Ann Oncol: Efficacy and safety of pembrolizumab combined with pemetrexed + platinum in the treatment of patients with metastatic non-squamous non-small cell lung cancer: KEYNOTE-189

KEYNOTE-189 (NCT02578680) is a double-blind, randomized, placebo-controlled phase III clinical study conducted in 126 cancer centers in 16 countries
.

To evaluate the efficacy and safety of pembrolizumab combined with pemetrexed + platinum in the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer compared with placebo combined with pemetrexed + platinum

KEYNOTE-189 (NCT02578680) is a double-blind, randomized, placebo-controlled phase III clinical study conducted in 126 cancer centers in 16 countries

After a median follow-up of 31 months, the pembrolizumab group significantly improved the OS of the patients compared with the placebo group [22 months vs 10.
6 months, HR=0.
56; 95% CI, 0.
46-0.
69]
.

The 24-month OS rates were 45.

After a median follow-up of 31 months, the pembrolizumab group significantly improved the OS of the patients compared with the placebo group [22 months vs 10.

OS

 OS

Similarly, the pembrolizumab group significantly improved the PFS of the patients compared with the placebo group (9.
0 months vs 4.
9 months, HR=0.
49; 95% CI, 0.
41-0.
59)
.

The 24-month PFS rates were 22.

Similarly, the pembrolizumab group significantly improved the PFS of the patients compared with the placebo group (9.

                    PFS

PFS

The objective response rates (ORR) of the two groups were 48.
3% and 19.
9%, respectively.
Regardless of the PD-L1 level, the ORR of the pembrolizumab group could benefit
.

The median duration of response (DOR) of the two groups were 12.

The objective response rates (ORR) of the two groups were 48.

PFS2 is defined as the time from the start of second-line treatment to progression or death from any cause

                    PFS2

  PFS2

84 patients (40.
8%) in the placebo group crossed over to pembrolizumab treatment after progression
.

From the beginning of pembrolizumab treatment, the median OS was 6.

84 patients (40.

The incidence of treatment-related adverse events in the two groups were 92.
8% and 90.
6%, respectively
.
The incidence of grade 3-5 adverse events was 72.
1% and 66.
8%, respectively
.
No new adverse events occurred
.

56 patients completed 35 cycles (2 years) of pembrolizumab treatment, with an ORR of 85.
7% and a median DOR of 34.
5 months
.
At the time of the data cutoff, 53 patients (94.
6%) were still alive (PD-L1 TPS >50%, n = 30; PD-L1 TPS 1%-49%, n = 15; PD-L1 <1%, n = 6 ; And PD-L1 are not evaluable, n = 2), 3 patients (5.
4%) died
.
The incidence of grade 3-4 adverse events was 60.
7%); the common ones were neutropenia (17.
9%), anemia (12.
5%), and fatigue (7.
1%)
.
The incidence of immune- related adverse events was 37.
5%; 6 patients (10.
7%) had grade 3-4 immune-related adverse events
.
No fatal immune-related adverse events occurred
.

56 patients completed 35 cycles (2 years) of pembrolizumab treatment, with an ORR of 85.
7% and a median DOR of 34.
5 months
.
At the time of the data cutoff, 53 patients (94.
6%) were still alive (PD-L1 TPS >50%, n = 30; PD-L1 TPS 1%-49%, n = 15; PD-L1 <1%, n = 6 ; And PD-L1 are not evaluable, n = 2), 3 patients (5.
4%) died
.
The incidence of grade 3-4 adverse events was 60.
7%); the common ones were neutropenia (17.
9%), anemia (12.
5%), and fatigue (7.
1%)
.
The incidence of immune- related adverse events was 37.
5%; 6 patients (10.
7%) had grade 3-4 immune-related adverse events
.
No fatal immune-related adverse events occurred
.
56 patients completed 35 cycles (2 years) of pembrolizumab treatment, with an ORR of 85.
7% and a median DOR of 34.
5 months
.
56 patients completed 35 cycles (2 years) of pembrolizumab treatment, with an ORR of 85.
7% and a median DOR of 34.
5 months
.
At the time of the data cutoff, 53 patients (94.
6%) were still alive and3 patients (5.
4%) died
.
immunity

           Survival benefit for patients who completed 35 cycles

Survival benefit for patients who completed 35 cycles

In summary, pembrolizumab combined with pemetrexed + platinum first-line treatment can improve the prognosis of metastatic non-squamous non-small cell lung cancer, and the toxicity is controllable and tolerable
.

In summary, pembrolizumab combined with pemetrexed + platinum first-line treatment can improve the prognosis of metastatic non-squamous non-small cell lung cancer, and the toxicity is controllable and tolerable
.
Pembrolizumab combined with pemetrexed + platinum first-line treatment can improve the prognosis of metastatic non-squamous non-small cell lung cancer, and the toxicity is controllable and tolerable
.
Pembrolizumab combined with pemetrexed + platinum first-line treatment can improve the prognosis of metastatic non-squamous non-small cell lung cancer, and the toxicity is controllable and tolerable
.

Original source:

Original source:

D Rodríguez-Abreu, SF Powell, MJ Hochmair, et al.
Pemetrexed plus platinum with or without pembrolizumab in patients with previously untreated metastatic nonsquamous NSCLC : protocol-specified final analysis from KEYNOTE-189.
Ann Oncol.
2021 Jul;32(7) :881-895.
doi: 10.
1016/j.
annonc.
2021.
04.
008.
 

D Rodríguez-Abreu, SF Powell, MJ Hochmair, et al.
Pemetrexed plus platinum with or without pembrolizumab in patients with previously untreated metastatic nonsquamous NSCLC : protocol-specified final analysis from KEYNOTE-189.
Ann Oncol.
2021 Jul;32(7) :881-895.
doi: 10.
1016/j.
annonc.
2021.
04.
008.
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