Non-Small Cell Lung Cancer (NSCLC)

A biologics license application for sintilimab plus chemotherapy in first-line nonsquamous non–small cell lung cancer was not approved by the FDA and a complete response letter was issued to the drug developer.

The FoundationOne CDx diagnostic was approved as a companion diagnostic to help identify EGFR 19 deletions or exon 21 alterations in non–small cell lung cancer.

Recently presented data from the KEYNOTE-091 trial show a trend toward survival benefit with adjuvant pembrolizumab in patients with resected non–small cell lung cancer, especially in patients with PD-L1–positive disease.

Kira MacDougall, MD, and co-investigators, research the importance of peripheral biomarkers in patients with advanced non–small cell lung cancer who are treated with pembrolizumab.

Statistically significant progression-free survival benefit of toripalimab plus chemotherapy vs matched placebo was reported in patients with untreated metastatic non–small cell lung cancer, according to data from the CHOICE-1 trial.

Based on results of the phase 3 CheckMate-816 trial, the FDA granted approval to the combination of nivolumab plus platinum-doublet chemotherapy for the treatment of non–small cell lung cancer prior to surgery.

Patients treated with ceritinib who had ALK-positive non–small cell lung cancer with active brain metastases and/or leptomeningeal disease experienced encouraging responses in the phase 2 ASCEND-7 trial.

Ofer Sharon, MD, spoke about the PROphet diagnostic platform for non–small cell lung cancer and the latest interim results from the prospective PROPHETIC trial in the most recent episode of CancerNetwork’s® "Oncology Peer Review On-The-Go" podcast.

Based on results from the CheckMate-816 trial, the FDA has accepted a supplemental biological license agreement for nivolumab plus chemotherapy for patients with resectable non–small cell lung cancer.

A new drug application has been accepted by the FDA for poziotinib in patients with advanced or metastatic non–small cell lung cancer with HER2 exon 20 insertion mutations.

The European Commission has approved tepotinib for use in patients with advanced non–small cell lung cancer with MET exon 14 skipping alterations.

A new drug application for adagrasib was accepted by the FDA for the treatment of patients with KRAS G12C–mutated non–small cell lung cancer.

The FDA's Oncologic Drugs Advisory Committee stated that additional clinical research demonstrating applicability within the United States is necessary to support the biologics license application for a sintilimab combination regimen for non–small cell lung cancer.

In patients with completely resected non–small cell lung cancer with mediastinal N2 involvement, postoperative radiotherapy was not associated with an increase in disease-free survival.

Patients with PD-1/PD-L1–refractory metastatic non–small cell lung cancer did not achieve additional benefit when radiotherapy was added to durvalumab and tremelimumab.

The European Commission approves the use of lorlatinib for the treatment of ALK-positive advanced non–small cell lung cancer.

The supplemental biologics license application for cemiplimab plus chemotherapy for patients with advanced non–small cell lung cancer was based on findings from the phase 3 EMPOWER-Lung 3 study and was accepted for review by the FDA.

Patients with stage IV non–small cell lung cancer treated with sugemalimab plus chemotherapy experienced a prolonged overall survival benefit compared with those who received placebo and chemotherapy.

The Japan Ministry of Health, Labour and Welfare granted approval to the KRAS inhibitor sotorasib for the treatment of adults with KRAS G12C–mutated non–small cell lung cancer.

Lyudmila Bazhenova, MD, and Federico Albrecht, MD, detailed the importance of using real-world evidence to inform treatment for patients with EGFR-mutated non–small cell lung cancer.

Patients with stage IB to IIIA non–small cell lung cancer saw an improvement in disease-free survival when treated with pembrolizumab compared with the placebo regardless of PD-L1 expression.

Patients with locally advanced or metastatic EGFR exon 20–mutant non–small cell lung cancer may benefit from treatment with CLN-081, which was granted breakthrough therapy designation by the FDA.

Telisotuzumab vedotin’s breakthrough therapy designation for EGFR wild-type non–small cell lung cancer was supported by results from the phase 2 LUMINOSITY trial.

The combination of quaratusugene ozeplasmid immunogene therapy plus pembrolizumab was granted fast track designation by the US FDA for the treatment of patients with unresectable stage III or IV non–small cell lung cancer who previously progressed on pembrolizumab.

Patients with EGFR-mutated metastatic non–small cell lung cancer may achieve benefit from treatment with patritumab deruxtecan, which was granted breakthrough therapy designation by the FDA.

Zofia Piotrowska, MD, discusses potential therapies for patients with EGFR exon 20 insertion-positive non–small cell lung cancer.

The anti-TIGIT therapy tiragolumab administered in combination with atezolizumab showed clinically meaningful improvement at the 2.5-year follow-up vs atezolizumab alone for patients with PD-L1–positive metastatic non–small cell lung cancer.

Oncomine Dx Target Test has been approved by the FDA as a companion diagnostic to identify EGFR exon 20 insertion mutations in patients with non–small cell lung cancer who may undergo treatment with amivantamab.

The use of alectinib to treat ALK-positive non–small cell lung cancer resulted in better overall survival compared with ceritinib.

As the year 2021 comes to a close, CancerNetwork® reviews ongoing clinical research and upcoming innovations in the non–small cell lung cancer space.