Studies show that immunotherapies may alter the treatment of kidney cancer

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"It's a proof of principle that we can do it if the drugs are in the same class and tolerated when they are combined," said Dr. Toni Choueiri, director of the Lank Genitourinary Cancer Center. at the Dana-Farber Cancer Institute / Brigham and Women's Professor of Medicine at Harvard Medical School in Boston, lead author of the study on avelumab. He participated in previous research on pembrolizumab, but not in the new pembrolizumab study.

The new immunotherapies as a whole "have revolutionized many tumors," he said.

Immunotherapy is a therapeutic approach that exploits certain parts of the body's immune system to target and attack a disease, such as cancer. This approach can take different forms – vaccines, antibody therapies or cells, or drugs – and can be given by injection, pills or capsules, topical ointments or creams or a catheter.

Immunotherapy may also be associated with another therapy as a form of treatment, as shown by the two new studies.

The study avelumab-axitinib involved 886 patients with kidney cancer. Of these, 442 received avelumab plus axitinib as treatment, and 444 received the sunitinib chemotherapy drug, or Sutent, a first-line treatment for advanced-stage kidney cancer.

The study showed that the average progression-free survival was 13.8 additional months of life in patients treated with avelumab plus axitinib, compared to 7.2 months in those treated with sunitinib.

The study on pembrolizumab-axitinib involved 861 patients with renal cell cancer. Of these, 432 received intravenous pembrolizumab plus treatment with axitinib and 429 with sunitinib.

The study showed that the average progression-free survival was 15.1 months in the pembrolizumab-axitinib group and 11.1 months in the sunitinib group. Patients who received the combination therapy had a risk of death of less than 47% and a risk of progression of the disease or death 31% lower than those receiving sunitinib.

The percentage of patients alive after 12 months of treatment was 89.9% in the pembrolizumab-axitinib group, compared with 78.3% in the sunitinib group.

The results of this study "will absolutely change the standard treatment of this disease.What has been observed is truly unprecedented results in terms of overall benefit for survival with the lowest risk ratio, the greatest benefit ever seen in kidney cancer, "said Dr. Brian Rini, oncologist at the Cleveland Clinic and professor of medicine at Case Western Reserve University in Cleveland, first author of the study on pembrolizumab.

"We measure the effectiveness of anticancer drugs in many different ways – patients live longer, in the first place – but also other measures, and of all these measures, this combination was superior to sunitinib," he said. he declared. These other measures include the response to treatment and the progression of the disease.

In both studies, the limitations and side effects of combination therapy were what could be expected if immunotherapy or targeted therapy were administered individually. Side effects of immunotherapy may include flu-like symptoms, diarrhea or risk of infection. Side effects of targeted cancer treatments may include diarrhea, high blood pressure, thyroid problems or liver problems, such as hepatitis and elevated liver enzymes.

"These are not easy-to-tolerate treatments," said Dr. J. Leonard Lichtenfeld, Acting Medical Director of the American Cancer Society, who did not participate in either study.

"We have learned from other studies, not about kidney cancer, but on other studies, when we start to combine some of these treatments, the side effects can be considerable, which can This being said, the reality is that the addition of the immunotherapy drug has prolonged survival longer than standard treatment, "he said.

"Some would say it's only a matter of a few months and it's really an improvement given the cost and side effects of immunotherapy drugs? patients long enough, "he said." It is therefore possible that some patients show remarkable improvement as a result of this treatment. "

The combined treatments studied in both studies are not yet approved by the US Food and Drug Administration for kidney cancer, and the cost of treatments is not known.

However, the question remains: "Will this change the standard of care? Well, I think that will or will not change the issue of due diligence that will be discussed by experts," Lichtenfeld said.

"I do not think this study will make an immediate difference overnight, but I suspect that over time, it will become a more standard treatment for metastatic or recurrent renal cell carcinoma – kidney cancer."

Dr. Bernard Escudier, former president of the Genitourinary Group at the Gustave Roussy Institute in Villejuif, France, wrote an editorial that accompanied the two studies in the New England Journal of Medicine.

He indicated that sunitinib had become the standard treatment for kidney cancer in 2007. Last year, the combination of two immunotherapies – nivolumab or Opdivo and ipilimumab or Yervoy – s & # It has proven to be more effective than sunitinib and has become the new standard.

Now, "it should be noted that these two trials have had positive results and shown superiority over sunitinib in terms of progression-free survival and objective response rate.The pembrolizumab trial also showed a benefit in terms of overall survival, "wrote Escudier. "Both combinations should become new standards of care and be incorporated into future guidelines."

Experts in the field continue to scrutinize not only new studies, but also how immunotherapeutics influence treatment approaches.

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