409MO - Induction chemo-immunotherapy with camrelizumab plus modified TPF (nab-paclitaxel, cisplatin, and S1) in locally advanced nasopharyngeal carcinoma: A phase II, single-arm study

Background

Immunotherapy has emerged as a transformative treatment approach for various malignancies, including nasopharyngeal carcinoma (NPC). Immunotherapeutic agents targeting the immune checkpoints, particularly anti-PD-1/PD-L1 antibodies, have demonstrated remarkable efficacy in NPC. There is still a lack of studies regarding camrelizumab in the induction therapy of locally advanced nasopharyngeal carcinoma (LANPC). This phase II trial aimed to determine the efficacy and safety of induction chemoimmunotherapy of camrelizumab plus modified TPF (nab-paclitaxel, cisplatin, and S1) in LANPC (ChiCTR2400086030).

Methods

Patients with stage III–IVA NPC who received induction chemoimmunotherapy were enrolled between July 2023 and May 2024. Patients received induction chemoimmunotherapy for three cycles: camrelizumab 200 mg d1, nab-paclitaxel 260 mg/m² d1, cisplatin 25 mg/m² d1-3, and S1 40 mg/m² bid d1-14, q21d. The primary endpoint was complete response (CR) rate, and secondary endpoints were objective response rate (ORR), 3-year overall survival (OS), and 3-year progression-free survival (PFS). The study enrollment has been completed, and we report the preliminary CR rate of chemoimmunotherapy.

Results

A total of 29 patients were enrolled, 28 (95.6%) patients had completed three cycles of induction chemoimmunotherapy. After induction chemoimmunotherapy, the CR rate was 41.4% (12/29), meeting the prespecified endpoint, with a CR rate of the primary nasopharyngeal tumor and cervical lymph nodes of 69.0% (20/29) and 62.1% (18/29), respectively. Immune-related adverse events of any grade were reported in 18 (62.1%) patients. There were 11 patients (37.9%) who experienced reactive cutaneous capillary endothelial proliferation, all of which were grade 1 or 2. One (3.5%) patient had a grade 3 rash, and one (3.5%) patient had a grade 1 thyroid dysfunction. No other grade 3 or higher adverse events occurred. No treatment-related death occurred.

Conclusions

The induction chemoimmunotherapy of camrelizumab plus modified TPF showed an excellent CR rate with an acceptable safety profile in LANPC.

Clinical trial identification

ChiCTR2400086030 (June 24, 2024).

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.