, offering hope of a clinical advance in a cancer that remains very difficult to treat.
The drug is nimotuzumab, developed as a joint Chinese-Cuban venture, a monoclonal antibody that targets the epidermal growth factor receptor (EGFR), inhibiting tumor cells that overexpress EGFR.
When nimotuzumab was added to gemcitabine, it significantly improved overall survival, compared with gemcitabine alone, in a trial conducted in China in 92 patients with advanced pancreatic cancer who had KRAS wild-type tumors.
One-year survival rates were 43.6% with nimotuzumab versus 26.8% with placebo, while 3-year survival rates were 13.9% versus 2.7%.
The results were presented at the annual meeting of the American Society of Clinical Oncology and highlighted at a press briefing.
“We believe our NOTABLE trial will be a breakthrough in the field of pancreatic cancer,” co-lead author Shukui Qin, MD, department of medical oncology, Cancer Center, Jinling Hospital, Nanjing, China, commented in an ASCO press release.
“The outcomes in this trial may bring new hope to patients with KRAS wild-type pancreatic cancer,” he added.
“To see any survival benefit in a trial for metastatic pancreatic cancer is of interest,” commented Cathy Eng, MD, an ASCO expert in gastrointestinal cancers.
However, she pointed out that the subgroup of patients who may benefit is small – KRAS wild-type tumors are found in fewer than 10% of patients with pancreatic cancer.
“Additional studies in comparison with the combination of gemcitabine/nab-paclitaxel would be of interest,” Dr. Eng added, to validate “any potential advances to make a true difference in the lives of all patients with pancreatic cancer.”
Already marketed in China
Nimotuzumab is already marketed in China: It was approved in 2008 by the Chinese National Medical Products Administration for the treatment of nasopharyngeal carcinoma and is currently being investigated in head and neck, cervical, esophageal, and other cancers.
Julie R. Gralow, MD, ASCO chief medical officer and executive vice president, commented in an interview that it will be “interesting to see the U.S. Food and Drug Administration’s response to the current data.”
She explained that the FDA has recently rejected drugs developed and tested in China, mostly notably sintilimab in non–small cell lung cancer, because the clinical data submitted were from China and not “reflective of the U.S. cancer population” and also because in this case there were already a number of other similar drugs available in this therapeutic area.
However, pancreatic cancer represents an unmet clinical need, which is a different situation, and there may be some consideration for an accelerated approval while awaiting a U.S. clinical trial, she speculated.
This trial showed an interesting proof of principle, she added – it showed that an EGRF inhibitor was active in KRAS wild-type advanced pancreatic cancer. This opens the door for exploration with other drugs that also act as EGFR blockers, as well as drugs with other actions such as BRAF antagonists, MAP kinase inhibitors, and/or immunotherapy.
Study details
The phase 3 NOTABLE trial involved 92 Chinese patients with locally advanced or metastatic KRAS wild-type pancreatic cancer randomized to nimotuzumab weekly or placebo plus gemcitabine until progression or unacceptable toxicity.