KEY TAKEAWAYS
- The phase 2 trial aimed to evaluate PD-1 combined with plat and pacli as a potential first-line alternative in R/M HNSCC pts.
- The primary endpoint was to access ORR.
- The result concluded that pembro + nab-pacli and plat extend life in R/M HNSCC without safety concerns.
The established initial therapy for individuals with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) involves the use of pembrolizumab (pembro) in conjunction with platinum (plat) and fluorouracil. The findings from the KN-B10 study have substantiated the favorable outcomes achieved by combining pembro with carboplatin and paclitaxel(pacli).
Herein, to establish the effective first-line treatment (1L) for R/M HNSCC, XiaoHui He and other researchers evaluated the combination of PD-1 with plat and pacli as a potential alternative for initial treatment.
In the interventional study, patients with untreated R/M HNSCC possessing at least one measurable lesion per RECIST 1.1 criteria were enrolled. The treatment regimen included administration of 200mg pembro, 260mg/m2 nab-pacli, and 75 mg/m2 cisplatin on day 1 every 21 days for a maximum of six cycles. This was followed by pembro maintenance therapy until disease progression, unacceptable toxicity, or completion of 35 cycles, whichever came first. The primary outcome measured was the overall response rate (ORR), while secondary endpoints encompassed safety, disease control rate (DCR), overall survival (OS), and progression-free survival (PFS).
About 30 patients were enrolled as a part of the study. six patients (20%) achieved a complete response, with an ORR of 63.3% and a DCR of 96.7%. The median follow-up duration was 14.5 months, revealing a median PFS of 12.3 months, while the median OS remained unreached. Adverse events (AEs) included one case of immune-related grade 3 diarrhea, which improved with symptomatic treatment. Additionally, one patient discontinued treatment due to immune-related grade 3 pneumonia but later resumed immunotherapy. The most prevalent non-hematological toxicity observed was hypothyroidism.
The study concluded that the combination of pembro with nab-pacli and plat demonstrated extended survival in previously untreated patients with R/M HNSCC, with no new toxicities identified.
This study is sponsored by Yuankai Shi.
Source: https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/show/session/42
Clinical Trial: https://clinicaltrials.gov/study/NCT04857164
Gui L, Chen X, He XH, et al. “Pembrolizumab plus nab-paclitaxel and platinum as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (R/M HNSCC): A prospective phase II study”. Presented at ESMO ASIA Congress 2023. (Abstract: 360MO).
