Opdivo: Bristol Drug Extends Survival Rate for Kidney Cancer Patients

The study was halted for ethical reasons, to offer the comparison group nivolumab.

According to the website’s section, “statistics and outlook for kidney cancer”, roughly 70% of people with kidney cancer will survive for a year or more after initial diagnosis.

Kidney cancer is a disease that takes 14,000 American lives every year and 62,000 people yearly have to cope with the idea that their demise will probably come faster than they had anticipated or were ready for. Exact causes are not known, but risk factors include smoking, certain chemical exposures, obesity, high blood pressure, genetic mutations and heredity. Complete responses, in which doctors can’t find remaining evidence of disease, were ” disappointingly elusive”, the editorial said.

The trial on 821 patients showed average survival was increased from 19.6 months with standard therapy, to 25 months with nivolumab. “We have a real opportunity to change clinical practice for patients when other therapies have failed”, said principal investigator Padmanee Sharma, MD, PhD, professor, Departments of Genitourinary Medical Oncology and Immunology and scientific director of the Immunotherapy Platform, part of MD Anderson’s Moon Shots Program.

The results of the study was published online in the New England Journal of Medicine.

Opdivo is one of a new class of drugs that stimulate the immune system to attack cancers. The one-year survival rate was 73 per cent for those on Opdivo compared to 42% for DTIC. The median PFS was 4.6 months with nivolumab and 4.4 months with everolimus.

The second drug, cabozantinib, was also tested against everolimus.

The study had 658 patients, with half taking cabozantinib and half everolimus. Only one other drug has shown a survival benefit, and that drug was studied in a much narrower population.

Regardless of combination hopes, Mr. Morrissey believes that the progression-free survival benefit shown for Cometriq – 7.4 months vs. 3.8 months for Afinitor – will be persuasive as a monotherapy.

“This is the only phase III randomized trial to demonstrate a survival advantage in previously treated renal cell carcinoma versus standard therapy”, Sharma said during a press briefing.

Both studies were paid for by the makers of the drugs – Bristol-Myers Squibb, for nivolumab; and Exelixis, for cabozantinib. The primary endpoint was PFS, and secondary endpoints included overall survival and objective response rate.

Incidence of the disease has more than doubled since the mid-1970s. Such patients are then usually given everolimus.

The FDA recently granted nivolumab a breakthrough therapy designation for the treatment of patients with advanced RCC, which will expedite the development and regulatory review of the anti-PD-1 agent in this setting. The late stage trial set the drug up to be used for more than just a lung cancer and melanoma treatment. It was the first approved treatment proven to extend survival for patients with living with this deadliest form of skin cancer. Cabozantinib is sold as Cometriq and is generally used for the treatment of thyroid cancer.

Patient characteristics were well balanced between the two arms. Dr Alan Worsley from Cancer Research United Kingdom, explains that, “Cabozantinib, a targeted therapy, and nivolumab, an immunotherapy, fight cancer in very different ways, so making either available for use in the clinic will greatly expand the arsenal for clinicians to treat kidney cancer patients.”.

“Maybe they’re not curative, but patients will likely live longer and be around for their families and have more options, with the goal always, of course, the cure”, he said.