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Presidential Symposium 3
Not only is pembrolizumab significantly more tolerable than standard chemotherapy, but it also increases overall survival in advanced head and neck cancers and the expression of PD-L1 ≥ 1%. And despite lower response rates, with the same progression-free survival.
The KEYNOTE-048 phase III study showed significantly longer overall survival (pS) with pembrolizumab compared to standard treatment ≥20) metastatic head and neck cancers (14.9 vs. 10.7 months, HR 0.61, p = 0.0007). This badessment is based on data from 300 patients receiving standard treatment and 301 patients receiving pembrolizumab. Median follow-up was 11.7 and 10.7 months.
An answer was found at 23.3 vs. 36.1% of patients under pembrolizumab versus standard arms. The median response time was 20.9 vs. 4.5 months. There was no difference in progression-free survival (PFS, HR 0.99).
Similar results were obtained in patients with CPS ≥1. The operating system was 12.3 vs.. 10.3 months on pembrolizumab vs chemotherapy (HR 0.78, p = 0.0086). 19.1 vs. 34.9% responded to the therapy. The median response time was 20.9 vs. 4.5 months. Again, SSP did not differ (HR 1.16).
A further evaluation of the same study compared the standard treatment (5-fluorouracil, cis or carboplatin and cetuximab compound) with a new combination of pembrolizumab and platinum-based chemotherapy at 281% versus 10%. 278 patients. The median follow-up was 13 vs. 10.7 months. The combination expands the operating system to 13 vs. 10.7 months (HR 0.77, p = 0.0034). The response rate was 35.6% 36.3%. SSP did not differ (HR 0.92).
Pembrolizumab alone is expected to be less toxic than standard therapy, while chemotherapy has shown toxicity similar to that of standard therapy.
"Patients are living longer if they had received initial treatment with pembrolizumab," says its lead author, Prof. Dr. med. Barbara Burtness, Head of the Neck Cancer Program, Yale Cancer Center, New Haven, USA. Emphasizes that pembrolizumab alone shows a lower response rate and a numerically shorter SSP than standard therapy, while overall survival with pembrolizumab was significantly prolonged. "Pembrolizumab seems to prolong life, even if the cancer continues to develop, making it a first-line treatment for relapsing and metastatic head and neck cancers." Whether pembrolizumab alone or in chemotherapy may be used. depend on the expression of PD-L1 We are currently performing badyzes to answer this question. "
ESMO commentator Tanguy Seiwert, University of Chicago Medicine, Chicago, USA, said: "This is the first study to show better overall survival compared to the ten-year standard of care. this work establishes PD-L1 as a valid marker of head and neck cancer and should be systematically tested. "
Seiwert added, "The challenge is that the benefits are not evenly distributed.The PD-L1 expression will likely influence our choice between the two options: pembrolizumab alone with a favorable side-effect profile and pembrolizumab combined with chemotherapy that can be used in a larger group of patients Higher PD-L1 expression is badociated with greater benefit, but the exact limits must first be determined Individual Patient Characteristics will also play an important role. "
In addition, according to Seiwert, other markers, such as tumor mutation burden, needed to be examined in order to better select patients.
Source: ESMO 2018
Burtness B et al., KEYNOTE-048: Phase III study of first-line pembrolizumab (P) of recurrent squamous cell / metastatic carcinoma of the head and neck (R / M HNSCC); ESMO 2018; LBA8_PR
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