Roche: delayed clinical trial results disclosure for BP22572 (Kadcyla/Perjeta) due to misclassification

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Key facts

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Case number	AUTH/2898/11/16 and AUTH/2901/11/16
Parties	PMCPA Director v Roche
Issue	Clinical trial disclosure (Kadcyla and Perjeta)
Complaint received	06 December 2016
Completed	13 March 2017
Review	May 2017
Applicable Code year	2012
Products	Kadcyla (trastuzumab emtansine); Perjeta (pertuzumab)
Trial at issue	BP22572 (Phase Ib/IIa); ClinicalTrials.gov NCT00934856
UK involvement	One UK trial site
Trial completion date	24 October 2013
Panel view of results due date	24 October 2014 (posting on a publicly accessible, internet-based clinical trials database)
Breach findings	Clause 13.1 and Clause 9.1 breached; no breach of Clause 2
Sanctions	Undertaking received

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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The PMCPA Director opened a complaint after a CMRO transparency study (published 25 Nov 2016) suggested Roche had not disclosed one evaluable trial result within the required timeframe for Kadcyla and Perjeta.
The “missing” disclosure for both products related to the same Phase Ib/IIa multi-centre trial (BP22572; ClinicalTrials.gov NCT00934856) that included both Kadcyla (trastuzumab emtansine) and Perjeta (pertuzumab).
The trial included one UK site, so it was within scope of the ABPI Code for disclosure.
The trial completed (last patient, last visit) on 24 Oct 2013; the Panel considered results should have been posted on a publicly accessible, internet-based clinical trials database by 24 Oct 2014.
Roche said results were not posted to ClinicalTrials.gov because the study was incorrectly categorised internally as Phase I (rather than Phase I/II), and Phase I trials were excluded from FDAAA 801 results submission requirements.
Roche initiated EudraCT posting in March 2015 but missed the 21 Jul 2015 deadline (vendor issues and review/approval delays). Results were posted on EudraCT on 17 Feb 2016 and finalised 4 Mar 2016.
Roche noted interim/partial data were presented at San Antonio Breast Cancer Symposium (Dec 2012 and Dec 2013), and a manuscript was ultimately published (online 6 Apr 2016) after journal rejection and resubmission.

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Breach found: Clause 13.1 (clinical trial disclosure requirements).
Breach found: Clause 9.1 (high standards not maintained due to delay).
No breach: Clause 2 (as the data had now been disclosed, the Panel did not consider Clause 2 was breached).
Applicable Code year (as recorded on the case page): 2012.

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