Lung Cancer

Under the FDA’s Real-Time Oncology Review Pilot Program and Project ORBIS, the FDA is reviewing a supplemental new drug application for lorlatinib (Lorbrena) as a first-line treatment for patients with ALK-positive metastatic non–small cell lung cancer.

The Emory University Winship Cancer Institute expert discussed FDA approvals and other treatment advances that occurred this year.

This study found that among patients with lung cancer from Latin America, Native American ancestry was associated with increased mutations in the EGFR gene, independent of smoking status.

Full approval has been granted by the FDA to osimertinib (Tagrisso) for use as adjuvant therapy following tumor resection among patients with non–small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.

The American Lung Association’s annual “State of Lung Cancer” (SOLC) report tracked the toll of lung cancer at national and state levels, identifying both promising improvements for the overall population and significant health disparities for racial and ethnic minorities.

The FDA granted breakthrough therapy designation to sotorasib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutation, as determined by an FDA-approved test, following at least 1 prior systemic therapy.

Janssen submitted a biologics license application to the FDA seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

The director of the new Women’s Lung Cancer Program at Mount Sinai spoke about the gaps in lung cancer research for women and what she hopes this new program will offer women moving forward.

This study found that state-level lung cancer screening rates were not aligned with disease burden, with the exception of Kentucky, which has supported comprehensive efforts to implement lung cancer screening.

Though researchers found that Black patients with early-stage non-small cell lung cancer are now more likely to receive the most effective treatment compared to a decade ago, the disparity for this patient population persists.

Given that diagnosing lung cancer in its early stages can lead to successfully eliminating lung cancer with surgery alone, the importance of closing this disparity gap is critical.

An interim analysis of the trial revealed that among patients with previously untreated advanced ALK-positive non-small cell lung cancer, those who received lorlatinib (Lorbrena) had significantly longer PFS, a higher overall and intracranial response, and better quality of life.

These study results suggest that osimertinib as adjuvant therapy is an effective treatment strategy for patients with stage IB to IIIA EGFR-positive non-small cell lung cancer following complete tumor resection.

The SU2C–LUNGevity Foundation–American Lung Association Lung Cancer Interception Dream Team have developed laboratory models to understand the inflammatory process in the lung’s bronchial cells, and how that relates to early lung cancer development.

The FDA approved a 1500 mg fixed dose of durvalumab (Imfinzi) administered every 4 weeks for the treatment of unresectable stage III non-small cell lung cancer after chemoradiation therapy and previously treated advanced bladder cancer.

The clinical trial is designed to evaluate the efficacy and safety of tislelizumab compared to docetaxel in the second- or third-line setting in patients with locally advanced or metastatic non-small cell lung cancer who have progressed on a prior platinum-based chemotherapy.

Researchers suggested that the tumors of patients with stage I and II early-stage non-small cell lung cancer demonstrate the highest tumor mutational burden and most often display the mutational signature associated with tobacco smoking.

This study found that found that mini-strokes and heart attacks were significantly less common among patients with locally advanced non-small cell lung cancer who underwent proton therapy versus conventional photon-based radiation therapy.

Merck is discontinuing the study after an independent Data Monitoring Committee recommendation, which determined the benefit/risk profile of pembrolizumab in combination with ipilimumab did not support continuing the trial.

The results for the phase 2 SUMMIT trial examining neratinib to treat patients of metastatic non-small cell lung cancer (NSCLC) were recently announced by Puma Biotechnology.

This study indicated that patients with up to 3 lung metastases from primary tumors in other sites who were treated with stereotactic body radiation therapy fared comparably well whether their radiation was delivered in 1 or 4 treatment sessions.

This study found that fragment analysis had the ability to detect large MET exon 14 skipping deletions that were missed by next-generation sequencing in non-small cell lung cancer tumor samples.

The FDA approved expanded claims for the cobas EGFR Mutation Test v2 as a companion diagnostic for a broader group of therapies in the treatment of non-small cell lung cancer.

The FDA granted priority review to the supplemental biologics license application for cemiplimab-rwlc (Libtayo) as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer with 50% or more PD-L1 expression.

The FDA accepted and granted priority review to the supplemental new drug application for osimertinib (Tagrisso) for the adjuvant treatment of patients with early-stage EGFR-mutated non-small cell lung cancer after complete tumor resection with curative intent.