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We rounded up a few research highlights from the 2021 meeting of the American Society of Clinical Oncology (ASCO).

Dr. Toni Choueiri discussed the results of the KEYNOTE-564 trial.

A “quantum leap” in post-nephrectomy treatment

Treatment with the immunotherapy pembrolizumab (Keytruda) after nephrectomy significantly reduced the risk of disease recurrence or death compared with treatment with placebo in people with high-risk clear cell renal cell carcinoma (RCC). Dr. Toni Choueiri of the Dana-Farber Cancer Institute in Boston, Massachusetts, who reported the results of the phase III KEYNOTE-564 trial, said “pembrolizumab is a potential new standard of care for patients with RCC in the adjuvant setting.”

After 1 and 2 years, 85.7% and 77.3%, of patients, respectively, treated with pembrolizumab after nephrectomy were disease free compared with 76.2% and 68.1% who received placebo. Overall survival did not reach statistical significance but this is the first positive phase III of adjuvant immunotherapy in RCC.

Discussant Dr. Rana McKay of the University of California San Diego pointed out that sunitinib (Sutent) was an approved post-surgery treatment in high-risk RCC but because it hasn’t shown overall survival benefit and has associated toxicity and reduced quality of life, it is used infrequently. Therefore, she said, while the overall survival results of KEYNOTE-564 are not yet certain, the evidence suggests pembrolizumab could be a practice-changing alternative.

Probiotics and the gut microbiome could affect immunotherapy response

Treatment with live bacteria alongside first-line immunotherapy may help the body respond to immunotherapy in metastatic kidney cancer. Results from a small early phase study showed that, compared with those who received nivolumab (Opdivo)/ipilimumab (Yervoy) immunotherapy alone, people with metastatic RCC who also received a probiotic containing a live bacterium product showed significant improvement in progression-free survival (55 weeks vs 11 weeks in the nivolumab/ipilimumab only group). Although the primary endpoint, which was an overall change in beneficial gut bacteria, which are suggested to help immune response, was not met at the end of the 12-week study, the results have implications for nutrition advice in the management of some kidney cancers.

“This is the first randomized study to prospectively assess a live bacteria product in combination with checkpoint inhibitors,” said lead researcher Dr. Luis Meza, a postdoctoral fellow at City of Hope in Duarte, California. “Although further investigation is needed, CBM-588 seems to enhance clinical benefit in patients with metastatic RCC receiving immune checkpoint inhibitors.”

Comparing VEGF-targeted treatments

Dr. Andrea Apollo, a medical oncologist and researcher at the National Cancer Institute in Bethesda, Maryland reviewed the results of a trio of studies on combinations of vascular endothelial growth factor (VEGF)-targeted treatments, including axitinib (Inlyta), lenvatinib (Lenvima), and cabozantinib (Cabometyx), against the chemotherapy sunitinib (Sutent). 

Results after 42 months of follow up from the KEYNOTE-426 study confirmed the benefit (for progression-free survival, overall survival, treatment response, and complete response) of combination axitinib/pembrolizumab over sunitinib and continues to support the use of the combination in first-line treatment for advanced clear cell RCC, for which it received FDA approval in 2019. Although a comparison of trials on different first-line combination treatments – axitinib plus pembrolizumab, lenvatinib plus pembrolizumab, cabozantinib plus nivolumab, and nivolumab plus ipilimumab – against sunitinib all favored the combination regimens, which were quite comparable, Apollo said the axitinib/pembrolizumab regimen should remain the standard of care, particularly in the intermediate and poor risk patient groups.  

Some factors to consider in choosing first-line treatments include the potential for discontinuing treatment while continuing to benefit from treatment effects and the frequency of moving on to subsequent lines of therapy as well as treatment tolerance, serious adverse events, and quality of life. 

Apollo discussed quality of life in more detail with the results of the CLEAR study, which examined health-related quality of life in metastatic clear cell RCC patients randomized to lenvatinib/pembrolizumab, lenvatinib/everolimus/ or sunitinib. Across three different tools that assessed quality of life factors including energy, pain, activity levels, and depression, the overall analysis showed no significant health-related quality of life between the three groups. Comparing the results to additional combination therapies versus sunitinib did show that patients on a nivolumab/ipilimumab regimen (the Checkmate-214 trial) did report better quality of life compared with a sunitinib group. 

For patients on their second or third line of therapy, the CANTATA study did not show a benefit with the glutaminase inhibitor telaglenastat in combination with cabozantanib compared with cabozantinib plus a placebo. Despite lacking benefit, Apollo said the results contribute valuable data about cabozantinib in second- and third-line treatment. 

Contact the Patient Navigator Program for more information about kidney cancer treatment.

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