Paboli pearl monoantigen and beval pearl monotherapy treat relapse high-level glioma

Treatment options for relapsed high-grade glioma (high grade glioma, HGG) are limited and there is currently no treatment strategy that can significantly improve survival.
preclinical studies have shown that anti-procedural death protein 1 (PD-1) or anti-PD-1 ligand (PD-L1) in association with radiotherapy can promote tumor-specific immune response and improve HGG survival.
Solmaz Sahebjam, of Moffitt Cancer Center in Tampa, Florida, USA, to assess the paboliju monoantigen (all-human immunoglobulin IgG4 monoclonal antibody inhibitor) against PD-1 In combined with Beval bead monoanti, hypofraction stereotatic radiotherapy (hypofractionation stereotactic irradiation, HFSRT) treats the safety and toad of HGG patients, as well as initial efficacy, and recommends appropriate dosages.
results were published online in November 2020 in Neuro Oncol.
study, a single-arm, open clinical Phase I trial conducted between 2015 and 2019, included patients with relapsed glioblastoma or mesodynamotic glioblastoma.
total treatment plan is a combined HFSRT (30Gy, 5 times) treatment with Pabli pearl monoanti (100 or 200 mg, Q3W) and beval bead monoanti (10 mg/kg, Q2W).
At the beginning of cycle 1, HFSRT treated 5 days with beeval bead monoantigen (10mg/kg, IV, Q2W);
After 5 days of HFSRT treatment, continue to use Paboliju monoantigen and beva bead monoantigen, and continuously assess adverse complications (treatment-related adverse event, TRAE) until the disease progresses, insulable toxicity occurs, or the patient withdraws informed consent.
at the beginning of the treatment, a baseline assessment of the tumor is made every 6 weeks (±7 days) thereafter, or based on clinical referral assessment.
for patients with samples, immunoglostification was used to retrospectively analyze tumor PD-L1 expression.
results were included in 32 HGG patients, of which 24 were in the beval bead mono-anti-primary treatment group, which had not previously received beva-bead-resistant treatment, and 8 in the beval-beaded single-anti-drug group, where tumor progression occurred during the previous beval-bead-resistant treatment.
of 6 patients treated during the paboliju monoanti-dose exploration phase, 3 doses were 100 mg and 3 cases were 200 mg;
most common drug toxicity reactions were proteinuria (40.6%), fatigue (25%), elevated alanine amino transferase (25%) and hypertension (25%).
the beval bead single anti-primary treatment group, 20 patients (83%) had complete symptom relief (response, CR) or partial remission (partial response, PR).
total lifetime (overall survival, OS) 13.45 months (95% CI, 9.46-18.46);
the beval bead single anti-dosing group, 5 patients (62%) reached PR.
9.3 months (95% CI, 8.97-18.86) and the medium PFS is 6.54 months (95% CI, 5.95-18.86).
26 patients with samples, only 6 (23%) had PD-L1 expression ≥1% in tumor cells or tumor micro-environments, and the remaining 20 (77%) had PD-L1 expression <1%.
the results show that HFSRT combined with Pabli pearl monoanti and beva bead monoantigen therapy relapse HGG patients with good safety and tolerance.
phase I clinical trial suggests that Pablic pearl monoantigen may enhance the efficacy of HFSRT plus beva bead monoantigen, and therefore has good clinical application value.
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