Figitumumab development discontinued for non-adenocarcinoma NSCLC

Dec 12 2014

By medwireNews Reporters

Adding the novel insulin-like growth factor 1 receptor (IGF-1R) inhibitor figitumumab to the epidermal growth factor receptor (EGFR)–tyrosine kinase inhibitor erlotinib does not improve survival in patients with non-adenocarcinoma non-small-cell lung carcinoma (NSCLC), research shows.

The phase III controlled trial was closed early by an independent data safety monitoring committee when the results crossed a pre-specified futility boundary.

“These results are disappointing given preclinical findings that suggested blockade of IGF-1R signalling may sensitize tumors to inhibition of EGFR”, the study authors comment.

Patients with stage IIIB/IV or recurrent NSCLC with non-adenocarcinoma histology who had previously received at least one platinum-based chemotherapy regimen were randomly assigned to receive figitumumab plus erlotinib (investigational group; n=289) group or erlotinib alone (control group; n=290).

All patients received erlotinib at 150 mg/day; for those receiving figitumumab as well, the drug was administered intravenously at 20 mg/kg on day 1 of each 3-week cycle of treatment, with an additional dose on day 2 of cycle 1.

Lead author Giorgio Scagliotti (University of Torino, Italy) and colleagues report that the primary endpoint of median overall survival did not differ significantly between the groups, at 5.7 months for figitumumab plus erlotinib and 6.2 months for erlotinib alone.

Median progression-free survival was also similar for patients in the investigational and control arms, at 2.1 months and 2.6 months, respectively.

Adverse events that occurred more frequently in the investigational than in the control group included nausea or vomiting, diarrhoea, decreased appetite and asthenia. Additionally, certain serious adverse events, specifically dehydration, diarrhoea and dyspnoea, were also more common in the figitumumab plus erlotinib compared with the erlotinib alone arm.

“When our study was designed, there was a good preclinical rationale for combining figitumumab with erlotinib in NSCLC,” the researchers write in the journal Annals of Oncology.

However, given these results, the team concludes that “figitumumab development has been discontinued.”

Licensed from medwireNews with permission from Springer Healthcare Ltd. ©Springer Healthcare Ltd. All rights reserved. Neither of these parties endorse or recommend any commercial products, services, or equipment.