11 September 2017 - - Kenilworth, New Jersey-based global healthcare solutions provider Merck (NYSE: MRK) has provided 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, the company said.
With an additional five months of follow-up, significant improvements observed in prior analyses were maintained, including improvements in overall response rate and progression-free survival 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]).
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.
Cohort G1 of the multicenter, open-label, phase 1/2 multi-cohort KEYNOTE-021 study evaluated the efficacy and safety of Keytruda in combination with pemetrexed and carboplatin (Keytruda + pem/carbo) compared with pemetrexed and carboplatin (pem/carbo) in 123 patients with metastatic, nonsquamous, EGFR- and ALK-negative NSCLC in the first-line treatment setting.
The KEYNOTE-021G1 trial was conducted in collaboration with Eli Lilly and company, the maker of pemetrexed.
As part of its focus on cancer, Merck is exploring the potential of immuno-oncology, and is currently executing an expansive research program evaluating its anti-PD-1 therapy across more than 30 tumor types.
Merck, known as MSD outside of the United States and Canada, provides healthcare solutions worldwide through four segments: pharmaceutical, animal health, healthcare services, and alliances. The company serves drug wholesalers and retailers, hospitals, government agencies and entities, physicians, physician distributors, veterinarians, distributors, animal producers, and managed health care providers.