73P - Camrelizumab plus famitinib as first-line treatment in patient with locally advanced or metastatic pulmonary sarcomatoid carcinomas (CAPSTONE)?A multi-center, single-arm, phase II study

Background

Pulmonary sarcomatoid carcinoma (PSC) is a rare, poorly differentiated, highly invasive subtype of non-small cell lung cancer (NSCLC), with extremely poor prognosis. Immunotherapy and targeted therapy have become the mainstay of management of advanced NSCLC, however, have been scarcely reported in PSC. Herein, we conducted a multi-center, single-arm, phase II study to assess the efficacy and safety of camrelizumab plus famitinib as first-line treatment in pts with locally advanced or metastatic PSC.

Methods

In this study, treatment-naïve pts with histologically confirmed stage IIIB-IV PSC received camrelizumab (200 mg, i.v., q3w) plus famitinib (20 mg, orally, qd) until disease progression or intolerable toxicity. Simon's two-stage design was adopted, and 15 pts were planned to be enrolled in the first stage, with 3 or more responses observed to progress to the second stage. The primary endpoint was objective response rate (ORR) as per RECIST 1.1. Here, we reported the first-stage results.

Results

From August 4, 2021 to April 24, 2023, 15 pts were enrolled, with a median age of 64 years (range 45-72) and all being male (100%). Of the 15 pts, seven (46.7%) achieved a partial response and six (40.0%) had stable disease, with the confirmed ORR of 46.7% (95% CI 21.3-73.4) and disease control rate of 86.7% (95% CI 59.5-98.3). As of August 16, 2023, the median follow-up was 10.0 months (IQR 3.9-14.5). The median duration of response was 7.1 months (95% CI 5.0-NR), median progression-free survival was 7.8 months (95% CI 1.6-NR), and median overall survival was 18.2 months (95% CI 18.0-NR). The median number of camrelizumab cycles was 7.0 (range 1-19). Treatment-related adverse events (TRAEs) of any grade occurred in 15 pts (100.0%), with seven (46.7%) developing grade ≥3 TRAEs. The most common TRAEs were proteinuria (53.3%), hypertension, neutrophil count decreased, and platelet count decreased (46.7% each). Two pts had grade 5 AEs (unknown cause).

Conclusions

Camrelizumab plus famitinib as first-line therapy for PSC showed promising activity and acceptable safety during the first stage of this study. Enrollment for the second stage is ongoing.

Clinical trial identification

NCT04888429; May 17, 2021.

Legal entity responsible for the study

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.