“The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to the immune checkpoint inhibitor pembrolizumab (Keytruda) for use in combination with chemotherapy as a first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC).
“This new approval of pembrolizumab was based on the results of the phase II KEYNOTE-021 clinical trial of 123 patients with advanced or metastatic nonsquamous NSCLC without mutations in the EGFR gene or alterations in the ALK gene, for which there are existing targeted therapies. Patients in the trial had not been treated previously and were randomly assigned to receive either pembrolizumab plus chemotherapy or chemotherapy alone.”
“BerGenBio ASA (OSE:BGBIO) announces today that on a top-line, preliminary basis, the first efficacy endpoint has been met in its Phase II clinical trial (BGBC008) evaluating bemcentinib, a first-in-class oral selective AXL inhibitor, in combination with the Merck & Co., Inc., Kenilworth, N.J., USA anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as a potential new treatment regimen for advanced non-small cell lung cancer (NSCLC). The primary efficacy endpoint requires at least four patients (out of the first 22 treated patients) to achieve clinical responses when treated with the novel drug combination, defined as either complete or partial response, as measured by Response Evaluation Criteria in Solid Tumors (RECIST).”
“The FDA has accepted a supplemental biologics license application (sBLA) for the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) for the frontline treatment of patients with advanced non–small cell lung cancer (NSCLC) with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb), according to Bristol-Myers Squibb (BMS), the manufacturer of both immune checkpoint inhibitors.
“The sBLA is based on findings from the phase III CheckMate-227 trial presented at the 2018 AACR Annual Meeting and published in the New England Journal of Medicine, in which the 1-year progression-free survival (PFS) rate was 43% for patients with high TMB (≥10 mut/Mb) assigned to the immunotherapy combination compared with 13% for those assigned to platinum-doublet chemotherapy. The median PFS was 7.2 months versus 5.5 months, respectively, representing a 42% reduction in risk of disease progression or death (HR, 0.58; 97.5% CI, 0.41-0.81; P <.001).”
“Upfront treatment with the combination of bevacizumab (Avastin) and erlotinib (Tarceva) is superior to erlotinib alone as for patients with non–small cell lung cancer (NSCLC) harboring EGFR mutations, according to results of a preplanned interim analysis of the phase III study known as NEJ026.
“The analysis showed a median progression-free survival (PFS) by independent review (the primary endpoint) of 16.9 months with the bevacizumab/erlotinib combination compared with 13.3 months with erlotinib by itself, said Naoki Furuya, MD, PhD, at the 2018 ASCO Annual Meeting.”
“The combination of nivolumab (Opdivo) and low-dose ipilimumab (Yervoy) reduced the risk of progression or death by 52% compared with standard platinum doublet chemotherapy for patients with metastatic PD-L1–negative, tumor mutation burden (TMB)-high non–small cell lung cancer (NSCLC), according to findings from the phase III CheckMate 227 trial presented at the 2018 ASCO Annual Meeting.
“In the PD-L1–negative (<1% expression), TMB-high (≥10 mutations/megabase) subgroup, regardless of histology, median progression-free survival (PFS) with nivolumab/ipilimumab was 7.7 months compared with 5.3 months for chemotherapy and 6.2 months for nivolumab and chemotherapy. The 1-year PFS rate was 45% with nivolumab/ipilimumab compared with 27% for nivolumab/chemotherapy and just 8% for chemotherapy.”
“The combination of bevacizumab (Avastin) and erlotinib (Tarceva) is superior to erlotinib alone as upfront treatment for non–small cell lung cancer (NSCLC) harboring EGFR mutations. A preplanned interim analysis of the phase III study known as NEJ026 showed a median progression-free survival (PFS) by independent review (the primary endpoint) of 16.9 months with the bevacizumab/erlotinib combination compared with 13.3 months with erlotinib by itself, said Naoki Furuya, MD, PhD, at the 2018 ASCO Annual Meeting.”
“Updated results of the global phase III ALEX trial comparing alectinib with crizotinib as first-line treatment against ALK-positive non-small cell lung cancer show a median progression-free survival (PFS) of 34.8 months in 152 patients treated with alectinib versus 10.9 months in 151 patients treated with crizotinib.
” ‘Think of it like a horse race, only it’s not about who crosses the finish line first, but how far the horses can run,’ says D. Ross Camidge, MD, Ph.D., the Joyce Zeff Chair in Lung Cancer Research at the University of Colorado Cancer Center, director of Thoracic Oncology at the CU School of Medicine, and the study’s first author. ‘In this trial, it’s as if half of the people “riding” crizotinib had exhausted their horses at about 11 months. For patients on alectinib, when this trial first started reporting data last year, more than half were still on their horses, still running. Now enough time has elapsed to estimate the median performance of these alectinib ‘horses’ more accurately.’ ”
“Patients with advanced non-small-cell lung cancer (NSCLC) treated with pembrolizumab (Keytruda) had a greater median survival than patients treated with standard chemotherapy, even if the former had low levels of PD-L1, researchers reported here.
“Depending on the percentage of PD-L1 expression in the tumor, survival was between 4 and 8 months longer for patients treated with immunotherapy alone versus those treated with chemotherapy, according to Gilberto Lopes, MD, MBA, of the Sylvester Comprehensive Cancer Center at the University of Miami, and colleagues.”
“Adding atezolizumab (Tecentriq) to nab-paclitaxel (Abraxane) and carboplatin in the frontline setting significantly improved overall survival (OS) in patients with advanced non–small cell lung cancer (NSCLC), according to findings from the phase III IMpower130 study.
“Atezolizumab also improved progression-free survival (PFS), the coprimary endpoint of the IMpower130 study, according to Genentech (Roche), the manufacturer of the PD-L1 inhibitor. The company plans to share the study data at an upcoming oncology meeting.”