(Solid Tumors) Is Keytruda (Pembrolizumab) Effective as Neoadjuvant Therapy?
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- February 3, 2023
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On January 9, 2023, Kaysia Ludford and colleagues from The University of Texas MD Anderson Cancer Center published Phase 2 clinical trial (NCT04082572) results in the Journal of Clinical Oncology, evaluating the efficacy and safety of Keytruda (pembrolizumab) as neoadjuvant therapy in patients with advanced metastatic solid tumors with MSI-High and dMMR status.
Trial Design
This was an open-label, independent-facility Phase 2 trial administering Keytruda (600 mg every 3 weeks, maximum 6 months) as neoadjuvant therapy to patients with advanced metastatic MSI-High/dMMR solid tumors. Following surgery, patients could continue treatment for up to one year based on individual choice. Primary endpoints: pathologic complete response (pCR) rate and safety. Secondary endpoint: organ preservation rate in patients not undergoing surgery.
Efficacy Results
Among 35 enrolled patients (27 colorectal cancer, 8 non-colorectal cancer):
- ORR (33 evaluable patients): 82%
- Pathologic complete response rate (17 surgical patients): 65%
Safety Profile
No new adverse events were identified; safety profile was consistent with known Keytruda data from other clinical trials.
Conclusions
Based on Phase 2 results, Kaysia Ludford et al. concluded that neoadjuvant Keytruda in MSI-High/dMMR advanced metastatic solid tumor patients demonstrated good tolerability and favorable pathologic complete response rates, offering patients an organ-preservation option.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.22.01351?journalCode=jco
- Clinical trial drug
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