FDA approves Bristol-Myers Squibb's Opdivo, the first NSCLC neoadjuvant therapy

Recently, Bristol-Myers Squibb (BMS) PD-1 inhibitor Opdivo received FDA approval for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC)
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For BMS, the approval expands opdivo's role in the treatment of NSCLC
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Opdivo, in combination with BMS' Yervoy, is also approved as first-line treatment for adult patients with metastatic NSCLC whose tumors express PD-L1, as well as first-line treatment for adult patients with metastatic or recurrent NSCLC without EGFR or ALK tumor genetic abnormalities
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During the COVID-19 pandemic, the FDA has given many regulatory priorities to COVID-19 products, but the same week it accepted the application, it issued an ultrafast cancer approval, introducing the first preoperative treatment for early-stage non-small cell lung cancer (NSCLC).
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The FDA made its decision 4 months ahead of schedule (originally scheduled for July 13) within 5 days of accepting the BMS priority review application
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The FDA noted that this is not only the first approval of immunotherapy, but also the first approval of neoadjuvant therapy for NSCLC
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The approval is based on data from Opdivo's Phase III CheckMate-816 trial, the first positive late-stage study of an immunotherapy-based combination used prior to surgery for resectable NSCLC
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Non-metastatic cases account for about 60% of NSCLC diagnoses, and before Opdivo treatment, about 30%-55% of cases may recur and die from surgery
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Trial data showed a statistically significant improvement in event-free survival (EFS) after Opidvo was given preoperatively in combination with chemotherapy
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The study data showed that the addition of Opdivo to chemotherapy in patients with stage 1b to 3a NSCLC significantly improved EFS compared to chemotherapy alone, reducing the risk of progression, recurrence or death by 37%
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Median EFS was 31.
6 months in the Opdivo-treated arm versus 20.
8 months with chemotherapy alone
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In addition, 24% of patients who received Opdivo in combination with chemotherapy achieved a pathological complete response, compared with only 2.
2% of patients who received chemotherapy alone
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However, regardless of their tumor PD-L1 status, it is unclear how Opdivo performs in patients with different PD-L1 expression levels
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At the time of the EFS analysis, data on whether neoadjuvant Opdivo could prolong patients' lives were still immature as only 26% of patients had died
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But the prespecified interim analysis showed a 43% reduction in the risk of death, although it did not exceed the criteria for statistical significance
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Full data from the Opdivo study will be presented in April at the 2022 Annual Meeting of the American Association for Cancer Research
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