Treatment with a combination of Ofev and chemotherapy was shown to have a survival benefit in a group of patients with bladder cancer.
Although treatment with Ofev (nintedanib) —a targeted inhibitor currently approved for use in the European Union to treat non-small cell lung cancer — failed to improve complete response rates in patients with bladder cancer combination improved survival at one, two and three years when combined with chemotherapy in the neoadjuvant setting (initial treatment given to shrink a tumor before surgery), according to recent study results.
“This is a very exciting and important trial,” Dr. Syed A. Hussain, an author on the study and professor of medical oncology at the University of Sheffield in England, said in a press release. “Although we did not see an improvement in adding (Ofev) to chemotherapy in terms of immediate outcome of pathological complete response, we found promising results in terms of improving the overall survival rate of bladder cancer patients.”
Patients included in the study, the findings of which were published in The Lancet Oncology, received either Ofev in combination with chemotherapy in the neoadjuvant setting (57 patients) or placebo (63 patients). “This was a small trial, but the findings are promising and need further investigation in a larger randomized trial,” Hussain noted.
At a median follow up of 33.5 months, a complete response (or the disappearance of cancer as a response to treatment) was achieved in 37% of patients receiving Ofev and 32% of patients in the placebo group — which was not considered a statistically significant improvement.
However, adding Ofev to chemotherapy improved the overall survival rate (time from diagnosis or treatment start when patients are alive)for these patients.
“These results could be related to changes in the microenvironment of cancer cells translating into survival benefit,” he explained in the release
At one-year, overall survival rates were 96% for those in the Ofev group compared to 81% with placebo. At two years, it was 89% and 69% and at three years it was 60% and 49%, respectively.
“The study also showed that the treatment — which patients can take at home in tablet form — was well tolerated. This is extremely positive as it does not appear to add significant side effects to those already experienced by patients undergoing chemotherapy,” he added in the release.
The most common severe or worse side effects associated with Ofev included thromboembolic events (blood clots; 30%) and decreased neutrophil count (39%).
“We are particularly eager to explore the potential impact of adding this targeted cancer drug to the standard care of chemotherapy on those patients with alteration in specific biomarkers targeted by this drug who may be at much higher risk of cancer cells leaving the tumor and spreading throughout the body,” Hussain concluded. “This is where the treatment has the biggest potential as there is some evidence to suggest that by blocking these specific biomarkers, nintedanib may improve clinical outcome. Further translational studies to learn from patient samples are now planned.”
Of note, in the United States, Ofev is only indicated to treat idiopathic pulmonary fibrosis (a disease that causes scarring of the lungs), interstitial lung disease (a group of diseases that cause scarring of the lung) and to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease.
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