Although researchers have made great advances in NSCLC screening, diagnosis, and treatment, there remain several areas of unmet need, including the development of individual risk-based screening criteria, research into optimal biopsy types for molecular profiling, and greater focus on effective side-effect management plans for patients on multimedication regimens.
Updated results of the phase 3 CASPIAN clinical trial continue to show that durvalumab (Imfinzi) added to standard chemotherapy improves overall survival (OS) for patients with treatment-naïve extensive-stage small-cell lung cancer (ES-SCLC), according to a presentation at the ASCO 2020 virtual annual meeting.
Capmatinib (Tabrecta), an oral kinase inhibitor, has shown clinical activity in patients with high-level MET-amplified advanced non–small-cell lung cancer (NSCLC), according to new data presented at the ASCO 2020 virtual annual meeting.
According to results of the phase 3 multinational ADAURA clinical trial, treatment with osimertinib in the adjuvant setting significantly improves disease-free survival in patients with localized non–small-cell lung cancer (NSCLC) with EGFR mutation.
This section provides a brief overview of new cancer drugs or new indications approved by the FDA between May 26 and June 15, 2020.
On June 15, 2020, the FDA accelerated the approval of lurbinectedin (Zepzelca; Jazz Pharma/Pharma Mar), an intravenous alkylating drug, for the treatment of adults with metastatic small-cell lung cancer that has progressed during or after platinum-based chemotherapy. The FDA granted lurbinectedin an orphan drug designation for this indication.
On May 29, 2020, the FDA approved ramucirumab (Cyramza; Eli Lilly) in combination with erlotinib (Tarceva) for first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. Ramucirumab was previously approved for several types of cancer, including, in combination with docetaxel, for metastatic NSCLC, after platinum-based chemotherapy.
Opdivo plus Yervoy and Chemotherapy Approved as First-Line Therapy for Metastatic NSCLC, Regardless of PD-L1 Expression
On May 26, 2020, the FDA approved nivolumab (Opdivo; BMS) and ipilimumab (Yervoy; BMS) plus chemotherapy as first-line treatment of recurrent or metastatic squamous or nonsquamous non–small-cell lung cancer (NSCLC), regardless of PD-L1 expression, and with no EGFR or ALK aberrations. On May 15, the FDA approved nivolumab plus ipilimumab as first-line treatment of metastatic NSCLC with PD-L1 ≥1% expression.
On May 18, 2020, the FDA approved a new indication for atezolizumab (Tecentriq; Genentech), a PD-L1 inhibitor, for the first-line treatment of adults with metastatic non–small-cell lung cancer (NSCLC) whose tumor has high PD-L1 expression (PD-L1 stained ≥50% of tumor cells or PD-L1 stained tumor-infiltrating immune cells covering ≥10% of the tumor area), and no EGFR or ALK genomic aberrations, as determined by an FDA-approved test.
Opdivo-Yervoy First Immunotherapy Combo Approved for First-Line Therapy of Patients with Metastatic NSCLC
On May 15, 2020, the FDA approved a new indication for the first immunotherapy combination with the PD-1 inhibitor nivolumab (Opdivo; BMS) and the CTLA-4 inhibitor ipilimumab (Yervoy; BMS) as first-line treatment of adults with metastatic non–small-cell lung cancer (NSCLC) and PD-L1 expression of ≥1%, as determined by an FDA-approved test, but without EGFR or ALK genomic alterations.