ASCO GI 2021: Pabli Pearl Monoantigen significantly improves PFS in MSI-H/dMMR mCRC patients (KEYNOTE-177 study)

From January 15 to 18, the American Society of Clinical Oncology (ASCO-GI), the world's premier academic event in the field of gastrointestinal tumors, will be held as an online conference.
results of the KEYNOTE-177 study, here's a detailed report.
background and methodology: KEYNOTE-177 is a Phase III randomized open-label clinical study designed to assess the efficacy of first-line Pabli pearl monoantigen or chemotherapy ±bevar bead monoantibilisie or sitoxysin monoantigen therapy (microsatellial highly unstable/misalised repair defects) MSI-H/dMMR metastatic colorectal cancer (mCRC).
final PFS and PFS2 results were announced at this meeting.
study included patients with ECOG scores of 0-1, MSI-H/dMMR mCRC, and randomly assigned to receive Pablo pearl monoanti (200mg, Q3W, up to 2 years) or the researcher's choice of mFOLFOX6 or FOLFIRI±beva bead monoantigen or silcibutoxys, until the disease progressed or be resistant to toxicity, or the researcher/researcher withdrew from the study.
the patients in the chemotherapy group can be crossed to the Pabliju monoantigen group after the disease progresses.
end points are progress-free lifetime (PFS) (RECIST1.1, central evaluation) and total lifetime (OS), while secondary endpoints include objective mitigation rate (ORR) (RECIST1.1, central assessment) and safety.
end points include remission duration (DoR), PFS2 (from random to second-line treatment progression or the time of death for any cause), and health-related quality of life (HRQoL).
data analysis deadline is February 19, 2020.
results: At the data cut-off, the study included 307 patients, 153 cases in the Paboliju monoantigen and 154 in the chemotherapy group, respectively.
32.4 months of the medium follow-up, the PFS of the Paboli pearl monoantigen group was significantly better than that of the chemotherapy group, at 16.5 months and 8.2 months (HR-0.60) (P-0.0002), respectively.
PFS rates were 55.3 percent and 48.3 percent, 37.3 percent and 18.6 percent, respectively, in the 1-year and 2-year PFS groups in the Paboli pearl monoantigen and chemotherapy groups, while the ORR in the two groups was 43.8 percent and 33.1 percent, respectively, and the middle DoR was not reached and 10.6 months were not reached, respectively.
PFS2 of the Pabli Pearl mono-resistance group is longer (not up to vs 23.5 months) (HR s 0.63).
groups of Paboliju monoantigen and chemotherapy, the ≥-level treatment-related adverse events were 22% and 66%, respectively.
level 5 adverse events in the single-level treatment of paboliju monoantigroup, and level 5 adverse events (intestinal perforation) occurred in 1 patient in the chemotherapy group.
, the HRQoL score of the Pabli pearl monoantigen group was better than that of the chemotherapy group.
conclusion: Compared with chemotherapy group, Pabli pearl monoantigen group can significantly improve PFS in MSI-H/dMMR mCRC patients, and the treatment-related adverse event rate is lower, in addition, Paboli pearl monoantigen group can significantly improve MSI-H/dMMR mCRC patients PFS2.
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