On July 14, 2014 Roche reported that the Phase III coBRIM study (NCT01689519) met its primary endpoint (Press release Hoffmann-La Roche, JUL 13, 2014, View Source [SID:1234500628]). The study demonstrated that the investigational MEK inhibitor cobimetinib, used in combination with Roche’s BRAF inhibitor Zelboraf, helped patients with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer without their disease worsening (progression-free survival; PFS) compared to Zelboraf alone. Adverse events were consistent with those observed in a previous study of the combination.

“Despite great progress in our understanding and therapy in recent years, advanced melanoma remains a difficult and deadly disease that requires more treatment options,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. “These encouraging data support the potential combined use of cobimetinib with Zelboraf to block tumour growth longer than Zelboraf alone. We hope this combination therapy will lead to a new option for patients.”

Data from this pivotal study will be presented at an upcoming medical meeting. Additionally, Roche plans to submit these data to the U.S. Food and Drug Administration, European Medicines Agency, and other health authorities around the world for potential approval.

Cobimetinib is designed to selectively block the activity of MEK,2 one of a series of proteins inside cells that make up a signaling pathway that helps regulate cell division and survival. Cobimetinib binds to MEK while Zelboraf binds to mutant BRAF, another protein on the pathway, to interrupt abnormal signaling that can cause tumours to grow.
About the coBRIM study

CoBRIM is an international, randomised, double-blind, placebo-controlled Phase III study evaluating the safety and efficacy of cobimetinib in combination with Zelboraf, compared to Zelboraf alone, in 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma, previously untreated for advanced disease.6 The primary endpoint for coBRIM is PFS. Secondary endpoints include overall survival, objective response rate, duration of response and other safety, pharmacokinetic and quality of life measures.

The coBRIM study used the Roche cobas 4800 BRAF Mutation Test to determine eligibility of patients for the study. This test identifies people whose tumours carry the BRAF V600 mutation, and therefore, patients who are most appropriate to receive this combination of treatments.

On July 8, 2014 Regeneus (ASX: RGS) reported that it has signed today an agreement with Northern Sydney Local Health District (NSLHD) for the exclusive worldwide rights to develop and commercialise a new personalised therapeutic human cancer vaccine. The technology was developed at the Bill Walsh Translational Cancer Research Laboratory which is part of the Kolling Institute of Medical Research at Royal North Shore Hospital in Sydney.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have secured the rights for human applications of the cancer vaccine technology following preclinical efficacy data and promising safety data generated from the treatment of a variety of dogs with a wide range of cancer types," said Professor Graham Vesey, CEO of Regeneus.* Regeneus holds the exclusive worldwide commercialisation rights of the vaccine technology for veterinary applications.

The production of the cancer vaccine for an individual patient requires a patient tumour sample obtained either by complete surgical removal or by small biopsy. This approach is a truly personalised therapeutic cancer immunotherapy.

Regeneus will fund a first-in-man trial (safety study) scheduled to commence in the first quarter of 2015 and further research at the Bill Walsh Cancer Research Lab to support the trial. Leading oncologists Professor Stephen Clarke and Associate Professor Nick Pavlakis, from the University of Sydney’s Northern Clinical School at the Kolling Institute, will be the investigators on the trial. "Following the positive results we have seen in canines, this has been an encouraging prelude to undertaking a human clinical trial. It’s exciting to see world-class innovative cancer research done at the Kolling Institute translated into the clinic as a potential new therapeutic cancer vaccine," Professor Clarke said. The trial design and target tumour type will be finalised prior to seeking ethics approval.

"The therapeutic vaccine has the potential to target a wide range of hard-to-treat cancers with a single product. As the vaccine uses the patient’s own tumour cells and can be prepared under the supervision of the treating clinician, the local regulatory environment for biological therapies in Australia may allow for an accelerated clinical pathway for the autologous cancer vaccine removing the need for expensive and time consuming phase III trials" said Professor Vesey.

Under the Licence Agreement, Regeneus is responsible for the clinical and commercial development of the cancer vaccine for human applications and will pay royalties to NSLHD on the commercial use of the product.

Over the last few years there has been an increased focus on therapeutic vaccines with the US Food and Drug Administration approving the first therapeutic vaccine for cancer in 2010. There is a growing pipeline of therapeutic vaccines for an array of chronic conditions including cancer. The market for therapeutic vaccines is projected to grow at 55% per year reaching $13billion in revenues by 2018.**

*Cancer Immunology Research, a peer-reviewed journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), published this trial data in February 2014.

**Oliver Wynan’s MedTRACK analysis, 2012.

On July 8, 2014 Incyte reported that it has earned a $25 million milestone payment from Novartis in connection with the approval of Jakavi (ruxolitinib) in Japan for the treatment of patients with myelofibrosis (Press release Incyte, JUL 8, 2014, View Source [SID:1234500622]). Incyte will record this amount as contract revenue in the third quarter. Under the Incyte-Novartis Collaboration and License Agreement, Novartis received exclusive development and commercialization rights to ruxolitinib outside of the United States for all hematologic and oncologic indications and sells ruxolitinib under the name Jakavi. Ruxolitinib is marketed by Incyte in the United States as Jakafi (ruxolitinib).

“We are very pleased with the progress that Novartis is making in the global roll-out of Jakavi,” stated Hervé Hoppenot, President and Chief Executive Officer of Incyte. “The recent approval of Jakavi in Japan is further evidence of that progress.”

Novartis also continues to make progress in obtaining formal pricing and reimbursement approval for a third major European country and expects this to occur in the second half of 2014. Once achieved, Incyte will earn an additional $60 million milestone payment.