Camu Camu Shows Safety in Patients with Melanoma and Non–Small Cell Lung Cancer

Results from a phase 1 clinical trial (NCT05303493)¹ show that the prebiotic camu camu was safe in the treatment of patients with melanoma and non–small cell lung cancer (NSCLC) in combination with immune checkpoint inhibition (ICI). The results of the trial were presented at the 2025 European Society for Medical Oncologists (ESMO) Congress on October 18 in Berlin, Germany, and announced by Jade Maillou, PhD candidate, CHUM Microbiome Centre in Montreal, Canada.

Castalagin, the active compound in camu camu, possesses antitumor activity and can shift the gut microbiome.

What were the results of the trial?

The median follow-up was 13 months (95% CI, 11–23). Grade < 2 adverse events (AEs) occurred in 5% of patients with camu camu pre-ICI.

In the melanoma cohort, ≥ grade 3 AEs were in 23% of patients, which was consistent with the known safety profile. The most reported AEs were rash, hypothyroidism, and diarrhea. In the NSCLC arm, 27% of patients experienced ≥ grade 3 AEs related to chemotherapy/anti–PD-1 therapy. The most common AEs were rash, fatigue, and diarrhea.

In patients with refractory melanoma, the overall response rate (ORR) was 13% with 1 patient achieving complete response (CR) and 1 patient achieving partial response (PR). Disease control rate (DCR) was 40%, including 2 patients with stable disease (SD) > 6 months and 2 patients with SD > 15 months. The overall survival (OS) was 56% at 1 year.

The ORR was 57% with 4 patients achieving PRs in the first-line melanoma arm. In the NSCLC arm, ORR was 40% and DCR was 93%, with 6 patients reaching SD > 6 months. The OS rate was 77% in this arm.²

What was the design of the study?

This is a phase 1, multicenter, open label study with an enrollment of 45 patients across 3 cohorts, with 1 cohort closing early due to approval of relatlimab, a LAG-3 checkpoint inhibitor, and nivolumab (Opdualag). One cohort was made up of 15 patients with advanced melanoma refractory to ICI rechallenged with anti–PD-1 therapy plus camu camu, and the other had 15 patients with advanced NSCLC amenable to first-line platinum doublet in combination with anti–PD-1 plus camu camu. Patients received camu camu at 1500 mg daily for 1 week prior to ICI.

The primary end point of the trial was safety, and the secondary end points were ORR and DCR. The exploratory end points were impact on the metabolite and immune profile including in the preclinical model.²

What were patient characteristics?

The median age of patients in the first-line melanoma cohort was 76, and 57% of patients were male. Patients had an ECOG score of 0 or 1. The median age of patients in the refractory melanoma cohort was 75, which was older than what was published in the clinical trial, Maillou noted. Majority of patients in the NSCLC cohort were male, (53%), and had an ECOG score of 0 or 1.²

Patient eligibility criteria included but was not limited to having evaluable disease as per RECIST v1.1, ECOG status of 0 to 2, ability to ingest capsules, and taking highly effective contraception for male and female patients throughout the study and at least 60 days after the last treatment.¹

Patient exclusion criteria included but was not limited to having a diagnosis of severe immunodeficiency, taking probiotics, taking natural supplements, and the use of antibiotics within 2 weeks of enrollment in the study.¹

“Now, we are trying to unravel the mechanism behind castalagin, and based on those results we will launch a phase 1 trial of pure capsules of castalagin in 2026,” concluded Maillou.²

DISCLOSURES: Maillou did not have any disclosures.

REFERENCES:

1. Camu-Camu Prebiotic and Immune Checkpoint Inhibition in Patients With Non-small Cell Lung Cancer and Melanoma. ClinicalTrials.gov. Updated July 30, 2025. Accessed October 23, 2025. https://clinicaltrials.gov/study/NCT05303493

2. Maillou J. Phase 1 Trial of Camu-Camu Prebiotic Plus Immunotherapy in Patients with Melanoma and Non-Small Cell Lung Cancer (NSCLC). Presented at: ESMO 2025 Congress; October 17–21, 2025; Berlin, Germany. Abstract LBA62.