Basel, Switzerland (Press Release) – 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.

About Roche

Roche is a global pioneer in pharma­ceu­ticals and diagnostics focused on ad­vanc­ing science to im­prove people’s lives. The com­bined strengths of pharma­ceuticals and diagnostics under one roof have made Roche the leader in personalised health­care – a strategy that aims to fit the right treat­ment to each patient in the best way possible.

Roche is the world’s largest bio­tech com­pany, with truly dif­fer­en­ti­ated medicines in on­col­ogy, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a front­runner in diabetes man­age­ment.

Founded in 1896, Roche con­tinues to search for better ways to prevent, diagnose and treat diseases and make a sustainable con­tri­bu­tion to society. The com­pany also aims to im­prove patient access to medical inno­va­tions by work­ing with all relevant stake­holders. Thirty medicines developed by Roche are in­cluded in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, anti­malarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharma­ceuticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sus­tain­ability Indices (DJSI).

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.

Source: Roche.