Research press release


Nature Medicine

Cancer: Probiotic may boost immunotherapy to treat renal cell cancer



今回、S Pal、S Highlanderたちは、29人の転移性腎細胞がん患者からなるコホート(平均年齢66歳、72%が男性)で、第1相臨床試験を行った。患者たちは、免疫チェックポイント阻害剤(免疫療法の一種)の標準的な組み合わせの投与に加えて、ビフィズス菌群などを含むマイクロバイオームを補助することが期待される生菌製剤CBM588を経口投与する群としない群に無作為に分けられた。ビフィズス菌群は、免疫チェックポイント阻害剤に対する応答の改善に関連していることがすでに報告されている。CBM588の投与を受けた患者では免疫チェックポイント阻害剤療法に対する応答が改善されて長く続き、しかも毒性の面では対照群に比べて差がないことが分かった。これらの患者から採取された糞便試料の解析により、臨床応答が改善された患者ではビフィズス菌群の数が増えていることが確認され、これが無増悪生存期間の延長と免疫の活性化に結び付くことが確かめられた。


Combining live biotherapeutic product CBM588 (a probiotic) with immunotherapy can enhance anti-tumour responses in patients with metastatic renal cell cancer, according to the results of a phase 1 clinical trial published in Nature Medicine. These findings underscore the potential of modulating the bacteria within the gut to augment immunotherapy in patients with cancer.

The collection of microorganisms in the gut (microbiota) are involved in regulating the immune system, with the specific composition of the microbiome known to modulate the efficacy of immunotherapy in patients with cancer. An imbalance between strains of bacteria in the gut is associated with diseases such as inflammatory bowel disease, and some specific bacteria relate to an increased risk of cancer through the production of carcinogenic toxins, or resistance to anti-tumour therapies.

Sumanta Pal, Sarah Highlander and colleagues conducted a phase 1 clinical trial in a cohort of 29 patients (mean age of 66 years, 72% male) with metastatic renal cell carcinoma. Patients were randomized to receive a standard combination of immune checkpoint inhibitors — a form of immunotherapy — with or without oral supplementation with a live biotherapeutic product (CBM588) that modulates the microbiome, including bifidobacteria, within the gut. Bifidobacterium species have been previously associated with improved response to immune checkpoint inhibitors. The authors found that patients who received CBM588 achieved improved and durable responses to immune checkpoint inhibitor treatment, with no differences in toxicity compared to the control group. Analysis of stool samples from these patients confirmed an increase in the number of bifidobacteria species in clinical responders and was associated with longer progression-free survival and immune activation.

The authors conclude that their data appear to support the potential of CBM588 to improve the outcomes of patients with cancer who are undergoing immunotherapy. The results will, however, need to be confirmed in larger studies and for additional tumour types.

doi: 10.1038/s41591-022-01694-6

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