Dr. Chao on Key Trials Leading to FDA Approvals in Metastatic NSCLC


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Yvonne Chao, MD, PhD, discusses key trials leading to FDA approvals in metastatic non–small cell lung cancer.

Yvonne Chao, MD, PhD, member, Cancer Biology Program, UPMC Hillman Cancer Center, assistant professor, Division of Hematology/Oncology, University of Pittsburgh School of Medicine, discusses key trials leading to FDA approvals in metastatic non–small cell lung cancer (NSCLC).

The addition of a PD-1 or PD-L1 inhibitor to chemotherapy can improve overall survival (OS) in patients with metastatic NSCLC, based on data from the phase 3 KEYNOTE-189 (NCT02578680), KEYNOTE-407 (NCT02775435), and IMpower-150 (NCT02366143) trials, Chao begins.

KEYNOTE-189 evaluated the safety and efficacy of platinum-based chemotherapy with or without pembrolizumab (Keytruda) vs chemotherapy alone in patients with advanced or metastatic nonsquamous NSCLC who were not previously treated with systemic therapy for advanced disease. Data from this phase 3 trial led to the FDA approval of pembrolizumab used in combination with chemotherapy as a first-line treatment option for metastatic nonsquamous NSCLC in May 2017. Similarly, KEYNOTE-407 examined treatment carboplatin and paclitaxel or nab-paclitaxel (Abraxane) with or without pembrolizumab vs chemotherapy alone as a first-line treatment option in metastatic squamous NSCLC, leading to the FDA approval for pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of metastatic squamous NSCLC in October 2018.

Finally, the randomized, open-label IMpower-150 study evaluated the safety and efficacy of atezolizumab (Tecentriq) in combination with carboplatin plus paclitaxel with or without bevacizumab (Avastin), compared with treatment of carboplatin plus paclitaxel and bevacizumab in chemotherapy-naïve participants with stage IV nonsquamous NSCLC.

During an OncLive State of the Science Summit™, Chao also highlighted information from trials published within the last few years that led to FDA approvals for nivolumab (Opdivo), an PD-1 inhibitor, in combination with ipilimumab (Yervoy), an CTLA-4 inhibitor, either with or without chemotherapy, for the frontline treatment of NSCLC. Data from the phase 3 CheckMate 227 trial (NCT02477826) led to the approval of the combination of nivolumab plus ipilimumab, and findings from the phase 3 CheckMate 9LA trial (NCT03215706) supported the approval of nivolumab and ipilimumab plus chemotherapy. Results of these trials showed that combination immunotherapy regimens with or without chemotherapy can lead to improved OS and durable responses compared with chemotherapy alone, Chao concludes.

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