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ASCO Updates NSCLC Guidelines With New Directives for Genomic Testing

NEW YORK (GenomeWeb) – The American Society of Clinical Oncology has updated its clinical practice guidelines, clarifying the role of immunotherapy in the treatment of patients with advanced non-small-cell lung cancer and providing new recommendations on the use of targeted therapies for patients with EGFR, ALK, and ROS1 alterations.

To support the revision, published today in the Journal of Clinical Oncology, panelists reviewed medical literature published between February 2014 and December 2016, and used 14 randomized controlled clinical trials as the evidence base for the new recommendations.

The most recent prior update to ASCO's NSCLC treatment guidelines was in 2015, the society said.

Key points from the new updated guide include a recommendation for the use of the immunotherapy drug pembrolizumab (Merck's Keytruda) as a first-line treatment in patients who don’t have sensitizing EGFR mutations, ALK rearrangements, or ROS1 rearrangements, but who do have high PD-L1 expression.

If these mutation-negative patients have low PD-L1 expression, clinicians should offer standard chemotherapy, the guidelines state. Using checkpoint inhibitors, combinations of checkpoint inhibitors, or combining these drugs with chemotherapy are not recommended.

Second-line therapy recommendations in the new revision now include the use of single-agent immunotherapy using either nivolumab, pembrolizumab, or atezolizumab in patients with high PD-L1 expression who haven't had immune treatment before. If the tumor has low PD-L1 expression or the PD-L1 expression level is unknown, clinicians can use nivolumab, atezolizumab, or chemotherapy, but the guide doesn't detail how doctors should make this choice.

Despite recommending different treatments based on PD-L1 status, the guideline update does not direct physicians to use a specific PD-L1 assay or test, nor does it delineate a cutoff point for what it considers high or low PD-L1 expression.

Various immunotherapies have been approved by the US Food and Drug Administration with different companion or complementary PD-L1 assays. Because of observed differences in the way these different assays classify patients, drug companies and other stakeholders have been engaged in an effort to harmonize available tests.

Concerning molecularly targeted therapies, the guidelines recommend the use of first-line targeted treatment as outlined in 2015 for patients with EGFR mutation-positive, ALK rearrangement-positive, or ROS1 rearrangement-positive tumors.

However, if there is progression following first-line EGFR targeted therapy, osimertinib is recommended for cases that are postivie for the T790M mutation. If a patient's tumor lacks the T790M mutation, doctors should turn to chemotherapy.

The guidelines also state that patients with ROS1 alterations should be offered crizotinib if they haven't been treated with it before. If they have, they should get chemotherapy.