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CHICAGO -- 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), , 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.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
- Note that this trial of an anti-EGFR antibody demonstrated a small, but statistically significant benefit in terms of overall survival in patients with squamous cell lung cancer.
- Be aware that the increase in survival failed to meet conventional "clinically meaningful" definitions.
"It's the first time that we've seen benefit in this group of patients over the last 20 to 25 years," he reminded attendees here at the American Society of Clinical Oncology meeting where he presented the results.
One member of the audience argued, though, that calling this an advance may be setting the bar too low.
"We all would love to see advances in squamous cell carcinoma," he said during the question-and-answer period. "I really think we have to look at this seriously in light of the costs of these drugs, and say is this meaningful?"
Study discussant , of Johns Hopkins, agreed, saying it didn't meet of 2.5 to 3 months in squamous cell carcinoma.
Most disappointing, she said, was that the predictive biomarker developed through the FLEX trial flopped as well.
The EGFR H-score with a 200 point cutoff wasn't consistently associated with progression-free and overall survival. Nor was there a treatment-by-cutpoint interaction.
"Let's put the H-score to rest," Brahmer said.
The open-label trial included 1,093 patients with stage 4 squamous NSCLC and good performance status, regardless of EGFR status.
They were randomized to first-line treatment with standard gemcitabine and cisplatin chemotherapy (maximum of six cycles) alone or with necitumumab every 3 weeks, with that drug continued until progression of disease.
The improvement in progression-free survival was equally small but significant (median 5.7 versus 5.5 months, hazard ratio 0.85, P=0.020).
Overall response rates were similar between groups (31.2% with necitumumab and 28.8% without, P=0.400).
Thatcher called the adverse event profile "quite reasonable," with no increase in hematologic toxicity and no unexpected side effects.
Disclosures
The trial was sponsored by Eli Lilly.
Thatcher disclosed relationships with Eli Lilly.
Brahmer disclosed relationships with Eli Lilly and Merck.
Primary Source
American Society of Clinical Oncology
Thatcher N, et al "A randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin (GC) chemotherapy plus necitumumab (IMC-11F8/LY3012211) versus GC alone in the first-line treatment of patients (pts) with stage IV squamous non-small cell lung cancer (sq-NSCLC)" ASCO 2014; Abstract 8008.