Can Nivolumab Effectively Treat Metastatic RCC When Resources Are Limited?

Nivolumab immunotherapy could effectively treat metastatic renal cell carcinoma (mRCC) in resource-constrained settings where intervals between dosages are lengthened and when treatment is cut short for patients who have shown a response, according to an abstract presented by researchers from Indian at the 2019 American Society of Clinical Oncology Annual Meeting, held May 31 to June 4, 2019, in Chicago, Illinois.

“Nivolumab is now a standard second-line treatment for patients of mRCC who progress on first line sunitinib or pazopanib,” researchers wrote. “Most western centers use nivolumab for either 2 years duration, or indefinitely, or [until] severe side effects. Due to high drug cost and lack of insurance, it is difficult for most of our Indian patients to afford this duration of treatment. So, we decided to study the impact of increasing intervals between standard doses of nivolumab, and stopping treatment early in responding patients of mRCC.”

Researchers conducted a single-center, retrospective study of patients with mRCC. A total of 28 participants were treated with nivolumab between May 2016 and December 2018. Of the total, 24 patients initially received oral tyrosine kinase inhibitors (TKIs).

• 13 received sunitinib
• 10 received pazopanib
• 1 received sorafenib

The 4 patients who were not initially given TKIs received nivolumab as first-line therapy: 2 as a single agent and 2 with oral TKIs.

Participants received either 3 mg/kg or 240 mg of nivolumab at 2 weekly intervals for 6 initial cycles. The interval between cycles was extended to 3 weeks if patients had complete response (CR), partial response (PR), or stable disease. The doses were extended to 4 weekly intervals after a period of 9 months. The study’s end points were objective response rate (ORR), overall survival (OS), and adverse events.

Patient response was assessed by Response Evaluation Criteria in Solid Tumors.

Researchers found:

• 3 (10.7%) patients achieved CR
• 7 (25.0%) patients achieved PR
• 7 (25.0%) patients had stable disease
• 11 (39.2%) patients had progressive disease.

Treatment was halted after 18 doses for the 3 patients who had achieved CR. The duration of follow-up after the conclusion of treatment ranged from 8 months to 18 months. The 3 patients who had achieved CR remained in CR. Of the 3 patients with stable disease, 1 received 22 cycles and 2 received 19 cycles. OS at 1 year was 60%. The median OS had not been reached.

“An ORR of 36% and OS at 1 year of 60% is the best we have seen. Long-lasting responses, even after discontinuing therapy, have been seen. This enables us to reduce the cost of treatment without possibly losing efficacy, and this could be an important step forward for treating more patients with nivolumab in our resource constraint setting,” researchers concluded.

Reference

Rauthan A, Patil P, Yashas N, et al. Immunotherapy with nivolumab in metastatic renal cell carcinoma in resource constraint settings: Impact of increasing intervals between standard doses, and stopping treatment early in responding patients. Presented at: American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2019; Chicago, Illinois. Abstract e16078.