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Treatment Beyond Progression Benefit Reported For CheckMate 141 Study

Patients with recurrent or metastatic head and neck cancer may experience a tumour burden reduction by continuing with nivolumab after disease progression
03 Jul 2019
Head and Neck Cancers;  Immunotherapy

Author:  By Lynda Williams, Senior medwireNews Reporter

medwireNews: A group of patients who continued nivolumab treatment despite progression of their recurrent or metastatic squamous cell carcinoma of the head and neck subsequently experienced tumour shrinkage, the CheckMate 141 investigators say. 

The open-label phase III trial permitted treatment beyond progression (TBP) at a nivolumab dose of 3 mg/kg every 2 weeks for 60 patients with a first instance of RECIST progression. The patients were eligible to continue nivolumab up until a 10% further increase in tumour volume as long as treatment was well tolerated and they had a stable performance status, clinical benefit and no rapid disease progression. 

Post-hoc analysis showed that 25% of these participants experienced no change in their tumour burden but 25% had a target lesion shrinkage that lasted a median of 3.0 months, including three patients with a 30% or greater reduction in tumour size. Five of the responders had previously experienced a 20% or greater increase in their target lesion at the time of progression, say Robert Haddad, from the Dana-Farber Cancer Institute in Boston, Massachusetts, USA, and co-workers. 

TBP achieved responses in patients with HPV-positive and -negative disease, and in patients with and without tumour PD-L1 expression of at least 1%, the investigators report in Cancer

Exploratory analysis of patients with evaluable peripheral blood cells revealed that the three TBP patients who responded had a significant reduction in their PD-1-positive regulatory T-cell levels between baseline and day 43 of treatment, a difference that was not found among 11 evaluable patients who did not respond. 

However, the researchers emphasize that “sample sizes were small, and this research should be considered hypothesis-generating.” 

Median overall survival (OS) was 12.7 months for the TBP cohort, with 12- and 18-month rates of 52% and 30%, respectively. This compared with a median overall survival of 7.7 months and corresponding rates of 34% and 22% for the intention-to-treat study population, including the 84 patients who did not continue nivolumab after progression. 

And landmark analysis indicated that the median OS from week 6 after RECIST progression was 8.4 months for the patients who continued nivolumab versus 3.8 months for those who did not. 

There were no new safety signals for nivolumab among the TBP arm, add Robert Haddad et al. 

“Our results underscore the importance of conducting prospective trials aimed at evaluating the eligibility and appropriate selection of patients who may derive a benefit from TBP”, the team concludes.

“Additional research is also needed to determine whether a response to TBP can be predicted on the basis of immunologic factors or patient clinical characteristics.” 


Haddad R, Concha-Benavente F, Blumenschein Jr G, et al. Nivolumab treatment beyond RECIST-defined progression in recurrent or metastatic squamous cell carcinoma of the head and neck in CheckMate 141: A subgroup analysis of a randomized phase 3 clinical trial. Cancer; Advance online publication 27 June 2019. https://doi.org/10.1002/cncr.32190

Last update: 03 Jul 2019

medwireNews (www.medwireNews.com  ) is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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