Five Months of Additional Data from KEYNOTE-021, Cohort G, Including Updated Overall Survival, to be Presented at ESMO 2017 Congress
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced updated results from Cohort G of the phase 2 KEYNOTE-021 trial investigating KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in combination with pemetrexed and carboplatin (pem/carbo) in patients with previously untreated advanced nonsquamous non-small cell lung cancer (NSCLC), with or without PD-L1 expression. With an additional five months of follow-up, significant improvements observed in prior analyses were maintained, including improvements in overall response rate (ORR) and progression-free survival (PFS) for KEYTRUDA + pem/carbo compared to pem/carbo alone. With a median of 18.7 months of follow-up, more than half of patients in the KEYTRUDA combination arm responded to treatment compared to approximately one-third in the pem/carbo arm (ORR of 56.7% vs. 31.7% [95% CI, 7.2-40.9], p=0.0029). The risk of progression or death continued to be reduced by nearly half with KEYTRUDA + pem/carbo compared to pem/carbo alone (HR 0.54 [95% CI, 0.33-0.88, p=0.0067]). In addition, despite the crossover design, a trend in improvement in overall survival continues to be seen for KEYTRUDA + pem/carbo compared to pem/carbo alone (HR, 0.59 [95% CI, 0.34-1.05, p=0.03]). Findings are being presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, in an oral presentation on Friday, Sept. 8 from 5:03 – 5:15 p.m. CEST (Location: Madrid Auditorium) (Abstract #LBA49).
“The continued benefit observed with KEYTRUDA plus pem/carbo in overall response rate and progression-free survival reinforce the importance of this combination therapy for the treatment of patients with advanced nonsquamous non-small cell lung cancer, with or without PD-L1 expression,” said Dr. Hossein Borghaei, chief of the division of thoracic medical oncology, Fox Chase Cancer Center.
“Lung cancer is one of the most common and devastating cancers, and these additional data confirm that KEYTRUDA in combination with pemetrexed and carboplatin has the potential to have a meaningful impact in the lives of many of these patients,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.
Merck is currently advancing multiple registration-enabling studies in NSCLC with KEYTRUDA (pembrolizumab) as monotherapy and in combination, including the combination of KEYTRUDA plus a platinum/pemetrexed-based chemotherapy regimen in patients with previously untreated nonsquamous NSCLC in the ongoing phase 3 KEYNOTE-189 trial.