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JAMA Oncol: Nivolumab combined with Ipilimumab vs. Nivolumab in the treatment of previously treated stage IV squamous non-small cell lung cancer: Phase 3 clinical study Lung-MAPS1400I

 Last Update: 2021-08-02
 Source: Internet
 Author: User

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In advanced non-small cell lung cancer, the first-line treatment of nivolumab combined with ipilimumab improves the prognosis of patients compared with platinum-based chemotherapy
.

In the second-line treatment of advanced NSCLC patients, Nivolumab also used more sitoxet to improve the prognosis of patients

In advanced non-small cell lung cancer, the first-line treatment of nivolumab combined with ipilimumab improves the prognosis of patients compared with platinum-based chemotherapy

The Lung-MAPS1400I study is a phase 3 open-label randomized trial
.

The patients were randomly assigned 1:1 to the Nivolumab combined with Ipilimumab group or the Nivolumab group

The Lung-MAPS1400I study is a phase 3 open-label randomized trial

Research Overview

Included 275 patients, of which 252 patients were evaluable, 125 patients in the Nivolumab combined with Ipilimumab group, and 127 patients in the Nivolumab group
.

The median OS of the Nivolumab combined with Ipilimumab group and Nivolumab group was 10 months (95% CI, 8.

Included 275 patients, of which 252 patients were evaluable, 125 patients in the Nivolumab combined with Ipilimumab group, and 127 patients in the Nivolumab group

OS and PFS

The median IA-PFS of the two groups were 3.
8 months (95%CI, 2.
7-4.
4) and 2.
9 months (95%CI, 1.
8-4.
0) respectively, and there was also no significant statistical difference (HR=0.
80, 95% CI, 0.
61-1.
03; P = 0.
09)
.

The 1-year and 2-year PFS rates of the two groups were 17% (95% CI, 12%-25%) vs 10% (95% CI, 6%-17%) and 12% (95% CI, 7%- 19%) vs 5% (95%CI, 2%-10%)

The median IA-PFS of the two groups were 3.

The ORRs of the

In patients with TMB ≥ 10 mt/Mb and PD-L1 <1%, nivolumab combined with ipilimumab improved the prognosis of patients compared with nivolumab (HR=0.

PD-L1 and TMB layered OS comparison

The incidence of treatment-related adverse events in the two groups was 39.
5% and 33.
3%, respectively; the incidence of treatment interruption caused by toxicity was 25% and 15%, respectively
.

Common ones include fatigue (8.

The incidence of treatment-related adverse events in the two groups was 39.
5% and 33.
3%, respectively; the incidence of treatment interruption caused by toxicity was 25% and 15%, respectively
.
Common ones include fatigue (8.
9% and 5.
7%) and pneumonia (7.
3% and 4.
9%)
.
Treatment-related deaths occurred in 2.
4% of the nivolumab combined with ipilimumab group and 0.
8% of the nivolumab group
.

Adverse reactions

Adverse reactions adverse reactions

In summary, the Phase 3 clinical study showed that in patients with stage IV squamous NSCLC who have been treated but have not been treated with immunotherapy, adding ipilimumab to nivolumab does not improve the prognosis of patients
.
This phase 3 clinical study showed that in patients with stage IV squamous NSCLC who have been treated before but who have not used immunotherapy, adding ipilimumab to nivolumab does not improve the prognosis of patients
.
This phase 3 clinical study showed that in patients with stage IV squamous NSCLC who have been treated before but who have not used immunotherapy, adding ipilimumab to nivolumab does not improve the prognosis of patients
.

Original source:

Scott N.
Gettinger; Mary W.
Redman; Lyudmila Bazhenova, et al.
Nivolumab Plus Ipilimumab vs Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer: The Lung-MAPS1400I Phase 3 Randomized Clinical Trial.
JAMA Oncol.
doi:10.
1001/jamaoncol.
2021.
2209 .
PublishedonlineJuly15, 2021.

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