Therapeutic efficacy of Pralsetinib

1.Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

The efficacy of Pralsetinib was evaluated in patients with RET fusion-positive metastatic NSCLC in a multicenter, non-randomized, open-label, multi-cohort clinical trial (ARROW,  NCT03037385).

The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR), as assessed by a blinded independent central review (BICR) according to  RECIST v1.1.

Metastatic RET Fusion-Positive NSCLC Previously Treated with Platinum Chemotherapy

Efficacy was evaluated in 130 patients with RET fusion-positive NSCLC with measurable disease who were previously treated with platinum chemotherapy enrolled into a cohort of  ARROW.

For the 54 patients who received an anti-PD-1 or anti-PD-L1 therapy, either sequentially or concurrently with platinum-based chemotherapy, an exploratory subgroup analysis of ORR was  59% (95% CI: 45, 72) and the median DOR was 22.3 months (95% CI: 8.0, NE).

Among the 130 patients with RET-fusion positive NSCLC, 10 had measurable CNS metastases at baseline as assessed by BICR. No patients received radiation therapy (RT) to the brain within 2 months prior to study entry. Responses in intracranial lesions were observed in 7 of these 10 patients including 2 patients with a CNS complete response; 71% of responders had a DOR of ≥ 6 months.

Treatment-naïve RET Fusion-Positive NSCLC

Efficacy was evaluated in 107 patients with treatment-naïve RET fusion-positive NSCLC with measurable disease enrolled into ARROW.

Efficacy results for treatment-naïve RET fusion-positive NSCLC are summarized in Table 11.

from FDA，2024.03