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Clinical Trial Design Improvements Could Spur Drug Development for Autism and Traumatic Brain Injury, While Biomarkers Appear Key in the Discovery of Treatments for Amyotrophic Lateral Sclerosis

Decision Resources Group finds that neurologists specializing in autism spectrum disorder (ASD) consider its heterogeneity a key obstacle to developing pharmacotherapies that effectively address core behavioral symptoms—the greatest unmet need among patients with ASD. Relying on differences in clinical presentation to guide patient selection for clinical trials is put forward as a possible way to enhance the chance of observing a therapeutic effect, a suggestion that is echoed by neurologists treating traumatic brain injury (TBI) patients, a neurological condition with similarly complex pathophysiological underpinnings. For amyotrophic lateral sclerosis (ALS), a rare disease that in most cases is not caused by genetic mutations known to date, the development of biomarkers is a prerequisite to discovering effective disease-modifying interventions, according to interviewed experts.

Surveyed European Oncologists Indicate that Predictive Biomarkers that Identify Patients Most Likely to Respond to Therapies Are a Clear Advantage for Costly Oncology Drugs

Decision Resources Group finds that biomarker driven prescribing is likely to positively influence perceptions of oncology drugs for both oncologists and payers. Drawing on insights from over 300 surveyed medical oncologists and 15 interviewed payers across the EU5 (FranceGermanyItalySpain, and the United Kingdom), the findings reveal that although an increase in biomarker testing is seen as a likely future event, the incorporation of additional biomarker tests (e.g. PD-L1 expression for non-small-cell lung cancer) into the diagnosis could prove challenging in cost-conscious countries like ItalySpain, and the United Kingdom. Overall, however, surveyed physicians and interviewed payers are universal in their opinion that the market access of a costly novel agent would be significantly aided by the presence of a companion biomarker test. 

Thought Leaders are Optimistic that Emerging Therapies will Offer Efficacy Benefits Over Current Therapies for Metastatic Gastric Cancer; Augmenting Biomarker-Driven Prescribing

Decision Resources Group finds that interviewed oncologists’ are optimistic that emerging targeted therapies will offer efficacy advantages over current treatment options for metastatic gastric cancer. Physicians anticipate that Roche/Genentech/Chugai’s Perjeta and Roche/Genentech/Chugai’s Kadcyla will join Roche/Genentech/Chugai’s Herceptin in the HER2-targeted treatment armamentarium for metastatic gastric cancer. Moreover, oncologists express enthusiasm for c-Met overexpression as a predictive biomarker in metastatic gastric cancer, and anticipate that rilotumumab (Amgen/Astellas Pharma) and onartuzumab (Roche/Genentech/Chugai), both in combination with chemotherapy, will demonstrate efficacy advantages over chemotherapy alone. Interviewed physicians also expressed enthusiasm for the angiogenesis inhibitor ramucirumab (Eli Lilly/ImClone Systems), based on positive Phase III data from the REGARD and RAINBOW trials.

Surveyed Oncologists Indicate that the Use of Biomarker Testing is Increasing Rapidly in Non-Small-Cell Lung Cancer in China and South Korea

Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of non-small-cell lung cancer (NSCLC), biomarker testing is already widely employed in the China and South Korea markets, and is set to increase to European levels in the next two years.

Use of Biomarkers in Clinical Trials for Drugs Outside of Oncology is Increasing

Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that while most of the biomarker-drug success stories are in oncology, biomarkers play a critical role in pharmaceutical development of chronic conditions, and their use in clinical trials of drugs outside of oncology is building.