Background: This multicenter phase 2 trial evaluated the safety and efficacy of osimertinib and platinum-based chemotherapy (OPP) in patients with previously untreated EGFR-mutated advanced non-squamous non-small cell lung cancer (NSCLC).
Patients And Methods: Patients received osimertinib 80 mg once daily (QD), with either cisplatin 75 mg/m (arm A) or carboplatin (area under the curve [AUC] = 5; arm B), plus pemetrexed 500 mg/m for four cycles and maintenance therapy of osimertinib 80 mg QD with pemetrexed 500 mg/m every 3 weeks. The primary end-points were safety and objective response rate (ORR), and the secondary end-points were complete response rate (CRR), disease control rate (DCR), and progression-free survival (PFS).
Results: In total, 67 patients (34 in arm A and 33 in arm B) were enrolled between July 2019 and February 2020. At the data cutoff (28th February 2022), 35 (52.2%) patients had discontinued the protocol treatment, including 10 (14.9%) due to adverse events. No treatment-related deaths occurred. In the full analysis set, the ORR, CRR, and DCR were 90.9% (95% confidence interval [CI], 84.0-97.8), 3.0% (0.0-7.2), and 97.0% (92.8-100.0), respectively. Based on updated survival data (data cutoff on August 31, 2022, median follow-up time: 33.4 months), the median PFS was 31.0 months (95% CI, 26.8 months-not reached) and median overall survival was not reached.
Conclusions: This is the first study to show that OPP has excellent efficacy with acceptable toxicity in previously untreated EGFR-mutated advanced non-squamous NSCLC patients.
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Article Synopsis
- Osimertinib is more effective than first-generation EGFR-TKIs for treating EGFR-mutated non-small cell lung cancer, but its overall survival benefits for Japanese patients needed further investigation.
- A study was conducted using real-world data from 46 hospitals in Japan to compare the overall survival of patients receiving osimertinib versus other EGFR-TKIs; the study included 1,062 patients and lasted from April 2010 to April 2023.
- Results showed no significant difference in overall survival between patients receiving first-line osimertinib and those on other first-line treatments, while those receiving osimertinib as a later-line treatment had notably longer survival times.*
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