Date of first round report: 1 September 2016 Date of second round report: 30 January 2017

Major protocol violations/deviations

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Major protocol violations/deviations

No protocol deviations were reported with the updated PFS from data cut-offs of 16 March 2015 and 23 October 2015, so the report for the data cut-off date is 5 December 2014 will be used.

Comment: The information provided at randomisation (Impala) and subsequent CRF data are very similar and any of the very minor discordances reported are unlikely to affect results of the study.
        1. Baseline data

The demographic data were generally well-balanced as were the baseline disease data (see Table 13) except for:

Comment: Overall the two arms were reasonably balanced – the control arm had more patients with the poorer outlook due to having more liver metastases, and fewer with the better prognosis associated with de novo presentation but had more patients with a better ECOG PS 0.

Table 16 in the CSR includes data about the recurrence type. This includes ‘newly diagnosed’ as a significant category (17.7% of total population) amongst breakdown by anatomical site which makes it difficult to establish how many in the each arm of the study had locoregional disease only. The sponsor is requested to provide this information as this is a population identified in the indication. (Clinical Question)

Table 13: Study A5481023 Summary of demographic and baseline characteristics by treatment (ITT population).

Prior treatments presented in the Table 14 and in more detail in Table 15.

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