Therapy Areas: Respiratory
Five-Year Survival Data for US Merck's Keytruda in Advanced Non-Small Cell Lung Cancer (NSCLC) from First KEYNOTE Trial at 2019 ASCO Annual Meeting
3 June 2019 - - US-based pharmaceutical company Merck (NYSE: MRK) has presented five-year efficacy and safety data for Keytruda, Merck's anti-PD-1 therapy, as monotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the first KEYNOTE trial (Phase 1b KEYNOTE-001).
In this study, Keytrudademonstrated a five-year overall survival rate of 23.2% in treatment-naïve patients (n=101) and 15.5% in previously treated patients (n=449).
Of note, the five-year OS rate among patients whose tumors expressed PD-L1 (tumor proportion score [TPS] ≥50%) was 29.6% in treatment-naïve patients and 25.0% in previously treated patients (n=138).
These findings, which represent the longest follow-up for Keytrudain lung cancer, were highlighted at the 2019 American Society of Clinical Oncology (ASCO) annual meeting (Abstract #LBA9015) during the official press programme and presented during a poster discussion on Sunday, June 2.
After 60.6 months (range, 51.8 to 77.9) of median follow-up, results from KEYNOTE-001 demonstrated the effect of Keytrudamonotherapy across primary and secondary endpoints, including OS, objective response rate and duration of response.
The investigator-reported ORR was 41.6% (95% CI, 31.9-51.8) in treatment-naïve patients and 22.9% (95% CI, 19.1-27.1) in previously treated patients. Median DOR was 16.8 months (range, 2.1+ to 55.7+) and 38.9 months (range, 1.0+ to 71.8+), respectively.
Among the 60 patients who received two or more years of treatment with KEYTRUDA, the five-year OS rate was 78.6% in treatment-naïve patients and 75.8% in previously treated patients. The ORR in these patients was 86% and 91%, respectively.
Median DOR was 52.0 months (range, 10.2 to 55.7+) in treatment-naïve patients and was not reached (range, 12.5 to 71.8+) in previously treated patients.
The safety profile of Keytrudawas consistent with what has been seen in previously reported studies among patients with advanced NSCLC.
Treatment-related adverse events (TRAEs) of any grade occurred in 71% (n=388) of patients receiving Keytruda; grade 3-5 TRAEs occurred in 13% of patients. Immune-mediated adverse events were reported in 17% of patients.
Hypothyroidism was the most commonly reported immune-mediated adverse event, followed by pneumonitis, hyperthyroidism and skin toxicities.
New and updated data from the Phase 3 KEYNOTE-189 trial evaluating Keytrudain combination with ALIMTA (pemetrexed) and platinum (cisplatin or carboplatin) for the first-line treatment of metastatic nonsquamous NSCLC compared with pemetrexed plus platinum alone, will also be presented on Sunday, June 2 at ASCO (Abstract #9013).
An updated analysis of the OS endpoint showed that after a median follow-up of 18.7 months (range, 0.2 to 30.9), Keytrudain combination with pemetrexed-platinum chemotherapy reduced the risk of death by 44% compared with chemotherapy alone (HR=0.56 [95% CI, 0.45-0.70]; median OS 22.0 months vs. 10.7 months).
An improvement in progression-free survival was also observed, with a 52% reduction in the risk of progression or death compared with chemotherapy alone (HR=0.48 [95% CI, 0.40-0.58]; median PFS 9.0 months vs. 4.9 months).
Fifty four percent of patients in the chemotherapy alone arm received subsequent immunotherapy, including 41% who received in-study crossover.
New findings at ASCO from KEYNOTE-189 also include the first-time presentation of the progression-free survival 2 study endpoint, a clinical endpoint used to assess the impact of next-line treatment on disease control, in the entire study population and different PD-L1 subgroups.
Among patients who received Keytrudain combination with chemotherapy, findings showed a 51% reduction in risk from time of randomisation to objective tumor progression on next-line treatment or death from any cause, whichever comes first, compared with patients who received chemotherapy alone (HR=0.49 [95% CI, 0.40-0.59]; median PFS2 17.0 months vs. 9.0 months).
Results were consistent across all three PD-L1 categories evaluated with a 54% reduction in patients with a TPS
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