Loading

Nivolumab Plus Ipilimumab, Cabozantinib Plus Nivolumab Get Top Scores for Emerging RCC Therapeutics

By Cecilia Brown - July 28, 2022

A new analysis of data from six clinical trials that evaluated emerging therapeutics for patients with renal cell carcinoma (RCC) gave top value measurement scores to nivolumab plus ipilimumab and cabozantinib plus nivolumab.

Cabozantinib plus nivolumab received the highest American Society of Clinical Oncology value framework (ASCO-VF) score and the second highest European Society for Medical Oncology magnitude of clinical benefit (ESMO-MCBS) grade in the analysis. Nivolumab plus ipilimumab received the highest ESMO-MCBS grade and the third highest ASCO-VF score.

The results of the analysis, led by Hyerim Ha of Inha University Hospital, were published in BMC Health Services Research.

Two medical oncologists used ASCO-VF and ESMO-MCBS to assess data from six clinical trials (COMPARZ, CheckMate 214, JAVELIN renal 101, Keynote 426, CLEAR, and CheckMate 9ER) that evaluated first-line treatments for patients with metastatic RCC. Sunitinib treatment was used in control arms for all trials.

ASCO-VF Scores

ASCO-VF net health benefit was calculated by clinical benefit and toxicity, plus bonus points, with a higher score meaning a greater treatment benefit.

The ASCO-VF net health benefit was highest in cabozantinib plus nivolumab (50.8), followed by axitinib plus pembrolizumab (48.7), nivolumab plus ipilimumab (41.9), lenvatinib plus pembrolizumab (35.2), axitinib plus avelumab (22.4), and pazopanib (11).

ESMO-MCBS Grades

The ESMO-MCBS evaluation form used depended on the primary endpoints of the trials and survival duration. The preliminary clinical benefit grade was determined by the hazard ratio and duration of survival gain, while the final grade was obtained by adjusting for early stops or crossovers, quality of life, toxicity or plateau of the survival curve. Higher grades mean a greater treatment benefit.

Nivolumab plus ipilimumab received the highest ESMO-MCBS score, grade 5. Pazopanib, lenvatinib plus pembrolizumab, and cabozantinib plus nivolumab received grade 4 scores. Pembrolizumab, and axitinib plus avelumab received grade 3 scores.

Interpreting Differences Between Evaluation Tools

While pazopanib had the second highest ESMO-MCBS grade, it received the lowest ASCO-VF score, highlighting the differences between assessments.

Investigators posited that the “discrepancy of results by the two evaluation tools may be due to the different purpose of the tools,” as “ESMO recommends the use of ESMO-MCBS for comparison of trials, while ASCO recommends against the use of VF for comparison.”

“Considering the purpose of ‘value evaluation of chemotherapeutics’, it is desirable to verify the results for the consistent results,” the researchers concluded. “…. The results show that the highest score in one assessment tool does not mean the best treatment.”

The authors also noted that “these tools warrant further discussion and improvement,” asking, “How should these assessment tools be applied in the real-world setting for approval, decisions of reimbursement or post-marketing assessment, and for patients, clinicians, decision-makers or payers (government or insurance company)?”

Reference

The value measurement of emerging therapeutics in renal cell carcinoma: ASCO value framework and ESMO-MCBS.

Did you like this article?