Roche announced positive results for Tecentriq from the phase III study, OAK. The study met its co-primary endpoints and showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared with docetaxel chemotherapy in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed on or after treatment with platinum-based chemotherapy. Adverse events were consistent with what has been previously observed for Tecentriq. Roche looks forward to presenting full results at an upcoming medical meeting in 2016.

“These results add to the growing body of evidence that supports the role of Tecentriq as a potential new treatment for specific types of advanced NSCLC,” said Sandra Horning, MD, chief medical officer and head of global product development. “This is very encouraging news for people living with this disease because lung cancer is the leading cause of cancer deaths around the world. We hope to bring this treatment option to patients as soon as possible.”

The FDA granted Breakthrough Therapy Designation (BTD) for Tecentriq for the treatment of people with PD-L1(programmed death-ligand 1) positive non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy (and appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumour). Roche’s Biologics Licence Application (BLA) for NSCLC was granted Priority Review with an action date of 19 October 2016.

Roche has eight phase III lung studies underway evaluating Tecentriq alone or in combination with other treatments in patients with early and advanced stages of lung cancer.

OAK is a phase III, global multicentre open-label randomised controlled study, evaluating the efficacy and safety of Tecentriq compared with docetaxel in patients with locally advanced or metastatic NSCLC whose disease progressed on or after treatment with platinum-containing chemotherapy.

The study’s co-primary endpoints were overall survival in:  All people randomised to treatment in the study (intention-to-treat or ITT population);  PD-L1 selected subgroup of people; PD-L1 expression was assessed on both tumour cells (TC) and tumour-infiltrating cells (IC) with an investigational immunohistochemistry (IHC) test based on the SP142 antibody being developed by Roche Tissue Diagnostics, and was defined as people whose tumours were determined to express PD-L1 with an IHC score of TC1/2/3 or IC1/2/3 ; Secondary endpoints included objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR).

A total of 1225 patients were enrolled and randomised 1:1 to receive either docetaxel (75 mg/m2 intravenous infusion) or Tecentriq (1200 mg intravenous infusion) every three weeks. Treatment on Tecentriq continued as long as patients experienced clinical benefit as assessed by the investigator or until unacceptable toxicity. The primary efficacy analysis was based on the first 850 randomised patients, and the secondary efficacy analysis will include all 1,225 randomised patients.

Tecentriq is a monoclonal antibody designed to target and bind to a protein called PD-L1 (programmed death ligand-1), which is expressed on tumour cells and tumour-infiltrating immune cells. PD-L1 interacts with PD-1 and B7.1, both found on the surface of T cells, causing inhibition of T cells. By blocking this interaction, Tecentriq may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells.

Tecentriq is the first and only anti-PD-L1 cancer immunotherapy approved by the FDA, and is indicated for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). This indication for Tecentriq is approved under accelerated approval based on tumour response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

For more than 50 years, Roche 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.

The aim of personalised cancer immunotherapy (PCI) is to provide patients and physicians with treatment options tailored to the specific immune biology associated with a person’s individual tumour. The purpose is to inform treatment strategies which provide the greatest number of people with a chance for transformative benefit. In the case of Tecentriq, the goal of PD-L1 as a biomarker is to explore PD-L1 expression on tumour cells and tumour infiltrating immune cells and how that correlates with clinical benefit either as a monotherapy or in combination, and across a broad range of tumour types. The Roche PCI research and development programme comprises more than 20 investigational candidates, ten of which are in clinical trials.