Skip to main content

Advertisement

Table 2 Clinical trials testing the combination of a MEK inhibitor and an EGFR-TKI for the treatment of NSCLC patients

From: MET inhibitors for targeted therapy of EGFR TKI-resistant lung cancer

Study NCT01244191 NCT01982955 NCT01610336 NCT01456325
Phase III II II III
Treatment arms Tivantinib (360 mg twice a day) + erlotinib (150 mg once a day) vs. placebo (twice a day) + erlotinib (150 mg once a day) Tepotinib (500 mg once a day) + gefitinib (250 mg once a day) vs. pemetrexed + cisplatin/carboplatin Capmatinib (400 mg twice a day) + gefitinib (250 mg once a day) Onartuzumab (15 mg/kg IV) + erlotinib (150 mg once a day) vs. placebo + erlotinib (150 mg once a day)
Patients (n) 1048 55 100 499
ORR (%) 10.3 vs. 6.5 66.7 vs. 42.9a 47b 8.4 vs. 9.6
PFS (months) 3.6 vs. 1.9 (HR = 0.74; P < 0.001) 21.2 vs. 4.2a 5.5b 2.7 vs. 2.6 (HR = 0.99; P = 0.92)
OS (months) 8.5 vs. 7.8 (HR = 0.98; P = 0.81) NA NA 6.8 vs.9.1 (HR = 1.27; P = 0.067)
Main grade 3 or higher toxicities (over 5%) Fatigue or asthenia (9%), dyspnea (8.8%), and anemia (6.3%) in erlotinib plus tivantinib arm vs. fatigue or asthenia (7.9%) and dyspnea (7.4%) in erlotinib plus placebo arm 51.6% in tepotinib plus gefitinib arm and 52.2% in chemotherapy arm had grade ≥ 3 TRTEAEs Nausea (5%), peripheral edema (5%), fatigue (6%), increased amylase (6%), and increased lipase (6%) Overall skin and subcutaneous tissue disorders (17.3), rash (7.7%), and dyspnea (5.2%) in onartuzumab plus erlotinib arm vs. overall skin and subcutaneous tissue disorders (10.7%) and rash (5.3%) in erlotinib plus placebo arm
  1. aIn patients with MET gene amplification
  2. bIn patients with a MET gene copy number ≥ 6