Basel, 15 September 2017
TECENTRIQ GO29695 (NCT02431208) and BO29562 (NCT02631577) partial clinical hold reactive statement
Roche (SIX: RO, ROG; OTCQX: RHHBY): Based on emerging safety data from clinical trials evaluating pembrolizumab in combination with either lenalidomide or pomalidomide in multiple myeloma, the FDA has requested that a Phase Ib and a Phase Ib/II TECENTRIQ study be placed on partial clinical hold. At Roche/Genentech we remain committed to patient safety and will continue to work closely with the FDA. It is our understanding that the FDA is evaluating all ongoing blood cancer trials investigating an anti-PD1/PDL1 medicine in combination with an immunomodulatory medicine to determine if it is a class-wide (anti-PD1/PDL1) concern in multiple myeloma/blood cancers or a specific concern with certain combinations with immunomodulatory medicines.
The two studies include cohorts evaluating TECENTRIQ in combination with an immunomodulatory medicine (IMiDs) in relapsed/refractory multiple myeloma and relapsed/refractory follicular lymphoma. While the partial clinical hold is in place, patients who are currently enrolled in these trials and are deriving clinical benefit may continue to receive treatment, but no additional patients will be enrolled. Although the trials are early and ongoing, we have not seen evidence of similar findings of increased death or serious events with the use of TECENTRIQ in combination with immunomodulatory medicines.
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The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.