Genentech Reports Positive Results From Two Phase I Cancer Studies

Genentech has announced results from two Phase I cancer studies. One study of the investigational immunotherapy agent MPDL3280A found that it shrank tumors in 43 percent of metastatic bladder cancer patients. In another Genentech-funded study, researchers at the University of Texas MD Anderson Cancer Center announced that a combination of vermurafenib, cetuximab, and irinotecan induced a clinical response in patients with advanced colorectal cancer.

Genentech, a member of the Roche Group, presented both findings at the American Society of Clinical Oncology (ASCO) meeting in Chicago. Genentech announced earlier in May, that it would present data on nine approved and 18 investigational medicines in 320 abstracts and 40 oral presentations at the conference. 

MPDL3280A

MPDL3280A is a monoclonal antibody, Fc optimized against the protein ligand PD-L1 (programmed cell death-1 ligand 1). It has immune-modulating and antineoplastic action, binding to PD-L1 and enhancing the T-cell-mediated immune response. The Food and Drug Administration (FDA) gave MPDL3280A a Breakthrough Therapy Designation in bladder cancer.

In the new Phase I open-label study, results showed the immunotherapy provided an overall response rate of 43 percent, shrinking tumors in people previously treated for metastatic urothelial bladder cancer (UBC) whose tumors were characterized as PD-L1 (Programmed Death Ligand-1) positive.

Sandra Horning, M.D., CMO and head of Global Product Development at Genentech said, "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.”

Anderson Cancer Center Study

Roche and Genentech funded a study of the drugs vermurafenib, cetuximab, and irinotecan at the University of Texas MD Anderson Cancer Center. Patients with advanced colorectal cancer responded well to the combination treatment. The Phase I trial examined the drugs’ effect on a BRAF gene mutation, present in 5 to 10 percent of colorectal cancer patients. David Hong, M.D., associate professor of Investigational Cancer Therapeutics and the study’s lead investigator, said that this subgroup of colorectal patients often does not respond to standard chemotherapy.

Researchers combined escalating doses of the drugs and took radiographic images. Scans revealed that 50 percent of patients showed a favorable response to treatment. A Phase II trial of the combination therapy in BRAF-mutation colorectal cancer will begin by the end of the summer.