Chemotherapy Plus Nimotuzumab Improves Survival in Certain Patients with Advanced Pancreatic Cancer

Compared with treatment with the chemotherapy gemcitabine alone, adding nimotuzumab to gemcitabine increased overall survival in patients with KRAS wild-type advanced pancreatic cancer, according to new findings.

The data also showed that the combination improved overall survival among those who did not need surgery for an obstruction of a pancreatic bile duct.

“We believe our NOTABLE trial will be a breakthrough in the field of pancreatic cancer,” co-lead study author Dr. Shukui Qin, a professor and chief physician of the Cancer Center, Jinling Hospital, Nanjing University of Chinese Medicine, said in a press release.“The outcomes in this trial may bring new hope to patients with KRAS wild-type pancreatic cancer.”

In the prospective, double-blind study, median overall survival in patients treated with nimotuzumab plus gemcitabine was significantly longer when compared with those who received gemcitabine plus a placebo at 10.9 months versus 8.5 months, respectively. Moreover, the combination regimen elicited one- and three-year overall survival rates of 43.6% and 13.9%, respectively, compared with 26.8% and 2.7% with the placebo regimen.

Among those who did not need surgery to remove a biliary obstruction, median overall survival was 11.9 months and 8.5 months with the combination versus the placebo regimens, respectively. Similarly, overall survival was improved for those who had no surgical history and received treatment with nimotuzumab plus gemcitabine at 15.8 months compared with placebo and gemcitabine at 6 months.

Median progression-free survival (time during and after treatment a patient is alive without the disease getting worse) was also improved with nimotuzumab plus gemcitabine at 4.2 months versus gemcitabine alone at 3.6 months.

The incidence of side effects was similar among both groups. The most common side effects with the anti-epidermal growth factor receptor monoclonal antibody, nimotuzumab, were neutropenia (11.1%), leukopenia (8.9%), and thrombocytopenia (6.7%)

The phase 3 trial evaluated the efficacy and safety of nimotuzumab in combination with gemcitabine versus gemcitabine alone in patients with KRAS wild-type locally advanced or metastatic pancreatic cancer. In addition, subgroup analyses were conducted based on the need for surgery to remove bile duct obstructions prior to receiving chemotherapy, as those who do not need surgery to repair obstructions typically have better liver function and no jaundice, indicating a potential advantage for tolerating chemotherapy, according to the release.

“To see any survival benefit in a trial for metastatic pancreatic cancer is of interest,” ASCO expert in gastrointestinal (GI) cancers Dr. Cathy Eng, who is the co-leader of the Gastrointestinal Cancer Research Program and co-director of GI Oncology at the Vanderbilt-Ingram Cancer Center in Nashville, Tennessee, said in the release.

“The investigators have evaluated a subset of pancreatic cancer, KRAS wild-type, which is rarely investigated prospectively because this form of the cancer represents less than 10% of all pancreatic cancer patients,” she added. “Additional studies in comparison with the combination of gemcitabine/nab-paclitaxel would be of interest. We should consider validating any potential advances to make a true difference in the lives of all patients with pancreatic cancer.”

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