Opdivo also known as nivolumab has been extended as treatment for non-squamous non-small cell lung cancer by the U.S. Food and Drug Administration.

The decision was based on evidence from an international, randomised open-label study comparing the safety and effectiveness of Opdivo with docetaxel in 582 patients with progressive NSCLC during or after treatment with platinum-based chemotherapy and appropriate biologic therapy.

Patients treated with Opdivo were observed to live longer, with average overall survival of 12.2 months compared with 9.4 months in patients treated with docetaxel. Additionally more patients in the Opdivo treated group compared with the docetaxel treated group (19% vs. 12%) experienced complete or partial shrinkage of their tumors lasting an average of 17 months and 6 months respectively.

Fatigue, musculoskeletal pain, decreased appetite; cough and constipation were mentioned as major adverse events of Opdivo.

Further details on the press release can be read here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm466413.htm

Please follow and like us:

Herpes is an infection caused by the herpes simplex virus (HSV). The infection can affect various parts of the body, usually the mouth or the genitals depending on the herpes virus responsible (HSV-1 or HSV-2) 1. Recently, scientists linked the HSV-1 to the cure of melanoma skin cancer, a type of cancer that can spread to other organs in the body. Though not the most common type of skin cancer, it is by far the most deadly accounting for nearly 37,000 annual deaths and about 132,000 cases diagnosed yearly 2-3.

The clinical trial from which this findings were made was a randomised study of 436 adult patients with non-surgically resectable, stage IIIB to IV melanoma. The study was conducted in 64 research centres across the world and overseen by independent data monitoring committee. The patients received intralesional talimogene laherparepvec (T-VEC) or subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF).

Clinical findings:

Overall response rate was higher with T-VEC than with GM-SCF (26.4% vs. 5.7%). Also greater proportion of patients treated with T-VEC compared with those treated with GM-SCF experienced response that lasted continuously for at least 6 months (16.3% vs. 2.1%). The patients treated with GM-SCF were more likely to report a treatment failure than those treated with T-VEC, with average time to failure reported as 2.8 months vs. 8.2 months, respectively. Furthermore, overall survival was longer with T-VEC than with GM-SCF (23.3 months vs. 18.9 months). T-VEC was well tolerated with 2.1% of the patients reporting cellulitis as the only grade 3 or 4 adverse events.

The study was published in the Journal of Clinical Oncology

General overview:

Although approval of immunotherapeutic and targeted agents has significantly changed the management of patients with advanced melanoma, treatment alone cost an estimated $1.5 billion a year 2. Surprisingly, the bulk of this cost is spent on patients’ diagnosed with advanced stage of the disease and during terminal phase of care 7. Evidence suggest that If melanoma is diagnosed early, for instance at stage 0 or stage 1, the annual direct cost of care in patients aged ≥ 65 years would be lower by about 40% to 65% than their current values, resulting in large healthcare cost savings 7. Moreover, patients stand a greater chance of survival than if diagnosed late 7.

Given the substantial cost of melanoma care, which is expected to raise due to increasing incidence of the disease, does this new drug (T-EVC) stand a chance for reimbursement in certain healthcare systems even if it is Food and Drug Administration and the European Medicines Agency approved? Should care for melanoma be more targeted toward primary and secondary prevention strategies, since previous research have linked their potentials not only in improving health, but also in saving life and money 8-10? With so many questions to be answered, when the price of T-VEC is released, the clinical findings though interesting may not be remarkable in the context of current melanoma treatments.

Reference:

  1. American Academy of Dermatology. Herpes simplex. Available at: https://www.aad.org/dermatology-a-to-z/diseases-and-treatments/e---h/herpes-simplex assessed November 6 2015
  2. Frost and Sullivan. 2011 European Technology Award in Skin Cancer Diagnosis. Available at: http://scibase.se/en/wp-content/blogs.dir/2/files/2013/04/Frost_Sullivan-Analyst-Report-1108241.pdf assessed November 6 2015
  3. World Health Organisation. Skin cancers: how common is skin cancer? Available at: http://www.who.int/uv/faq/skincancer/en/index1.html assessed November 6 2015
  4. Guy GP, Ekwueme DU, Tangka FK, et al. Melanoma treatment costs. A systematic review of literature, 1990-2011. Am J Prev Med 2012; 43(5): 537–545
  5. Hirst N, Gordon L, Gies P, Green AC. Estimation of avoidable skin cancers and cost-savings to government associated with regulation of the solarium industry in Australia. Health Policy 2009; 89(3): 303–11.
  6. Kyle JW, Hammitt JK, Lim HW, et al. Economic evaluation of the U.S. Environmental Protection Agency’s SunWise program: sun protection education for young children. Pediatrics 2008; 121(5): e1074 – e1084.
  7. Shih S, Carter R, Sinclair C, Mihalopoulos C, Vos T. Economic evaluation of skin cancer prevention in Australia. Prev Med 2009; 49(5): 449 –53
Please follow and like us: