Global oncologists share insights into cancer immunology
Cancer immunotherapy has become one of the hottest fields of clinical research in decades.
By targeting the immune system, rather than the tumor, onco-immunology represents a paradigm shift in the way cancer is treated. The impact of this research has been so tremendous Science magazine named cancer immunotherapy the breakthrough of 2013, citing anecdotes such as a 6-year-old near death from leukemia who now is in third grade, clinical data points from anti-CTLA-4 trials and major business moves such as Bristol-Myers Squibb’s acquisition of Medarex in 2010 for more than $2 billion.
According to experts I’ve spoken with, the race to leverage immunotherapy will continue to heat up. But several questions remain unanswered: does the global oncology community truly see immunotherapy as the future of cancer? If so, where should clinical research focus next, specifically? And who do they view as the real innovators in the space?
To gain insights, I surveyed oncologists from Brazil, Germany, India, Turkey and the U.K. Their responses reveal a heightened level of interest in multiple areas of cancer research. While recent new product launches—including Amgen’s Xgeva for bone metastases, Genentech’s Kadcyla for metastatic breast cancer and Lilly’s Cyramza for advanced gastric cancer—all are viewed as critical breakthroughs, respondents report unmet needs remain in bladder, cervical and head and neck cancers.
Many studies already underway are a continuation of the investigation into targeting programmed death receptor-1 (PD-1) interactions, which, if proven successful, could open novel avenues for cancer immunotherapy. But when asked which trials experts have been watching most closely, three stood out:
- POEMS (Prevention of Early Menopause Study): This phase III trial evaluated the use of luteinizing hormone-releasing hormone (LHRH) with chemotherapy to reduce premature ovarian failure, a common toxicity of chemotherapy in early-stage breast cancer patients. The results presented at this year’s ASCO meeting showed less premature ovarian failure and more pregnancies, a very positive conclusion.
- ADAPT: This phase III trial, initiated by Mount Sinai, is evaluating a novel, personalized vaccine for newly-diagnosed kidney cancer. The study is examining the potential of investigational immunotherapy AGS-003 to improve survival when combined with standard renal cancer treatment. There currently are few treatment options for people with metastatic kidney cancer, whose average survival rate is six months to two years. The need for new therapies in this area is critical.
- MARIANNE: Roche is sponsoring the first phase III evaluation of the combination of a targeted antibody and an antibody-drug conjugate (ADC) for first-line metastatic breast cancer, which would spare patients from chemotherapy and potentially introduce a new treatment paradigm by optimizing efficacy while minimizing toxicity.
Immunotherapy may not be the only breakthrough in cancer research, but it clearly is on the top of everyone’s mind and generating a huge amount of commercial investment. It also is a beneficiary of private funding from parties with no financial incentive. The Cancer Research Institute, which has a scientific board of the world’s leading immunologists and tumor immunologists, awards research grants and fellowships to support scientists at leading research universities and clinics around the world in the study of cancer immunotherapy.
When asked which company the experts view as most innovative, it is no surprise they identified Roche as the leader by far, with both an impressive legacy in cancer research and an envious pipeline. At the same time, experts said Merck lays claim to the most important news in immunotherapy in 2014 with the approval of Keytruda, the first anti-PD-1 therapy approved in the U.S. It also has received the FDA’s Breakthrough Therapy designation for advanced melanoma, based on early study findings and unmet medical need.
But for all the product innovations cited by respondents, perhaps the most interesting finding from the survey was that unmet needs in less clinical areas such as quality of life measures, ethnic differences in treatment and palliative care, which may be less expected areas of research investment, could be opportunities for researchers and sponsors.
Lastly, let’s not forget about drug lag in endemic countries. For all the advancements in oncology research, certain regions of the world are dealing with unmet needs. One respondent bemoaned the fact that Brazil still does not have crizotinib, Pfizer’s treatment for non-small cell lung cancer that has spread to other parts of the body. The FDA cleared the drug for market in the U.S. under the brand name Xalkori in 2011.
Matthew Howes is head of strategic services at inVentiv Digital + Innovation, the digital center of excellence for inVentiv Health. A leader in digital strategy, Matthew has provided the fuel for digital businesses visited by over 100 million people every month and generate billions of dollars in revenue every year.
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