Abstract 34P
Background
Pm-Pac is a novel Cremophor EL-free, nanoparticle micellar formulation of paclitaxel. Pm-Pac plus cisplatin has shown efficacy and safety in patients(pts) with locally advanced or metastatic NSCLC. However, its combination with PD-1/PD-L1 inhibitors for advanced or metastatic nsq-NSCLC have not been reported.
Methods
This was a prospective, single-arm phase II study. Treatment-naive, stage IIIB–IV nsq-NSCLC pts with ECOG PS 0-1 and driver gene negative were eligible to receive sintilimab (200 mg IV, d1,q3w) plus pm-Pac (230 mg/m² IV, d1,q3w, followed by dose escalation to 300 mg/m² from the second cycle if no predefined toxicities were observed) and carboplatin (AUC 5 IV, d1,q3w) for 4 cycles, followed by sintilimab monotherapy or plus pm-Pac until disease progression, death, or intolerable toxicity. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety.
Results
A total of 28 pts (median age: 64 years)were enrolled. ORR was 82.1% (95% CI: 64.4–92.1) and DCR was 89.3% (95% CI: 72.8–96.3) with 1 complete response, 22 partial responses (PR), 2 stable diseases, 2 not evaluated and 1 progressive disease (gene testing suggested ALK positive after 2 cycles). 4 pts with PR received subsequent local treatment, 2 received radiotherapy and 2 underwent surgery (1 achieved major pathologic response). As of Dec 25, 2024, the median follow-up was 14 months (range: 8–21) and 15 pts (53.6%) remained on treatment. The median PFS and OS were not reached and the 12m-PFS rate was 61.5% (95%CI: 38.1–78.3). Grade≥3 treatment emergent adverse events occurred in 16 (57.1%) pts. Grade≥3 immune-related adverse events occurred in 5 (17.9%) pts, 7 pts discontinued immunotherapy and 1 pt dead due to immune-mediated pneumonitis.
Conclusions
This is the first report on the new chemotherapy agent pm-Pac combined with a PD-1 inhibitor as first-line therapy for advanced nsq-NSCLC. This regimen demonstrates promising efficacy and tolerable safety, warranting further investigation.
Clinical trial identification
NCT05782426.
Legal entity responsible for the study
The authors.
Funding
Innovent Biologics, Suzhou, China Shanghai Yizhong Pharmaceutical Company., Ltd.
Disclosure
All authors have declared no conflicts of interest.