Researchers with Johns Hopkins Kimmel Cancer Center in Baltimore recently published research that followed 270 cancer patients treated with Bristol-Myers Squibb’s checkpoint inhibitor Opdivo (nivolumab). The patients were treated at 13 different medical centers in the U.S. for advanced melanoma, renal cell carcinoma or non-small-cell lung cancer (NSCLC) who had exhausted all other treatment options before receiving Opdivo. The research reported impressive improvements in five-year survival rates.
The study, which was published in JAMA Oncology, described the secondary analysis from the CA209-003 clinical trial. It found that five-year survival “was negatively associated with presence of bone or liver metastases and positively associated with Eastern Cooperative Oncology Group performance status of 0, objective response, degree of tumor burden reduction, and adverse event occurrence.”
What that means it there were dramatic increases in the proportion of patients that survived five years after receiving Opdivo. Patients with advanced melanoma, before the introduction of Opdivo, had a 5% chance of surviving three years, and those with NSCLC had a 6% chance of surviving five years. The study indicates a 34.2% five-year-survival rate for advanced melanoma patients and 15.6% five-year-survival rate for NSCLC patients after receiving Opdivo.
“The new study provides much-needed data on long-term clinical outcomes associated with nivolumab, a drug that blocks the activity of a molecule called PD-1, removing restraints on cancer-killing cells,” Suzanne Topalian, professor of surgery, associate director of the Bloomberg Kimmel Institute for Cancer Immunotherapy and the lead author of the study, told Forbes.
They also identified useful information about which patients were most likely to benefit from treatment with Opdivo.
All of the patients in the trial had received conventional therapies before entering the trial. However, 40.4% of the patients had been given three or more rounds of previous treatments.
“While all patients had been treated previously, the number of prior treatments did not make a statistical difference in terms of five-year survival in this study,” Topalian told Forbes.
The study found that patients with larger tumor burdens or whose cancer had spread to the bone or liver were less likely to survive five years after Opdivo treatment, nor were those with low lymphocyte counts.
Unexpectedly, the researchers found that patients who had serious side effects of the Opdivo treatment had significantly longer survival. About 10 to 20% of Opdivo patients experience serious side effects such as intestinal and lung inflammation. However, these patients seemed to respond better to the therapy as long as the side effects are managed well enough to not become life-threatening.
Topalian indicates that this may be a measure of immune response.
“Nivolumab activates immune responses,” Topalian told Forbes. “Although we would like those responses to be directed only at cancer cells, in some cases there is a spillover effect and we encounter immune responses against normal tissues. Based on the findings in this study, we can reassure our patients that if they develop these side effects, it may very well put them in a better response and long-term effect category. The real issue is whether we can devise treatments to manage these side effects that will not interfere at all with the anti-tumor immune response.”
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