Investor Update

Basel, 31 May 2014

Roche presents encouraging new data in common blood cancers for its investigational BCL-2 inhibitor GDC-0199/ABT-199 and polatuzumab vedotin, an anti-CD79b antibody drug conjugate

  • GDC-0199/ABT-199 combined with rituximab in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) shows encouraging activity
  • Head-to-head ROMULUS data in R/R non-Hodgkin lymphoma (NHL) support further development of polatuzumab vedotin (anti-CD79b ADC)

Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented positive interim results of a phase 1b study for its investigational BCL-2 inhibitor GDC-0199/ABT-199, which is being developed in collaboration with AbbVie, at the ASCO 2014 Annual Meeting. The data showed that GDC-0199/ABT-199 combined with MabThera/Rituxan (rituximab) achieved either a complete response or complete response with incomplete blood count recovery (CR/CRi) rate of 36% in patients with R/R CLL. Importantly, of the patients achieving CR, 75% were free of minimal residual disease (MRD).

At ASCO, additional data will be presented from the global clinical development program of GDC-0199/ABT-199. This includes updated data from the previously reported phase 1 study of GDC-0199/ABT-199 monotherapy in CLL and small lymphocytic lymphoma and new data from a phase 1 study in R/R diffuse large B-cell (DLBCL) and R/R follicular lymphoma (FL) which evaluates the use of higher dosing in these lymphoma settings.

At ASCO, Roche also presented results of the randomized phase 2 ROMULUS study which assessed two novel antibody drug conjugates (ADC) in patients with R/R DLBCL and FL. ROMULUS investigated the safety and preliminary efficacy of anti-CD79b ADC (polutuzumab vedotin) compared with that of anti-CD22 ADC (pinatuzumab vedotin), both in combination with rituximab. Results showed that both molecules were generally well-tolerated in NHL patients, with a higher CR rate recorded in R/R FL patients with anti-CD79b ADC (40%) compared with anti-CD22 ADC (10%). The overall response rate (ORR) and CR rates were similar in patients with DLBCL.

“These early data are promising, especially in these blood cancer patients who have progressed following their initial therapy,” said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head, Global Product Development. “Importantly they show the potential benefit of targeted combinations using a proven anti-CD20 antibody combined with investigational molecules that focus on a different pathway. We look forward to presenting more data on these compounds in the near future.”

ASCO abstract information

Phase I study of ABT-199 (GDC-0199) in patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL): Responses observed in diffuse large B-cell (DLBCL) and follicular lymphoma (FL) at higher cohort doses. Poster Presentation, Friday May 30 during the Lymphoma and Plasma Cell Disorders session (Abstract #8522)

ABT-199 (GDC-0199) combined with rituximab (R) in patients (pts) with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL): Interim results of a phase 1b study. Poster Presentation, Saturday May 31 during the Leukemia, Myelodysplasia, and Transplantation session (Abstract #7013)

ABT-199 (GDC-0199) in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL): High complete-response rate and durable disease control. Poster Presentation, Saturday May 31 during the Leukemia, Myelodysplasia, and Transplantation session (Abstract #7015)

A phase 2 open-label study of the efficacy of ABT-199 (GDC-0199) in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) harboring 17p deletion. Poster Presentation, Monday June 2 during the Leukemia, Myelodysplasia, and Transplantation session (Abstract #TPS7121)

Preliminary results of a phase II randomized study (ROMULUS) of polatuzumab vedotin (PoV) or pinatuzumab vedotin (PiV) plus rituximab (RTX) in patients (Pts) with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL). Oral presentation, Saturday May 31 during the Targeted Therapies in Early, Mid, and Late Development session (Abstract #8519)

About GDC-0199/ABT-199

GDC-0199/ABT-199 is a novel small molecule being developed in collaboration with AbbVie and is designed to selectively block the function of BCL-2 proteins with the goal of enhancing programmed cell death (apoptosis). BCL-2 proteins play a central role in enhancing cell death activity and are thought to impact tumor formation, growth and resistance. They are expressed at high levels in cancers such as non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) and in other B-cell neoplasms.

As previously reported from the phase 1b study of GDC-0199/ABT-199 in combination with rituximab for R/R CLL, during the GDC-0199/ABT-199 lead-in period, a fatal episode of tumor lysis syndrome (TLS) occurred. Dosing and scheduling modifications have been implemented and no cases of clinical TLS have been reported to date under the modified protocol.

About anti-CD79b antibody drug conjugate (polatuzumab vedotin)

Polatuzumab vedotin is an anti-CD79b antibody drug conjugate (ADC) consisting of an anti-CD79b monoclonal antibody that is linked to a potent microtubule-disrupting agent. Both polatuzumab vedotin and pinatuzumab vedotin, an anti CD22 ADC, are being developed by Roche utilizing Seattle Genetics ADC technology.

About Roche in hematology

For more than 20 years, Roche has been developing medicines that redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with cancers of the blood.

Roche’s pipeline of potential hematology medicines includes two antibody-drug conjugates (anti-CD79b [RG7596] and anti-CD22 [RG7593]), a small molecule antagonist of MDM2 (RG7112) and in collaboration with AbbVie, a small molecule BCL-2 inhibitor (RG7601/GDC-0199/ABT-199).

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. 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.

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