Oncology News – August 2015

August 2015, Vol 6, No 7 - Oncology News

In This Article

Top US Oncologists Issue a Call to Lower Costs of Cancer Drugs, Assess Value

Some 118 oncologists from top US cancer hospitals—including the Mayo Clinic in Rochester, MN; M.D. Anderson Cancer Center in Houston, TX; and Dana-Farber Cancer Institute in Boston, MA—have just published an editorial in the Mayo Clinic Proceedings titled “In support of a patient-driven initiative and petition to lower the high price of cancer drugs.”

Joining the growing number of healthcare stakeholders who are pointing to the unsustainable growth in the cost of cancer drugs, the 118 oncologists have issued a call to action in support of growing efforts from patients and providers to change the approach to cancer drug pricing, pointing to the harsh reality that patients are facing regarding out-of-pocket costs that often result in bankruptcy or in patients forgoing therapy because of cost, even in the face of a deadly disease such as cancer.

“For a patient with cancer who needs one cancer drug that costs $120,000 per year, the out-of-pocket expenses could be as high as $25,000 to $30,000—more than half the average household income and possibly more than the median take-home pay for a year. Patients with cancer then have to make difficult choices between spending their incomes (and liquidating assets) on potentially life-saving therapies or forgoing treatment to provide for family necessities (food, housing, education),” the oncologists wrote.

Furthermore, “In the United States, the average price of new cancer drugs increased 5- to 10-fold over 15 years, to more than $100,000 per year in 2012,” the oncologists note, adding that because of these costs, as many as 10% to 20% of patients with cancer skip doses or avoid taking their medications altogether. In addition, recent changes to health insurance coverage have shifted much of the cost burden to patients, whose out-of-pocket costs now reach 20% or 30% of the total cost of care.

“It is documented that the greater the out-of-pocket cost for oral cancer therapies, the lower the compliance,” the oncologists suggest. Citing an article on adherence to tyrosine kinase inhibitors in chronic myeloid leukemia, they note that high out-of-pocket cost is “a structural disincentive for compliance with some of the most effective and transformative drugs in the history of cancer.”

The oncologists suggest that a few “simple and measured incremental actions can improve the situation and allow market forces to work better.” They list the following actions as such simple solutions:

  1. “Creating a post-FDA drug approval review mechanism to propose a fair price for new treatments, based on the value to patients and health care”
  2. “Allowing Medicare to negotiate drug prices”
  3. “Allowing the Patient-Centered Outcomes Research Institute…to evaluate the benefits of new treatments, and similar organizations to include drug prices in their assessments of the treatment value”
  4. Importation of cancer drugs
  5. “Passing legislation to prevent drug companies from delaying access to generic drugs”
  6. Making the system more difficult to extend the period of drug patent exclusivity
  7. “Encouraging organizations that represent cancer specialists and patients…to consider the overall value of drugs and treatments in formulating treatment guidelines,” the oncologists conclude.
Source: Mayo Clinic Proceedings; published online July 23, 2015.

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Inovio Launches Immunotherapy Trial in Prostate Cancer

Based on strong CD8+ T-cell responses in animal studies with INO-5150, a novel immunotherapy for prostate cancer, Inovio Pharmaceuticals, Inc, has launched a phase 1 trial to assess the impact of INO-5150 on men with prostate cancer. INO-5150 targets both prostate-specific antigen (PSA) as well as prostate-specific membrane antigen, an antigen that is present in the majority of prostate cancer cells.

The responses seen with INO-5150 were similar to the immune responses seen with VGX-3100, Inovio’s immunotherapy for human papillomavirus (HPV) infection, which reduced precancerous cervical lesions and cured HPV infection in a phase 2 clinical trial.

This new trial with INO-5150 will assess the safety and immunogenicity of this immunotherapy, alone or in combination with INO-9012, a DNA-based interleukin-12 immune activator. This phase 1, multicenter trial will also investigate changes in PSA levels in men with prostate cancer.

J. Joseph Kim, MD, President and CEO of Inovio, said, “Inovio is focused on taking immunotherapy to the next level. Inovio is the only immunotherapy company that is generating T cells, in vivo, in high quantity that are fully functional whose killing capacity correlates with relevant clinical outcomes. With positive results from our phase II study of VGX-3100, Inovio’s active immunotherapy technology is a promising approach to treat various solid tumors by targeting the most important antigens for a particular tumor. Today’s launch of our SynCon® prostate cancer immunotherapy builds on Inovio’s current trials for several difficult-to-treat cancers including head and neck, cervical, breast, lung, and pancreatic cancer.”

Source: Inovio Press Release; July 27, 2015.

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European Regulatory Agency Grants Accelerated Review for 2 Multiple Myeloma Drugs

The European Medicines Agency (EMA) has granted “accelerated assessment” status (similar to the FDA’s breakthrough therapy designation) to 2 investigational therapies for multiple myeloma that are being developed by 2 different pharmaceutical companies—ixazomib (from Takeda) for patients with relapsed and/or refractory multiple myeloma, and elotuzumab (from Bristol-Myers Squibb and AbbVie) for use in combination therapy in patients who have received ?1 previous therapies.

Both drugs are in their last stages of development. Ixazomib is the first oral proteasome inhibitor for multiple myeloma to begin late-stage clinical trials, and elotuzumab is a novel immunotherapy targeting this patient population. Both drugs have shown promising results in clinical trials, both have received a breakthrough therapy designation from the FDA, and are anticipated to be approved by the FDA in the near future.

Source: Pharmaphorum news; July 27, 2015.

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Partnership between Genomics and Big Data Companies Promotes Next-Generation Sequencing Innovation

The partnership between KeyGene, a molecular genetics Ag Biotech company, and GENALICE MAP, a biomedical big data company focused on biormarkers, is advancing the research in personalized medicine and next-generation sequencing analysis. This partnership between the biomedical research conducted by KeyGene and the multivariome analysis platform from GENALICE MAP enables the 2 companies to accelerate the pace of genetic research and expand their discovery pipeline in cancer genomics. In a recent report issued by the companies, Roeland van Ham, PhD, Vice President of Bioinformatics and Modeling at KeyGene, said, “The early results on simulated data seemed too good to be true, but also intrigued me and triggered us to do further exploration of the product….With a shared passion for innovation, it was the starting point of an extremely pleasant and productive partnership.”

Jos Lunenberg, Chief Business Officer of GENALICE, said, “We are very pleased with the partnership with KeyGene. It is exemplary for its kind. In a very short time, we have managed to complete product development and make sure it excels in the AgBio genomics environment, with all its specific challenges. The synergy between KeyGene and GENALICE is the foundation of true collaboration and innovation. The companies are continuing on this path towards innovative Big Data analytics solutions to add real value to genomic workflows in business and research.”

Source: KeyGene Press Release; July 15, 2015.

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