Roche v Merck Serono: Erbitux FIRE-3 press release ruled misleading (survival headline, subgroup analysis and licence context)

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Key facts

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Case number	AUTH/2705/3/14
Parties	Roche v Merck Serono
Material	UK press release about FIRE-3 AIO trial results (ref ERB13-0152)
Press release date	28 September 2013 (issued in the UK on 30 September 2013)
Therapy area	Metastatic colorectal cancer (mCRC)
Medicine	Erbitux (cetuximab)
Comparator mentioned	Bevacizumab (Avastin marketed by Roche)
Key issue	Misleading headline and summary of secondary endpoint (OS) from subgroup analysis; lack of prominent context (primary endpoint failure); unclear exploratory/retrospective nature; omission of licence/contraindication context; exaggerated quotation; unbalanced public information
Applicable Code	Second 2012 Edition (amended)
Complaint received	17 March 2014
Case completed	10 October 2014
Breach clauses	Clause 2, Clause 7.2 (x5), Clause 7.3 (x2), Clause 7.10 (x2), Clause 9.1, Clause 10.2, Clause 22.2 (x2)
No breach clauses	Clause 7.4
Sanctions	Undertaking received; Advertisement

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

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Roche complained about a UK press release (ref ERB13-0152) dated 28 September 2013 (issued in the UK on 30 September 2013) about the FIRE-3 AIO phase III trial comparing cetuximab (Erbitux) + FOLFIRI vs bevacizumab + FOLFIRI in first-line metastatic colorectal cancer.
The press release headline stated: “Merck Serono’s Erbitux Significantly Extends Survival by 7.5 Months in mCRC RAS Wild-Type Patients When Compared With Bevacizumab: New Analysis of FIRE-3 AIO Study”.
Two prominent bullet points highlighted (1) OS 33.1 vs 25.6 months (p=0.011) in “RAS wild-type” and (2) OS 20.3 vs 20.6 months (p=0.60) in “any RAS mutations”.
Roche argued the trial failed its primary endpoint (overall response rate) and that the press release “cherry picked” a secondary endpoint from an exploratory subgroup without prominent context.
Roche also argued the “any RAS mutations” bullet implied relevance/efficacy in a population where cetuximab was not licensed (and could be contraindicated with certain chemotherapy combinations), without stating licence restrictions/contraindications or explaining the pooled nature of the analysis.
A quotation in the press release described the OS prolongation as “a paradigm shift in mCRC treatment since the introduction of monoclonal antibodies”.
The press release was distributed to 40 medical/pharmaceutical titles, 23 health journalists at national print/online titles and 16 freelance health journalists, and was publicly available.

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Breach found for: Clause 2, Clause 7.2 (x5), Clause 7.3 (x2), Clause 7.10 (x2), Clause 9.1, Clause 10.2 and Clause 22.2 (x2).
No breach found for: Clause 7.4 (on appeal, on a narrow point about substantiation of the OS bullet being factually correct).
The Panel’s key findings (misleading headline/bullets; lack of context; licence/contraindication omissions; exaggerated quotation; unbalanced public information; high standards; Clause 2 censure) were largely upheld by the Appeal Board.

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