Gemzar Gets Indication for First-Line Treatment of NSCLC

INDIANAPOLIS--Eli Lilly and Company’s Gemzar (gemcitabine) has received FDA approval for use as first-line treatment of inoperable, locally advanced, or metastatic non-small-cell lung cancer (NSCLC) in combination with cisplatin (Platinol). The agent was previously approved as first-line, single-agent therapy of locally advanced or metastatic pancreatic cancer.

"When left untreated, advanced lung cancer can take the lives of patients within 4 months," said Alan Sandler, MD, assistant professor of medicine, Indiana University School of Medicine, and lead investigator for the pivotal trial. "Our study showed that 39% of patients who received Gemzar plus cisplatin were still alive after 1 year, compared with only 28% of patients who received cisplatin alone."

Two randomized, multicenter trials supported gemcitabine’s supplemental new drug application for NSCLC. The pivotal phase III trial included 522 patients who had received no previous chemotherapy; more than two-thirds of these patients had stage IV disease.

In addition to significantly improved 1-year survival, the patients receiving gemcitabine-cisplatin had significantly longer median survival than those on cisplatin alone (9 months vs 7.6 months); a significantly higher response rate (26% vs 10%); and significantly longer median time to progression (5.2 months vs 3.7 months).

In the second trial of 135 patients with no prior chemotherapy, approximately 50% of whom were stage IV, gemcitabine-cisplatin was compared with cisplatin-etoposide. Those receiving gemcitabine had significantly higher response rates (33% vs 14%) and significantly longer median time to progression (5 months vs 4.1 months). Survival was not an endpoint for this trial, but results showed that 1-year survival probability was comparable between the two groups.

In the pivotal study, myelosuppression was the most common severe side effect and, as expected, occurred more frequently in the combination arm. There were four possibly treatment-related deaths with gemcitabine-cisplatin, three from myelosuppression. No such deaths occurred on the cisplatin-alone arm.

Other commonly reported side effects of the gemcitabine-cisplatin combination included nausea, vomiting, and alopecia. Kidney and sensory dysfunctions were also reported, but serious events were uncommon.