Talazoparib plus temozolomide appears efficacious in ES-SCLC

The combination of talazoparib plus temozolomide reached the primary efficacy endpoint in a phase 2 study that tested this combination therapy in patients with extensive-stage small cell lung cancer (ES-SCLC). Since the safety profile was manageable, a phase 3 study is appropriate to confirm the clinical benefits of this treatment [1].

The current phase 2 trial (NCT03672773) evaluated the efficacy of the PARP inhibitor talazoparib in combination with temozolomide in 28 patients with relapsed or refractory ES-SCLC. Dr Jonathan Goldman (David Geffen School of Medicine at UCLA, CA, USA) presented the findings. An objective response rate (ORR) of 29% was needed to meet the primary endpoint.

The ORR was 39.3%, representing 11 patients with partial responses. The median time to response was 1.8 months, and the median duration of response was 4.3 months. In addition, the progression-free survival was 4.3 months and the overall survival was 11.9 months.

Haematologic adverse events (AEs) were commonly observed in this patient population. A total of 53.6%, 32.1%, and 60.7% of the participants experienced grade 3 or 4 anaemia, decreased neutrophil count, or decreased platelet count, respectively. The most frequently observed non-haematologic AEs were fatigue, nausea, diarrhoea, and anorexia, predominantly being grade 1 or 2 events. Dr Goldman mentioned that exploratory results are currently being investigated. “This is the second study to demonstrate the clinical benefits of a PARP inhibitor in combination with temozolomide in patients with SCLC,” added Dr Goldman [2]. “Therefore, a phase 3 trial is appropriate to confirm the safety and efficacy of this combination regimen in SCLC.”

1. Goldman J, et al. Phase 2 study analysis of talazoparib plus temozolomide for extensive-stage small cell lung cancer (ES-SCLC). OA12.03, WCLC 2022, Vienna, Austria, 06–09 August.
2. Farago AF, et al. Cancer Discov. 2019 Oct;9(10):1372-1387.

 

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Posted on 23 August, 202225 March, 2024