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European Medicines Agency Validates the Marketing Authorization Application for Nivolumab in Non-Small Cell Lung Cancer

On September 29, 2014 Bristol-Myers Squibb reported that the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for nivolumab in non-small cell lung cancer (NSCLC) – the first completed regulatory submission for a PD-1 immune checkpoint inhibitor in this tumor type (Press release Bristol-Myers Squibb, SEP 29, 2014, View Source [SID:1234500765]).

“Lung cancer is the leading cause of cancer death worldwide, and there remains a significant need for effective treatment options for patients with this disease,” said Michael Giordano, M.D., senior vice president, Head of Oncology Development, Bristol-Myers Squibb. “We are pleased to have two applications for nivolumab now under review in the E.U., and look forward to continued collaboration with health authorities around the world as we work to bring nivolumab to patients.”

The MAA submitted to the EMA in lung cancer is based on data from the Phase 2 study of nivolumab in third-line pre-treated squamous cell NSCLC (Study -063).

In addition to the MAA for lung cancer in the E.U., the company previously announced that it has initiated a rolling submission with the FDA for Opdivo in third-line pre-treated squamous cell NSCLC and expects to complete the submission by year-end.

Ipsen presents preliminary results of exploratory proof-of-concept study with tasquinimod in four advanced tumor types at the ESMO 2014 Congress

On September 27, 2014 Ipsen reported the presentation at the ESMO (Free ESMO Whitepaper) 2014 Congress (26-30 September in Madrid) of the preliminary results of the phase II proof-of-concept clinical trial with tasquinimod in monotherapy, evaluating the compound in four advanced tumor types (Press release Ipsen, SEP 27, 2014, View Source [SID:1234500764]).

The main objective of the study was to determine the clinical activity of tasquinimod in advanced hepatocellular (HCC), ovarian (OC), renal cell (RCC) and gastric (GC) carcinomas in patients who had progressed after standard anti-tumor therapies. Primary endpoint was the PFS rate at a predefined time for each cohort. Secondary objectives included PFS, response rate, OS, safety, pharmacokinetics and biomarkers.

The data did not support further development of tasquinimod in monotherapy in heavily pretreated patients with advanced OC, RCC and GC. Pharmacokinetic and biomarkers analyses are ongoing. Preliminary results from the futility analysis reported sufficient clinical activity to complete the recruitment of the HCC cohort for which results are expected in 2015.
The safety profile was consistent with the known safety profile of tasquinimod in previous studies.

Data from the HCC cohort was presented (Poster p-171)1 at the International Liver Cancer Association 8th Annual Conference (5–7 September 2014, Kyoto, Japan).

IRESSA receives CHMP positive opinion to include blood based diagnostic testing in European label

On September 26, 2014 AstraZeneca reproted that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a Type-II variation update* to the European label for IRESSA (gefitinib) (Press release AstraZeneca, SEP 26, 2014, View Source;iressa-receives-chmp-positive-opinion-to-include-blood-based-diagnostic-testing-in-european-label [SID:1234501058]). The label update will help doctors to identify lung cancer patients – based on the specific genetic drivers of their tumour – who could benefit from treatment with IRESSA but are unable to provide a suitable tumour sample.

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IRESSA is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) indicated for the first line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of the EGFR tyrosine kinase. Therefore, only patients whose tumours are EGFR mutation positive are eligible to receive treatment. Tumour samples gained through biopsy are the primary method for determining a patient’s EGFR mutation status, without which patients are not eligible for treatment with an EGFR TKI such as IRESSA, which is the standard of care in Europe. However, up to 25 percent of patients with locally advanced or metastatic NSCLC do not have an available or evaluable tumour sample for this method of testing.

Following today’s CHMP opinion, IRESSA will be the first EGFR TKI in Europe to have a label allowing the use of circulating tumour DNA (ctDNA) obtained from a blood sample, to be used for the assessment of EGFR mutation status in those patients where a tumour sample is not an option. The update will take effect immediately and will be applicable in all 28 European Union member countries.

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca said: "At AstraZeneca, we are committed to developing targeted medicines that improve health outcomes for patients. Understanding the nature of an individual’s tumour and therefore which medicine is most likely to benefit them is vital if we are to transform the way cancer patients are treated. If doctors are unable to assess the mutation status of a tumour, then patients’ access to potentially life-changing medicines such as IRESSA becomes restricted. Today’s decision by the CHMP to endorse a label update for IRESSA is a significant step forward."

AstraZeneca has pioneered the use of innovative blood-based diagnostic testing for solid tumours and recently announced a partnership with Qiagen to develop a ctDNA test as a companion diagnostic for IRESSA.

Approval for Sustained-Duration G-CSF Product G-Lasta in Japan

On September 26, 2014 Kyowa Hakko Kirin reported that it has received approval for sustained-duration G-CSF product G-Lasta subcutaneous injection 3.6mg (G-Lasta) [generic name: pegfilgrastim (genetical recombination)] by the Ministry of Health, Labour and Welfare (MHLW) (Press release Kyowa Hakko Kirin, SEP 26, 2014, View Source [SID:1234500782]).

G-Lasta is a sustained duration form of Granulocyte Colony-Stimulating Factor (G-CSF) product, which is produced by PEGylation of filgrastim, for treatment of chemotherapy-induced neutropenia. While filgrastim requires repeated daily doses over several days, G-Lasta shows comparable efficacy with a single dose per chemotherapy cycle. G-Lasta is therefore expected to reduce the burden of drug administration and to decrease frequent hospital visits of outpatients undergoing chemotherapy. Also, prophylactic administration of G-Lasta prior to neutropenia is expected to reduce risks of infection, which results in clinical benefits such as improving the compliance with doses and schedules of chemotherapy.

Pegfilgrastim, originally generated by Amgen, Inc., was licensed from Kirin-Amgen Inc., to Kyowa Hakko Kirin. It has already been approved in 107 countries and regions around the world.

Cancer Research UK and MedImmune establish joint CRUK-MEDI Alliance Laboratory to develop new biologic cancer medicines

On September 25, 2014 CANCER RESEARCH UK, with its commercial arm Cancer Research Technology (CRT), reported that they have entered into an innovative collaboration with AstraZeneca and MedImmune, its global biologics research and development arm, to establish a joint laboratory in Cambridge, UK (Press release, Cancer Research Technology, SEP 25, 2014, View Source [SID1234523222]). The new laboratory, representing a first of its kind partnership for both organisations, will focus on the discovery and development of novel biologic cancer treatments over an initial five-year period.

As part of the collaboration, scientists from both organisations will work side-by-side on multiple oncology projects at the new CRUK-MEDI Alliance Laboratory. Cancer Research UK will provide set-up and operational funding for the laboratory and will contribute a portfolio of novel drug targets together with a team of scientists. MedImmune will oversee the laboratory activities and provide access to its human antibody phage display libraries and established antibody-engineering technologies. The joint team will share knowledge and expertise to discover and develop antibodies to treat cancer.

Bahija Jallal, executive vice president at MedImmune, said: "Oncology is a core therapeutic area for AstraZeneca and we are pleased to enter this strategic antibody discovery and development collaboration with Cancer Research UK, one of the leading charitable cancer research institutions in the world. Our collaboration represents an innovative public-private business model for biologic drug development as we will share knowledge and expertise in a dedicated laboratory to discover potentially ground-breaking medicines for cancer patients."

Jane Osbourn, vice president of R&D and Cambridge site leader at MedImmune, said: "The creation of the CRUK-MEDI Alliance laboratory underscores our strong commitment to building a broad science base across the UK and deepening our research roots here in Cambridge. Through this transformative collaboration, Cancer Research UK will have access to MedImmune’s capabilities and technology to help them develop pre-clinical candidates, while MedImmune will benefit from access to Cancer Research UK’s principal investigators and scientists."

Biological therapies are a major priority in Cancer Research UK’s new research strategy, which includes a commitment to increase investment in this area over the next few years. Collaborations that unite leading researchers together with latest technology platforms are a fundamental part of this strategy, helping turn new discoveries into treatments that can benefit patients as quickly as possible.

Keith Blundy, chief executive officer of Cancer Research Technology, said: "MedImmune is one of Cancer Research UK’s important strategic partners as we seek to advance biologic treatments for cancer. This unique partnership will bring together cutting-edge research with the most advanced antibody technologies industry can offer under one roof, to deliver significant output over a number of years.

"Cancer Research UK-funded scientists from across the UK will have the opportunity to access this unique lab and expertise. It’s the first of what we hope will be many such pioneering collaborations that will help to accelerate the translation of our research into potential new drugs."