“Patients with epidermal growth factor receptor (EGFR) expressing advanced squamous non-small-cell lung cancer benefit most from necitumumab added to gemcitabine and cisplatin chemotherapy, according to a subgroup analysis from the SQUIRE trial presented today at the European Lung Cancer Conference (ELCC) 2016 in Geneva, Switzerland.
“The randomised phase III SQUIRE trial demonstrated that the addition of necitumumab to gemcitabine and cisplatin chemotherapy improved overall survival in patients with stage IV squamous non-small-cell lung cancer by 1.6 months compared to chemotherapy alone. The current study analysed outcomes in the subgroup of patients with EGFR expressing tumours compared to those with no EGFRs.”
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“The International Association for the Study of Lung Cancer (IASLC) is pleased to hear of another approval by the U.S. Food and Drug Administration (FDA) that helps in the fight against lung cancer—the fourth in two months. The FDA approved necitumumab (Portrazza) in combination with standard chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for their advanced disease.
“Necitumumab binds to the epidermal growth factor receptor (EGFR), a protein commonly found on squamous NSCLC tumors, and blocks EGFR from binding its ligands, thus preventing tumor growth. Necitumumab is the first monoclonal antibody type of EGFR inhibitor to be approved in lung cancer, whereas there are a number of tyrosine kinase type of EGFR inhibitors (TKI) already FDA approved and used in clinical practice. These TKIs include gefitinib, erlotinib, afatinib, and osimertinib.”
“The U.S. Food and Drug Administration today approved Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer.
“Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015. The most common type of lung cancer, non-small cell lung cancer, is further divided into two main types named for the kinds of cells found in the cancer – squamous cell and non-squamous cell (which includes adenocarcinoma).”
“Eli Lilly & Co.’s experimental lung cancer drug necitumumab improved overall survival by an average of 1.6 months but also increased the risk of sometimes fatal blood clots, according to a preliminary review by the U.S. Food and Drug Administration.
“The FDA’s review was posted on its website on Tuesday ahead of July 9 meeting of outside experts who will discuss the drug and recommend whether it should be approved. The FDA usually follows the advice of its advisory panels.
“Necitumumab is a second-generation monoclonal antibody for patients with stage IV squamous non-small cell lung cancer.
“In a 1,093-patient clinical trial patients who received necitumumab together with the chemotherapy drugs gemcitabine and cisplatin survived an average of 11.5 months compared with 9.9 months for patients who received gemcitabine and cisplatin alone.”
“In the phase III SQUIRE trial reported in The Lancet Oncology, Thatcher et al found that the addition of the second-generation epidermal growth factor receptor (EGFR) antibody necitumumab to first-line gemcitabine-cisplatin improved overall survival among patients with stage IV squamous non–small cell lung cancer (NSCLC).
“In this open-label trial, 1,093 patients from 26 countries were randomly assigned between January 2010 and February 2012 to receive gemcitabine-cisplatin with (n = 545) or without (n = 548) necitumumab. Necitumumab 800 mg was given intravenously on days 1 and 8 of 3-week cycles and continued after the end of chemotherapy until disease progression or intolerable toxicity. Gemcitabine 1,250 mg/m² was given on days 1 and 8, and cisplatin 75 mg/m² was given on day 1 of 3-week cycles. Randomization was stratified by Eastern Cooperative Oncology Group (ECOG) performance status and geographic region. The primary endpoint was overall survival in an intent-to-treat analysis.
“For the necitumumab and control groups, the median age was 62 years in both; 83% and 84% of patients were male; 84% and 83% were white; the geographic region was North America, Europe, or Australia for 87% in both South America, South Africa, or India for 6% in both, and Eastern Asia for 8% and 7%; Eastern Cooperative Oncology Group (ECOG) performance status was 0 in 30% and 33%, 1 in 61% and 58%, and 2 in 9% in both; and 55% in both had metastatic disease involving more than two organ systems.”
“In the phase III INSPIRE trial reported in The Lancet Oncology, Paz-Ares et al found that the addition of the anti-EGFR IgG1 monoclonal antibody necitumumab to first-line pemetrexed (Alimta)-cisplatin did not improve overall survival in patients with previously untreated stage IV nonsquamous non–small cell lung cancer (NSCLC). Enrollment was stopped due to excess fatal and nonfatal thromboembolic events in the necitumumab group.
“In this open-label trial, 633 patients from 103 sites in 20 countries were randomly assigned between November 2009 and February 2011 to receive cisplatin at 75 mg/m² and pemetrexed at 500 mg/m² on day 1 of 3-week cycles for a maximum of six cycles with (n = 315) or without (n = 318) necitumumab at 800 mg on days 1 and 8 of each cycle. Necitumumab was continued after the end of chemotherapy until disease progression or unacceptable toxicity. The primary endpoint was overall survival in the intention-to-treat population.
“Enrollment was stopped in February 2011 based on the observation of excess fatal and nonfatal thromboembolic events and overall number of deaths from all causes in the experimental group. Analysis indicated that most fatal thromboembolic events occurred within the first two cycles of therapy, with necitumumab thus being discontinued in patients who had not completed two cycles…
“The investigators concluded: ‘Our findings show no evidence to suggest that the addition of necitumumab to pemetrexed and cisplatin increases survival of previously untreated patients with stage IV non-squamous NSCLC. Unless future studies identify potentially useful predictive biomarkers, necitumumab is unlikely to provide benefit in this patient population when combined with pemetrexed and cisplatin.’ ”
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…
“The novel anti-EGFR monoclonal antibody necitumumab modestly improved survival in squamous non-small cell lung cancer (NSCLC) in a pivotal trial, but many called the effect too small to count.
“Adding the drug to a standard chemotherapy regimen improved overall survival by 16% (P=0.012), Nick Thatcher, MD, of Christie Hospital in Manchester, England, and colleagues found in the SQUIRE trial.
“While only about a 6-week gain over chemotherapy alone (median 11.5 versus 9.9 months), Thatcher called the findings an important advance.”
Editor’s note: Necitumumab is a drug that may hold promise for some patients with squamous non-small cell lung cancer (NSCLC). In a clinical trial to test the drug on volunteer patients, researchers found that necitumumab can increase survival by 6 weeks, compared to standard chemotherapy treatment. Some researchers say a 6 week increase in survival time is not terribly meaningful, and may be setting the bar too low for treatment of squamous NSCLC.
“A large phase III study investigating necitumumab (IMC-11F8) in combination with gemcitabine and cisplatin as first-line treatment for advanced squamous non–small cell lung cancer show a statistically significant improvement in overall survival of patients with stage IV disease.
“Patients receiving necitumumab plus chemotherapy had a median survival of 11.5 months compared to 9.9 months for patients treated with chemotherapy alone.
“Progression-free survival and disease control rate were also significantly improved.”
Editor’s note: This story is about a clinical trial that is testing the effectiveness of a new treatment for lung cancer patients. So far, the trial has found that the treatment is promising for people with stage IV squamous non-small cell lung cancer (NSCLC). To learn more about clinical trials, and the risks and advantages for patients who participate in them, click here.