On December 10, Microbio Pharmaceutical announced groundbreaking results from an exploratory clinical trial combining its innovative drug MICRSOY® with Keytruda® (pembrolizumab), the world's top-selling cancer immunotherapy drug. The trial demonstrated that adding MICRSOY® to Keytruda® tripled the immunotherapy response rate (to 75%) compared to Keytruda® alone and extended the median progression-free survival (PFS) from 4.5 months to over 12 months. Notably, the complete tumor disappearance rate (CR) reached 12.5%, indicating that MICRSOY® enhances survival outcomes for patients with advanced lung cancer.
Combining MICRSOY® with Keytruda®: Promising Outcomes for Late-Stage Lung Cancer
Wan-Jiun Chen, Executive Vice President of Microbio Pharmaceutical, highlighted the significance of these findings. Keytruda®, developed by Merck & Co., generates $25 billion in annual sales but has shown low overall clinical response rates. To address this, over 70 of Keytruda®’s more than 100 global clinical trials involve combination therapies. MICRSOY®, a proprietary postbiotic drug developed by Microbio, leverages the byproducts of probiotic fermentation and is currently approved to mitigate chemotherapy side effects.
Scientific research increasingly points to gut microbiota as a key factor influencing cancer immunotherapy outcomes. Microbio’s randomized, double-blind, placebo-controlled clinical trial examined the combination of MICRSOY® and Keytruda® in treating advanced non-small cell lung cancer (NSCLC). The trial’s one-year treatment period yielded positive results, demonstrating that MICRSOY® can significantly enhance the efficacy of immunotherapy for NSCLC patients.
Clinical Trial Overview and Key Findings
The trial enrolled 15 patients, randomly assigned in a 1:2 ratio to receive either a placebo with Keytruda® or MICRSOY® with Keytruda®. Data from 12 patients were included in the modified intent-to-treat (mITT) analysis, with four in the placebo group and eight in the MICRSOY® group.
Key outcomes included:
Objective Response Rate (ORR): The MICRSOY® combination achieved an ORR of 75%, with six of eight participants responding positively to immunotherapy, compared to an ORR of 25% in the placebo group.
Complete Response (CR): One patient in the MICRSOY® group experienced complete tumor disappearance (12.5%), sustained for over 22 months. In contrast, none in the placebo group achieved CR.
When compared to a previously published 299-patient Keytruda® trial with a CR rate of 0.6%, MICRSOY®’s CR rate of 12.5% represents a 20-fold improvement, achieved with just eight participants.
Additionally, the median PFS for the MICRSOY® group exceeded 12 months, significantly longer than the 4.5 months observed in the placebo group.
Mechanism and Future Implications
Chen emphasized that these results validate Microbio’s preclinical findings, published in the prestigious journal Gut Microbes in July 2024. The study revealed that MICRSOY® enhances cancer immunotherapy by modulating gut microbiota and increasing functional CD8 T cells in the tumor microenvironment.
Looking ahead, Microbio plans to leverage these clinical trial results for international collaborations and drug commercialization, aiming to enter the burgeoning tumor immunotherapy market. This marks a critical step in expanding MICRSOY®’s role in improving outcomes for late-stage lung cancer patients and addressing unmet needs in cancer treatment.
Resource: 中天上市新藥與全球抗癌藥併用臨床結果 可提高3倍反應
