KEY TAKEAWAYS
- A Phase 2 trial assessed the safety and efficacy of osimertinib and platinum-based chemotherapy (OPP) in patients with advanced non-squamous NSCLC and EGFR mutations.
- The primary aim was to evaluate OPP’s safety and objective response rate.
- The subjects received OPP, followed by maintenance therapy of osimertinib and pemetrexed.
- The study showed that OPP had a remarkable efficacy with tolerable toxicity, with an ORR of 90.9%, CRR of 3.0%, and DCR of 97.0%.
- The trial enrolled 67 patients, with 34 patients in arm A and 33 in arm B, among the 35 patients who terminated the protocol treatment.
- The study demonstrated that OPP is safe and effective in previously untreated patients with advanced non-squamous NSCLC and EGFR mutations.
In this multicenter phase 2 study, the safety and efficacy of osimertinib and platinum-based chemotherapy (OPP) were assessed in patients with advanced non-squamous non-small cell lung cancer (NSCLC) who had not received prior treatment and had EGFR mutations. The subjects were administered osimertinib at a dosage of 80 mg once daily (QD), along with either cisplatin 75 mg/m2 (arm A) or carboplatin (area under the curve [AUC] = 5; arm B), and pemetrexed 500 mg/m2 for four cycles. They were also given maintenance therapy of osimertinib 80 mg QD with pemetrexed 500 mg/m2 every 3 weeks. The study’s primary endpoints included safety and objective response rate (ORR), while the secondary endpoints were complete response rate (CRR), disease control rate (DCR), and progression-free survival (PFS).
A total of 67 patients were enrolled in the study, with 34 patients in arm A and 33 in arm B. The enrollment period was from July 2019 to February 2020. As of the data cutoff on February 28th, 2022, 35 patients, accounting for 52.2% of the total, had terminated the protocol treatment. Among them, 10 patients, representing 14.9% of the total, had discontinued the treatment due to adverse events. There were no fatalities related to treatment. The ORR, CRR, and DCR in the full analysis set were observed to be 90.9% (95% CI, 84.0-97.8), 3.0% (0.0-7.2), and 97.0% (92.8-100.0), respectively. As per the latest survival data (data cutoff on August 31, 2022, median follow-up time: 33.4 months), the median progression-free survival (PFS) was 31.0 months (95% CI, 26.8 months-not reached), and the median overall survival (OS) was not reached. The study demonstrated that OPP exhibits remarkable efficacy with tolerable toxicity in previously untreated patients with advanced non-squamous NSCLC and EGFR mutations.
Source:https://pubmed.ncbi.nlm.nih.gov/36966696/
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT04035486
Saito R, Sugawara S, Ko R, Azuma K, Morita R, Maemondo M, Oizumi S, Takahashi K, Kagamu H, Tsubata Y, Seike M, Kikuchi T, Okamoto I, Satoshi M, Asahina H, Tanaka K, Sugio K, Kobayashi K. 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. Eur J Cancer. 2023 Mar 2;185:83-93. doi: 10.1016/j.ejca.2023.02.023. Epub ahead of print. PMID: 36966696.
