BURLINGTON, Mass.--()--Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that the launches of Bristol-Myers Squibb’s immunotherapy Yervoy and Roche/Genentech/Chugai/Daiichi Sankyo BRAF inhibitor Zelboraf have transformed the treatment of advanced malignant melanoma and, in 2011, these agents accounted for two-thirds of total malignant melanoma sales. Through 2021, the line-extension of these agents into the adjuvant setting, and launches of other emerging novel therapies will drive a robust 9 percent annual growth in the malignant melanoma drug market in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.
“We forecast the launch of this combination in 2015 in the United States and Europe in the first-line unresectable and metastatic BRAF-mutation-positive setting, where it will compete directly with Zelboraf and rapidly attain patient share leader status by 2017.”
The Pharmacor Malignant Melanoma advisory service also finds that, according to interviewed experts, the launch of Zelboraf has resulted in the rapid segmentation of unresectable and metastatic malignant melanoma patients by their BRAF mutational status. Zelboraf has rapidly overtaken Yervoy as the therapy of choice for BRAF-mutation-positive patients. Zelboraf, as well as GlaxoSmithKline’s recently filed BRAF inhibitor dabrafenib and MEK inhibitor trametinib, will relegate Yervoy to predominantly being a welcome second-line option for the BRAF-mutated population. However, due to Yervoy’s anticipated line-extension into the adjuvant setting and its premium price, the agent is expected to maintain its sales leader status throughout the forecast period.
The findings also reveal that interviewed experts anticipate that dual inhibition of MEK and BRAF will increase the duration of response compared with BRAF inhibitor monotherapy. Based on promising early clinical data, the combination of dabrafenib and trametinib is now in Phase III development in advanced disease, and, it will quickly follow Zelboraf into Phase III development in the adjuvant setting.
“Interviewed thought leaders expect the combination of dabrafenib and trametinib to deliver both efficacy and toxicity benefits compared with Zelboraf, and with dabrafenib and trametinib monotherapies,” said Decision Resources Analyst Savade Solanki, Ph.D. “We forecast the launch of this combination in 2015 in the United States and Europe in the first-line unresectable and metastatic BRAF-mutation-positive setting, where it will compete directly with Zelboraf and rapidly attain patient share leader status by 2017.”
The Pharmacor Patient Flow Model for Malignant Melanoma, which contains detailed methodology that includes the modeling of recurrent cases of malignant melanoma, finds that growth in key malignant melanoma patient populations will be modest over the next decade as disease risk is forecast to stabilize and new therapies expected to launch in the adjuvant setting may limit the risk of disease recurrence. New therapies launched in the unresectable disease setting will partly contribute to a projected 6 month improvement in life expectancy over the next 10 years, with a further 3 months by 2031 if historic trends continue.
The risk of disease recurrence is low in early stage disease, but increases to a risk of non-curatively re-treatable recurrence exceeding 60 percent among cases of resected stage IIIC disease. Among cases of recurrence that may be curatively re-treated, the majority of cases are localized.
Decision Resources’ Pharmacor advisory service offers clients in the biopharmaceutical industry the most up-to-date information available on commercially significant disease topics.
About Pharmacor Patient Flow Models
By utilizing our proprietary Pharmacor epidemiological data, Decision Resources now provides Pharmacor Patient Flow Models covering bladder cancer, breast cancer, hepatocellular carcinoma, malignant melanoma, non-small-cell lung cancer, ovarian cancer, prostate cancer, renal cell carcinoma, sarcoma and thyroid cancer. Using Pharmacor Patient Flow Models, users can build their own oncology patient flow model and/or validate the logic behind their own internal models. This interactive tool allows users to track changing disease and population dynamics over a 20-year annualized forecast, improve their modeling accuracy with clearly depicted methods and transparent assumptions and identify untapped market potential within lines of therapy. Pharmacor Patient Flow Models is available as an add-on product to the Pharmacor advisory service.
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