Five-year survival results from the pivotal phase 3 KEYNOTE-024 trial were presented at ESMO Virtual Congress 2020.
Sustained, long-term survival benefit and durable responses with Pembrolizumab ( Keytruda ), an anti-PD-1 therapy, versus chemotherapy as first-line treatment in patients with metastatic non-small cell lung cancer ( NSCLC ) whose tumors express PD-L1 ( tumor proportion score [ TPS ] greater than or equal to 50% ) with no EGFR or ALK genomic tumor aberrations, was demonstrated.
At five years, the overall survival ( OS ) rate was twice as high for patients who received Pembrolizumab ( 31.9%; n=154 ) versus chemotherapy ( 16.3%; n=151 ).
Pembrolizumab has also reduced the risk of death by 38% ( hazard ratio, HR=0.62 [ 95% CI, 0.48-0.81 ) versus chemotherapy, with a median overall survival of 26.3 versus 13.4 months.
Results from KEYNOTE-024 represent the longest follow-up and first-ever five-year survival data for an immunotherapy in a randomized phase 3 study for the first-line treatment of NSCLC.
Before 2014, the five-year survival rate for patients in the U.S. with advanced non-small cell lung cancer was only 5%.
Data from KEYNOTE-024 have shown that 31.9% of patients treated with Pembrolizumab were alive at five years.
New data from KEYNOTE-024, a randomized, open-label trial, have demonstrated a sustained, long-term survival benefit with versus chemotherapy after 59.9 months of median follow-up ( range, 55.1 to 68.4 ).
KEYNOTE-024 has evaluated Pembrolizumab monotherapy versus standard of care Platinum-based chemotherapy as first-line treatment in patients with metastatic NSCLC whose tumors express high levels of PD-L1 ( TPS 50% or more ) with no EGFR or ALK genomic tumor aberrations.
Pembrolizumab has reduced the risk of death by 38% ( HR=0.62 [ 95% CI, 0.48-0.81 ] ) versus chemotherapy alone, with a median overall survival of 26.3 versus 13.4 months.
The five-year OS rate was 31.9% for patients who received Pembrolizumab versus 16.3% for those who received chemotherapy.
The OS benefit was observed, despite a 66% ( n=99/150 ) effective crossover rate from chemotherapy to subsequent anti-PD-1/PD-L1 therapy.
Pembrolizumab has also reduced the risk of disease progression or death by half ( HR=0.50 [ 95% CI, 0.39-0.65 ] ) versus chemotherapy as assessed by investigators, with a median progression-free survival of 7.7 versus 5.5 months.
The objective response rate ( ORR ) was 46.1% for Pembrolizumab versus 31.1% for chemotherapy.
The median duration of response was 29.1 months ( range, 2.2 to 60.8+ ) for Pembrolizumab versus 6.3 months ( range, 3.1 to 52.4 ) for chemotherapy.
Of the patients who completed two years of treatment with Pembrolizumab ( n=39/154 ), 81.4% were alive at five years and nearly half ( 46% ) remained treatment-free.
These data suggest that patients who have completed two years of treatment with Pembrolizumab experienced a long-term OS benefit.
The ORR was 82% for patients who completed two years of treatment with Pembrolizumab.
Additionally, 12 patients received a second course of therapy.
No new safety signals for Pembrolizumab were identified with long-term follow-up. Among all patients who were treated, 31.2% of those who received Pembrolizumab and 53.3% of those who received chemotherapy experienced grade 3-5 treatment-related adverse events ( TRAEs ). Among patients who completed two years of treatment with Pembrolizumab, grade 3-5 TRAEs occurred in 15.4%. ( Xagena )
Source: Merck / MSD, 2020