Lilly’s NSCLC drug necitumumab shows risk of blood clots
Posted: 8 July 2015 |
Lilly’s NSCLC drug, necitumumab, has raised concerns with the FDA after trial data suggested that the drug might increase the likelihood of fatal clots…
Lilly’s non-small cell lung cancer (NSCLC) drug, necitumumab, has raised concerns with the FDA after trial data suggested that even though it improved survival, the drug might increase the likelihood of fatal clots.
Lilly is seeking initial approval of necitumumab in combination with gemcitabine and cisplatin for use in first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer.
The efficacy for the proposed indication is based on the results of an international study of 1093 patients with advanced squamous NSCLC who had not received prior chemotherapy for metastatic disease. Eligible patients were randomised 1:1 to receive either necitumumab with gemcitabine and cisplatin (N+GC) or gemcitabine and cisplatin (GC) alone. The primary efficacy endpoint of the study is overall survival (OS). Key secondary endpoints are progression-free survival (PFS) and overall response rate (ORR). The addition of necitumumab to GC resulted in a 1.6 month improvement in OS which was statistically significant. The median PFS was 5.7 months in the necitumumab arm compared to 5.5 months in the control arm.
The INSPIRE study was closed prematurely due to the number of deaths attributed to thromboembolic events
Data from a second randomised, controlled study INSPIRE (I4X-IE-JFBB) of necitumumab in patients with advanced non-squamous NSCLC who had not received prior chemotherapy for metastatic disease was submitted to provide safety information. Eligible patients were randomized 1:1 to receive either necitumumab with pemetrexed and cisplatin (N+PC) or pemetrexed and cisplatin (PC) alone. The study was closed prematurely at the request of the data monitoring committee (DMC) due to an imbalance on the number of deaths attributed to potential thromboembolic events (TE) and deaths of all causes observed in the N+PC arm compared to the PC arm.
The incidences of TE were higher in the necitumumab-containing arms in both SQUIRE and INSPIRE trials. The incidence of grade ≥3 TEs were 9% vs. 5% in the SQUIRE trial and 11% vs. 6% in the INSPIRE trial.
The FDA is due to hold a meeting on 9 July 2015 with cancer experts to discuss the risk/benefits of necitumumab and whether the drug should be approved.