Abstract 360MO
Background
Pembrolizumab plus platinum and fluorouracil is the standard first-line treatment in patients with R/M HNSCC. The KN-B10 study alsoconfirmed that pembrolizumab combined with carboplatin and paclitaxel has a good effect. Therefore, it is considered that PD-1 combined-with platinum and paclitaxel is a possible alternative for first-line treatment.
Methods
Patients with untreated R/M HNSCC and with ≥1 measurable lesion according to RECIST 1.1 were included. Patients received pembro 200mg, nab-paclitaxel 260mg/m2 plus cisplatin 75 mg/m2 on day 1 every 21 days for up to six cycles followed by pembro maintenance therapy until progression or unacceptable toxicity or 35 cycles, whichever occurred first. The primary endpoint was overall response rate (ORR). Secondary endpoints comprised safety, disease control rate (DCR), overall survival (OS) and progression free survival (PFS).
Results
From April 30, 2021 until August 22 2023, 30 patients were enrolled. Baseline information was shown in the table. Six patients (20%) achieved complete response, ORR was 63.3% and the DCR was 96.7%. Median follow-up was 14.5 months, the median PFS was 12.3-months and the median OS was not reached. One patient had immune-related grade 3 diarrhea, which improved after symptomatic-treatment. One patient discontinued treatment due to immune-related grade 3 pneumonia, and then continued immunotherapy. The most common non-hematological toxicity was hypothyroidism. Table: 360MO
| Patient number | 30 |
| Age, years old | |
| Median (range) | 57 (38-73) |
| Gender (male / female) | 29 / 1 |
| ECOG PS | |
| 0 | 6 (20.0%) |
| 1 | 20 (66.7%) |
| 2 | 4 (13.3%) |
| Primary tumor | |
| Hypopharynx | 8 (26.7%) |
| Larynx | 9 (30.0%) |
| Oropharynx | 5 (16.7%) |
| Oral cavity | 8 (26.7%) |
| PD-L1 combined positive score | |
| < 1 | 1 (3.3%) |
| 1-20 | 11 (36.7%) |
| ≥20 | 15 (50.0%) |
| Unknow | 3 (10.0%) |
| TMB tumor mutation burden | |
| ≥10 | 2 (6.7%) |
| ＜10 | 8 (26.7%) |
| Unknow | 20 (66.7%) |
| Disease status | |
| Distant metastatic disease | 9 (30.0%) |
| Local disease | 11 (36.7%) |
| Distant and local diseases | 10 (33.3%) |
Conclusions
Pembrolizumab in combination with nab-paclitaxel and platinum showed prolonged survival in untreated R/M HNSCC patients, while nonew toxicities were identified.
Clinical trial identification
NCT04857164; April 23, 2021.
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.
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