Communication VJToday

FDA approves osimertinib with platinum-based chemotherapy in EGFR-mutated NSCLC

Lung cancer accounts for approximately one in ten cases of cancer, with non-small cell lung cancer (NSCLC) accounting for a substantial portion of cases.1 Targeted therapies have played a significant role in managing patients with corresponding genetic mutations, and epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) have become a cornerstone in the management of NSCLC, particularly for patients with EGFR-mutant NSCLC.2

The Food and Drug Administration (FDA) announced on February 16, 2024, the approval of osimertinib, a third generation TKI, with platinum-based chemotherapy for patients with locally advanced or metastatic EGFR-mutant NSCLC, based on data from the Phase III randomized, open-label FLAURA 2 trial (NCT04035486). 3 557 treatment-naïve patients with EGFR exon 19 deletion or L858R mutation NSCLC were randomized to either receive osimertinib with chemotherapy or osimertinib monotherapy. Progression-free survival (PFS), the primary endpoint, were 25.5 months (95% CI: 24.7, not estimable [NE]) and 16.7 months (95% CI: 14.1, 21.3) in the respective arms, marking significant improvement in patients receiving combination therapy. Furthermore, the safety profile of the combination therapy was generally manageable, with expected side effects consistent with those observed with individual treatments.4

Chul Kim, MD, MPH, Georgetown University Lombardi Comprehensive Cancer Center, Washington, DC, comments on the findings presented at WCLC 2023 in Singapore, stating

“One of the biggest updates in the field was the FLAURA II clinical trial, where osimertinib was combined with a platinum-based chemotherapy and showed about close to nine months difference … It’s a study that we’ve been waiting for a long time, and the field has been waiting for the results. And now we have to understand the data, digest the data, and how that may be, applicable to the day-to-day clinical practice.”

The approval of osimertinib in combination with chemotherapy for EGFR-mutated NSCLC represents a significant milestone in the rapidly evolving lung cancer treatment landscape. Findings from the FLAURA 2 trial underscore the potential of this combination therapy, offering renewed hope for improved outcomes and enhanced quality of life in this setting.

References:

  1. Araghi M, Reza M, Ali HM, Hamidi A, Rostami S, Salar HS, et al. Recent advances in non-small cell lung cancer targeted therapy; an update review. Cancer Cell International. 2023 Aug 11;23(1).
  2. ‌Fu K, Xie F, Wang F, Fu L. Therapeutic strategies for EGFR-mutated non-small cell lung cancer patients with osimertinib resistance. Journal of Hematology & Oncology. 2022 Dec 8;15(1).
  3. ‌Research C for DE and. FDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancer. FDA [Internet]. 2024 Feb 20 [cited 2024 Feb 23]; Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-chemotherapy-egfr-mutated-non-small-cell-lung-cancer?utm_medium=email&utm_source=govdelivery
  4. ‌Planchard D, Jänne PA, Cheng Y, Yang JC-H, Yanagitani N, Kim S, et al. Osimertinib with or without Chemotherapy in EGFR-Mutated Advanced NSCLC. The New England Journal of Medicine. 2023 Nov 8;