Phase 2 Study of Osimertinib in Combination with Platinum and Pemetrexed in Patients with Previously Untreated EGFR-Mutated Advanced Non-Squamous Non-Small Cell Lung Cancer: The OPAL Study
Mené sur 67 patients atteints d'un cancer du poumon non épidermoïde non à petites cellules de stade avancé et présentant une mutation EGFR, cet essai multicentrique de phase II évalue l'efficacité, du point de vue du taux de réponse objective, et la toxicité de l'osimertinib en combinaison avec une chimiothérapie de première ligne à base de sels de platine et de pémétrexed
Résumé en anglais
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/m2 (arm A) or carboplatin (area under the curve [AUC] = 5; arm B), plus pemetrexed 500 mg/m2 for four cycles and maintenance therapy of osimertinib 80 mg QD with pemetrexed 500 mg/m2 every 3 weeks. The primary endpoints were safety and objective response rate (ORR), and the secondary endpoints 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 (February 28, 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.
Conclusion: 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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