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Genmab Announces New Phase III Study of Daratumumab in Front Line Multiple Myeloma

On August 11, 2014 Genmab reported that its collaboration partner, Janssen Biotech plans to start a new Phase III study of daratumumab in multiple myeloma (Press release Genmab, AUG 11, 2014, View Source [SID:1234500695]). The study (MMY3008) will compare daratumumab in combination with lenalidomide and dexamethasone to lenalidomide and dexamethasone alone as front line treatment for patients who are not considered candidates for stem cell transplantation (SCT). The study is planned to start in the first half of 2015. The first Phase III study in front line multiple myeloma was announced in July and is expected to start towards the end of this year. Today’s news is the fourth daratumumab Phase III study to be announced.

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"This new study of daratumumab in front line multiple myeloma is part of the extensive development plan created under our collaboration with Janssen Biotech for our CD38 antibody daratumumab," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the MMY3008 study
This Phase III study is a randomized, open-label, multicenter study and will include approximately 700 newly diagnosed, chemotherapy naïve multiple myeloma patients ineligible for stem cell transplantation (SCT). Patients will be randomized to receive either daratumumab combined with lenalidomide (an immunomodulatory agent) and dexamethasone (a corticosteroid) or lenalidomide and dexamethasone alone. The primary endpoint of the study is progression free survival (PFS).

Bayer Receives EU Approval for EYLEA® in Diabetic Macular Edema (for specialized target groups only)

On August 11, 2014 Bayer HealthCare reported that EYLEA (aflibercept solution for injection into the eye) has been approved by the European Commission for the treatment of visual impairment due to diabetic macular edema (DME) (Press release Bayer, AUG 11, 2014, View Source [SID:1234500692]). Bayer plans for an immediate roll-out with Germany being one of the first launch countries in Europe.

“The approval of EYLEA in Europe in this important indication is great news for the increasing number of patients suffering from visual impairment due to DME,” said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “This is an important step that further demonstrates our commitment in ophthalmology to bring new treatment options to patients suffering from serious ophthalmologic conditions.”

“The results of two phase 3 studies were very encouraging with the majority of patients with visual impairment due to diabetic macular edema experiencing a significant two-line improvement in visual acuity with aflibercept solution for injection,” said Prof. Jean-Francois Korobelnik, Principal Investigator of the VIVID-DME trial and Chief of Ophthalmology, CHU Bordeaux. “Early diagnosis of DME is critical, and if not treated rigorously, there is a high risk of DME leading to blindness.”

EYLEA has been approved in many countries for the treatment of neovascular age-related macular degeneration (wet AMD) and for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). Regulatory submissions have been made in Asia Pacific including Japan and Latin America for the treatment of DME. In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV). Furthermore a regulatory submission has been made in Europe and the U.S. for EYLEA for the treatment of visual impairment due to macular edema following branch retinal vein occlusion.

Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a percentage of net sales

FDA Approves VELCADE® (bortezomib) Retreatment in Patients with Multiple Myeloma

On August 11, 2014 Millennium (Takeda) reported that the U.S. Food and Drug Administration (FDA) has approved VELCADE (bortezomib) for the retreatment of adult patients with multiple myeloma (MM) who had previously responded to VELCADE therapy and relapsed at least six months following completion of prior VELCADE treatment (Press release Takeda, AUG 10, 2014, View Source [SID:1234500700]). The labeling update includes dosing guidelines as well as safety and efficacy findings for the use of VELCADE as a single agent or VELCADE in combination with dexamethasone in patients previously treated with VELCADE. VELCADE retreatment may be started at the last tolerated dose.

The approved retreatment sNDA consisted of a Phase 2 study and other supportive data. The Phase 2 international RETRIEVE trial showed a 38.5 percent overall response rate (ORR) in multiple myeloma patients who had been previously treated with a VELCADE-based regimen (median of two prior lines of therapy) and had previously achieved a partial response or better. The safety profile seen with VELCADE retreatment was consistent with the known safety profile of intravenous VELCADE in relapsed multiple myeloma; no cumulative toxicities were observed upon retreatment. The most common adverse drug reaction was thrombocytopenia, which occurred in 52 percent of the patients.

“For the past 11 years, VELCADE has played an important role as the only therapy proven to extend overall survival for patients with newly diagnosed and relapsed multiple myeloma,” said Michael Vasconcelles, MD, Global Head, Oncology Therapeutic Area Unit, Takeda. “With these newly approved dosing guidelines, physicians will be able to provide their patients, who have previously received VELCADE, with an effective treatment extending VELCADE use across the continuum of care of multiple myeloma.”

RETRIEVE was a single arm, open-label trial. The study enrolled 130 patients ages 18 years and older who had previously responded to VELCADE-based therapy and relapsed at least six months after prior treatment with VELCADE. The study met its primary endpoint of best confirmed response to retreatment as assessed by European Group for Blood and Marrow Transplantation (EBMT) criteria.

* Patients had received a median of two prior therapies (range of 1-7).

* Dexamethasone was administered in combination with VELCADE in 94 patients.

* Of the 130 patients, one patient achieved complete response and 49 achieved partial response (50/130; ORR 38.5 percent).

* In the 50 responding patients, the median duration of response was 6.5 months (range of 0.6 to 19.3 months).
The incidence of grade ≥3 thrombocytopenia was 24 percent. Peripheral neuropathy occurred in 28 percent of patients, with the incidence of grade ≥3 peripheral neuropathy reported at 6 percent. The incidence of serious adverse reactions was 12.3 percent; the most commonly reported serious adverse reactions were thrombocytopenia (3.8 percent), diarrhea (2.3 percent), herpes zoster and pneumonia (1.5 percent each). Adverse reactions leading to discontinuation occurred in 13 percent of patients.

Cancer Research UK and Cancer Research Technology join forces with Astellas on autophagy to find new cancer treatments

On August 8, 2014 Cancer Research UK and its commercial arm, Cancer Research Technology ("CRT"), reported to join forces with Astellas Pharma Inc. (Tokyo, President & CEO: Yoshihiko Hatanaka, "Astellas") to find new drug targets in the fight against cancer, with an initial focus on pancreatic cancer (Press release, Cancer Research Technology, AUG 8, 2014, View Source [SID1234523225]).

As part of a new collaboration, Cancer Research UK, CRT and Astellas will conduct a two-year research programme in the UK to find promising new drug targets for pancreatic cancer.

Certain pancreatic cancers are dependent on autophagy, the process of consuming your own cellular parts for energy, in order to grow. Blocking this pathway may help stop some pancreatic cancers in their tracks.

Under the terms of the deal, the first stage aims to identify and then validate the best possible drug targets to block the autophagy pathway in pancreatic cancer cells. This research will be carried out by Professor Kevin Ryan at the Cancer Research UK Beatson Institute and Dr Sharon Tooze at the Cancer Research UK London Research Institute. Astellas has an exclusive license to progress the most promising candidates through further drug discovery and development, subject to certain milestone and royalty payments to CRT.

Professor Kevin Ryan, Cancer Research UK scientist based at the Cancer Research UK Beatson Institute, said: "This is an exciting opportunity to develop new drugs for pancreatic cancer where there is an urgent need for new treatments. Research suggests that pancreatic cancer can be dependent on autophagy making it an excellent pathway to target for drug discovery."

Kenji Yasukawa, PhD, senior vice president and chief strategy officer, Astellas, said: "Since May 2013, Astellas has invited researchers from around the world to collaborate to increase drug discovery opportunities and expand development pipelines. The aim is to establish links with overseas researchers who have ideas that possess a high level of novelty and creativity. This consortium with Cancer Research UK and CRT is one of the collaborations to be achieved through this global initiative."

New treatments are desperately needed for pancreatic cancer – one of the deadliest forms of cancer. Every year 8,800 people are diagnosed with the disease in the UK but survival rates remain very low, with only three per cent of people diagnosed with pancreatic cancer surviving their disease for five years or more after their diagnosis*.

Dr Keith Blundy, Cancer Research Technology’s chief executive officer, said: "In establishing this significant collaboration, the first of its kind between CRT and a Japanese pharmaceutical company, we’re bringing together Cancer Research UK’s world-leading target validation expertise and Astellas’ proven track record on drug development. We hope this will lead to new drugs for pancreatic cancer patients. We’re excited to commence this collaboration and look forward to furthering our relationship with Astellas in the future."

Vernalis and Servier achieve two Research Milestones in their Oncology Collaborations

On August 6, 2014 Vernalis and Servier reported the achievement of two milestones in their oncology drug discovery collaborations, triggering a payment of €0.75m to Vernalis (Press release, Servier, AUG 6, 2014, View Source [SID:1234508827]).

Vernalis and Servier have been working in partnership since initiating their first collaboration in May 2007. The collaborations utilise Vernalis’ proprietary fragment and structure-based drug discovery platform on a number of oncology targets, of which only Bcl-2 has been disclosed. Under the collaborations, Vernalis receives fees and a share in the future success of any products in the form of development milestones and royalties on sales. Financial terms are not disclosed.

Ian Garland, CEO of Vernalis, commented: "We are delighted to achieve these milestones, recognising our very successful partnership with Servier, and we look forward to further success from this relationship."

Jean Pierre Abastado, Head of the Center for Therapeutic Innovation in Oncology at Servier, said: "Small molecules tailored against specific targets can have very high therapeutic potential. These new successes with Vernalis demonstrate the ability of this partnership to identify and characterize promising compounds which further extend Servier’s portfolio to treat cancer patients."