Background
According to data from the CHOICE-1 trial, Toripalimab (anti–PD-1) in combination with chemotherapy showed significant improvement in the length of time until progression of the disease (Also called, Progression-Free Survival, PFS) and Survival in the first-line treatment of advanced Non–Small Cell Lung Cancer, NSCLC, regardless of tumor PD-L1 expression.
The addition of toripalimab to chemotherapy for the treatment of patients with previously untreated advanced Non–Small Cell Lung Cancer, NSCLC, derived superior survival outcomes verses chemotherapy alone, according to results from the phase 3 CHOICE-1 trial that were presented as part of the American Society of Clinical Oncology, ASCO, plenary sessions.
About the Study in Lung Cancer
The double-blind, multicenter, randomized trial compared the efficacy and safety of Toripalimab vs placebo plus frontline standard chemotherapy in patients with advanced NSCLC.
To be eligible for inclusion on the trial, patients needed to have stage IIIB or IV disease, have no prior treatment for locally advanced or metastatic disease. There were more inclusion criteria to be eligible for the trial.
456 patients were randomized to receive either Toripalimab at 240 mg on day 1 of each 3-week cycle plus either Alimta and Cisplatin/Carboplatin for 4 to 6 cycles followed by Alimta. For patients with non-squamous histology or nab-paclitaxel (Abraxane) plus carboplatin for 4 to 6 cycles in those with squamous histology; those in the control arm received the same chemotherapy regimens as in the experimental arm plus matched placebo.
Study Results
Final PFS analysis revealed a 51% reduction in the risk of disease progression or death with Toripalimab vs chemotherapy, with medians of 8.4 months and 5.6 months, respectively.
The PFS rate at 1 year, which is the percentage of patients with no disease progression at 1 year of treatment, in the Toripalimab group was 36.7% vs 17.2% with the placebo.
65.7% of patients in the Toripalimab group had their tumors shrunken vs 46.2% with chemo + placebo.
At the interim Survival analysis revealed a 31% reduction in the risk for death.
Median Survival in the study population was still not reached at time of the analysis in the Toripalimab arm vs 17.1 months with placebo.
Side Effects
The occurrence of hard and severe side effects was greater in the Toripalimab group. 5.5% vs 2.6% resulted in death.
Patients on Toripalimab experienced higher rates of therapy discontinuation and interruption.
Takeaway message for lung cancer patients
Toripalimab (anti–PD-1) in combination with chemotherapy showed significant improvement in the treatment outcomes. It was given as first-line treatment of advanced Non–Small Cell Lung Cancer, NSCLC, regardless of tumor PD-L1 expression.
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