly Patients with EGFR-Mutant Lung Cancer

A retrospective study in Japan examined 55 patients aged 75 years or over with inoperable non-small cell lung cancer (NSCLC) who had a mutation in the EGFR gene and received gefitinib (Iressa) as first-line therapy. The treatment was generally well tolerated and patients experienced longer periods without cancer progression (median: 13.8 months) and longer overall survival (median: 29.1 months) than commonly reported for similar patients. While studies using control groups will need to confirm that Iressa is indeed more effective than standard chemotherapy or a placebo, these findings suggest that Iressa may be a preferable first-line treatment in elderly patients with advanced EGFR-mutant NSCLC.

Research paper: http://link.springer.com/article/10.1007/s12032-012-0450-2/fulltext.html