“The FDA granted priority review designation to a supplemental biologics license application that seeks approval of pembrolizumab for use in combination with chemotherapy as first-line treatment of metastatic squamous non-small cell lung cancer regardless of PD-L1 expression.
“The use of steroids at baseline was associated with inferior survival outcomes in patients with advanced non-small cell lung cancer who were starting either PD-1 or PD-L1 blockade therapy, according to retrospective data presented at ASCO Annual Meeting.
” ‘Treatment with PD-1 and PD-L1 inhibitors is now standard therapy for nearly all patients with advanced non-small cell lung cancer,’ Kathryn C. Arbour, MD, a fellow at Memorial Sloan Kettering Cancer Center, said during her presentation. ‘The potential impact of steroids in patients with PD-1 or PD-L1 blockade has been an open question. Steroids are frequently used as a supportive medication in cancer care and can provide rapid relief of numerous cancer-related symptoms, including dyspnea, anorexia, pain, fatigue and symptoms associated with brain metastases. However … [physicians] routinely recognize that there can be substantial toxicities associated with long-term steroid use.’ ”
“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).”
“As part of our coverage of the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 1–5 in Chicago, we spoke with lung cancer specialist Dr. Geoff Oxnard, an associate professor of medicine at Boston’s Dana-Farber Cancer Institute and Harvard Medical School. At ASCO, Dr. Oxnard presented data from a study he and colleagues conducted on a blood test that could potentially noninvasively detect early-stage lung cancer.”
“In a randomized, Phase II trial led by researchers at The University of Texas MD Anderson Cancer Center, adding the PARP inhibitor veliparib to a standard chemotherapy agent improved overall response rates (ORR) in patients with small cell lung cancer (SCLC). Researchers also identified a select group of patients—those whose tumors expressed SLFN11— who also saw a progression-free survival (PFS) and overall survival (OS) benefit, suggesting a promising biomarker for the PARP-inhibitor sensitivity in SCLC.
“The study was published in Journal of Clinical Oncology. Ongoing follow-up studies are underway to confirm the results, which could result in the first new therapeutic option for this rare and aggressive lung cancer in more than three decades, said Lauren Averett Byers, M.D., associate professor of Thoracic/Head and Neck Medical Oncology.”
“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.”