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Nivolumab ‘likely to change the treatment’ of advanced renal cell carcinoma
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Nivolumab significantly prolonged OS compared with everolimus in patients with advanced renal cell carcinoma whose disease progressed following initial treatment, according to the results of the phase 3 CheckMate 025 trial presented at European Society for Medical Oncology’s European Cancer Congress.
Further, patients treated with nivolumab (Opdivo, Bristol-Myers Squibb) experienced fewer grade 3 or grade 4 adverse events than patients who received standard-of-care everolimus (Afinitor, Novartis), according to the results, which were simultaneously published in The New England Journal of Medicine.
“CheckMate 025 is the first and only study in which immunotherapy with an immune checkpoint inhibitor — used after a prior treatment has failed — has shown a benefit in OS among patients with advanced kidney cancer for whom treatment options are currently limited,” Padmanee Sharma, MD, PhD, scientific director of the immunotherapy platform and professor in the departments of immunology and genitourinary medical oncology at The University of Texas MD Anderson Cancer Center, said in a press release.
Renal cell carcinoma is the most commonly diagnosed kidney cancer in adults, according to Sharma. Current treatments for advanced or metastatic renal cell carcinoma are associated with poor OS in previously treated patients, with a global 5-year OS rate of 12.1%.
The PD-1 checkpoint inhibitor nivolumab demonstrated encouraging OS in uncontrolled studies of previously treated patients with renal cell carcinoma, according to study background.
Sharma and colleagues conducted a randomized, open label phase 3 trial comparing nivolumab with everolimus in 821 patients (median age, 62 years; 75% men) with advanced clear-cell renal cell carcinoma who had received previous treatment with one or two regimens of antiangiogenic therapy.
Researchers randomly assigned patients to a treatment regimen of IV nivolumab (3 mg/kg every 2 weeks) or oral everolimus (10 mg once daily).
OS served as the primary endpoint. Objective response rate and safety served as secondary endpoints.
Participants assigned nivolumab achieved a median OS of 25 months (95% CI, 21.8-not estimable), whereas patients assigned everolimus achieved a median OS of 19.6 months (95% CI, 17.6-23.1) for participants assigned everolimus.
The HR for death with nivolumab vs. everolimus (HR = 0.73; 98.5% CI, 0.57-0.93) met the pre-specified criterion for superiority (P ≤ .0148).
Further, more patients assigned nivolumab responded to treatment than patients assigned everolimus (25% vs. 5%; OR = 5.98; 95% CI, 3.68-9.72).
Median PFS appeared comparable in both arms (4.6 months vs. 4.4 months; HR = 0.88; 95% CI, 0.75-1.03).
Nineteen percent of the nivolumab arm experienced treatment-related grade 3 or grade 4 adverse events, compared with 37% of the everolimus arm. Fatigue was the most common adverse event associated with nivolumab (2%), whereas anemia was the most common adverse event associated with everolimus (8%).
No treatment-related deaths occurred in the nivolumab arm and two treatment-related deaths occurred in the everolimus arm.
The researchers closed the trial early in July 2015 based on the superiority of nivolumab. Patients had the opportunity to continue nivolumab treatment or switch from everolimus to nivolumab.
“It is exciting to see the outcome of this study, as the results are significant and clinically meaningful to patients and health care professionals alike,” Sharma said. “They are likely to change the treatment of patients with advanced kidney cancer, whose disease has progressed on prior treatment. Although we cannot speculate at this time on when nivolumab might enter the clinic, we hope that this study will quickly lead to approval of nivolumab as a standard of care therapy for these patients.” – by Cameron Kelsall
Reference:
Sharma P, et al. Abstract 3LBA. Presented at: European Cancer Congress; September 25-29, 2015; Vienna.
Disclosure: Sharma reports personal fees from Amgen, AstraZeneca/MedImmune, Bristol-Myers Squibb, GlaxoSmithKline and Jounce Therapeutics. Please see the abstract for a list of all other researchers’ relevant financial disclosures.
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