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Pembrolizumab in combination with chemotherapy has improved overall survival versus chemotherapy alone as first-line treatment for patients with advanced NSCLC whose tumors do not express PD-L1


The first-line treatment with Pembrolizumab ( Keytruda ), an anti-PD-1 therapy, in combination with chemotherapy has demonstrated improvements in overall survival ( OS ), progression-free survival ( PFS ) and objective response rate ( ORR ) in a pooled analysis of a subgroup of patients with advanced nonsquamous and squamous non-small cell lung cancer ( NSCLC ) whose tumors do not express PD-L1 ( tumor proportion score [ TPS ] less than 1% ) from three randomized trials.
Patients with nonsquamous NSCLC with EGFR or ALK genomic tumor aberrations were ineligible.

Results from KEYNOTE-189, KEYNOTE-407 and KEYNOTE-021 ( Cohort G ) were consistent with those observed in the overall study populations across all three trials.

Findings from the pooled subgroup analysis of 428 patients showed that Pembrolizumab in combination with chemotherapy has reduced the risk of death by 44% ( hazard ratio, HR=0.56 [ 95% CI, 0.43-0.73 ] ) compared to chemotherapy alone.
The Pembrolizumab-chemotherapy combinations has also reduced the risk of disease progression or death by 33% ( HR=0.67 [ 95% CI, 0.54-0.84 ] ) compared to chemotherapy alone.
The ORR was 46.9% for patients treated with the Pembrolizumab-chemotherapy combinations versus 28.6% for those treated with chemotherapy alone.
The safety profile of Pembrolizumab was consistent with what has been seen in previously reported studies among patients with advanced NSCLC.

Data presented at WCLC are from a pooled subgroup of 428 previously untreated patients whose tumors do not express PD-L1 ( TPS less than 1% ) from the KEYNOTE-189 ( nonsquamous NSCLC; n=190 ), KEYNOTE-407 ( squamous NSCLC; n=194 ) and KEYNOTE-021 ( nonsquamous NSCLC; n=44 [ Cohort G ] ) trials.
Patients were randomized to receive Pembrolizumab 200 mg every three weeks plus chemotherapy ( n=243 ) or chemotherapy alone ( n=185 ).
Patients with nonsquamous NSCLC received Pemetrexed ( Alimta ) and Platinum chemotherapy; patients with squamous NSCLC received Carboplatin and either Paclitaxel or nab-Paclitaxel.
Patients with nonsquamous NSCLC with EGFR or ALK genomic tumor aberrations were ineligible. Key efficacy outcome measures include OS, PFS and ORR.

With a median follow-up of 10.2 months, Pembrolizumab in combination with chemotherapy reduced the risk of death by 44% ( HR=0.56 [ 95% CI, 0.43-0.73 ] ) compared to chemotherapy alone.
Estimated 12-month overall survival rates were 66% with the Pembrolizumab-chemotherapy combinations compared to 47% with chemotherapy alone; the 18-month overall survival rates were 52% and 29%, respectively.
Median overall survival was 19.0 months ( 95% CI, 15.2-24.0 ) with the Pembrolizumab-chemotherapy combinations compared to 11.0 months ( 95% CI, 9.2-13.5 ) with chemotherapy alone.

The Pembrolizumab-chemotherapy combinations also reduced the risk of disease progression or death by 33% ( HR=0.67 [95% CI, 0.54-0.84 ] ) compared to chemotherapy alone.
Estimated 12-month progression-free survival rates were 29% with the Pembrolizumab-chemotherapy combinations compared to 17% with chemotherapy alone; the 18-month PFS rates were 22% and 9%, respectively.
Median progression-free survival was 6.5 months ( 95% CI, 6.2-8.5 ) with the Pembrolizumab-chemotherapy combinations compared to 5.4 months ( 95% CI, 4.7-6.2 ) with chemotherapy alone.

The ORR was 46.9% ( n=114 ) for patients who received the Pembrolizumab-chemotherapy combinations and 28.6% ( n=53 ) for those who received chemotherapy alone.
Median DOR was 7.9 months ( range, 1.1+ to 28.4+ ) with the Pembrolizumab-chemotherapy combinations and 6.7 months ( range, 1.4+ to 30.1+ ) with chemotherapy alone.
For patients receiving the Pembrolizumab - chemotherapy combinations, 42.4% experienced a response lasting 12 months or longer compared to 35.3% of those receiving chemotherapy alone.

Among patients who received Pembrolizumab in combination with chemotherapy, 68% ( n=165 ) experienced a grade 3-5 adverse event compared to 72% ( n=131 ) of those who received chemotherapy alone.
Grade 3-5 adverse effects that led to death occurred in 9% ( n=23 ) of patients who received the Pembrolizumab-chemotherapy combinations and 6% ( n=11 ) of those who received chemotherapy alone.
Grade 3-5 immune-mediated adverse effects and infusion reactions occurred in 11% ( n=27 ) of patients who received the Pembrolizumab-chemotherapy combinations compared to 3% ( n=5 ) of those who received chemotherapy alone.
Deaths resulting from immune-mediated adverse effects and infusion reactions occurred in 1% ( n=2 ) of patients who received the Pembrolizumab-chemotherapy combinations compared to no deaths among patients who received chemotherapy alone.

Lung cancer is the leading cause of cancer death worldwide. Each year, more people die of lung cancer than die of colon and breast cancers combined.
The two main types of lung cancer are non-small cell and small cell.
Non-small cell lung cancer ( NSCLC ) is the most common type of lung cancer, accounting for about 85% of all cases.
Small cell lung cancer ( SCLC ) accounts for about 10 to 15% of all lung cancers.
Between 2008 and 2014, the five-year survival rate for patients diagnosed in the U.S. with advanced NSCLC was only 5%. ( Xagena )

Source: IASLC 2019 World Conference on Lung Cancer ( WCLC )

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