Genentech Bladder Cancer Med Anti-PDL1 (MPDL3280A) Nabs Breakthrough Status

CHICAGO--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from a Phase I open-label study that showed the investigational cancer immunotherapy MPDL3280A (anti-PDL1) shrank tumors (overall response rate) in 43 percent (13/30) of people previously treated for metastatic urothelial bladder cancer (UBC) whose tumors were characterized as PD-L1 (Programmed Death Ligand-1) positive by a test being developed by Roche. Adverse events (AEs) were consistent with what has been previously reported for MPDL3280A. There were no severe (Grade 4-5) treatment-related AEs.

The FDA has granted MPDL3280A Breakthrough Therapy Designation. This designation is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible.

“Bladder cancer is the ninth most common cancer worldwide, for which there have been no new treatment advances in nearly 30 years, so we are pleased the FDA has granted breakthrough designation for MPDL3280A in metastatic bladder cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are evaluating MPDL3280A in a broad range of tumors, and have begun pivotal studies that include a companion diagnostic test in lung and bladder cancers.”

Full results of the study will be presented today at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) by Thomas Powles, M.D., clinical professor of Genitourinary Oncology, Barts Cancer Institute at the Queen Mary University of London, United Kingdom (Abstract #5011, Saturday, May 31, 3:36–3:48 p.m. CDT).

About the Phase I MPDL3280A Study

* The Phase I study is a single-arm, multi-center, open-label trial with a cohort of 68 people with previously treated, metastatic bladder cancer.
* The study included 30 patients who were identified as PD-L1 positive (immunohistochemistry [IHC] 2/3) using an investigational PD-L1 diagnostic test being developed by Roche.
* After six weeks of follow-up, the objective response rate (ORR) as measured by RECIST criteria was 43 percent (13/30), and after 12 weeks, ORR was 52 percent (13/25) in people with PD-L1-positive tumors.
- A complete response (no radiographic evidence of tumor) was observed in 7 percent of PD-L1-positive people (2/30).
- The ORR was 11 percent (4/35) in people whose tumors were identified as PD-L1-negative (IHC 0/1) by our investigational test.
- People in the study experienced a median time to response of 42 days.
* Treatment-related Grade 3 AEs occurred in 4 percent (3/68) of people in the study and included weakness (asthenia; 2 percent), low platelet count (thrombocytopenia; 2 percent) and low phosphate levels (blood phosphorus decrease; 2 percent).
* The most common AEs observed to date occurring in more than 5 percent of people in the study were decreased appetite (12 percent), fatigue (12 percent), nausea (12 percent), fever (pyrexia; 9 percent) and weakness (asthenia; 7 percent).

About MPDL3280A (anti-PDL1)

MPDL3280A (also known as anti-PDL1) is an investigational monoclonal antibody designed to interfere with a protein called PD-L1. MPDL3280A is designed to target PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells. By inhibiting PD-L1, MPDL3280A may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells.

About Bladder Cancer

Metastatic urothelial bladder cancer is associated with a poor prognosis and limited treatment options. According to the American Cancer Society (ACS), it is estimated that more than 74,000 Americans will be diagnosed with bladder cancer in 2014, and approximately 15,000 of new diagnoses are made when bladder cancer is in advanced stages. There is a dramatic difference in survival rates between early and advanced bladder cancer. The ACS estimates that approximately 15 percent of people with advanced bladder cancer (stage IV) will live for five years, compared to 88 percent when diagnosed during stage I. Men are about three to four times more likely to get bladder cancer during their lifetime than women.

About Genentech in Cancer Immunotherapy

For more than 30 years, Genentech has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer. Our personalized cancer immunotherapy research and development program comprises more than 20 investigational candidates, which include the evaluation of biomarkers to determine which people may be appropriate candidates for our medicines.

About Genentech

Founded more than 35 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Genentech Media: Holli Dickson, 650-922-1269 Advocacy: Jen Mills, 650-467-6722 Investors: Thomas Kudsk Larsen, 650-467-2016 Karl Mahler, 011 41 61 687 8503

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