Lancet Subsidon: Paborizumab can significantly improve the disease-free survival period of the IB-IIIA phase NSCLC patients with a tumor.

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Lancet Subsidon: Paborizumab can significantly improve the disease-free survival period of the IB-IIIA phase NSCLC patients with a tumor.

▎ Clinical issue:

Paborzab is a standard treatment drug for advanced non-small cell lung cancer (NSCLC), but it is unclear as a complete resection of the IB-IIIA phase NSCLC auxiliary therapy.

A study from Lancet sub-magazines shows that compared with placebo, Paborizumab can significantly improve the IB-IIIA phase NSCLC patients who have completely removed the tumor (DFS) Essence

▎ Research plan:

(1) Patients are included in the standard: age is 18 years old or above, the tumor is completely removed, and the level of expression or PD-L1 expression is suffered from the level of the AJCC tumor staging system (seventh edition) ≥4cm), II or IIIA NSCLC, and the status of ECOG activity is 0 or 1; a total of 1955 people;

(2) Use the central interactive voice response system, and use the minimized technology according to the disease stage, the previous auxiliary chemotherapy, PD-L1 expression, and geographical area to conduct participants. Eligible participants are randomly assigned (1: 1) To Paborzab's 200mg group (n = 590, of which 168 people PD-L1 TPS ≥ 50%) or placebo group (n = 587; of which 165 people PD-L1 TPS ≥ 50%) were per 3 groups Weekly accepts intravenous injection, up to 18 cycles;

(3) Treatment distribution schemes are kept secret of participants, investigators and analysts;

(4) Dual endpoints are DFS with DFS and PD-L1 TPS of the overall population;

(5) Evaluate the efficacy in people who care for the treatment (ITT) (that is, all random distribution to the participants in the treatment group);

(6) Safety assessment of all participants who are randomly distributed to treatment, and these participants have received at least one dose of research and treatment.

▎ Main discovery:

(1) As of the deadline of data (September 20, 2021), the median follow-up time analyzed in this period is 35.6 (IQR 27.1-45.5);

(2) In the overall crowd, the median DFS of the Paborizumab group is 53.6 (95%CI; 39.2-not achieved), while the placebo group is 42.0 (95%CI; 31.3-not achieved). Month [HR is 0.76 (95%CI; 0.63-0.91), P = 0.0014];

(3) Among the people with a PD-L1 TPS of not less than 50%, whether it is the Paborizumab (95%CI; 44.3-not reached) or the placebo group [95%CI; 35.8-not achieved; HR's HR; HR It is 0.82 (95%CI; 0.57-1.18); P = 0.14] has not reached the median of DFS;

(4) Among the 580 participants who were receiving Paborzab, 198 people (34%) occurred 3 or more serious adverse events; 150 of the participants who received placebo were received (581 participants who accepted the placebo ( 26%) Class 3 or more serious adverse events occur;

(5) At least 10 of the Paborizumab group of at least 10 participants occurred or more severe adverse incidents were hypertension [35 people (6%)] and lung infection [12%(2%)], comforting The dosage group is hypertension [32 people (6%)];

(6) The number of serious adverse incidents, 142 people (24%) in the Paborizumu monetary group, and 90 people (15%) in placebo groups; serious adverse incidents with an incidence of more than 1%are Paborzab's counterfeit anti -resistance. The lung infection of the group [13 people (2%)], limited pneumonia [12%(2%)], diarrhea [7) and the lung infection of the placebo group [9 people (2%) ];

(7) Treatment of related adverse events leads to 4 (1%) participants in the Paborzab's anti -resistance group (1 death because of cardiac syrup and myocarditis, 1 death because of purulent toxic shock and myocarditis, and 1 death because of lungs because of lungs. The ministry was infected, and one death was killed because of sudden death). The placebo therapy group did not die.

▎ Looking out:

Regardless of the expression of PD-L1, when the auxiliary chemotherapy is recommended, Paborizumab may be a new treatment option for the IB-IIIA phase NSCLC after the tumor is completely removed.

references:

[1] https://www.thelancet.com/journals/lanonc/article/piis1470-2045 (22) 00518-6/fullText

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