Immunotherapy drug Opdivo improved survival in kidney cancer25 Sep 2015
Bristol-Myers Squibb's immunotherapy drug Opdivo extended kidney cancer survival rates by more than two years in a late-stage trial, setting it up to be used beyond melanoma and lung cancer.
Opdivo is already approved for melanoma and lung cancer, with most attention focused on the big lung cancer opportunity. But analysts noted that RCC prevalence was twice that of melanoma. Drugs like Opdivo work by targeting molecules that play an important role in the immune system's ability to recognize and attack tumors.
A real improvement in overall survival
The U.S. Company reported that in July the study was stopped early because its drug was more effective than Novartis' established product Afinitor, but detailed results were only disclosed now. The successful outcome means Opdivo is the first so-called immune checkpoint inhibitor drug to show an improvement in overall survival in patients with renal cell carcinoma (RCC), a common type of kidney cancer.
According to Padmanee Sharma of the U.S. MD Anderson Cancer Center, one of the lead researchers on the study, the analysis of the results showed that:
- Patients taking Opdivo had a median overall survival of 25 months as compared to 19.6 months for those taking Afinitor
- A greater proportion of patients also had tumors that shrank in response to the Bristol drug than to the Novartis one, with an objective response rate of 25% for Opdivo against 5 percent for Afinitor.
“Opdivo can change the treatment of advanced kidney cancer”
"The results are significant and clinically meaningful to patients and healthcare professionals alike," Sharma said. "They are likely to change the treatment of patients with advanced kidney cancer, whose disease has progressed on prior treatment."
Michael Giordano, Bristol's head of oncology development declined to give a precise date for submission to regulators. However, analysts estimate that Opdivo could be approved for the new use by early 2016 and the U.S. National Comprehensive Cancer Network might endorse its off-label in kidney cancer before the end of 2015.Source: Reuters