First phase III data on Roche’s TECENTRIQ (atezolizumab) to feature at the 2016 European Society for Medical Oncology (ESMO) Congress

On October 3, 2016 Roche reported that new results from studies with its approved or investigational medicines across more than 20 cancer types will be presented during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress from 7 – 11 October 2016 in Copenhagen, Denmark (Press release, Hoffmann-La Roche , OCT 3, 2016, View Source [SID:SID1234515529]). These include the first pivotal phase III results for Tecentriq, outcomes from early studies of cancer immunotherapy-based combinations, results from clinical studies with a broad range of Roche’s investigational medicines, and new insights from studies that continue to shape a better understanding of how different types of cancer develop and affect people around the world.

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"At Roche, our focus on understanding human immunology and cancer biology is helping us to develop new medicines that improve outcomes for people with cancer," said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. "We look forward to the presentation of the pivotal OAK data for Tecentriq during ESMO (Free ESMO Whitepaper)’s Presidential Symposium, as well as other presentations such as new data from our collaboration with Foundation Medicine that showcase how we are expanding our understanding of each individual’s cancer."

At ESMO (Free ESMO Whitepaper), positive results from the Tecentriq phase III lung cancer study known as OAK will be presented as a "late-breaking" abstract in the ESMO (Free ESMO Whitepaper) Presidential Symposium 2 on Sunday, 9 October. Roche recently announced that 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. In the United States, Roche’s Biologics License Application (BLA) for Tecentriq in NSCLC was granted Priority Review with an action date of 19 October 2016.

In addition to OAK, 19 Roche cancer immunotherapy abstracts featuring Tecentriq and other innovative molecules will be presented. This includes early data assessing Tecentriq in an investigational combination with the approved, targeted Roche medicines Zelboraf (vemurafenib) and Cotellic (cobimetinib) in melanoma, and as a novel investigational combination with Cotellic in colorectal cancer.

Overview of key presentations at ESMO (Free ESMO Whitepaper) 2016
Investigational medicine Abstract title Abstract number

Updated efficacy and safety from the global phase II NP28673 study of alectinib in patients (pts) with previously treated ALK+ non-small-cell lung cancer (NSCLC)

Ipatasertib (RG7440) PTEN loss as a predictive biomarker for the Akt inhibitor ipatasertib combined with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (mCRPC) 718O

Tecentriq (atezolizumab)

Primary analysis from OAK, a randomized phase III study comparing atezolizumab with docetaxel in 2L/3L NSCLC LBA44

Atezolizumab (atezo) in platinum (plat)-treated locally advanced/metastatic urothelial carcinoma (mUC): Updated OS, safety and biomarkers from the Ph II IMvigor210 study

IMvigor210: updated analyses of first-line (1L) atezolizumab (atezo) in cisplatin (cis)-ineligible locally advanced/metastatic urothelial carcinoma (mUC)​

Safety, clinical activity and biomarkers of atezolizumab (atezo) in advanced ovarian cancer (OC)​

Efficacy and safety of cobimetinib (cobi) and atezolizumab (atezo) in an expanded phase 1b study of microsatellite-stable (MSS) metastatic colorectal cancer (mCRC)​

Preliminary safety and clinical activity of atezolizumab combined with cobimetinib and vemurafenib in BRAF V600-mutant metastatic melanoma​

Clinical activity, safety and predictive biomarker results from a phase Ia atezolizumab (atezo) trial in extensive-stage small cell lung cancer (ES-SCLC)​

Safety, clinical activity and biomarkers of atezolizumab (atezo) in advanced ovarian cancer (OC)​

The SP142 PD-L1 IHC assay for atezolizumab (atezo) reflects pre-existing immune status in NSCLC and correlates with PD-L1 mRNA

Tumor mutation load assessed by FoundationOne (FM1) is associated with improved efficacy of atezolizumab (atezo) in patients with advanced NSCLC 77P

Real-World Data Second-line metastatic urothelial carcinoma treatment and survival in real-world patients in the US 801P