https://doi.org/10.55788/d28eff76
The combination of cabozantinib and nivolumab is a standard first-line systemic treatment for mRCC [1]. Both retrospective and prospective clinical data suggests that CBM588, an orally available liver bacterial product containing a specific strain of Clostridium butyricum, can improve the response to immune checkpoint blockade in patients with cancer [2,3]. To explore the effect of CBM588 on standard first-line therapy in patients with mRCC, Dr Hedyeh Ebrahimi (Tehran University of Medical Sciences, Iran) and colleagues conducted a phase 1 trial (NCT05122546) [4].
A total of 30 participants were randomised 2:1 to cabozantinib/nivolumab/CBM588 or cabozantinib/nivolumab. CBM588 (80 mg) was administered twice daily. The primary endpoint of the study was change in Bifidobacterium species from baseline to week 12. Secondary endpoints were PFS, response rate (RR), and toxicity.
No statistically significant difference was observed in the relative abundance of Bifidobacterium species between baseline and week 12 in the control arm or experimental arm. Also, no statistically significant difference was observed in the alpha diversity between the control arm and experimental arm, both at baseline and at week 12. Therefore, the study did not meet its primary endpoint.
The median PFS, a secondary endpoint, was significantly improved in the experimental arm compared with the control arm: not reached versus 5.8 months (P=0.042). In addition, the response rate was improved in the experimental arm (56 vs 25%). No difference in toxicity was observed between the study arms.
Based on these results, Dr Ebrahimi concluded that “the addition of CBM588 to cabozantinib/nivolumab was not associated with significant changes in the gut microbiome. However, CBM588 improved both response rate and PFS of cabozantinib/nivolumab treatment in mRCC. This is in line with previous clinical data.”
- Choueiri TK, et al. N Engl J Med 2021;384:829–841.
- Tomita Y, et al. Cancer Immunol Res. 2020;8:1236–1242.
- Dizman N, et al. Nature Med. 2022;28:704–712.
- Ebrahimi H, et al. Effect of CBM588 in combination with cabozantinib plus nivolumab for patients with metastatic renal cell carcinoma (mRCC): a randomized clinical trial. Abstract LBA104, ASCO Annual Meeting 2023, 2–6 June, Chicago, USA.
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Table of Contents: ASCO 2023
Featured articles
Real-world data support new SOC in patients with SCLC
What can real-world evidence teach us about atezolizumab plus bevacizumab in HCC?
Colorectal Cancer
7-year outcomes of PRODIGE 23 trial
Neoadjuvant chemotherapy may be viable option in locally advanced colon cancer
De-escalation of neoadjuvant treatment of locally advanced rectal cancer is non-inferior
Breast Cancer
SONIA: No survival benefit with first-line versus second-line CDK4/6 inhibition in metastatic breast cancer
Adjuvant ribociclib improves invasive DFS in early breast cancer
Gene expression profiles predict benefit of neoadjuvant immune checkpoint therapy in triple-negative breast cancer
Lung Cancer
Adding pembrolizumab to perioperative chemotherapy improves EFS in early-stage NSCLC
TTFields therapy: a new treatment modality for metastatic NSCLC
Adding chemotherapy to EGFR TKI does not improve OS in advanced EGFR-mutated NSCLC
Upper GI Cancer
No improved OS in pancreatic cancer after neoadjuvant mFOLFIRINOX
AI detects gastric cancer with high accuracy in common blood tests
Melanoma
Response-directed treatment personalisation in stage III melanoma
Prognostic and predictive biomarkers in patients with resected stage IIB/C melanoma
GU Cancers
Combining PARP inhibition and androgen receptor-signalling inhibition improves radiographic progression-free survival in HRR-deficient mCRPC
Erdafitinib outperforms chemotherapy in FGFR-altered advanced urothelial cancer
Probiotic CBM588 seems to improve clinical effect cabozantinib/nivolumab in mRCC
Exploratory analysis of IMvigor130 trial finds no OS benefit from atezolizumab in subgroups
Miscellaneous
Immune checkpoint inhibition improves PFS in non-BRCA-mutated ovarian cancer
First-line nivolumab-AVD improves PFS both in adult and paediatric patients with advanced Hodgkin lymphoma
Vorasidenib successfully targets IDH1/2-mutated glioma
ASCO Interviews
IMbrave050: Adjuvant atezolizumab plus bevacizumab provides landmark recurrence-free survival for HCC
What can real-world evidence teach us about atezolizumab plus bevacizumab in HCC?
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