September 8, 2015
By Alex Keown, BioSpace.com Breaking News Staff
SOUTH SAN FRANCISCO – With an eye at setting new standards in oncology treatment,Genentech will present data from 138 abstracts supporting clinical drug studies of lung, bladder and skin cancers at this month’s annual European Cancer Congress.
Genentech, a member of the Roche family, will present data related to three investigational medications, alectinib, atezolizumab and cobimetinib. Earlier this month, cobimetinib won regulatory approval in Switzerland under the name Cotellic for combination use with Roche’s Zelboraf (vemurafenib) to treat patients with advanced melanoma. Annual sales of the approved drug are expected to hit $800 million in Europe. A U.S. regulatory decision is expected Nov. 11
Sandra Horning, Genentech’s chief medical officer, said the company is hoping to win regulatory approval for new oncology medications based on the research that will be presented at the ECC later this year.
Genentech’s investigational cancer drug atezolizumab successfully shrank tumors in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expressed PD-L1. Atezolizumab, MPDL3280A, is an investigational monoclonal antibody designed to interfere with a protein called PD-L1 (Programmed Death Ligand-1). Atezolizumab 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, the company said. By inhibiting PD-L1, atezolizumab may enable the activation of T cells in the treatment of cancer.
Atezolizumab was granted breakthrough therapy status by the U.S. Food and Drug Administration (FDA) earlier this year. The drug is also showing promise in the treatment of breast cancer and bladder cancers. Phase II data released earlier this month showed atezolizumab shrank tumors in people with locally advanced or metastatic urothelial bladder cancer.
Genentech said it has seven Phase III studies evaluating atezolizumab alone or in combination with other medicines as a potential new treatment for people with early and advanced stages of lung cancer.Some of the abstract data to be presented at the ECC include:
Atezolizumab studies include:
•POPLAR: Atezolizumab monotherapy vs docetaxel in 2L/3L non-small cell lung cancer: Primary analyses for efficacy, safety and predictive biomarkers from a randomized phase II study.
•BIRCH: Phase II, single-arm trial of atezolizumab as first-line or subsequent therapy for locally advanced or metastatic PD-L1–selected non-small cell lung cancer.
•Mvigor210: Atezolizumab in patients (pts) with locally-advanced or metastatic urothelial carcinoma (mUC): Results from a pivotal multicenter phase II study (IMvigor 210).
Alectinib data presentation includes updated efficacy and safety results from a global phase II, open-label, single-arm study (NP28673) of alectinib in crizotinib-refractory ALK+ non-small cell lung cancer.
Cobimetinib data includes the impact of baseline genetic heterogeneities on progression-free survival (PFS) in patients (pts) with advanced BRAFV600-mutated melanoma treated with cobimetinib (COBI) + vemurafenib (VEM) in the phase III coBRIM study.
In addition to data for alectinib, atezolizumab and cobimetinib, results will be presented across multiple tumor types from Genentech’s cancer immunotherapy and targeted medicines pipeline including CEA-IL2v (RG7813), IDO Inhibitor (GDC-0919) and vanucizumab (anti-Ang2/VEGF, RG7221).
