On December 17, 2015 The European Medicines Agency (EMA) reported that it has recommended granting a conditional marketing authorisation for Tagrisso (osimertinib) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a specific mutation (T790M) of the epidermal growth factor receptor (EGFR) (Press release, Curis, DEC 17, 2015, View Source;mid=WC0b01ac058004d5c1 [SID:1234508640]).

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Lung cancer is among the most common cancers in the world. In Europe, in 2012, 313,000 patients were newly diagnosed and 268,000 people died from the disease, accounting for one in five cancer deaths. Approximately 80-90% of all lung cancers are NSCLCs, which occur when cancer cells form in the tissues of the lung. EGFR is a protein involved in the growth and spread of cancer cells.

Despite progress in early detection and treatment, NSCLC is most often diagnosed at an advanced stage and the outlook for patients with the disease is poor. Once NSCLC has progressed to a locally advanced or metastatic stage, treatment is focused on extending life, delaying disease progression and improving symptoms and quality of life.

Tagrisso is a tablet that should be taken orally once per day. It is intended for patients who have developed a mutation in the EGFR gene. Mutations of the EGFR gene may develop in tumours and reduce the effect of EGFR-blocking medicines. Tagrisso is intended for use in tumours with one such mutation, T790M.

The Committee for Medicinal Products for Human Use (CHMP) reviewed Tagrisso under EMA’s accelerated assessment program and recommended conditional approval for the medicine. These are two of the Agency’s main mechanisms to facilitate earlier access by patients to medicines that fulfill unmet medical needs. Conditional approval allows EMA to recommend a medicine for marketing authorisation before the availability of confirmatory clinical trial data, if the benefits of making this medicine available to patients immediately outweigh any risks related to the lack of comprehensive data.

The safety and efficacy of Tagrisso were demonstrated in two single-arm phase II trials involving a total of 411 patients with advanced EGFR T790M mutation-positive NSCLC whose disease progressed after treatment with EGFR-blocking therapies.

Results from these two trials showed that a high proportion of patients (around 66%) responded and their tumour shrunk. This response appeared to be long-lasting. The benefits in terms of progression free survival and/or overall survival have not yet been determined.

The most common side effects of Tagrisso are diarrhoea and skin and nail conditions such as dry skin, rash and acne.

As part of the conditional marketing authorisation, the applicant for Tagrisso must provide results from an ongoing phase III study. Until availability of full data, the CHMP will review the benefits and risks of Tagrisso annually to determine whether the conditional marketing authorisation can be maintained.

The opinion adopted by the CHMP at its December 2015 meeting is an intermediary step on Tagrisso’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, each Member State will take a decision on price and reimbursement based on the potential role/use of this medicine in the context of its national health system.

On December 17, 2015 OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, reported that the European Commission has granted orphan drug designation to OXi4503 for the treatment of acute myeloid leukemia (AML) (Press release, OXiGENE, DEC 17, 2015, View Source [SID:1234508604]). The designation provides for ten years of marketing exclusivity in EU member countries following product approval. OXi4503 has previously received orphan drug designation from the U.S. Food and Drug Administration, which provides for seven years of marketing exclusivity after approval.

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"The European Commission’s decision highlights the need for new AML treatment options and improves the commercial potential of OXi4503," stated William D. Schwieterman, M.D. President and Chief Executive Officer of OXiGENE. "We have recently put plans in place to accelerate the development of this promising agent by immediately advancing into the next phase of our ongoing phase 1b/2 clinical trial in the U.S., in which OXi4503 will be used in combination with the approved AML drug cytarabine instead of as a stand-alone investigational agent for the treatment of refractory AML."

Orphan designation in the European Union is granted to product candidates that are intended to treat life-threatening or chronically-debilitating conditions that affect no more than five patients per 10,000 of the EU population. Among other benefits, orphan designation provides for regulatory assistance and scientific advice from the European Medicines Agency during product development.

About OXiGENE

OXiGENE is a clinical-stage biopharmaceutical company developing vascular disrupting agents (VDAs) to treat cancer. VDAs selectively disrupt abnormal blood vessels that sustain tumors. The company’s investigational drugs include CA4P (fosbretabulin), which is in development as a treatment for solid tumors, and OXi4503, which is in development for acute myeloid leukemia (AML). OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients.

On December 17, 2015 Bristol-Myers Squibb Company (NYSE:BMY) and The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) reported that they have entered into a collaborative agreement as part of Bristol-Myers Squibb’s Immuno-Oncology Rare Population Malignancy (I-O RPM) program in the U.S (Press release, Bristol-Myers Squibb, DEC 17, 2015, View Source [SID:1234508602]). The I-O RPM program is a multi-institutional initiative with academic-based cancer centers focused on the clinical investigation of immuno-oncology therapeutics as potential treatment options for patients with high risk, poor prognostic cancers, defined as a rare population malignancy.

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As part of the I-O RPM program, Bristol-Myers Squibb and OSUCCC – James will conduct a range of early phase clinical studies, and Bristol-Myers Squibb will fund training positions within the Hematology and Medical Oncology fellowship programs of the Ohio State University College of Medicine, Department of Internal Medicine.

"Immuno-oncology is rapidly evolving with the potential to play a significant role in the treatment of a broad range of cancers and we are committed to finding innovative and efficient ways to further the science, research and development of these compounds for patients," said Laura Bessen, M.D., head of U.S. Medical, Bristol-Myers Squibb. "OSCUCC- James is a leading cancer research institution with a shared goal of improving outcomes for patients and we look forward to our collaboration through the I-O RPM program."

"It is clear based on existing and emerging scientific data that immuno-oncology therapeutics, which harness the patient’s own immune system to attack cancer cells, have tremendous potential to tailor patient treatments based on the individual’s unique tumor characteristics, and this clinical research partnership has the potential to give our patients – both locally and who travel here from across the globe – access to some of the most novel treatments available," said Richard Goldberg, M.D., Physician-in-Chief at The OSUCCC – James.

About I-O RPM

Immuno-oncology is an innovative approach to cancer research and treatment that is designed to harness the body’s own immune system to fight cancer. The I-O RPM research program focuses on significant areas of high unmet need marked by poor outcomes among patients with rare population malignancies. A rare population malignancy is a subpopulation within a higher incident disease population. These patients have aggressive disease with an increased potential for early metastasis to multiple sites and/or are initially refractory or subject to early recurrences with conventional cancer therapies. Existing clinical research provide a strong rationale for further research into the potential of immunotherapies for these cancers.

The I-O RPM research program is a multi-institutional initiative with Robert H. Lurie Comprehensive Cancer Center of Northwestern University and the Northwestern Medicine Developmental Therapeutics Institute, Moffitt Cancer Center, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, UCLA and now OSUCCC – James. I-O RPM builds on Bristol-Myers Squibb’s formation in 2012 of the International Immuno-Oncology Network (II-ON), which is a global collaboration between Bristol-Myers Squibb and academia focused on facilitating the translation of scientific research findings into clinical trials and, eventually, clinical practice.

On December 18, 2015 Boehringer Ingelheim reported that the latest data from its oncology portfolio will be presented at the ESMO (Free ESMO Whitepaper) Asia 2015 Congress in Singapore, 18-21 December 2015 (Press release, Boehringer Ingelheim, DEC 17, 2015, View Source [SID:1234508601]). New data for BI 1482694* (HM61713**) demonstrate a strong anti-tumour activity (confirmed objective response and disease control rates) with a favourable safety profile in patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) whose tumours have acquired the most common mechanism of resistance, the T790M mutation, and have stopped responding to treatment with previous 1st- and/or 2nd-generation EGFR targeted therapies. BI 1482694 is a novel, 3rd-generation, EGFR mutant-specific tyrosine kinase inhibitor (TKI).

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Dr Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented, "We are looking forward to presenting the exciting new data from our oncology portfolio at ESMO (Free ESMO Whitepaper) Asia 2015 Congress. The results of the two head-to-head trials of afatinib versus 1st-generation TKIs, gefitinib and erlotinib, could provide guidance to the practicing oncologist on the choice of TKIs in EGFR-mutated and squamous cell lung cancer, respectively. We are also excited to present the latest results for BI 1482694, Boehringer Ingelheim’s newest compound, as we strive to extend the continuum of treatment with targeted therapies for patients with EGFR-mutated lung cancer and delay the burdensome side effects of chemotherapy for even longer."

On December 17, 2015 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in the use of TCR engineered T-cell therapy to treat cancer, reported that it has initiated a Phase I/II study of its affinity enhanced T-cell therapy targeting the MAGE-A10 cancer antigen in patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC), the most prevalent type of lung cancer representing approximately 85 percent of lung cancers (Press release, Adaptimmune, DEC 17, 2015, http://www.adaptimmune.com/company-news/adaptimmune-announces-initiation-of-study-to-evaluate-its-new-affinity-enhanced-t-cell-therapy-targeting-mage-a10-in-patients-with-nsclc-the-most-common-form-of-lung-cancer/ [SID:1234508591]).

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This will be the first study of Adaptimmune’s unpartnered affinity enhanced T-cell therapy targeting MAGE-A10, a highly immunogenic member of the MAGE-A family of cancer testis antigens. MAGE-A10 is expressed in a number of solid tumor cell types, and the immunogenicity of the MAGE-A10 antigen has been robustly established. Cancer testis antigen expression in cancer is often associated with higher grade tumors.

"The initiation of this study is an important step in our goal to identify and develop new T-cell-based immunotherapeutics to combat non-small cell lung cancer and other cancers, and we are excited to initiate clinical development of another of our promising affinity enhanced TCR therapeutic candidates," said Dr. Rafael Amado, Adaptimmune’s Chief Medical Officer. "We have already seen encouraging clinical responses in certain cancers to our lead T-cell therapeutic candidate, which targets the NY-ESO-1
cancer antigen, demonstrating that it is possible to utilize our proprietary affinity enhancement technology to modify TCRs to so that they target cancer cells effectively. It is our hope that we may one day offer patients suffering from non-small cell lung cancer an efficacious and well-tolerated therapeutic option."

This is an open label, 3+3 dose escalation study of autologous T-cells genetically engineered with an affinity optimized MAGE-A10 TCR in HLAA*0201 and HLA-A*0206 positive patients with stage IIIb or stage IV NSCLC expressing the MAGE-A10 antigen. Though the prevalence of HLA sub-types varies from population to population, the most common in the western world is HLA-A2. Among the HLA-A2 variants, the most prevalent are HLA-A*0201 and HLA-A*0206.

The study is intended to enroll up to 32 patients in leading clinical centers located in the United States and Europe and will assess the safety and tolerability of Adaptimmune’s affinity enhanced T-cell therapy targeting MAGE-A10. Secondary objectives will include the assessment of clinical efficacy, measurements of durability of persistence of MAGE-A10 T-cells in the blood, and exploratory tumor biomarker studies and evaluations of the phenotype and functionality of MAGE-A10 T-cells.

For more information on this clinical trial, visit ClinicalTrials.gov at: View Source (Identifier: NCT02592577).

About NSCLC
Lung cancer is the most common cancer worldwide, and is the leading cause of cancer deaths in both men and women in the United States. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined. Non-small cell lung cancer or NSCLC is the most common type of lung cancer, representing approximately 85 percent of lung cancers. There are 3 main subtypes of NSCLC. Approximately 40 percent of lung cancers are adenocarcinomas, which start in early versions of the cells that would normally secrete substances such as mucus. This type of lung cancer occurs mainly in current or former smokers, but it is also the most common type of lung cancer seen in non-smokers. Approximately 25 to 30 percent of all lung cancers are squamous cell carcinomas, which start in early versions of squamous cells which line the inside of the airways in the lungs and are generally linked to a history of smoking. Large cell (undifferentiated) carcinoma account for 10 to 15 percent of lung cancers and can appear in any part of the lung.