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Patient Selection Vital in Ensuring Improved Response to PD-1, PD-L1 Inhibitors in NSCLC

Surabhi Dangi-Garimella, PhD
A late afternoon extended education session on the first day of the 2017 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, was a discussion on the state-of-the-art uses for immunotherapy in the management of non-small cell lung cancer (NSCLC).
A late afternoon extended education session on the first day of the 2017 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, was a discussion on the state-of-the-art uses for immunotherapy in the management of non-small cell lung cancer (NSCLC). Oncologists shared their experiences with the management of toxicities resulting from immunotherapy, and also discussed the role of immunotherapy in specific patient populations.

Edward B. Garon, MD, director of the thoracic oncology program and associate professor of medicine at the David Geffen School of Medicine at University of California Los Angeles, spoke about using checkpoint inhibitors, primarily programmed death-1 (PD-1) inhibitors, in first-line therapy and sequencing these agents.

Garon discussed results from Keynote-024, a phase 3 randomized controlled trial that compared pembrolizumab as frontline therapy, compared with platinum-based chemotherapy, in patients diagnosed with programmed death ligand-1 (PD-L1)–expressing advanced NSCLC (50% PD-L1 expression threshold). The primary study endpoint was progression-free survival (PFS). Despite patients who crossed over from pembrolizumab to chemotherapy, overall survival increased .

Checkmate-026, which had a similar study design, compared first-line single agent nivolumab versus chemotherapy. Crossover was allowed and PFS was the primary endpoint. The main difference was that the PD-L1 expression cut-off was set at 5%, which would include a much broader patient population.

Nivolumab, however, failed in the frontline setting compared with chemotherapy. “Overall survival (OS) was not different in the 2 arms,” Garon said.

He lined up a series of differences to explain the differential results:
  • Failure of the randomized trial mechanism. The data showed that women were less likely to be on the nivolumab arm, as were patients with more than 50% PD-L1.
  • Difference in efficacy
  • Difference in the patient cohort
    • The most common clinical difference was the difference in radiotherapy. The Checkmate trial, Garon said, used higher dose of radiation. “However, a single-institution study has shown that patients who may have received prior radiation may have done better.
    • Use of PD-L1 expression. Selection of 50% cutoff for PD-L1 expression was used to select patients for pembrolizumab, as opposed to 5% for nivolumab.
Garon also drove home the point of a tumor’s mutation burden: “Higher the mutation burden, greater is the benefit,” he said.

The take-home messages from Garon’s presentation were:
  • Patients with staining in at least 50% of their tumor cells should be eligible for frontline pembrolizumab
  • Those with staining in less than half of their tumor cells should receive standard chemotherapy as frontline
  • Addition of non-selected therapy for each group remains a topic of debate


 
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