The interim results of the Phase 3 trial of Karelliju monoantigen and chemotherapy first-line treatment of non-scale NSCLC were published

Screenshot Source: The Lancet Hospital Medicine This randomized, open label, multi-center, Phase 3 trial (CameL) was conducted in 52 hospitals in China, with 412 cases between May 12, 2017 and June 6, 2018 without EGFR or APK mutations and no previous systemic chemotherapy SCLC patients were randomly grouped at 1:1 and treated with Carelli's single-anti-combined carbases with pyrethroids (n s 205) and maintained with carelli pearl monoantigen plus permeable curvature;
the mid-term analysis, there were 205 incidents of progress or death as of March 31, 2019.
follow-up time was 11.9 months.
progression-free lifetime (PFS) was significantly longer (medium 11.3 months vs 8.3 months) in the Karelliju monoantigen combination chemotherapy group, and the risk of progression or death was significantly reduced by 40 percent.
results reached the main end of the study.
Patients in the carelliju single-anti-combination chemotherapy group (blue line) had longer PFS (Photo Source: Reference: Reference) in the PD-L1 tumor ratio score of ≥1% in the patient subgroup, the Karelli-Pearl single-anti-combination chemotherapy group reduced the patient's risk of progression or death by 44% (median PFS 15.4 months vs 9.9 months).
had a higher rate of progression-free survival at 12 months (49.6% vs. 35.1%) in the Carelliju single anti-combination chemotherapy group.
-term analysis data showed that Carelli-Zhu monoanti-combination chemotherapy also provided a total survival (OS) advantage (the mid-OS did not reach vs 20.9 months), reducing the risk of death by 27%.
additional analysis, as of February 25, 2020, suggests that carelli's monoantigeno-combination chemotherapy may extend the meso-OS to 27.9 months and the chemotherapy group to 20.5 months.
survival rate was higher at 12 months (74.9% vs. 67.1%) in the Carelliju single anti-combination chemotherapy group. The most common adverse events associated with treatment level 3 or above in
trials were a decrease in the neutral granulocyte count (38 percent in the Karelli pearl monoantigen anti-combination chemotherapy group vs 30 percent in the chemotherapy group), a decrease in white blood cell count (20 percent vs. 14 percent), anemia (19 percent vs 11 percent) and a decrease in plate plate count (17 percent vs 12 percent).
36% (74 cases) of patients in the Karelliju single anti-combination chemotherapy group had treatment-related adverse events, which was 13% (27 cases) in the chemotherapy group.
Photo Source: Henrui Pharmaceuticals Website Research Team points out that the current interim analysis results support Karelli's pearl monoantigen-anti-combined carbasine-pemetroser as a first-line treatment option for non-scale NSCLC Chinese patients without EGFR and ALC mutations.
, the drug was approved by China's National Drug Administration (NMPA).
the trial is continuing to collect long-term prognostic data for all patients and will further count PFS data for the PD-L1-positive patient population.
References: s1. Caicun Zhou, et al., (2020). Camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in chemotherapy-naive patients with advanced non-squamous non-small-cell lung cancer (CameL): a randomised, open-label, multicentre, phase 3 trial. The Lancet Respiratory Medicine, DOI: Original title: Lancet - Respiratory Medicine, led by Professor Zhou Caissing: Total Survival Extended by 7 Months! Karelli pearl monoantigen is a new option for non-scale NSCLC first-line treatment