The drug is already approved for advanced melanoma and lung cancer. CheckMate-025 is an example of how investigators are examining approved immunotherapy drugs to determine potential impact on other tumor types.
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Dr James Larkin, a consultant at the Royal Marsden Hospital, told the BBC News website: “It’s another big day for immunotherapy for cancer and one of the biggest days for kidney cancer for some time. This is a new way forward”.
Results from CheckMate -025 mark the first and only Phase 3 study to demonstrate a significant survival advantage in previously treated patients with advanced RCC versus standard of care. At the median, overall survival of Opdivo patients was 25 months compared to 19.6 months for Afinitor patients.
The study included 821 patients with advanced RCC across 151 sites in 24 countries in North America, Europe, Australia, South America and Asia. The drug is playing an important role in the immune system’s ability to recognize and attack tumors.
At a minimum follow-up of 14 months, the median OS was 25.0 months with nivolumab versus 19.6 months with everolimus (HR, 0.73; 98.5% CI, 0.57-0.93; P =.002).
There were no drug-related deaths in the Opdivo group, but two occurred in the Afinitor group.
The interim analysis also showed a trend toward better survival with cabozantinib, but the results did not yet meet pre-established statistical criteria for significance.
PFS served as the primary endpoint. When the trial ended, the nivolumab arm had a 27% reduction in the survival hazard versus the everolimus arm (HR 0.73, 95% CI 0.57-0.93, P=0.002). “Today’s news is therefore very encouraging and will hopefully open the door to more options for patients in the future”.
The trial has stopped recruiting patients and researchers are hoping that cabozantinib may become available to patients with advanced kidney cancer some time in 2016.
In regard to safety, patients treated with nivolumab experienced less fatigue and nausea than those treated with everolimus and had an improved quality of life.
In Bristol’s phase III study known as CheckMate-025, patients with kidney cancer no longer responding to front-line therapy were randomized to receive an injection of Opdivo every two weeks or a daily dose of oral Afinitor.
Normally, cancerous tumours are able to “hide” from our body’s immune system.
In a separate trial being presented at the meeting, a thyroid cancer drug from Exelixis Inc. also yielded positive results in kidney cancer patients who had failed other treatment. The Breakthrough Therapy designation is intended to expedite the development and review of medicines with early signals of clinical benefit in serious diseases to help ensure patients have access to new therapies as soon as possible. The results of the METEOR study are remarkable and most likely will be practice changing. Those were presented at the European Cancer Congress in Vienna too.
Prof Choueiri, who is Associate Professor of Medicine at Harvard Medical School and Clinical Director and Kidney Cancer Center Director at The Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, USA, said: “I am very excited about the outcome of the study since the results may change the standard of care in patients with advanced kidney cancer who have received prior standard therapy that targets the vascular endothelial growth factor receptor (VEGFR)”.
“While these treatments have changed the therapeutic landscape for RCC, they are associated with limited survival following emerging resistance to therapy”, said Sharma.
In some cancer, checkpoint inhibitors are more effective against tumors which express higher levels of the PD-L1 protein.
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