Pembrolizumab combined with 5-FU-free paclitaxel and carboplatin was effective and tolerable as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell cancer (R/M HNSCC) and may be an alternative for standard 5-FU containing regiment, preliminary results from the phase 4 KEYNOTE-B10 trial demonstrated.
Standard-of-care treatment for patients with R/M HNSCC is pembrolizumab combined with 5-FU and platinum chemotherapy . However, alternatives to 5-FU are needed based on their toxicities, patient inconvenience and complications . The phase 4 KEYNOTE-B10 trial (NCT04489888) evaluated the efficacy and safety of pembrolizumab in combination with 5-FU-free carboplatin plus paclitaxel as first-line treatment for R/M HNSCC patients. Dr Marcin Dzienis (Gold Coast University Hospital, Australia) presented the first results of this ongoing study .
The KEYNOTE-B10 trial enrolled all patients with previously untreated R/M HNSCC of the oral cavity, oropharynx, larynx, or hypopharynx. Participants were treated with pembrolizumab (200 mg every 3 weeks) for ≤35 cycles, paclitaxel (100 mg/m2 every week on days 1 and 8; or 175 mg/m2 every 3 weeks on day 1) for 6 cycles, plus carboplatin (AUC 5 mg/mL/min every 3 weeks) for 6 cycles. The primary endpoint is the objective response rate (ORR). Results from the first 92 participants were presented.
After a median follow-up of 8.2 months, 51 participants had discontinued treatment: 31 due to disease progression, and 10 due to adverse events. ORR was 42.7% (4.9% complete responders). ORR was irrespective of age, sex, HPV status, and PD-L1 expression. The median time-to-response was 1.5 months and the median duration of response was 5.5 months.
Grade ≥3 treatment-related adverse events (AE) were observed in 70.7% of patients and serious treatment-related AEs in 17.4% of patients. The most common grade ≥3 treatment-related AEs were neutropenia, anaemia, and leukopenia.
Based on these (preliminary) results, Dr Dzienis concluded: “Efficacy and safety results of this trial suggest that this 5-FU-free combination may be an alternative to the current standard-of-care.”
- Burtness B, et al. Lancet. 2019;394(10212):1915–1928.
- Guigay J, et al. Front Oncol. 2019;9:668.
- Dzienis M, et al. Pembrolizumab (pembro) + carboplatin (carbo) + paclitaxel (pacli) as first-line (1L) therapy in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): Phase VI KEYNOTE-B10 study. Abstract 651O, ESMO Congress 2022, 09–13 September, Paris, France.
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Table of Contents: ESMO 2022
Letter from the Editor
High pathological responses to neoadjuvant immune checkpoint inhibition in locally advanced dMMR colon cancer
Fruquintinib: a potential new treatment for patients with refractory mCRC
Second-line avelumab is effective in patients with MSI-H/dMMR mCRC
Upper Gastrointestinal Cancer
Deep learning models predict the risk of relapse and the mutational profile in GIST
Addition of pembrolizumab to lenvatinib does not improve OS in advanced HCC
New, highly selective inhibitor of FGFR2 driver alterations and resistance mutations
Chemo-immunotherapy in gastric cancer is more effective when administered in parallel
Tumour infiltrating lymphocytes identify patients with immunogenic triple-negative breast cancer
OS benefit of abemaciclib in HR-positive/HER2-negative advanced breast cancer not (yet) statistically significant
OS benefit of sacituzumab govitecan in pre-treated HR-positive/HER2-negative metastatic breast cancer
A pathway from air pollution to lung cancer in non-smokers identified
Selective KRASG12C inhibitor sotorasib demonstrates superior PFS and ORR compared to docetaxel in previously treated patients with NSCLC
Promising clinical activity of tepotinib plus osimertinib in NSCLC with MET amplification after progression on first-line osimertinib
High pathological responses in borderline resectable NSCLC patients after induction with dual immunotherapy and concurrent chemoradiotherapy
Treatment with tumour-infiltrating lymphocytes for advanced melanoma outperforms ipilimumab
Neoadjuvant pembrolizumab outperforms adjuvant pembrolizumab in resectable stage III–IV melanomas
Survival-benefit of neoadjuvant T-VEC maintained over 5 years of follow-up
Baseline ctDNA predicts survival in resected stage III–IV melanoma
Genitourinary Cancer – Prostate Cancer
Overall survival benefit of abiraterone in mHSPC is maintained for 7 years
Limited benefit of adding long-term ADT to post-operative radiotherapy in prostate cancer
Intensified ADT benefits biochemical progression-free survival in biochemically relapsed prostate cancer
Genitourinary Cancer – Non-Prostate Cancer
Adjuvant nivolumab plus ipilimumab does not improve survival in patients with localised RCC at high risk of relapse after nephrectomy
Triple therapy improves progression-free survival in patients with advanced RCC versus dual therapy
Adjuvant atezolizumab does not improve outcomes for patients with RCC and increased risk of recurrence
OS benefit for advanced ovarian cancer patients treated with maintenance olaparib
Maintenance tegafur-uracil does not improve survival in locally advanced cervical cancer
Head and Neck Cancer
Adding first-line pembrolizumab to CRT in locally advanced HNSCC does not significantly prolong survival or event-free survival
5-FU-free chemotherapy combination as an alternative for first-line treatment of recurrent or metastatic HNSCC
Epstein Barr virus-specific autologous cytotoxic T lymphocytes do not improve survival in nasopharyngeal carcinoma