KEY TAKEAWAYS
- The study aimed to investigate the efficacy and safety of lenvatinib plus pembrolizumab in advanced B3-thymoma and TC.
- The primary endpoint was to determine PFS.
- Researchers noted that lenvatinib plus pembrolizumab may become a standard treatment for advanced B3-thymoma and TC.
The standard treatment for patients with platinum-refractory advanced B3-thymoma and thymic carcinoma (TC) remains undefined. Both lenvatinib and immune checkpoint inhibitors have demonstrated clinically significant outcomes in this context.
In this phase 2 single-arm PECATI trial (NCT04710628), Jordi Remon Masip and the team aimed to evaluate the efficacy and safety of combining lenvatinib (L) with pembrolizumab in patients with advanced, pre-treated B3-T and TC who do not have autoimmune disorders.
They performed an inclusive analysis involving patients who received lenvatinib (20 mg orally daily) combined with pembrolizumab (200 mg IV infusion once every three weeks) in 3-week cycles, continuing until disease progression, unacceptable toxicity, or a maximum of 35 cycles.
The primary endpoint was the 5-month progression-free survival (5-PFS) rate, with null and alternative hypotheses set at 5-PFS of ≤50% and >68.6%, respectively, assessed by investigators. Secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety, focusing on grade ≥3 treatment-related adverse events (TRAEs).
About 43 patients were enrolled from 09/2021 to 02/2024, with a median age of 57 years (range 33-80); 84% had TC. Masaoka Koga staging was IVA in 35% and B in 65%, with 56% of patients having ≥3 metastatic sites, including 37% with liver metastases. The median number of target lesions was 2, and the median sum of target lesions measured 86 mm (range 11-204). Previous treatment lines included 1 (54%), 2 (39%), and >2 (7%). PD-L1 expression (22C3, n=32) was <1% in 53%, 1-49% in 31%, and ≥50% in 16%.
The study achieved its primary endpoint, demonstrating a 5-PFS rate of 91%, with a 1-year PFS of 62%. The confirmed ORR was 21%, while the confirmed DCR reached 67%. Following a median follow-up of 10.6 months, the median OS was not estimated, but the 1-year OS was 85%.
The rate of grade ≥3 TRAEs was 34.9%, with the most common being diarrhea (7%), hypertension (7%), and hepatic cytolysis (5%). Serious grade ≥3 TRAEs occurred in 16% of patients (7/43), including 1 (2.3%) patient with myocarditis and 1 (2.3%) patient with pneumonitis. No treatment-related deaths were reported.
The study concluded that lenvatinib combined with pembrolizumab may serve as a potential standard treatment for pre-treated advanced B3-thymoma and TC, with a manageable toxicity profile that necessitates close monitoring.
The trial was sponsored by the MedSIR.
Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/17
Clinical Trial: https://clinicaltrials.gov/study/NCT04710628
Masip J.R, Bironzo P, Girard N, et al. (2024). “PECATI: A phase II trial to evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab in pretreated advanced B3-thymoma and thymic carcinoma.” Presented at ESMO 2024 (Abstract LBA83).
